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Observational Feasibility Study of Home-based Training With Therabands in PAD-patients

Sponsor
KU Leuven (Other)
Overall Status
Completed
CT.gov ID
NCT04043546
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
12
Actual Duration (Months)
1.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: aerobic+resistance exercise training program
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Patients enrolled in the study receive a novel physiotherapy program.Patients enrolled in the study receive a novel physiotherapy program.
Masking:
None (Open Label)
Primary Purpose:
Treatment
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.
Actual Study Start Date :
Oct 1, 2017
Actual Primary Completion Date :
Sep 30, 2018
Actual Study Completion Date :
Sep 30, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Exercise intervention

Behavioral: aerobic+resistance exercise training program
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.

Outcome Measures

Primary Outcome Measures

  1. user satisfaction [4 weeks]

    self-developed questionnaire based evaluation of user satisfaction

  2. walking distance [4 weeks]

    pain free and maximal walking distance are recorded using the Gardner treadmill protocol.

Secondary Outcome Measures

  1. Physical activity [2 months]

    Physical activity, defined total active energy expenditure (kcal) is obtained from objective measurement of physical activity during 7 consecutive days using the Sensewear device.

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 KU Leuven Leuven Belgium

Sponsors and Collaborators

  • KU Leuven

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Roselien Buys, Principal Investigator, KU Leuven
ClinicalTrials.gov Identifier:
NCT04043546
Other Study ID Numbers:
  • PAD-feasibility
First Posted:
Aug 2, 2019
Last Update Posted:
Aug 2, 2019
Last Verified:
Aug 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Peripheral Arterial Disease
Intermittent Claudication

Study Results

No Results Posted as of Aug 2, 2019