Feasibility and Acceptability of Non Weight-bearing Physical Activity for People With Diabetic Foot Ulceration
- Conditions
- Diabetic FootCardiopulmonaryPhysical Inactivity
- Interventions
- Behavioral: Non weight-bearing physical activity program
- Registration Number
- NCT06092827
- Lead Sponsor
- Université du Québec à Trois-Rivières
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 12
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Physical activity Non weight-bearing physical activity program Adults 18 to 75 with an active diabetic foot ulcer
- Primary Outcome Measures
Name Time Method 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
Feasibility of physical activity intervention At time 12 weeks Physical activity logbook, number of sessions completed with higher number meaning a greater feasibility
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
- Secondary Outcome Measures
Name Time Method Weight At times 0 and 12 weeks Standing on beam balance scale, kg
Body fat percentage At times 0 and 12 weeks With bio-impedance balance, %
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
Waist circumference At times 0 and 12 weeks With flexible measuring tape above ombilic, cm
Resting heart rate At times 0 and 12 weeks With automatic blood pressure monitor, bpm
Height At time 0 Standing with rigid measuring rod, cm
Arterial blood pressure At times 0 and 12 weeks With automatic blood pressure monitor, mm Hg
Glycated hemoglobin At times 0 and 12 weeks With venipuncture, %
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
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)
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
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
Lipid profile (total cholesterol, low density lipoprotein, high density lipoprotein, triglycerides, non-HDL cholesterol) At times 0 and 12 weeks Venipuncture, g/L
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
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
Trial Locations
- Locations (1)
Universite du Quebec à Trois-Rivieres
🇨🇦Trois-Rivieres, Quebec, Canada