Exercise for Elderly Peripheral Revascularized Patients

Not Applicable

Completed

• Conditions: Peripheral Artery Disease; Intermittent Claudication
• Interventions: Behavioral: Treadmill exercise

• Registration Number: NCT00667290
• Lead Sponsor: National Institute on Aging (NIA)

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2000-07
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Status Verified: 2008-04
• Study First Submitted: 2008-04-24
• Study First Submitted QC: 2008-04-24
• Last Update Submitted: 2008-04-24
• Study First Posted: 2008-04-28
• Last Update Posted: 2008-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Treadmill exercise	-

Primary Outcome Measures

Name	Time	Method
Change in the walking distance to onset of leg pain, and the change in walking distance to maximal leg pain

Secondary Outcome Measures

Name	Time	Method
Changes in walking efficiency, calf muscle circulation, and cardiopulmonary function.

Trial Locations

Locations (1)

General Clinical Research Center, University of Oklahoma Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States