Diabetes Research

Open journal

ISSN 2379-6375

Can Weight Bearing Aerobic Exercise be Done Safely with an Active Diabetic Plantar Foot Ulcer and Can It Improve Healing Time

Catherine Fall*

Catherine Fall, BSc (HONS) [Student]

Salford University, Manchester, UK; E-mail: C.Fall1@edu.salford.ac.ukv

INTRODUCTION

The diabetic foot (DF) is one of the most feared complications of diabetes due to its devastating effects; caused by a combination of diabetic neuropathy (DN) and peripheral arterial disease (PAD) which results in diabetic foot ulcers (DFU’s), critical ischemia, and infection.1 The economic burden of the DF on the National Health Service (NHS) in the UK is rising, with an estimated expenditure of over £837 million being cost on ulcer treatment and amputation during 2014-20152 to nearly one billion in 2022.3

DFU’s are one of the leading causes of lower limb amputation (LLA) in the UK4 with up to 85% of amputations caused by diabetes preceded by a DFU.3 DFU’s often arise due to infrequent foot checks by specialist physicians5 and/or due to the symptoms of DF being hard to recognise by the patient due to sensory loss combined with being under educated on what to look out for at home during a personal foot check.6 Recurrence of DFU’s is common; Armstrong et al7 states that ‘around 40% of DFU patients have a recurrence within 1-year after ulcer healing, almost 60% within 3-years, and 65% within 5-years’ and Moulik et al8 categorises the reported 5-year mortality rate as 45%, 18% and 55% for neuropathic, neuroischemic and ischemic ulcers, respectively.

Many diabetics have vascular complications and comorbidities9 and in general lead sedentary lives, which leads to the worsening of these co-morbidities.10 Research on the benefits of aerobic exercise on the vascular system in diabetics is vast with many studies indicating a reduced mortality rate and improved quality of life from exercising.11 However, research on the benefits of aerobic exercise on diabetics with active DFU’s is slim, making it difficult to assess whether aerobic exercise can be done safely in these patients. The general guidelines from the International Working Group on the DF is to offload the foot and make weight bearing minimal whilst recovering from a DFU12 but this therefore worsens the sedentary behaviour and contributes to the already bleak outcome of having a DFU,10 with between 15-20% of patients with DFU getting worse, leading to amputation.1 Staggeringly, 70% of people with DFU’s die within 10-years, with most of these deaths being vascular related.13

Study Selection

A total of 22 studies were found with keywords “active foot ulcer” AND “aerobic physical activity” AND “diabetic ulcer healing” via search databases PubMed, Elsevier, Academia and ResearchGate. After careful deselection of studies lasting less than 10-weeks and those that exclude PAD; 5 papers were included in the review (Table 1) (Appendix Table 2).

Table 1. Papers in Question

Author

Title
Lindberg et al18

An exercise program for people with severe peripheral neuropathy and diabetic foot ulcers – a case series on feasibility and safety.

Nwankwo et al16

Effect of Twelve Weeks Supervised Aerobic Exercise on Ulcer Healing and Changes in Selected Biomechanical Profiles of Diabetic Foot Ulcer Subjects.
Nwankwo et al17

Effect of Twelve Weeks Supervised Aerobic Exercise on Ulcer Healing and Changes in Selected Biomechanical Profiles of Diabetic Foot Ulcer Subjects.

LeMaster et al15

Effect of Weight-Bearing Activity on Foot Ulcer Incidence in People With Diabetic Peripheral Neuropathy: Feet Frist Randomized Controlled Trial.
Suryani et al14

Effect of foot-ankle flexibility and resistance exercise in the secondary prevention of plantar foot diabetic ulcer.

 

CRITIQUE OF THE LITERATURE

Participants

Suryani et al,14 LeMasters et al15 and Nwankwo et al16,17 included between 50-80 mixed gender participants split into an invention group and control, whereas Lindberg et al18 only included 5 male participants with no control. Holdcroft19 found that studies with mixed gender have been shown to be more accurate and states that ‘research funding for coronary artery disease in men is far greater than for women, yet the at-risk population of women, which is an older age group, suffers more morbidity and mortality’. Suryani et al14 and LeMasters et al15 used randomised selection methods but Nwankwo used own clinical judgement to recommend the participants, which has proven to increase bias.20

Age was slightly lower in the Suryani et al14 study with an average of 55-years, compared to other papers average of between 65-69-years, which coincides with the average age of most diabetes patients in the UK today.21 Lower age at disease onset correlated with participants having the longest duration of diabetes. Nwankwo’s et al16,17 average duration was considerably higher than other papers at 21.77-years. Song22 found that duration of diabetes has been shown to be an indicator of progression of diabetic comorbidities with ‘stroke and peripheral vascular disease levels becoming significantly higher in type 2 diabetics (T2D) after 20-years duration’ and Brownrigg et al23 found that increased peripheral vascular disease has a diminishing effect on the rate of healing.

