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

NCT04043546 | Completed

• 1 other identifier: PAD-feasibility
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Peripheral Artery Disease; Intermittent Claudication

Outcome Measures

Primary Outcomes (2)

• user satisfaction

  self-developed questionnaire based evaluation of user satisfaction

  4 weeks

• walking distance

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

  4 weeks

Secondary Outcomes (1)

• Physical activity

  2 months

Study Arms (1)

Exercise intervention

EXPERIMENTAL

Behavioral: aerobic+resistance exercise training program

Interventions

aerobic+resistance exercise training program 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.

Exercise intervention

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• exercise induced signs of myocardial ischemia or complex ventricular arrhythmias;
• no access to laptop or internet;
• no medical clearance for exercise

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

KU Leuven

Leuven, Belgium

Location

Related Publications (1)

• 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.

  PMID: 33749616 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients enrolled in the study receive a novel physiotherapy program.

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: August 2, 2019
• Study Start: October 1, 2017
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2018
• Last Updated: August 2, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)