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

August 1, 2019 updated by: Roselien Buys, KU Leuven

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.

The study is an observational feasibility study to evaluate the feasibility of a combined aerobic+resistance training program in patients with IC.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium
        • KU Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
user satisfaction
Time Frame: 4 weeks
self-developed questionnaire based evaluation of user satisfaction
4 weeks
walking distance
Time Frame: 4 weeks
pain free and maximal walking distance are recorded using the Gardner treadmill protocol.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical activity
Time Frame: 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.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KU Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2017

Primary Completion (ACTUAL)

September 30, 2018

Study Completion (ACTUAL)

September 30, 2018

Study Registration Dates

First Submitted

July 10, 2018

First Submitted That Met QC Criteria

August 1, 2019

First Posted (ACTUAL)

August 2, 2019

Study Record Updates

Last Update Posted (ACTUAL)

August 2, 2019

Last Update Submitted That Met QC Criteria

August 1, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAD-feasibility

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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