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Completed

NCT Number: NCT00618670

Home-based vs. Supervised Exercise for People With Claudication

The purpose of this study is to examine the effects of a home-based exercise rehabilitation program compared to a supervised exercise program on intermittent claudication (leg pain or discomfort) and ambulatory function.

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Key information

Age range

35 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General Clinical Research Center, University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73117, United States

About this study

This study seeks to 1) compare the changes in ambulatory function, vascular function, and health-related quality of life in patients limited by intermittent claudication following a home-based exercise rehabilitation program, a supervised exercise program, and a light resistance training exercise program; and 2) determine whether changes in walking efficiency, calf muscle circulation, and calf muscle oxygen are the reasons by which both home-based and supervised exercise rehabilitation improve ambulatory function.

We hypothesize that a home-based exercise program utilizing new physical activity monitoring technology that can accurately quantify exercise adherence as well as the intensity, duration, and volume of exercise sessions will result in similar changes in ambulatory function, vascular function, and health-related quality of life compared to a standard, supervised exercise program. Further, both the home-based and supervised exercise rehabilitation programs will result in greater changes in ambulatory function, vascular function, and health-related quality of life than a light resistance training exercise program. Finally, we hypothesize that the changes in walking efficiency, calf muscle circulation, and calf muscle oxygen will each be predictive of improved ambulation following the home-based exercise program as well as the supervised exercise program.

The 3-month program will consist of walking 3 times per week, with progressive increases in duration and intensity. The two walking exercise programs will be matched on the estimated caloric expenditure during the training sessions. Patients in the control group will perform light resistance training without any walking exercise.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Positive history of intermittent claudication assessed by the San Diego Claudication Questionnaire
  • Exercise limited by intermittent claudication during a screening treadmill test using the Gardner protocol
  • Ankle/brachial index (ABI) less than 0.90 at rest, which decreases to less than 0.73 immediately following the treadmill exercise test

Exclusion criteria

  • Absence of PAD (peripheral artery disease)
  • Asymptomatic PAD (Fontaine stage I)
  • Rest pain due to PAD (Fontaine stage III)
  • Tissue loss due to PAD (Fontaine stage IV)
  • Medical conditions that are contraindicative for exercise according to the American College of Sports Medicine (e.g., acute myocardial infarction, unstable angina, etc.)
  • Cognitive dysfunction (mini-mental state examination score less than 24)

Treatment and study plan

Walking exercise

Behavioral

Three times per week for 3 months

Control--Resistance Training

Behavioral

Three times per week for 3 months

Primary outcomes

  1. Change in the walking distance to onset of leg pain, and the change in walking distance to maximal leg pain

    Time frame: 3 months

Secondary outcomes

  1. Change in walking efficiency

    Time frame: 3 months

  2. Change in calf muscle circulation and calf muscle oxygen

    Time frame: 3 months

  3. Change in health-related quality of life

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Collaborators

  • National Institute on Aging (NIA)
  • Oklahoma Center for the Advancement of Science and Technology

Registry information

Official study title

Home-based vs. Supervised Exercise for Claudicants

Important dates

Study start
2006
Primary completion
2016
Study completion
2016
First posted
Feb 20, 2008
Registry last updated
Apr 2, 2018

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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