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

October 17, 2023 updated by: Magali Brousseau-Foley, Université du Québec à Trois-Rivières

Feasibility and Acceptability Study of a Non Weight-bearing Physical Activity Program for People With Diabetic Foot Ulceration (DB ACTIV)

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of physical activity intervention
Time Frame: At time 12 weeks
Physical activity logbook, number of sessions completed with higher number meaning a greater feasibility
At time 12 weeks
Acceptability of physical activity intervention
Time Frame: At time 12 weeks
Treatment Acceptability and Preference (TAP) Questionnaire, minimum score 0/maximum score 16 with higher score meaning a greater acceptability
At time 12 weeks
Satisfaction towards physical activity intervention
Time Frame: At time 12 weeks
Client Satisfaction Questionnaire (CSQ-8), minimum score 8/maximum score 32 with higher score meaning a higher satisfaction
At time 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimated VO2max
Time Frame: At times 0 and 12 weeks
submaximal exercise test on a stationary bike (Aerobic Power Index submaximal exercise test), mL/kg/min
At times 0 and 12 weeks
Average daily step count over seven days
Time Frame: At times 0, 4, 8, and 12 weeks
At the waist and in the offloading boot using a FitBit Zip, number of steps
At times 0, 4, 8, and 12 weeks
Physical activity level
Time Frame: 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)
At times 0 and 12 weeks
Height
Time Frame: At time 0
Standing with rigid measuring rod, cm
At time 0
Weight
Time Frame: At times 0 and 12 weeks
Standing on beam balance scale, kg
At times 0 and 12 weeks
Waist circumference
Time Frame: At times 0 and 12 weeks
With flexible measuring tape above ombilic, cm
At times 0 and 12 weeks
Body fat percentage
Time Frame: At times 0 and 12 weeks
With bio-impedance balance, %
At times 0 and 12 weeks
Arterial blood pressure
Time Frame: At times 0 and 12 weeks
With automatic blood pressure monitor, mm Hg
At times 0 and 12 weeks
Resting heart rate
Time Frame: At times 0 and 12 weeks
With automatic blood pressure monitor, bpm
At times 0 and 12 weeks
Wound measurements (width, length, depth)
Time Frame: At times 0, 4, 8 and 12 weeks
With flexible ruler
At times 0, 4, 8 and 12 weeks
Classification of the ulcer
Time Frame: 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
At times 0, 4, 8 and 12 weeks
Non fasting venous blood glucose
Time Frame: At times 0 and 12 weeks
With venipuncture, mmol/L
At times 0 and 12 weeks
Glycated hemoglobin
Time Frame: At times 0 and 12 weeks
With venipuncture, %
At times 0 and 12 weeks
Lipid profile (total cholesterol, low density lipoprotein, high density lipoprotein, triglycerides, non-HDL cholesterol)
Time Frame: At times 0 and 12 weeks
Venipuncture, g/L
At times 0 and 12 weeks
Neuropathic pain (if present)
Time Frame: At times 0 and 12 weeks
Neuropathic pain (DN4) Questionnaire, 10 yes/no questions, higher number of yes indicates more severe neuropathic pain
At times 0 and 12 weeks
Sleep apnea symptoms
Time Frame: At times 0 and 12 weeks
Epworth sleepiness scale, minimum score of 0/maximum score of 24, higher score makes sleep apnea more likely
At times 0 and 12 weeks
Reported quality of life
Time Frame: 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
At times 0 and 12 weeks
Questionnaire on motivation to practice physical activity
Time Frame: 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
At times 0 and 12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resting electrocardiogram (safety parameter)
Time Frame: At time 0
To detect ST-T abnormalities at rest which has been shown to be most predictive for silent ischemia
At time 0
Estimated glomerular filtration rate (safety parameter)
Time Frame: 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
At times 0 and 12 weeks
Urine albumin/creatinine ratio (safety parameter)
Time Frame: 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
At times 0 and 12 weeks
Hemoglobin (safety parameter)
Time Frame: 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
At times 0 and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université du Québec à Trois-Rivières

Collaborators

Université de Montréal
Fondation Santé Trois-Rivières
Centre intégré universitaire de santé et services sociaux Mauricie et Centre-du-Québec (CIUSSS MCQ)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2023

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

January 16, 2023

First Submitted That Met QC Criteria

October 17, 2023

First Posted (Actual)

October 23, 2023

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 17, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F11-3298 : DB-ACTIV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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