Cardiopulmonary, Diabetic Foot, Physical Inactivity
Conditions
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 the feet, with a duration of twelve (12) weeks, consisting of two supervised sessions and one unsupervised home session per week.
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 feasibility of a submaximal exercise test for cardiorespiratory capacity; and 4. 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.
Interventions
BEHAVIORALNon weight-bearing physical activity program
12-week duration, 2 supervised trainings/week, 1 unsupervised home-based training/week Aerobic, resistance and flexibility exercises
Sponsors
Université du Québec à Trois-Rivières
Fondation Santé Trois-Rivières
Centre intégré universitaire de santé et services sociaux Mauricie et Centre-du-Québec (CIUSSS MCQ)
Université de Montréal
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Feasibility and acceptability study
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of physical activity intervention | At time 12 weeks | Treatment Acceptability and Preference (TAP) Questionnaire, minimum score 0/maximum score 16 with higher score meaning a greater acceptability |
| Satisfaction towards physical activity intervention | At time 12 weeks | Client Satisfaction Questionnaire (CSQ-8), minimum score 8/maximum score 32 with higher score meaning a higher satisfaction |
| Feasibility of physical activity intervention | At time 12 weeks | Physical activity logbook, number of sessions completed with higher number meaning a greater feasibility |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lipid profile (total cholesterol, low density lipoprotein, high density lipoprotein, triglycerides, non-HDL cholesterol) | At times 0 and 12 weeks | Venipuncture, g/L |
| Neuropathic pain (if present) | At times 0 and 12 weeks | Neuropathic pain (DN4) Questionnaire, 10 yes/no questions, higher number of yes indicates more severe neuropathic pain |
| Estimated VO2max | At times 0 and 12 weeks | submaximal exercise test on a stationary bike (Aerobic Power Index submaximal exercise test), mL/kg/min |
| Average daily step count over seven days | At times 0, 4, 8, and 12 weeks | At the waist and in the offloading boot using a FitBit Zip, number of steps |
| Physical activity level | At times 0 and 12 weeks | 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) |
| Height | At time 0 | Standing with rigid measuring rod, cm |
| Weight | At times 0 and 12 weeks | Standing on beam balance scale, kg |
| Waist circumference | At times 0 and 12 weeks | With flexible measuring tape above ombilic, cm |
| Body fat percentage | At times 0 and 12 weeks | With bio-impedance balance, % |
| Arterial blood pressure | At times 0 and 12 weeks | With automatic blood pressure monitor, mm Hg |
| Resting heart rate | At times 0 and 12 weeks | With automatic blood pressure monitor, bpm |
| Wound measurements (width, length, depth) | At times 0, 4, 8 and 12 weeks | With flexible ruler |
| Classification of the ulcer | At times 0, 4, 8 and 12 weeks | 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 |
| Non fasting venous blood glucose | At times 0 and 12 weeks | With venipuncture, mmol/L |
| Sleep apnea symptoms | At times 0 and 12 weeks | Epworth sleepiness scale, minimum score of 0/maximum score of 24, higher score makes sleep apnea more likely |
| Glycated hemoglobin | At times 0 and 12 weeks | With venipuncture, % |
| Reported quality of life | At times 0 and 12 weeks | 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 |
| Questionnaire on motivation to practice physical activity | At times 0 and 12 weeks | 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 |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORMagali Brousseau-Foley, MD
Université du Québec à Trois-Rivières
Outcome results
None listed