Lindberg’s et al18 participants had a prevalence of 80% T2D, whereas LeMaster et al15 had T2 prevalence of 95% in the experimental group and 93.5% in both groups. Sunyani only included T2D and Nwankwo et al16,17 failed to mention which type the participants were. T2D is more heavily associated with obesity and peripheral vascular disease than T1, therefore excess plantar pressures and dyslipidaemia may be more prevalent in this study.24,25 However, recent findings are suggesting that obesity is a major predictor of T1D in children due to the ‘accelerator hypothesis’ by Wilkins.26

Body mass index (BMI) was higher for participants in LeMasters15 study, with an average BMI of 36.55 (SD), putting these patients in the obese class 2 category.27 Obesity has been proven to delay healing time due to vasculogenic impairment.28 In the experimental groups, Lindberg’s et al18 average BMI was 28.7 and Nwankwo’s et al16,17 27.66 but Nwankwo’s et al16,17 non-experimental group was 22.96, indicating a significant difference amongst the control and intervention group in this study. BMI was slightly lower in Suryani’s et al14 at 24.5, putting this group of participants in normal BMI range.27

Blood pressure (BP) allowance to participate in the exercise programmes also differed, whereby Lindberg et al18 did not signify the systolic/diastolic value but referred to advice from the responsible physician. However, Nwankwo’s et al16,17 systolic inclusion value was < 165 mmHg and LeMasters et al15< 200 mmHg to take part; this is a significant difference and above the recommended BP value of< 180/110 mmHg for completing light-moderate exercise in which no further evaluation is needed.29

Lindberg et al18 had a 60% non-smoker statistic, LeMasters et al15 had a 95% non-smoker statistic in the intervention group and a 91% accumulative percentage including control, but Nwankwo et al16,17  and Suryani et al14 failed to identify which participants were smokers. Smoking increases the risk of diabetic foot amputation and is the leading cause of PAD (Appendix Table 3).30

Method

All papers were randomized controlled trials (RCT) apart from Lindberg’ et al18 which was a research paper. RCT’s have been proven to be more accurate than research papers.31 Duration of exercise programmes ranged from 10-weeks to 12-months. Lindberg et al18 LeMaster et al15 and Suryani et al14 were mixed aerobic and resistance-based, whereas Nwankwo et al16,17  solely aerobic. A mixture of aerobic/resistance exercise has been proven to have more benefits on the cardiovascular system and overall fitness than one category alone.32

Lindberg et al18 and Nwankwo et al16,17  were fully supervised trials, whereas LeMaster et al15 was supervised for only the first 3-months and thereafter home based. Suryani et al14 was entirely home based with tri-weekly monitoring over the phone and exercises recorded in a logbook. Regular monitoring improves adherence and inaccuracy’s have been found when recording home exercise diaries.11 Adherence has been noticeably poor in diabetics when asked to exercise, supervision has been known to increase adherence and enhance the benefits of an exercise programme.33

Sessions during Lindberg’s et al18 study were not progressive and there was no pre-scheduled programme with an aim to encourage self-management and improve adherence, therefore it is impossible to determine the number of sessions each individual patient took part in per week. The study included a patient satisfaction survey form report (PSSF) but no motivational interviewing or counselling. Counselling and motivational interviewing have proven to improve patient adherence to exercise.34 Patients wore a removable air cast walker or orthopaedic shoe, completed 12-minute cardiovascular exercise plus light-moderate elastic band resistance exercises but many sessions were not completed due to adherence issues. Ulcer wound was evaluated by Wilcoxon Signed Ranks test, but the study did not mention if the wound was evaluated during the programme or just pre and post programme.

Nwankwo et al16,17  included counselling in a structured, progressive exercise programme. A systematic review by Irvine et al35 showed that progressive exercise programmes help increase adherence, motivation and reduce pain amongst diabetics. Variation in a programme can also have great purpose in motivating the participant.36 Nwankwo’s et al16,17  experimental group wounds were checked bi-weekly by the nurse, measured with a transparent ruler. Regular checks from the diabetic nurse improve patient ulcer outcome rates.37

LeMaster et al15 was the only full weight bearing walking programme that included at home daily living activity monitoring via accelerometer at 3, 6 and 12-month intervals. The patients performed 3×30 minute aerobic sessions per week in orthotic prescribed footwear, steps were recorded via pedometer throughout. The type of terrain the exercise was performed on was not mentioned. Even with the correct shoes, different terrain can cause sheer stresses and pressure38 and although patients had access to an ongoing dermatologist if needed, they self-managed footcare at home. Home examinations have proven poor in diabetic patients due to being uneducated on what to recognise as potential harm.6

Statistics amongst all papers were analysed to a p<0.05 significance using statistical package for social sciences (SPSS) or statistical analysis system (SAS) software. SPSS has been found to be more commonly used amongst RCT’s, with over 52.1% of studies using this software. However, SAS can be more useful for comparison graphs but can be time consuming (Appendix Table 4).39

