Feasibility and Acceptability of Non Weight-bearing Physical Activity for People With Diabetic Foot Ulceration

Study Overview
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Brief Summary
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Intervention in the form of a PA (physical activity) program combining aerobic, resistance, and flexibility exercises adapted for wearing a lower limb offloading device and limiting weight-bearing on the feet, with a duration of twelve (12) weeks, consisting of two supervised sessions and one unsupervised home session per week.

Detailed Description
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Objectives: Evaluate the acceptability of a non-weight bearing physical activity (PA) program; Assess the feasibility of the PA program and the data collection procedure; Evaluate the feasibility of a submaximal exercise test for cardiorespiratory capacity; and Verify the sensitivity of dependent variables to respond to a physical activity program (e.g., cardiorespiratory capacity, cardiovascular and metabolic risk factors, quality of life, PA level). Type of study: Feasibility and acceptability study with a pre-post evaluative design. Intervention: Intervention in the form of a PA (physical activity) program combining aerobic, resistance, and flexibility exercises adapted for wearing a lower limb offloading device and limiting weight-bearing on the feet, with a duration of twelve (12) weeks, consisting of two supervised sessions and one unsupervised home session per week. Subjects: 10-12 persons with an active diabetic foot ulcer 2-3 kinesiologists Data collection: Sociodemographic and health questionnaire (age, sex, gender, marital status, education level, employment status, average annual family income, medical and health history, pharmacological and non-pharmacological treatments); Feasibility assessment: PA (physical activity) logbook including 1) the number of supervised and unsupervised sessions completed, 2) the duration of each session, 3) participation rate (number of patients recruited/number of eligible patients), 4) attrition rate (number of participants who completed the follow-ups/number of participants recruited), and 5) perceived facilitators and barriers; Acceptability assessment: 1) Treatment Acceptability and Preference (TAP) Questionnaire, seven to nine additional questions to assess the use of provided material resources and required safety checks (capillary blood glucose and wound inspection) and collection of participants' feedback, and 2) Client Satisfaction Questionnaire (CSQ-8); Assessment of the sensitivity of dependent variables to respond to the PA program*: 1) estimation of VO2max by a submaximal exercise test on a stationary bike (Aerobic Power Index submaximal exercise test), 2) average daily step count over seven days at the waist and in the offloading boot at times 0, 4, 8, and 12 weeks, 3) Global Physical Activity Questionnaire (GPAQ), 3) clinical examination (height, weight, body mass index, waist circumference, body fat percentage, blood pressure, resting heart rate, characteristics of the DFU and classification (SINBAD), 4) paraclinical examinations (venous blood glucose, glycated hemoglobin, lipid profile), 5) neuropathic pain questionnaire (DN4), 6) Epworth sleepiness scale, quality of life questionnaire (EQ-5D-5L), 7) questionnaire on motivation to practice PA. Health and safety parameter measurements: electrocardiogram, oxygen saturation, estimated glomerular filtration rate, urine albumin/creatinine ratio, complete blood count. Data collection at 24 and 36 weeks is also planned for participants who agree to be contacted after completing the 12-week PA program.

Official Title
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Feasibility and Acceptability Study of a Non Weight-bearing Physical Activity Program for People With Diabetic Foot Ulceration (DB ACTIV)

Conditions
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Diabetic Foot, Cardiopulmonary, Physical Inactivity

Intervention / Treatment
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* Behavioral: Non weight-bearing physical activity program


Participation Criteria
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Eligibility Criteria
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For individuals with a diabetic foot ulcer: Inclusion: Male or female Aged over 18 up to 75 years Willing to engage in PA (physical activity) Committed to following wound care recommendations to the best of their ability for the duration of the study Understand and read French. Exclusion: Uncontrolled DFU infection Use of a non-removable offloading modality (total contact cast) Uncontrolled hyperglycemia (HbA1c ≥ 10.0% or fasting blood glucose ≥ 16.0 mmol/L for ≥ 2 consecutive days) confirmed by blood sample results during the initial assessment or access to recent blood test results (within the last 3 months) or the log of home capillary blood glucose readings Participation in sports or regular intense physical activities (≥ 2 times per week) The following pre-existing heart problems: a cardiovascular event (myocardial infarction, heart surgery, etc.) in the last 3 months, unstable cardiovascular disease (uncontrolled hypertension, i.e., ≥ 160/90 mmHg, uncompensated heart failure, etc.), chest pain and exertional dyspnea and/or uninvestigated intermittent claudication Recent neurovascular problem (stroke, transient ischemic attack, etc.) in the last 3 months Health problem that the research team considers a contraindication to participating in the study Diabetes complication making moderate-intensity PA unsafe, such as untreated proliferative diabetic retinopathy or a sensitivity disorder to hypoglycemia, critical ischemia of one or both lower limbs. For kinesiologists: Inclusion: Have completed a bachelor's degree in kinesiology Understand, read, and speak French. Exclusion: None

