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Diabetic FootDB-ACTIVNCT06092827

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

A study testing Non weight-bearing physical activity program in people with Diabetic Foot and Cardiopulmonary, run by Université du Québec à Trois-Rivières at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Non weight-bearing physical activity program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteCanada
Study dates
1 Dec 2023to 16 Jul 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Have completed a bachelor's degree in kinesiology
  • Understand, read, and speak French.

Who cannot join

  • 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
Show all 10Show fewer
  • 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:
  • None

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Universite du Quebec à Trois-Rivieres

    Trois-Rivières, Quebec, G8Z 4M3

Other trials in Canada

About this study

Official title: 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.

Read the 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.
Being tested
Non weight-bearing physical activity program
Medical subject headings
Diabetic Foot, Sedentary Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Non weight-bearing physical activity programBehavioural

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

Study groups in NCT06092827
Study groupRoleWhat they receive
Physical activityExperimentalAdults 18 to 75 with an active diabetic foot ulcer
Receives: Behavioral: Non weight-bearing physical activity program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of physical activity intervention

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

    Measured: At time 12 weeks

  2. Acceptability of physical activity intervention

    Treatment Acceptability and Preference (TAP) Questionnaire, minimum score 0/maximum score 16 with higher score meaning a greater acceptability

    Measured: At time 12 weeks

  3. Satisfaction towards physical activity intervention

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

    Measured: At time 12 weeks

Secondary outcomes (18)

  1. Estimated VO2max

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

    Measured: At times 0 and 12 weeks

  2. Average daily step count over seven days

    At the waist and in the offloading boot using a FitBit Zip, number of steps

    Measured: At times 0, 4, 8, and 12 weeks

  3. Physical activity level

    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)

    Measured: At times 0 and 12 weeks

  4. Height

    Standing with rigid measuring rod, cm

    Measured: At time 0

  5. Weight

    Standing on beam balance scale, kg

    Measured: At times 0 and 12 weeks

  6. Waist circumference

    With flexible measuring tape above ombilic, cm

    Measured: At times 0 and 12 weeks

  7. Body fat percentage

    With bio-impedance balance, %

    Measured: At times 0 and 12 weeks

  8. Arterial blood pressure

    With automatic blood pressure monitor, mm Hg

    Measured: At times 0 and 12 weeks

  9. Resting heart rate

    With automatic blood pressure monitor, bpm

    Measured: At times 0 and 12 weeks

  10. Wound measurements (width, length, depth)

    With flexible ruler

    Measured: At times 0, 4, 8 and 12 weeks

  11. Classification of the ulcer

    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

    Measured: At times 0, 4, 8 and 12 weeks

  12. Non fasting venous blood glucose

    With venipuncture, mmol/L

    Measured: At times 0 and 12 weeks

  13. Glycated hemoglobin

    With venipuncture, %

    Measured: At times 0 and 12 weeks

  14. Lipid profile (total cholesterol, low density lipoprotein, high density lipoprotein, triglycerides, non-HDL cholesterol)

    Venipuncture, g/L

    Measured: At times 0 and 12 weeks

  15. Neuropathic pain (if present)

    Neuropathic pain (DN4) Questionnaire, 10 yes/no questions, higher number of yes indicates more severe neuropathic pain

    Measured: At times 0 and 12 weeks

  16. Sleep apnea symptoms

    Epworth sleepiness scale, minimum score of 0/maximum score of 24, higher score makes sleep apnea more likely

    Measured: At times 0 and 12 weeks

  17. Reported quality of life

    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

    Measured: At times 0 and 12 weeks

  18. Questionnaire on motivation to practice physical activity

    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

    Measured: At times 0 and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2023
  2. Study start1 Dec 2023
  3. Primary completion28 Feb 2025
  4. Study completion16 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Feasibility and acceptability study
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06092827
Sponsor's protocol ID
F11-3298 : DB-ACTIV
Acronym
DB-ACTIV
Status last verified
May 2025
First submitted
16 Jan 2023
Last updated
4 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27255501

  • 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.

    PubMed 23160642

  • 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.

    PubMed 21540423

  • 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.

    PubMed 23185314

  • 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.

    PubMed 21525503

  • 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.

    PubMed 27990609

  • 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.

    PubMed 16735074

  • 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.

    PubMed 10766678

  • 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.

    PubMed 32176447

  • 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.

    PubMed 28614678

  • 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.

  • 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.

    PubMed 15644549

  • 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.

    PubMed 26340966

  • 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.

    PubMed 17091370

  • 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.

    PubMed 25608648

Questions about this trial

What is this clinical trial studying?

A study testing Non weight-bearing physical activity program in people with Diabetic Foot and Cardiopulmonary, run by Université du Québec à Trois-Rivières at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of physical activity intervention (time frame: At time 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06092827, which also lists 35 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.

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