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Completed

NCT Number: NCT00667290

Exercise for Elderly Peripheral Revascularized Patients

The purpose of this study is (1) to determine whether a 3-month exercise rehabilitation program will improve claudication distances, free-living daily physical activity, and health-related quality of life of older, revascularized patients with peripheral arterial disease, and (2) to determine whether the primary mechanisms by which exercise rehabilitation affects the above functional outcomes are through alterations in walking efficiency, peripheral circulation, and cardiopulmonary function.

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Key information

Age range

40 year–90 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

Peripheral arterial disease (PAD) patients with critical limb-threatening ischemia have improved peripheral circulation following infrainguinal revascularization. Despite this hemodynamic benefit, little change in functional status occurs, and many patients have residual ambulatory dysfunction. The lack of functional improvement in revascularized patients may be due to extreme physical deconditioning secondary to their pre-existing critical limb-threatening ischemia. Therefore, we hypothesize that a program of aerobic exercise training is necessary to optimize ambulation, free-living daily physical activity, and health-related quality of life through the mechanisms of improved walking economy, peripheral circulation, and cardiopulmonary function.

This is a prospective, randomized controlled clinical trial comparing an exercise group undergoing a program of graded treadmill walking, and a non-exercise control group. Eighty PAD patients will be randomized into either the exercise group (N = 40) or the non-exercise control group (N = 40) following successful lower extremity arterial bypass or angioplasty. The 3-month exercise program will consist of graded treadmill walking 3 times per week with progressive increments in exercise duration from 15 to 40 minutes, and progressive increments in exercise intensity from 50 to 80% of exercise capacity.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • lower extremity arterial bypass at least 3 months prior to screening
  • infrainguinal percutaneous transluminal angioplasty (PTLA) at least 2 weeks prior to screening

Exclusion criteria

  • persistent rest pain due to (peripheral artery disease (PAD) (Fontaine Stage III for PAD),
  • persistent tissue loss due to PAOD (Fontaine Stage IV for PAD),
  • 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 of less than 24)

Treatment and study plan

Treadmill Exercise

Behavioral

Graded treadmill walking 3 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

Secondary outcomes

  1. Changes in walking efficiency, calf muscle circulation, and cardiopulmonary function.

Sponsors and collaborators

Lead sponsor

National Institute on Aging (NIA)

Nih

Registry information

Important dates

Study start
2000
Primary completion
2007
Study completion
2007
First posted
Apr 28, 2008
Registry last updated
Apr 28, 2008

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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