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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
Table 4. Methods
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 |