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

NCT06092827 | Active Not Recruiting

• 1 other identifier: F11-3298 : DB-ACTIV
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot; Cardiopulmonary; Physical Inactivity

Outcome Measures

Primary Outcomes (3)

• Feasibility of physical activity intervention

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

  At time 12 weeks

• Acceptability of physical activity intervention

  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

  Client Satisfaction Questionnaire (CSQ-8), minimum score 8/maximum score 32 with higher score meaning a higher satisfaction

  At time 12 weeks

Secondary Outcomes (18)

• Estimated VO2max

  At times 0 and 12 weeks

• Average daily step count over seven days

  At times 0, 4, 8, and 12 weeks

• Physical activity level

  At times 0 and 12 weeks

• Height

  At time 0

• Weight

  At times 0 and 12 weeks

Other Outcomes (4)

• Resting electrocardiogram (safety parameter)

  At time 0

• Estimated glomerular filtration rate (safety parameter)

  At times 0 and 12 weeks

• Urine albumin/creatinine ratio (safety parameter)

  At times 0 and 12 weeks

Study Arms (1)

Physical activity

EXPERIMENTAL

Adults 18 to 75 with an active diabetic foot ulcer

Behavioral: Non weight-bearing physical activity program

Interventions

Non weight-bearing physical activity program BEHAVIORAL

12-week duration, 2 supervised trainings/week, 1 unsupervised home-based training/week Aerobic, resistance and flexibility exercises

Physical activity

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• Have completed a bachelor's degree in kinesiology
• Understand, read, and speak French.
• None

Sponsors & Collaborators

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

Study Sites (1)

Universite du Quebec à Trois-Rivieres

Trois-Rivières, Quebec, G8Z 4M3, Canada

Location

Related Publications (35)

• 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.

  PMID: 27255501 BACKGROUND

• 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.

  PMID: 23160642 BACKGROUND

• 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.

  PMID: 21540423 BACKGROUND

• 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.

  PMID: 23185314 BACKGROUND

• 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.

  PMID: 21525503 BACKGROUND

• 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.

  PMID: 27990609 BACKGROUND

• Nielsen PJ, Hafdahl AR, Conn VS, Lemaster JW, Brown SA. Meta-analysis of the effect of exercise interventions on fitness outcomes among adults with type 1 and type 2 diabetes. Diabetes Res Clin Pract. 2006 Nov;74(2):111-20. doi: 10.1016/j.diabres.2006.03.033. Epub 2006 Jun 2.

  PMID: 16735074 BACKGROUND

• Wei M, Gibbons LW, Kampert JB, Nichaman MZ, Blair SN. Low cardiorespiratory fitness and physical inactivity as predictors of mortality in men with type 2 diabetes. Ann Intern Med. 2000 Apr 18;132(8):605-11. doi: 10.7326/0003-4819-132-8-200004180-00002.

  PMID: 10766678 BACKGROUND

• Schaper NC, van Netten JJ, Apelqvist J, Bus SA, Hinchliffe RJ, Lipsky BA; IWGDF Editorial Board. Practical Guidelines on the prevention and management of diabetic foot disease (IWGDF 2019 update). Diabetes Metab Res Rev. 2020 Mar;36 Suppl 1:e3266. doi: 10.1002/dmrr.3266.

  PMID: 32176447 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.

  PMID: 28614678 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.

  BACKGROUND

• 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.

  PMID: 15644549 BACKGROUND

• 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.

  PMID: 26340966 BACKGROUND

• Ribu L, Hanestad BR, Moum T, Birkeland K, Rustoen T. A comparison of the health-related quality of life in patients with diabetic foot ulcers, with a diabetes group and a nondiabetes group from the general population. Qual Life Res. 2007 Mar;16(2):179-89. doi: 10.1007/s11136-006-0031-y. Epub 2006 Nov 8.

  PMID: 17091370 BACKGROUND

• Hopkins RB, Burke N, Harlock J, Jegathisawaran J, Goeree R. Economic burden of illness associated with diabetic foot ulcers in Canada. BMC Health Serv Res. 2015 Jan 22;15:13. doi: 10.1186/s12913-015-0687-5.

  PMID: 25608648 BACKGROUND

• Bissonnette V. Évaluation des coûts et éléments d'efficacité du traitement d'un ulcère du pied diabétique [Mémoire de maîtrise]: Université de Sherbrooke; 2011.

  BACKGROUND

• Pelletier C, Dai S, Roberts KC, Bienek A, Onysko J, Pelletier L. Report summary. Diabetes in Canada: facts and figures from a public health perspective. Chronic Dis Inj Can. 2012 Dec;33(1):53-4.

