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)

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* 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