Exercise for Elderly Peripheral Revascularized Patients - Full Text View

Sponsored by:	National Institute on Aging (NIA)
Information provided by:	National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:	NCT00667290

Purpose

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.

Condition	Intervention
Peripheral Artery Disease Intermittent Claudication	Behavioral: Treadmill exercise

MedlinePlus related topics: Exercise and Physical Fitness

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Parallel Assignment, Efficacy Study
Official Title:	Exercise for Elderly Peripheral Revascularized Patients

Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	80
Study Start Date:	July 2000
Study Completion Date:	June 2007
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Behavioral: Treadmill exercise Graded treadmill walking 3 times per week for 3 months
2: No Intervention

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.

Eligibility

Ages Eligible for Study:	40 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00667290

Locations

United States, Oklahoma
General Clinical Research Center, University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73117

Sponsors and Collaborators

National Institute on Aging (NIA)

Investigators

Principal Investigator:

Andrew W. Gardner, PhD

University of Oklahoma

More Information

Publications:

Gardner AW, Poehlman ET. Exercise rehabilitation programs for the treatment of claudication pain. A meta-analysis. JAMA. 1995 Sep 27;274(12):975-80.

Gardner AW, Katzel LI, Sorkin JD, Bradham DD, Hochberg MC, Flinn WR, Goldberg AP. Exercise rehabilitation improves functional outcomes and peripheral circulation in patients with intermittent claudication: a randomized controlled trial. J Am Geriatr Soc. 2001 Jun;49(6):755-62.

Gardner AW, Katzel LI, Sorkin JD, Goldberg AP. Effects of long-term exercise rehabilitation on claudication distances in patients with peripheral arterial disease: a randomized controlled trial. J Cardiopulm Rehabil. 2002 May-Jun;22(3):192-8.

Gardner AW, Killewich LA, Montgomery PS, Katzel LI. Response to exercise rehabilitation in smoking and nonsmoking patients with intermittent claudication. J Vasc Surg. 2004 Mar;39(3):531-8.

Gardner AW, Montgomery PS, Flinn WR, Katzel LI. The effect of exercise intensity on the response to exercise rehabilitation in patients with intermittent claudication. J Vasc Surg. 2005 Oct;42(4):702-9.

Responsible Party:	University of Oklahoma Health Sciences Center ( Andrew W. Gardner, PhD, CMRI Hobbs-Recknagel Professor )
Study ID Numbers:	AG0098, R01-AG-16685
Study First Received:	April 24, 2008
Last Updated:	April 24, 2008
ClinicalTrials.gov Identifier:	NCT00667290 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Aging (NIA):

functional ability
gait
musculoskeletal disorder therapy
peripheral blood vessel disorder

Study placed in the following topic categories:

Arterial Occlusive Diseases
Signs and Symptoms
Peripheral Vascular Diseases
Musculoskeletal Diseases

Vascular Diseases
Intermittent Claudication
Arteriosclerosis

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Signs and Symptoms
Vascular Diseases

Intermittent Claudication
Cardiovascular Diseases
Arteriosclerosis

ClinicalTrials.gov processed this record on May 07, 2009