Status:
ACTIVE_NOT_RECRUITING
Feasibility and Acceptability of Non Weight-bearing Physical Activity for People With Diabetic Foot Ulceration
Lead Sponsor:
Université du Québec à Trois-Rivières
Collaborating Sponsors:
Fondation Santé Trois-Rivières
Centre intégré universitaire de santé et services sociaux Mauricie et Centre-du-Québec (CIUSSS MCQ)
Conditions:
Diabetic Foot
Cardiopulmonary
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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 ...
Detailed Description
Objectives: 1. Evaluate the acceptability of a non-weight bearing physical activity (PA) program; 2. Assess the feasibility of the PA program and the data collection procedure; 3. Evaluate the feasib...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06092827
Start Date
December 1 2023
End Date
September 1 2025
Last Update
May 13 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Universite du Quebec à Trois-Rivieres
Trois-Rivières, Quebec, Canada, G8Z 4M3