Results

Lindberg showed that no DFU’s worsened during the programme, proving safety and feasibility towards this variable. However, there were many adverse events with delayed onset muscle soreness (DOMS) being reported in 3 out of 5 participants. DOMS is partly due to a build-up of lactic acid accumulating when tissues become oxygen deprived during exercise,40 which can be detrimental to diabetics because of their risk of lactic acidosis, often due to taking the popular medication metformin.41 Progression of the programme was halted amongst individuals suffering from DOMS. However, patient satisfaction survey scores (PSSF) and performing daily living activities improved following the programme which is highly beneficial in a diabetic patient who is depressed due to pain.42 One patient’s ulcer increased in size during a holiday where he was walking regularly, highlighting that weight bearing may increase ulcer size.

Nwankwo et al16proved at 12-weeks there was a reduction in fasting plasma glucose. Exercise has shown to reduce fasting glucose levels in diabetics, decreasing the risk of cardiovascular disease.11 Wound size percentage reduction was larger in the intervention group, however there was a large difference between baseline wound size in both groups, whereby the experimental groups size was 26.45+9.46 mm and the control 17.70+7.23 mm, indicating that results may be influenced by this. There was no difference in cholesterol levels at 12-weeks.

Nwankwo et al17 showed an increase in SPO2 in both groups, with greater increase in experimental group than the control. In the experimental group, ankle brachial index (ABI) levels also increased, wound size decreased with no correlation to BMI after 4-weeks but had a large connection to BMI level at 12-weeks, indicating that BMI is a large indicator in the duration of ulcers.23 However, there was no correlation between BMI, wound size and SPO2 in the control group.

LeMaster et al15 suggested there was no additional risk in weight bearing exercise on DFU’s in diabetics with DN. However, although he proved that there was no additional risk in plantar only ulcers, there was a significant increase in other types of lesions in the intervention group. Lesions on the dorsal toes or other areas of lower limb are associated with poor outcome in diabetics due to infection.43 Healing time was slower in the intervention group indicating that weight bearing exercise may have an adverse outcome on healing. Step count increased in the intervention group for the first 6-months but not in the control, however, both groups’ steps declined by 12-months, indicating a poorer adherence rate as time went on.

Suryani et al14 proved there was less reoccurrence of ulcers overall in the intervention group but on the contrary to Nwankwo et al16,17  ABI levels did not significantly improve. However, DN scores decreased in the intervention group and walking speed increased, even after 24-weeks, indicating that improved strength/ flexibility has an influence on walking speed.44 HBA1C remained unchanged after this study correlating with Nwanko’s et al16,17  study (Appendix Table 5).

Discussion

The level of bias in Nwankwo’s et al16,17  study was high, ulcer size was higher in the intervention group at baseline than the control, leading to obscured results. Suryani et al14 was less biased, with even parameters, making for a more viable outcome20 but only included seated exercises therefore less pressure was applied to the foot. Lindberg et al18 had no comparison control group and adherence was poor, therefore making conclusions on the relevance of the study is difficult. LeMasters et al15 ulcer healing time and non-plantar lesions were much greater in the intervention group than the control, indicating that weight bearing exercise on diabetic patients with DN is perhaps not the best intervention to reduce diabetic complications.

Outcome measures varied amongst these papers with no identical testing strategies or assessments. However, it is acceptable to predict that Hemoglobin A1C (HBA1C) is not a viable assessment tool due to it remaining unchanged in 2 of the studies. HBA1C is a percentage of glucose levels over an 8-12-week time frame,45 therefore changes in HBA1C level may not have changed for up to 3-months following an exercise programme. There was a contradiction between ABI measurement significance, however Nwankwo et al16,17  devised a more aerobic programme, which may indicate that aerobic exercise has a more significant effect on ABI measures than resistance-based exercise such as Suryani’s et al14 programme. These papers did not indicate smoking status, smoking alone is a major cause of PAD which can lower ABI levels. Smoking also influences a person’s ability to reach maximal cardiovascular benefits through hypercoagulation and respiratory distress.46 Cholesterol levels may also be influenced by this; therefore, cholesterol may still be a viable tool in assessing the benefits of a short-term 12-week exercise programme.47

A raised BMI is a huge indicator in recurrence of DFUs23 and aerobic exercise can decrease BMI. Flexibility exercises can improve cutaneous perfusion response.48 Resistance exercises can improve neuropathy sensation,14 which in turn increases balance, walking stability44 and may also increase healing.23

Based on this review it is fair to say that non-weight bearing or semi-weight bearing exercise in the presence of DFU alongside severe DN is safer and more feasible in the aim to try and stop the regression of diabetic complications. It has not been concluded whether aerobic exercise improves ulcer healing time.