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Feasibility and acceptability study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical activity<br>Adults 18 to 75 with an active diabetic foot ulcer | Behavioral: Non weight-bearing physical activity program<br>* 12-week duration, 2 supervised trainings/week, 1 unsupervised home-based training/week Aerobic, resistance and flexibility exercises<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of physical activity intervention | Physical activity logbook, number of sessions completed with higher number meaning a greater feasibility | At time 12 weeks | 
| Acceptability of physical activity intervention | Treatment Acceptability and Preference (TAP) Questionnaire, minimum score 0/maximum score 16 with higher score meaning a greater acceptability | At time 12 weeks | 
| Satisfaction towards physical activity intervention | Client Satisfaction Questionnaire (CSQ-8), minimum score 8/maximum score 32 with higher score meaning a higher satisfaction | At time 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimated VO2max | submaximal exercise test on a stationary bike (Aerobic Power Index submaximal exercise test), mL/kg/min | At times 0 and 12 weeks | 
| Average daily step count over seven days | At the waist and in the offloading boot using a FitBit Zip, number of steps | At times 0, 4, 8, and 12 weeks | 
| Physical activity level | Global Physical Activity Questionnaire (GPAQ), no minimum/maximum, details number of minutes/number of days per week of physical activity according to type of activity (work, leisures, commute, sedentary time) | At times 0 and 12 weeks | 
| Height | Standing with rigid measuring rod, cm | At time 0 | 
| Weight | Standing on beam balance scale, kg | At times 0 and 12 weeks | 
| Waist circumference | With flexible measuring tape above ombilic, cm | At times 0 and 12 weeks | 
| Body fat percentage | With bio-impedance balance, % | At times 0 and 12 weeks | 
| Arterial blood pressure | With automatic blood pressure monitor, mm Hg | At times 0 and 12 weeks | 
| Resting heart rate | With automatic blood pressure monitor, bpm | At times 0 and 12 weeks | 
| Wound measurements (width, length, depth) | With flexible ruler | At times 0, 4, 8 and 12 weeks | 
| Classification of the ulcer | Using SINBAD system, 6 categories graded 0 or 1 for a minimum of 0 and maximum of 6, with higher score meaning a more complicated ulcer | At times 0, 4, 8 and 12 weeks | 
| Non fasting venous blood glucose | With venipuncture, mmol/L | At times 0 and 12 weeks | 
| Glycated hemoglobin | With venipuncture, % | At times 0 and 12 weeks | 
| Lipid profile (total cholesterol, low density lipoprotein, high density lipoprotein, triglycerides, non-HDL cholesterol) | Venipuncture, g/L | At times 0 and 12 weeks | 
| Neuropathic pain (if present) | Neuropathic pain (DN4) Questionnaire, 10 yes/no questions, higher number of yes indicates more severe neuropathic pain | At times 0 and 12 weeks | 
| Sleep apnea symptoms | Epworth sleepiness scale, minimum score of 0/maximum score of 24, higher score makes sleep apnea more likely | At times 0 and 12 weeks | 
| Reported quality of life | Quality of life questionnaire (EQ-5D-5L), minimum score of 5/maximum of 25 + 10cm visual analog scale, higher score represents a lower quality of life + 10cm being the best health condition possible | At times 0 and 12 weeks | 
| Questionnaire on motivation to practice physical activity | With the Behavioural Regulation in Exercise revised Questionnaire (BREQ-2), 5 motivation categories graded from 0 to 4, Intrinsic (4 questions), Identified (3 questions), Introjected (3 questions), External (4 questions) and Amotivation (4 questions), with lower scores meaning lesser motivation for each category | At times 0 and 12 weeks |