Back to resultsObservational Feasibility Study of Home-based Training With Therabands in PAD-patients
Primary Purpose
Peripheral Artery Disease, Intermittent Claudication
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
aerobic+resistance exercise training program
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Artery Disease
Eligibility Criteria
Inclusion Criteria:
- age ≥ 50 yrs;
- ankle-brachial index (ABI) ≤ 0.9 in one or two legs;
- Fontaine stage II (Rutherford I 1-3) of PAD (new onset or conservatively treated);
- body mass index <35 kg/m 2 ;
- resting systolic blood pressure (BP) <160 mmHg and diastolic BP <105 mmHg;
- ability to walk at least 2 min at 2.0 mph;
- ability to undertake an incremental treadmill test;
- decrease of at least 15% in ABI after a maximal treadmill test;
- not currently engaging in any regular exercise program.
Exclusion Criteria:
- exercise induced signs of myocardial ischemia or complex ventricular arrhythmias;
- no access to laptop or internet;
- no medical clearance for exercise
Sites / Locations
- KU Leuven
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Exercise intervention
Arm Description
Outcomes
Primary Outcome Measures
user satisfaction
self-developed questionnaire based evaluation of user satisfaction
walking distance
pain free and maximal walking distance are recorded using the Gardner treadmill protocol.
Secondary Outcome Measures
Physical activity
Physical activity, defined total active energy expenditure (kcal) is obtained from objective measurement of physical activity during 7 consecutive days using the Sensewear device.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04043546
Brief Title
Observational Feasibility Study of Home-based Training With Therabands in PAD-patients
Official Title
Observational Feasability Study of Home-based Training With Therabands in PAD-patients - Addressing the Uncertainty of Acceptance, Satisfaction and Usability of a Home-based, Tele-monitored Program Combining Aerobic and Resistance Components in PAD-patients.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
September 30, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KU Leuven
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study is an observational feasibility study to evaluate the feasibility of a combined aerobic+resistance training program in patients with IC.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Artery Disease, Intermittent Claudication
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients enrolled in the study receive a novel physiotherapy program.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
aerobic+resistance exercise training program
Intervention Description
Personalized exercise program based on the inclusion testing and patient screening will be provided to the patient. The program will consist of a gradual walking program as well as a gradual resistance training program using therabands.
Primary Outcome Measure Information:
Title
user satisfaction
Description
self-developed questionnaire based evaluation of user satisfaction
Time Frame
4 weeks
Title
walking distance
Description
pain free and maximal walking distance are recorded using the Gardner treadmill protocol.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Physical activity
Description
Physical activity, defined total active energy expenditure (kcal) is obtained from objective measurement of physical activity during 7 consecutive days using the Sensewear device.
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age ≥ 50 yrs;
ankle-brachial index (ABI) ≤ 0.9 in one or two legs;
Fontaine stage II (Rutherford I 1-3) of PAD (new onset or conservatively treated);
body mass index <35 kg/m 2 ;
resting systolic blood pressure (BP) <160 mmHg and diastolic BP <105 mmHg;
ability to walk at least 2 min at 2.0 mph;
ability to undertake an incremental treadmill test;
decrease of at least 15% in ABI after a maximal treadmill test;
not currently engaging in any regular exercise program.
Exclusion Criteria:
exercise induced signs of myocardial ischemia or complex ventricular arrhythmias;
no access to laptop or internet;
no medical clearance for exercise
Facility Information:
Facility Name
KU Leuven
City
Leuven
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33749616
Citation
Cornelis N, Buys R, Dewit T, Benoit D, Claes J, Fourneau I, Cornelissen V. Satisfaction and Acceptability of Telemonitored Home-Based Exercise in Patients With Intermittent Claudication: Pragmatic Observational Pilot Study. JMIR Rehabil Assist Technol. 2021 Mar 22;8(1):e18739. doi: 10.2196/18739.
Results Reference
derived
Learn more about this trial
Observational Feasibility Study of Home-based Training With Therabands in PAD-patients
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