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

NCT ID: NCT04043546

Last Updated: 2019-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2018-09-30

Brief Summary

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

Detailed Description

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Conditions

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Peripheral Artery Disease Intermittent Claudication

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Patients enrolled in the study receive a novel physiotherapy program.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exercise intervention

Group Type EXPERIMENTAL

aerobic+resistance exercise training program

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Roselien Buys

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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KU Leuven

Leuven, , Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type DERIVED
PMID: 33749616 (View on PubMed)

Other Identifiers

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PAD-feasibility

Identifier Type: -

Identifier Source: org_study_id

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