Feasibility and Acceptability of Non Weight-bearing Physical Activity for People With Diabetic Foot Ulceration
NCT ID: NCT06092827
Last Updated: 2025-05-13
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
NA
Total Enrollment
12 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-12-01
Study Completion Date
2025-09-30
Brief Summary
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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.
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Detailed Description
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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.
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.
Conditions
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Diabetic Foot
Cardiopulmonary
Physical Inactivity
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Feasibility and acceptability study
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Physical activity
Adults 18 to 75 with an active diabetic foot ulcer
Group Type
EXPERIMENTAL
Non weight-bearing physical activity program
Intervention Type
BEHAVIORAL
12-week duration, 2 supervised trainings/week, 1 unsupervised home-based training/week Aerobic, resistance and flexibility exercises
Interventions
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Non weight-bearing physical activity program
12-week duration, 2 supervised trainings/week, 1 unsupervised home-based training/week Aerobic, resistance and flexibility exercises
Intervention Type
BEHAVIORAL
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
75 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Fondation Santé Trois-Rivières
UNKNOWN
Sponsor Role
collaborator
Centre intégré universitaire de santé et services sociaux Mauricie et Centre-du-Québec (CIUSSS MCQ)
UNKNOWN
Sponsor Role
collaborator
Université de Montréal
OTHER
Sponsor Role
collaborator
Université du Québec à Trois-Rivières
OTHER
Sponsor Role
lead
Responsible Party
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Magali Brousseau-Foley
Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Magali Brousseau-Foley, MD
Role: PRINCIPAL_INVESTIGATOR
Université du Québec à Trois-Rivières
Locations
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Universite du Quebec à Trois-Rivieres
Trois-Rivières, Quebec, Canada
Site Status
Countries
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Canada
References
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Liubaoerjijin Y, Terada T, Fletcher K, Boule NG. Effect of aerobic exercise intensity on glycemic control in type 2 diabetes: a meta-analysis of head-to-head randomized trials. Acta Diabetol. 2016 Oct;53(5):769-81. doi: 10.1007/s00592-016-0870-0. Epub 2016 Jun 2.
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Umpierre D, Ribeiro PA, Schaan BD, Ribeiro JP. Volume of supervised exercise training impacts glycaemic control in patients with type 2 diabetes: a systematic review with meta-regression analysis. Diabetologia. 2013 Feb;56(2):242-51. doi: 10.1007/s00125-012-2774-z. Epub 2012 Nov 16.
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Umpierre D, Ribeiro PA, Kramer CK, Leitao CB, Zucatti AT, Azevedo MJ, Gross JL, Ribeiro JP, Schaan BD. Physical activity advice only or structured exercise training and association with HbA1c levels in type 2 diabetes: a systematic review and meta-analysis. JAMA. 2011 May 4;305(17):1790-9. doi: 10.1001/jama.2011.576.
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Balducci S, Zanuso S, Cardelli P, Salvi L, Bazuro A, Pugliese L, Maccora C, Iacobini C, Conti FG, Nicolucci A, Pugliese G; Italian Diabetes Exercise Study (IDES) Investigators. Effect of high- versus low-intensity supervised aerobic and resistance training on modifiable cardiovascular risk factors in type 2 diabetes; the Italian Diabetes and Exercise Study (IDES). PLoS One. 2012;7(11):e49297. doi: 10.1371/journal.pone.0049297. Epub 2012 Nov 21.
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Chudyk A, Petrella RJ. Effects of exercise on cardiovascular risk factors in type 2 diabetes: a meta-analysis. Diabetes Care. 2011 May;34(5):1228-37. doi: 10.2337/dc10-1881.
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Cai H, Li G, Zhang P, Xu D, Chen L. Effect of exercise on the quality of life in type 2 diabetes mellitus: a systematic review. Qual Life Res. 2017 Mar;26(3):515-530. doi: 10.1007/s11136-016-1481-5. Epub 2016 Dec 18.
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BACKGROUND
Armstrong DG, Boulton AJM, Bus SA. Diabetic Foot Ulcers and Their Recurrence. N Engl J Med. 2017 Jun 15;376(24):2367-2375. doi: 10.1056/NEJMra1615439. No abstract available.
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BACKGROUND
Agence de la santé publique du Canada (ASPC). Le diabète au Canada : Perspective de santé publique sur les faits et chiffres 2011 [Available from: https://www.canada.ca/fr/sante-publique/services/maladies-chroniques/rapports-publications/diabete/diabete-canada-perspective-sante-publique-faits-chiffres.html.
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Singh N, Armstrong DG, Lipsky BA. Preventing foot ulcers in patients with diabetes. JAMA. 2005 Jan 12;293(2):217-28. doi: 10.1001/jama.293.2.217.
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van Netten JJ, Price PE, Lavery LA, Monteiro-Soares M, Rasmussen A, Jubiz Y, Bus SA; International Working Group on the Diabetic Foot. Prevention of foot ulcers in the at-risk patient with diabetes: a systematic review. Diabetes Metab Res Rev. 2016 Jan;32 Suppl 1:84-98. doi: 10.1002/dmrr.2701.
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Fernandez-Torres R, Ruiz-Munoz M, Perez-Panero AJ, Garcia-Romero JC, Gonzalez-Sanchez M. Clinician Assessment Tools for Patients with Diabetic Foot Disease: A Systematic Review. J Clin Med. 2020 May 15;9(5):1487. doi: 10.3390/jcm9051487.
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Spallone V, Morganti R, D'Amato C, Greco C, Cacciotti L, Marfia GA. Validation of DN4 as a screening tool for neuropathic pain in painful diabetic polyneuropathy. Diabet Med. 2012 May;29(5):578-85. doi: 10.1111/j.1464-5491.2011.03500.x.
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Ferrari M, Speight J, Beath A, Browne JL, Mosely K. The information-motivation-behavioral skills model explains physical activity levels for adults with type 2 diabetes across all weight classes. Psychol Health Med. 2021 Mar;26(3):381-394. doi: 10.1080/13548506.2020.1749292. Epub 2020 Apr 8.
Reference Type
BACKGROUND
Other Identifiers
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F11-3298 : DB-ACTIV
Identifier Type: -
Identifier Source: org_study_id
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