Home-Based vs. Supervised Exercise for People With Claudication - Full Text View

Sponsors and Collaborators:	National Institute on Aging (NIA) Oklahoma Center for the Advancement of Science and Technology
Information provided by:	National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:	NCT00618670

Purpose

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.

Condition	Intervention
Intermittent Claudication	Behavioral: Walking Exercise Behavioral: Control--Resistance Training

MedlinePlus related topics: Exercise and Physical Fitness

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	Home-Based vs. Supervised Exercise for Claudicants

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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in walking efficiency [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Change in calf muscle circulation and calf muscle oxygen [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Change in health-related quality of life [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	111
Study Start Date:	September 2006
Estimated Study Completion Date:	July 2011
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Home-based program with progressive increases in exercise duration and intensity (i.e., cadence); walking duration will be longer for the home-based group because the intensity of walking will be lower than the graded treadmill walking performed by the supervised group	Behavioral: Walking Exercise Three times per week for 3 months
2: Experimental Supervised program consisting of graded treadmill walking, with progressive increments in exercise duration from 15 to 40 minutes, and progressive increments in exercise intensity from 50 to 70% of exercise capacity	Behavioral: Walking Exercise Three times per week for 3 months
3: Active Comparator Light resistance training without any walking exercise	Behavioral: Control--Resistance Training Three times per week for 3 months

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	35 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00618670

Contacts

Contact: Polly Montgomery, MS

405-271-6764

polly-montgomery@ouhsc.edu

Locations

United States, Oklahoma
General Clinical Research Center, University of Oklahoma Health Sciences Center	Recruiting
Oklahoma City, Oklahoma, United States, 73117
Contact: Andrew W Gardner, PhD 405-271-4272 ext 42743 andrew-gardner@ouhsc.edu
Contact: Polly S Montgomery, MS 405-271-4272 polly-montgomery@ouhsc.edu
Principal Investigator: Andrew W Gardner, PhD
Sub-Investigator: Steven M Blevins, MD

Sponsors and Collaborators

National Institute on Aging (NIA)

Oklahoma Center for the Advancement of Science and Technology

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 )
Study ID Numbers:	AG0095, R01-AG-24296
Study First Received:	February 15, 2008
Last Updated:	February 15, 2008
ClinicalTrials.gov Identifier:	NCT00618670
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Aging (NIA):

aging
gait
musculoskeletal disorder therapy
peripheral blood vessel disorder

muscle function
muscle strength
quality of life

Study placed in the following topic categories:

Arterial Occlusive Diseases
Signs and Symptoms
Peripheral Vascular Diseases
Musculoskeletal Diseases

Vascular Diseases
Quality of Life
Intermittent Claudication
Arteriosclerosis

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009