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

Physical Inactivity Clinical Trial

— DB-ACTIV  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06092827
• Other study ID #: F11-3298 : DB-ACTIV
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: October 2023
• Source: Université du Québec à Trois-Rivières
• Contact: Magali Brousseau-Foley, MD
• Phone: 819-372-5011
• Email: magali.brousseau-foley[@]uqtr.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 per week.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiopulmonary
• Diabetic Foot
• Foot Ulcer
• Physical Inactivity

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (4)

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

References & Publications (35)

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.

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. — View Citation

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

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. — View Citation

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

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 35 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Resting electrocardiogram (safety parameter)	To detect ST-T abnormalities at rest which has been shown to be most predictive for silent ischemia	At time 0
Other	Estimated glomerular filtration rate (safety parameter)	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
Other	Urine albumin/creatinine ratio (safety parameter)	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
Other	Hemoglobin (safety parameter)	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
Primary	Feasibility of physical activity intervention	Physical activity logbook, number of sessions completed with higher number meaning a greater feasibility	At time 12 weeks
Primary	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
Primary	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	Estimated VO2max	submaximal exercise test on a stationary bike (Aerobic Power Index submaximal exercise test), mL/kg/min	At times 0 and 12 weeks
Secondary	Average daily step count over seven days	At the waist and in the offloading boot using a FitBit Zip, number of steps	At times 0, 4, 8, and 12 weeks
Secondary	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)	At times 0 and 12 weeks
Secondary	Height	Standing with rigid measuring rod, cm	At time 0
Secondary	Weight	Standing on beam balance scale, kg	At times 0 and 12 weeks
Secondary	Waist circumference	With flexible measuring tape above ombilic, cm	At times 0 and 12 weeks
Secondary	Body fat percentage	With bio-impedance balance, %	At times 0 and 12 weeks
Secondary	Arterial blood pressure	With automatic blood pressure monitor, mm Hg	At times 0 and 12 weeks
Secondary	Resting heart rate	With automatic blood pressure monitor, bpm	At times 0 and 12 weeks
Secondary	Wound measurements (width, length, depth)	With flexible ruler	At times 0, 4, 8 and 12 weeks
Secondary	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	At times 0, 4, 8 and 12 weeks
Secondary	Non fasting venous blood glucose	With venipuncture, mmol/L	At times 0 and 12 weeks
Secondary	Glycated hemoglobin	With venipuncture, %	At times 0 and 12 weeks
Secondary	Lipid profile (total cholesterol, low density lipoprotein, high density lipoprotein, triglycerides, non-HDL cholesterol)	Venipuncture, g/L	At times 0 and 12 weeks
Secondary	Neuropathic pain (if present)	Neuropathic pain (DN4) Questionnaire, 10 yes/no questions, higher number of yes indicates more severe neuropathic pain	At times 0 and 12 weeks
Secondary	Sleep apnea symptoms	Epworth sleepiness scale, minimum score of 0/maximum score of 24, higher score makes sleep apnea more likely	At times 0 and 12 weeks
Secondary	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	At times 0 and 12 weeks
Secondary	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	At times 0 and 12 weeks