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Completed

NCT Number: NCT04043546

Observational Feasibility Study of Home-based Training With Therabands 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.

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Key information

Conditions

Peripheral Artery Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Intermittent Claudication Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Signs and Symptoms Vascular Diseases

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KU Leuven

Leuven, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. user satisfaction

    Time frame: 4 weeks

    self-developed questionnaire based evaluation of user satisfaction

  2. walking distance

    Time frame: 4 weeks

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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Official study 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.

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 2, 2019
Registry last updated
Aug 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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