The purpose is to devise a safe and feasible aerobic/resistance exercise programme for diabetics with an active plantar DFU associated with PN and/or mild to moderate ischemia, to increase healing time, improve cardiovascular health and ultimately reduce amputation/mortality rates. The proposal aims to increase adherence and sustainability of exercise by not exhausting participants interest and keeping participants motivated, in the hope of improving quality of life and encouraging better lifestyle choices following the programme.

The study will be a RCT, comprised of a 12-week exercise programme which will be individually tailored to the patient including two types of semi weight bearing aerobic methods alongside a variety of non-weight bearing resistance exercises to keep the participants engaged. Patients with mild-moderate PAD will be allowed to participate, on the contrary to other related studies whereby PAD is amongst the exclusion criteria,49,50 in a bid to improve patient’s circulation and oxygenise lower extremities. The programme will be gradually progressive to avoid any adverse effects caused by excess pressure which can be predicted under the physical stress theory51 which will avoid any extreme muscular fatigue following exercise.

Background and Significance

Statistics by Mottolini3 report that ‘7957 major diabetic LLA were reported in England between 2017-2020’. Prognosis is poor for diabetics with PAD who have undergone first minor amputation, with 23% of patients undergoing subsequent major amputation approximately 1-year later.52 Quality of life following this loss is reduced markedly.53 Aerobic exercise can decrease the devastating effects of cardiovascular associated problems in diabetics, lower glucose levels54 and improve quality of life, which is of the upmost importance as 1 in 4 of the diabetic population suffer from depression.55 Recent studies on diabetic ulcers, using near infrared spectroscopy show that peripheral HbO2 and total Hb levels are increased following resistance-based exercise resulting in reduced ischemia.56 However, there are few studies on aerobic combined with resistance-based exercise amongst patients with an active DFU.

The current guidelines on treatment of an active DFU are to offload the foot, reducing weight bearing activity to a minimum for the ulcer to heal.12 However, being more sedentary worsens PAD, raises HBA1C levels and increases BMI, which has a negative effect on healing.23 It seems that a greater amount of time is spent on treating the DF, rather than preventing the co-morbidities. For patients with stable ischemic heart disease, exercise programmes are currently prescribed; Boden et al57 has shown that these programmes ‘reduce total mortality by 20%, cardiac mortality by 26%, and non-fatal myocardial infarction by 21%’, yet there is no current exercise prescription in place for diabetics when they share many of the same problems.

RESEARCH DESIGN

Participants

Participants are to give written informed consent and the study is to be approved by Manchester University Foundation Trust and Ethical approval given by the NHS research Ethics Committee (REC). Thirty (30) participants, 15 male, 15 female with T2D, active plantar DFU will be recruited to the study from the Peter Mount, Manchester Royal Infirmary Diabetes and Endocrine clinic. Prior to the trial, the participants will be signed off by their primary physician and randomized using simple randomisation software into an evenly split intervention group/control group. The intervention group will take part in the exercise programme whereas the control group will continue to have the usual wound care from the diabetic clinic (Appendix Table 6).

Pre-programme Assessments

Participants will complete a pre activity level form, however due to the progressive nature of the programme – any level of pre activity will be accepted. Participants will be asked to record their morning resting heart rate before rising on 3 consecutive days before the study begins to determine mean resting heart rate, from this maximum heart rate and heart rate reserve levels will be calculated via the Karvonen method,58 giving an indicator of patient’s fitness level. Workload will be set to 40-60% HRR to avoid patients undertaking physical exercise challenges that cannot be achieved wearing a removable cast walker such as the Astrand cycle test18 and follows the recommended cardiovascular guidelines of moderate exercise for diabetes with PAD complications (Appendix Table 7).59

Method

The programme will be fully supervised by Register for Exercise Professionals (REPs) Level 4 Advanced Exercise Trainer at the rehabilitation gym at Manchester Royal Infirmary (MRI). The trainer will provide monthly motivational interviewing. A band 7 diabetic nurse will complete foot checks biweekly. A band 5 Orthotist will prescribe new diabetic footwear for the participant once ulcer heals and will monitor removable walker’s condition.

Baseline, 6 and 12-weekly assessments include transparent ruler measurement, toe brachial pressure index (TBPI) toe pressures, SPo2, ABI, fasting blood glucose (FBG), blood cholesterol levels, Semmes monofilament test, BP, BMI. A polar heart rate monitor will be worn during exercise. Adverse events will be recorded. 2222 will be phoned for emergency care. An ankle pedometer will be worn by both groups to monitor steps at home to provide comparisons on activity levels and determine any correlation between higher activity/ulcer healing times outside of the programme. Whilst at home the guidelines on offloading devices will be advised.60 Results will be statistical analysed by SPSS version 28 with an accuracy of p<0.05 (Appendix Tables 8 and 9).

