Clinical trial NCT06092827: Feasibility and Acceptability of Non Weight-bearing Physical Activity for People With Diabetic Foot Ulceration
Official title: Feasibility and Acceptability Study of a Non Weight-bearing Physical Activity Program for People With Diabetic Foot Ulceration (DB ACTIV)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetic Foot
Cardiopulmonary
Physical Inactivity
Lead sponsor: Université du Québec à Trois-Rivières
Sponsor class: OTHER
Collaborators: name: Fondation Santé Trois-Rivières
name: Centre intégré universitaire de santé et services sociaux Mauricie et Centre-du-Québec (CIUSSS MCQ)
name: Université de Montréal
First posted: 2023-10-23
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Feasibility and acceptability study
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Feasibility of physical activity intervention
timeFrame: At time 12 weeks
measure: Acceptability of physical activity intervention
timeFrame: At time 12 weeks
measure: Satisfaction towards physical activity intervention
timeFrame: At time 12 weeks
Secondary outcomes:
measure: Estimated VO2max
timeFrame: At times 0 and 12 weeks
measure: Average daily step count over seven days
timeFrame: At times 0, 4, 8, and 12 weeks
measure: Physical activity level
timeFrame: At times 0 and 12 weeks
measure: Height
timeFrame: At time 0
measure: Weight
timeFrame: At times 0 and 12 weeks
measure: Waist circumference
timeFrame: At times 0 and 12 weeks
measure: Body fat percentage
timeFrame: At times 0 and 12 weeks
measure: Arterial blood pressure
timeFrame: At times 0 and 12 weeks
measure: Resting heart rate
timeFrame: At times 0 and 12 weeks
measure: Wound measurements (width, length, depth)
timeFrame: At times 0, 4, 8 and 12 weeks
measure: Classification of the ulcer
timeFrame: At times 0, 4, 8 and 12 weeks
measure: Non fasting venous blood glucose
timeFrame: At times 0 and 12 weeks
measure: Glycated hemoglobin
timeFrame: At times 0 and 12 weeks
measure: Lipid profile (total cholesterol, low density lipoprotein, high density lipoprotein, triglycerides, non-HDL cholesterol)
timeFrame: At times 0 and 12 weeks
measure: Neuropathic pain (if present)
timeFrame: At times 0 and 12 weeks
measure: Sleep apnea symptoms
timeFrame: At times 0 and 12 weeks
measure: Reported quality of life
timeFrame: At times 0 and 12 weeks
measure: Questionnaire on motivation to practice physical activity
timeFrame: At times 0 and 12 weeks
Other outcomes:
measure: Resting electrocardiogram (safety parameter)
timeFrame: At time 0
measure: Estimated glomerular filtration rate (safety parameter)
timeFrame: At times 0 and 12 weeks
measure: Urine albumin/creatinine ratio (safety parameter)
timeFrame: At times 0 and 12 weeks
measure: Hemoglobin (safety parameter)
timeFrame: At times 0 and 12 weeks
Locations:
city: Trois-Rivieres
country: Canada
facility: Universite du Quebec à Trois-Rivieres
state: Quebec
Study officials:
affiliation: Université du Québec à Trois-Rivières
name: Magali Brousseau-Foley, MD
role: PRINCIPAL_INVESTIGATOR
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