An interventional study of Non weight-bearing physical activity program in Diabetic Foot, Cardiopulmonary and Physical Inactivity, sponsored by Université du Québec à Trois-Rivières. Completed at 1 site in Canada. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Université du Québec à Trois-Rivières · Not applicable, Interventional, and Treatment
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.
Objectives:
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:
Data collection:
Health and safety parameter measurements: electrocardiogram, oxygen saturation, estimated glomerular filtration rate, urine albumin/creatinine ratio, complete blood count.
1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's enrollment of 12 is below the median of 60 across 826 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →Université du Québec à Trois-Rivières is the lead sponsor of 40 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
For individuals with a diabetic foot ulcer:
Inclusion:
Exclusion:
For kinesiologists:
Inclusion:
Exclusion:
None
Adults 18 to 75 with an active diabetic foot ulcer
Behavioral: Non weight-bearing physical activity program
12-week duration, 2 supervised trainings/week, 1 unsupervised home-based training/week Aerobic, resistance and flexibility exercises
Feasibility of physical activity intervention
Physical activity logbook, number of sessions completed with higher number meaning a greater feasibility
Time frame: 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
Time frame: 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
Time frame: At time 12 weeks
Estimated VO2max
submaximal exercise test on a stationary bike (Aerobic Power Index submaximal exercise test), mL/kg/min
Time frame: 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
Time frame: 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)
Time frame: At times 0 and 12 weeks
Height
Standing with rigid measuring rod, cm
Time frame: At time 0
Weight
Standing on beam balance scale, kg
Time frame: At times 0 and 12 weeks
Waist circumference
With flexible measuring tape above ombilic, cm
Time frame: At times 0 and 12 weeks
Body fat percentage
With bio-impedance balance, %
Time frame: At times 0 and 12 weeks
Arterial blood pressure
With automatic blood pressure monitor, mm Hg
Time frame: At times 0 and 12 weeks
Resting heart rate
With automatic blood pressure monitor, bpm
Time frame: At times 0 and 12 weeks
Wound measurements (width, length, depth)
With flexible ruler
Time frame: 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
Time frame: At times 0, 4, 8 and 12 weeks
Non fasting venous blood glucose
With venipuncture, mmol/L
Time frame: At times 0 and 12 weeks
Glycated hemoglobin
With venipuncture, %
Time frame: At times 0 and 12 weeks
Lipid profile (total cholesterol, low density lipoprotein, high density lipoprotein, triglycerides, non-HDL cholesterol)
Venipuncture, g/L
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At times 0 and 12 weeks
Resting electrocardiogram (safety parameter)
To detect ST-T abnormalities at rest which has been shown to be most predictive for silent ischemia
Time frame: At time 0
Estimated glomerular filtration rate (safety parameter)
With venipuncture, mL/min. Results lower than 15 mL/min will need a specialist consultation to get medical clearance
Time frame: At times 0 and 12 weeks
Urine albumin/creatinine ratio (safety parameter)
With urinalysis, mg/g. Results lower than 300 mg/g will need a specialist consultation to get medical clearance
Time frame: At times 0 and 12 weeks
Hemoglobin (safety parameter)
With venipuncture, g/L. Results lower than 100 g/L will need a specialist consultation to get medical clearance
Time frame: At times 0 and 12 weeks
Plan to share: No
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Université du Québec à Trois-Rivières