Limitations and Difficulties

Claudication may occur because of ischemia; breaks need to be taken and exercise restarted once pain subsides. Patient needs to be reassured that the pain experienced is not dangerous and the pain should subside further into the programme as fitness level improves.61 Hypoglycaemia should be managed appropriately with juice and snacks onsite if symptoms do occur. However, pre-exercise blood sugar checks will be taken prior to exercise; if levels are below 90 mg/dL, guidelines by Zaharieva et al62 will be followed (Appendix Table 1).

Adherence to the participant wearing the removable walker at home may be a problem, with patients choosing not to wear their walkers. However, the motivational interviewing is to encourage participants to follow the guidelines because removable walkers have a better outcome on healing when used appropriately.60

BUDGET AND JUSTIFICATION

Budget and Justification (Appendix Table 10). Total expenditure is £29413.09. However, costs of treatment/amputation are reaching nearly £1billion.3 Preventing the cause will be more cost effective in the long run.

FUNDING

The author received no financial support for the research and authorship of this research article and proposal.

DECLARATION OF CONFLICT OF INTEREST

The author declares that there are no potential conflicts of interest with respect to the research and authorship of this article. If the proposal is to be undertaken as a study, it would need permission from the Manchester Foundation Trust and would need ethical approval from the Health Research Authority’s (HSA) NHS RECS.

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54. Qui S, Cai X, Schumann U, Velders M, Sun Z, Steinacker JM. Impact of walking on glycemic control and other cardiovascular risk factors in type 2 diabetes: A meta-analysis. PLoS One. 2014; 9(10): e109767. doi: 10.1371/journal.pone.0109767

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56. Chen ML, Lin B-S, Su CW, et al. The application of wireless near infrared spectroscopy on detecting peripheral circulation in patients with diabetes foot ulcer when doing Buerger’s exercise. Lasers Surg Med. 2017; 49: 652-657. doi: 10.1002/lsm.22667

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58. Ignaszewski M, Lau B, Wong S, Isserow S. The science of exercise prescription: Martti Karvonen and his contributions. BC Medical Journal. 2017; 59(1): 38-41.

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APPENDICES

Table 1. Carbohydrate Intake Strategies Based on Pre-Exercise Blood Glucose Level62
Pre-Exercise Blood Glucose Concentration Author Requirements
< 90 mg/dL Ingest 15-30 g of fast-acting carbohydrates before the onset of exercise, depending on the size of the individual. Follow with extra carbs throughout exercise.
90-149 mg/dL Start consuming extra carbs at the onset of exercise (~0.5-1.0 g/kg body mass/hour of exercise), depending on the energy expenditure and the amount of circulating insulin at the time of exercise
150-249 mg/dL Initiate exercise and delay consumption of extra carbs until blood glucose levels drop to< 150 mg/dL
250-349 mg/dL Test for ketones: do not perform any exercise if moderate amounts of ketones are present58; contact your health care team. Initiate mild- to moderate-intensity exercise. Intense exercise should be delayed until glucose levels drop to< 250 mg/dL because intense exercise may exaggerate the huperglycemia.
≥350 mg/dL Test for ketones: do not perform any exercise if moderate to large amounts of ketones are present58; contact your health care team. If ketones are negative (or trace), consider conservative insulin correction (e. g., 50% correction) before exercise, depending on current “on board” (active) insulin status. Initiate mild to moderate exercise and avoid intense exercise (aerobic of anaerobic) until glucose levels drop
Blood glucose concentrations should always be checked before exercise, and if glucose is dramatically elevated (≥350 mg/dL), the urine or blood should also be tested for ketones. The target range for blood glucose before exercise is 90-250 mg/dL. Carbohydrate intake should depend on the glucose concentration at the start of exercise. Regardless of their initial blood glucose concentration, patients should continue to monitor blood glucose regularly during exercise (every 30-45-minutes) using an accurate glucose meter and to adjust insulin and carbohydrate intake accordingly. In general, adjusting insulin doses before exercise will reduce the need for increased carbohydrate intake. Adapted from Holt55, Ignaszewski et al58

 

Table 2. Study Selection
Study Selection Requirements
Population Human participants with type 1 or 2 diabetes with peripheral neuropathy and peripheral arterial disease and an active or recently healed plantar foot ulcer at time of study.
Intervention Aerobic exercise combined with resistance-based exercises or solely aerobic exercise programme lasting longer than 10 weeks in duration.
Outcomes Cardiorespiratory, glycaemic control, cholesterol and lipids, wound-healing, ankle brachial index, circulatory toe pressures, patient satisfaction scores.

