Ignite Creation Date:
2024-05-06 @ 7:40 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06092827
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-23
First Post:
2023-01-16
Brief Title:
Feasibility and Acceptability of Non Weight-bearing Physical Activity for People With Diabetic Foot Ulceration
Sponsor:
Université du Québec à Trois-Rivières
Organization:
Université du Québec à Trois-Rivières
Study Overview
Official Title:
Feasibility and Acceptability Study of a Non Weight-bearing Physical Activity Program for People With Diabetic Foot Ulceration DB ACTIV
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DB-ACTIV
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
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 eg 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 recruitednumber of eligible patients 4 attrition rate number of participants who completed the follow-upsnumber 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 albumincreatinine 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 eg 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 recruitednumber of eligible patients 4 attrition rate number of participants who completed the follow-upsnumber 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 albumincreatinine 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None