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DB-ACTIV: Feasibility and Acceptability of Non Weight-bearing Physical Activity for People With Diabetic Foot Ulceration

Sponsor
Université du Québec à Trois-Rivières (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06092827
Collaborator
Fondation Santé Trois-Rivières (Other), Centre intégré universitaire de santé et services sociaux Mauricie et Centre-du-Québec (CIUSSS MCQ) (Other), Université de Montréal (Other)
12
Enrollment
1
Arm
8
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Non weight-bearing physical activity program
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Feasibility and acceptability studyFeasibility and acceptability study
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Feasibility and Acceptability Study of a Non Weight-bearing Physical Activity Program for People With Diabetic Foot Ulceration (DB ACTIV)
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Physical activity

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

Outcome Measures

Primary Outcome Measures

  1. Feasibility of physical activity intervention [At time 12 weeks]

    Physical activity logbook, number of sessions completed with higher number meaning a greater feasibility

  2. 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

  3. 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

  1. Estimated VO2max [At times 0 and 12 weeks]

    submaximal exercise test on a stationary bike (Aerobic Power Index submaximal exercise test), mL/kg/min

  2. 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

  3. 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)

  4. Height [At time 0]

    Standing with rigid measuring rod, cm

  5. Weight [At times 0 and 12 weeks]

    Standing on beam balance scale, kg

  6. Waist circumference [At times 0 and 12 weeks]

    With flexible measuring tape above ombilic, cm

  7. Body fat percentage [At times 0 and 12 weeks]

    With bio-impedance balance, %

  8. Arterial blood pressure [At times 0 and 12 weeks]

    With automatic blood pressure monitor, mm Hg

  9. Resting heart rate [At times 0 and 12 weeks]

    With automatic blood pressure monitor, bpm

  10. Wound measurements (width, length, depth) [At times 0, 4, 8 and 12 weeks]

    With flexible ruler

  11. 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

  12. Non fasting venous blood glucose [At times 0 and 12 weeks]

    With venipuncture, mmol/L

  13. Glycated hemoglobin [At times 0 and 12 weeks]

    With venipuncture, %

  14. Lipid profile (total cholesterol, low density lipoprotein, high density lipoprotein, triglycerides, non-HDL cholesterol) [At times 0 and 12 weeks]

    Venipuncture, g/L

  15. 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

  16. 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

  17. 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

  18. 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

Other Outcome Measures

  1. Resting electrocardiogram (safety parameter) [At time 0]

    To detect ST-T abnormalities at rest which has been shown to be most predictive for silent ischemia

  2. Estimated glomerular filtration rate (safety parameter) [At times 0 and 12 weeks]

    With venipuncture, mL/min. Results lower than 15 mL/min will need a specialist consultation to get medical clearance

  3. Urine albumin/creatinine ratio (safety parameter) [At times 0 and 12 weeks]

    With urinalysis, mg/g. Results lower than 300 mg/g will need a specialist consultation to get medical clearance

  4. Hemoglobin (safety parameter) [At times 0 and 12 weeks]

    With venipuncture, g/L. Results lower than 100 g/L will need a specialist consultation to get medical clearance

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • 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

Investigators

  • Principal Investigator: Magali Brousseau-Foley, MD, Université du Québec à Trois-Rivières

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Magali Brousseau-Foley, Principal Investigator, Université du Québec à Trois-Rivières
ClinicalTrials.gov Identifier:
NCT06092827
Other Study ID Numbers:
  • F11-3298 : DB-ACTIV
First Posted:
Oct 23, 2023
Last Update Posted:
Oct 23, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Diabetic Foot
Foot Ulcer

Study Results

No Results Posted as of Oct 23, 2023