 

Table 3. Participant Compatibles Nr*=Non-recorded

droj-9-157table3

Table 4. Methods

DROJ-9-157Table4

 

Table 5. Results
Authors Adverse Reactions Adherence Results
Lindberg et al18 1 participant suffered from frozen shoulder pain and needed breaks.
3 out of 5 participants suffered from DOMS which compromised programme.
2 participants had extubate of ulcer.
2 participants had habitual back pain.
All patients completed programme – 92% average attendance. At 10 weeks
• 3 of 5 ulcers had healed and all had decreased in size.
• Ability to complete daily living activities improved.
• NRS score median 10.
• Patient satisfaction score had improved.
• All muscle groups had improved strength, mostly in hip abduction.

• Tandem and HBA1c inconclusive.

Nwankwo et al16 No participants absconded or died At 12 weeks
• Decrease in fasting plasma glucose in experimental group.
• No difference in total cholesterol blood levels.
• Wound size percentage reduction larger in experimental group
Nwankwo et al17 No participants absconded or died At 12 weeks
• Increase in SPO2 in both groups but more in experimental group.
• Increase in ABI in experimental group.
• Wound size reduction with no correlation to BMI after 4-weeks in experimental group.5
• Wound size reduction at 12 weeks in experimental group with a connection to BMI.
• In control group no connection between BMI, wound size and SPO2 .
LeMaster et al15 57 lesions detected in total.

4 ulcers in intervention group >1cmsq
1 ulcer in control group >1cmsq
Average duration of ulcer in intervention–74 days
Average duration of ulcer in control – 51.5 days.
1 participant suffered proximal phalangeal great toe fracture due to osteoporosis

1 person died from unrelated cause

Average sessions during first 6 months in intervention group – 3×per week. Average sessions during first 6 months in control – 1.5-days per week.
At 12-months average sessions per well for both groups was 1.5 sessions.

At 6 months
• Steps increased during 30-minute sessions by 14% in intervention group.
• Overall steps increased by 2.5% in intervention group.
• Overall steps decreased by 6% in control group.
At 12 months
• Steps decreased between 6-12 months for intervention groups during 30-minute exercise and overall daily steps.
• Overall steps decreased for control group.
Suryani et al14 6 participants did not complete programme.
No participants died.
According to logbook, very good

compliance in the intervention group

At 12 weeks
• Ulcers in 2 patients (4%) in intervention group.
• Ulcers in 17 patients (68%) in control group.
• DNE decreased in intervention group. • Walking speed increased in intervention group.
• HBA1C level unchanged in both groups.
• ABI no significant difference in both groups but did increase gradually in intervention group.

At 24 weeks

• Ulcers in 4 patients (16%) in intervention group.
• Ulcers in 17 patients (72%) in control group.
• DNE decreased in intervention group.
• Walking speed increased in intervention group.
• ABI no significant difference in both groups but did increase gradually in intervention group.

Table 6. Participant Criteria

Inclusion Criteria

Exclusion Criteria

Aged 40-70-years
Male or Female
Non-smoking status
Diagnosed peripheral neuropathy
Mild to Moderate Ischemia (ABI levels 0.6 hmm and above combined with TBPA toe

 

pressure of 40-59 hmm12

 

Controlled blood pressure< 180/110 mmHg29

Active plantar foot ulcer classification of grade 2 or below on the Wagner scale

 

Infection level of< 1 and below12

Cognitive function will be predicted to be sufficient by their primary physician based

 

on MiniCog assessment tool63

Patients wear a removable offloading walker on the affected foot

 

ABI, < 0.6, toe pressure, 40 hmm
Presence of gangrene, osteomyelitis, serious illness. Wagner score >2

Infection level >112
Unstable blood pressure or BP >180/11 mmHg

 

Unstable cardiovascular angina64 Cognitive function predicted to be insufficient based on Mini Cog assessment tool by primary their primary physician.

Table 7. Participant Criteria
Karvonen Example Method
(220)-(your age)=MaxHR (MaxHR)-(mean resting heart rate)=HRR (HRR)x(60% to 80%)=training range % (Training range %)+(mean resting heart rate)=(target training zone)

 

Table 8. Outcome Measures
Baseline 6-Weeks 12-Weeks
Pre-activity level questionnaire
Semmes monofilament test
SPO2 levels
TBPI toe pressures
ABI levels
Blood Pressure
Height
Weight
BMI
Wound size–transparent ruler Fasting blood glucose
Blood cholesterol
Removable walker check
Patient Satisfaction Survey
Semmes monofilament test

SPO2 levels

TBPI toe pressures

ABI levels

Blood Pressure

Height

Weight

BMI

Wound size – transparent ruler Fasting blood glucose

Blood cholesterol
Removable walker check

Patient Satisfaction Survey Semmes monofilament test SPO2 levels

TBPI toe pressures
ABI levels
Blood Pressure
Height
Weight
BMI
Wound size – transparent ruler
Fasting blood glucose
Blood cholesterol Removable walker check

 