  PMID: 23294922 BACKGROUND

• Eldridge SM, Lancaster GA, Campbell MJ, Thabane L, Hopewell S, Coleman CL, Bond CM. Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework. PLoS One. 2016 Mar 15;11(3):e0150205. doi: 10.1371/journal.pone.0150205. eCollection 2016.

  PMID: 26978655 BACKGROUND

• Wallman K, Goodman C, Morton A, Grove R, Dawson B. Test-retest reliability of the aerobic power index component of the tri-level fitness profile in a sedentary population. J Sci Med Sport. 2003 Dec;6(4):443-54. doi: 10.1016/s1440-2440(03)80270-0.

  PMID: 14723394 BACKGROUND

• Wallman KE, Campbell L. Test-retest reliability of the Aerobic Power Index submaximal exercise test in an obese population. J Sci Med Sport. 2007 Jun;10(3):141-6. doi: 10.1016/j.jsams.2006.05.024. Epub 2006 Jul 17.

  PMID: 16844410 BACKGROUND

• Diabetes Canada Clinical Practice Guidelines Expert Committee; Sigal RJ, Armstrong MJ, Bacon SL, Boule NG, Dasgupta K, Kenny GP, Riddell MC. Physical Activity and Diabetes. Can J Diabetes. 2018 Apr;42 Suppl 1:S54-S63. doi: 10.1016/j.jcjd.2017.10.008. No abstract available.

  PMID: 29650112 BACKGROUND

• Colberg SR, Sigal RJ, Yardley JE, Riddell MC, Dunstan DW, Dempsey PC, Horton ES, Castorino K, Tate DF. Physical Activity/Exercise and Diabetes: A Position Statement of the American Diabetes Association. Diabetes Care. 2016 Nov;39(11):2065-2079. doi: 10.2337/dc16-1728. No abstract available.

  PMID: 27926890 BACKGROUND

• Borg G. Borg's perceived exertion and pain scales: Human kinetics; 1998.

  BACKGROUND

• Thakur A, Sharma R, Sharma SK, Thakur K, Jelly P. Effect of buerger allen exercise on foot perfusion among patient with diabetes mellitus: A systematic review & meta-analysis. Diabetes Metab Syndr. 2022 Feb;16(2):102393. doi: 10.1016/j.dsx.2022.102393. Epub 2022 Jan 13.

  PMID: 35085917 BACKGROUND

• Sidani S, Epstein DR, Bootzin RR, Moritz P, Miranda J. Assessment of preferences for treatment: validation of a measure. Res Nurs Health. 2009 Aug;32(4):419-31. doi: 10.1002/nur.20329.

  PMID: 19434647 BACKGROUND

• Evenson KR, Goto MM, Furberg RD. Systematic review of the validity and reliability of consumer-wearable activity trackers. Int J Behav Nutr Phys Act. 2015 Dec 18;12:159. doi: 10.1186/s12966-015-0314-1.

  PMID: 26684758 BACKGROUND

• Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann. 1979;2(3):197-207. doi: 10.1016/0149-7189(79)90094-6. No abstract available.

  PMID: 10245370 BACKGROUND

• Sabourin S, Pérusse D, Gendreau P. Les qualités psychométriques de la version canadienne-française du Questionnaire de Satisfaction du Consommateur de services psychothérapeutiques (QSC-8 et QSC-18B). Canadian Journal of Behavioural Science/Revue canadienne des sciences du comportement. 1989;21(2):147.

  BACKGROUND

• Crews RT, Armstrong DG, Boulton AJ. A method for assessing off-loading compliance. J Am Podiatr Med Assoc. 2009 Mar-Apr;99(2):100-3. doi: 10.7547/0980100.

  PMID: 19299344 BACKGROUND

• Armstrong T, Bull F. Development of the world health organization global physical activity questionnaire (GPAQ). Journal of Public Health. 2006;14:66-70.

  BACKGROUND

• 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.

  PMID: 32429068 BACKGROUND

• 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.

  PMID: 22023377 BACKGROUND

• Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540.

  PMID: 1798888 BACKGROUND

• Matza LS, Boye KS, Stewart KD, Curtis BH, Reaney M, Landrian AS. A qualitative examination of the content validity of the EQ-5D-5L in patients with type 2 diabetes. Health Qual Life Outcomes. 2015 Dec 1;13:192. doi: 10.1186/s12955-015-0373-7.

  PMID: 26627874 BACKGROUND

• 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.

  PMID: 32266821 BACKGROUND

MeSH Terms

Conditions

Diabetic Foot; Sedentary Behavior

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Behavior

Study Officials

• Magali Brousseau-Foley, MD

  Université du Québec à Trois-Rivières

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Feasibility and acceptability study

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: October 23, 2023
• Study Start: December 1, 2023
• Primary Completion: February 28, 2025
• Study Completion: September 1, 2025
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)