Table 9. Programme Timetable to be Provided by the Physician
  Monday Tuesday Wednesday Thursday Friday Saturday Sunday
Week 1 2 minute warm up – 20-30% HRR
5 mins rowing – 30-40% HRR
2×30 reps –
Leg extension
Hamstring curl
Adductor
Abductor
* Stretching programme
2 minute warm up – 20-30% HRR 5 mins cycling – 30-40% HRR
2×30 reps –
Chest press Shoulder
press
Abdominal crunch

*Stretching programme

2 min warm up -20-30% HRR
8 mins rowing – 30-40% HRR
*Stretching programme
Week 2 2 minute warm up – 20-30% HRR
8 mins cycling – 30-40% HRR
2×30 reps –
Leg extension
Hamstring curl
Adductor
Abductor
*Stretching programme
2 minute warm up –20-30% HRR
10 mins rowing – 30-40% HRR
2×30 reps –
Chest press
Shoulder press
Abdominal crunch
*Stretching programme
2 minute warm up – 20-30% HRR
10 mins cycling -30-40% HRR
Diabetic nurse review and

motivational interviewing
*Stretching programme

Week 3 3 minute warm up – 30-40% HRR
10 mins rowing – 40-50% HRR
2×30 reps –
Leg extension
Hamstring curl
Adductor
Abductor
*Stretching programme
3 minute warm up –30-40% HRR
10 mins cycling – 40-50% HRR
2×30 reps –
Chest press
Shoulder press
Abdominal crunch
*Stretching programme
3 minute warm up – 30-40% HRR

12 mins rowing 40-50% HRR

*Stretching programme

Week 4 3 minute warm up – 30-40% HRR
12 mins cycle 40-50% HRR
2×30 reps –
Leg extension
Hamstring curl
Adductor
Abductor
*Stretching programme
3 minute warm up – 30-40% HRR
15 mins rowing – 40-50% HRR
2×30 reps
Chest press
Shoulder press
Abdominal crunch
*Stretching programme
3 minute warm up – 30-40% HRR

15 mins cycling – 40-50% HRR

Diabetic nurse review

*Stretching programme

Week 5 4 minute warm up
30-40% HRR
18 mins rowing – 40-50% HRR
2×15 reps
Leg extension
Hamstring curl
Adductor
Abductor
Chest press
Shoulder press
Abdominal crunch
*Stretching programme
4 minute warm up
30-40% HRR
18 mins cycling – 40-50% HRR
2×15 reps
Leg extension
Hamstring curl
Adductor
Abductor
Chest press
Shoulder press
Abdominal crunch
*Stretching programme
4 minute warm up 30-40% HRR 18 mins rowing 40-50% HRR
*Stretching programme
Week 6 4 minute warm up
30-40% HRR
20 mins cycling – 40-50% HRR
2×15 reps
Leg extension
Hamstring curl
Adductor
Abductor
Chest press
Shoulder press
Abdominal crunch
*Stretching programme
4 minute warm up
30-40% HRR
20 mins rowing – 40-50% HRR
2×15 reps
Leg extension
Hamstring curl
Adductor
Abductor
Chest press
Shoulder press
Abdominal crunch
*Stretching programme
4 minute warm up 30-40% HRR 20 mins cycling 40-50% HRR
*Stretching programme

Diabetic nurse review and motivational interviewing
Assessments

Week 7 5 minute warm up
30-40% HRR
20 mins rowing – 40-60% HRR
2×15 reps
Leg extension
Hamstring curl
Adductor
Abductor
Chest press
Shoulder press
Abdominal crunch
*Stretching programme
5 minute warm up
30-40% HRR
20 mins cycling – 40-60% HRR
2×15 reps
Leg extension
Hamstring curl
Adductor
Abductor
Chest press
Shoulder press
Abdominal crunch
*Stretching programme
5 minute warm up 30-40% HRR 20 mins rowing 40-60% HRR
*Stretching programme
Week 8 5 minute warm up
30-40% HRR
22 mins cycling – 40-60% HRR
2×15 reps
Leg extension
Hamstring curl
Adductor
Abductor
Chest press
Shoulder press
Abdominal crunch
*Stretching programme
5 minute warm up
30-40% HRR
22 mins rowing – 40-60% HRR
2×15 reps
Leg extension
Hamstring curl
Adductor
Abductor
Chest press
Shoulder press
Abdominal crunch
*Stretching programme
5 minute warm up 30-40% HRR 22 mins cycling 40-60% HRR Diabetic nurse review
*Stretching programme
Week 9 5 minute warm up
30-40% HRR
25 mins rowing – 40-60% HRR
2×12 reps
Leg extension

Hamstring curl
Adductor
Abductor
Chest press
Shoulder press
Abdominal crunch
*Stretching programme

5 minute warm up
30-40% HRR

25 mins cycling – 40-60% HRR
2×12 reps
Leg extension
Hamstring curl
Adductor
Abductor
Chest press
Shoulder press
Abdominal crunch
*Stretching programme

5 minute warm up 30-40% HRR 25 mins rowing 40-60% HRR
*Stretching programme
Week 10 5 minute warm up
30-40% HRR
28 mins cycling – 40-60% HRR
2×12 reps
Leg extension
Hamstring curl
Adductor
Abductor
Chest press
Shoulder press
Abdominal crunch
*Stretching programme
5 minute warm up
30-40% HRR
28 mins rowing – 40-60% HRR
2×12 reps
Leg extension
Hamstring curl
Adductor
Abductor
Chest press
Shoulder press
Abdominal crunch
*Stretching programme
5 minute warm up 30-40% HRR 28 mins cycling 40-60% HRR Diabetic nurse review and motivational interviewing
*Stretching programme
Week 11 5 minute warm up
30-40% HRR
30 mins rowing – 40-60% HRR
2×12 reps
Leg extension
Hamstring curl
Adductor
Abductor
Chest press
Shoulder press
Abdominal crunch
*Stretching programme
5 minute warm up
30-40% HRR
30 mins cycling – 40-60% HRR
2×12 reps
Leg extension
Hamstring curl
Adductor
Abductor
Chest press
Shoulder press
Abdominal crunch
*Stretching programme
5 minute warm up 30-40% HRR 30 mins rowing 40-60% HRR
*Stretching programme
Week 12 5 mins warm up
30-50% HRR
30 mins cycling – 50-60% HRR
2×12 reps
Leg extension
Hamstring curl
Adductor
Abductor
Chest press
Shoulder press
Abdominal crunch
*Stretching programme
5 minute warm up
30-50% HRR
30 mins rowing – 50-60% HRR
2×12 reps
Leg extension
Hamstring curl
Adductor
Abductor
Chest press
Shoulder press
Abdominal crunch
*Stretching programme
5 mins warm up 30-50% HRR 30 mins cycling 50-60% HRR
*Stretching programme Diabetic nurse review Assessments
HRR=Heart Rate Reserve
* Stretching programme – sat on exercise mat, hold each stretch for 30 seconds, repeat on both sidesx2.
Seated hamstring stretch, seated inner thigh stretch, kneeling quadricep stretch, kneeling hip flexor stretch, seated triceps stretch, seated deltoid stretch

 

Table 10. Budget and Justification
Personnel Hours/ Amount Cost
Level 4 Advanced Exercise Trainer 139.5 hours at £25 £3487.50
Band 5 Orthotist plus allowance for prescribed diabetic shoes 19 hours at £11.23 £213.37
Band 7 Diabetic nurse/ wound specialist 50 hours at £16.83 £841.50
Researcher
Band 2 Porter to transport pa-tients around hospital 150 hours at £8.61 £1291.50
Rehabilitation Gym Hire
To be included in clinic hire costs:
Recumbent bike
Rowing machine
Leg press machine
Hamstring curl machine
Abdominal crunch machine
Chest Press machine
Shoulder press machine
Exercise mats
Stadiometer
Digital weighing scales
144 hours at £50 £5400.00
Diabetic Clinic room 7-days estimated costs at £200 £1400.00
Equipment Make/Model Cost
Handheld – 8mHz doppler in-strument Hi Dop Vascular Doppler with 8 MHz Probe  
SPO2 pulsometer MediSupplies Finger Pulse Oximeter MD300C2
10 g Monofilament instrument Bailey Retractable Monofila-ment 10 g
Glucometer/ Ketometer Glucomen Areo Glucometer and Ketometer
Glucose testing strips – 2×50 Glucomen – 2×50 at £14.29
Ketone testing strips – 2×10 Glucomen – 2×10 at £14.29
Cholesterol meter GlucoRx X6 Multi Parameter Meter
Cholesterol strips GlucoRx X6 Total Cholester-ol Testing Strips 10×10 at £29.95
Polar heart rate monitor chest strap Polar H10 H HR Sensor BLE BLK M-XXLx5 at £66
Transparent wound ruler McKesson Wound measuring guide 5×7 inch clear plastic disposable–100 packx2 at £10.99
Blood Pressure machine Reister RBP–100 Blood Pressure Monitor Mobile De-vice
Lenovo Yoga Laptop 7 Pro X 14.5 inch slim
SPSS software (version 28) 6 months subscription
Sphygmomanometry Atys SysToe
Pedometer Besportable 3D Digital Pe-dometer–30x£13.59
Stopwatch Kalenji Onstart 110 Stop-watch
Supplies Amount Cost
Water from water machine
Glucogel 3xtubes
Carbohydrate snacks
Apple juice
Paper towels
Disinfectant
Logbook to document adverse events and attendance rates
Pens
Print out of exercise programme
Estimate allowance of £200.00
Travel Hours/ Amount Cost
Patient travel allowance – ambulance or taxi collection and drop off up to 5 miles distance from hospital Allowance of £15 per person per day £9000.00
Total cost: £27079.54
Total cost adding 40% margin
to staff costs: £29413.09

 

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