Exercise Rehabilitation of Younger and Older People With Claudication - Full Text View

Purpose

The purpose of this study is to examine the effect of age and the effect of exercise intensity of rehabilitation programs on claudication pain symptoms and leg circulation of younger and older patients with intermittent claudication.

Condition	Intervention
Intermittent Claudication	Behavioral: Walking Exercise

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Exercise Rehabilitation of Younger and Older People With Claudication

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness Rehabilitation

U.S. FDA Resources

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: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes in cardiopulmonary function, calf muscle circulation, and health-related quality of life. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment:	64
Study Start Date:	February 1994
Study Completion Date:	January 2000
Primary Completion Date:	January 2000 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Low intensity group (40% of maximal exercise capacity)	Behavioral: Walking Exercise Intermittent treadmill walking to near maximal claudication pain three days per week
Experimental: 2 High intensity group (80% of maximal exercise capacity)	Behavioral: Walking Exercise Intermittent treadmill walking to near maximal claudication pain three days per week

Detailed Description:

Thirty-one patients randomized to low-intensity exercise rehabilitation and 33 patients randomized to high-intensity exercise rehabilitation completed the study. The 6-month exercise rehabilitation programs consisted of intermittent treadmill walking to near maximal claudication pain three days per week at either 40% (low-intensity group) or 80% (high-intensity group) of maximal exercise capacity. Total work performed in the two training regimens was similar by having the patients in the low-intensity group exercise for a longer duration than patients in the high-intensity group. Measurements of physical function, peripheral circulation, and health-related quality of life were obtained on each patient before and after the rehabilitation programs.

Eligibility

Ages Eligible for Study:	45 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

History of intermittent claudication
Exercise tolerance limited by intermittent claudication during a screening treadmill test
Ankle/brachial index (ABI) at rest less than 0.90
Live independently at home

Exclusion Criteria:

Absence of PAD (peripheral artery disease)
Asymptomatic PAD (Fontaine stage I)
Rest pain PAD (Fontaine stage III)
Exercise tolerance limited by factors other than claudication (e.g., coronary artery disease, dyspnea, poorly controlled blood pressure)
Active cancer, renal disease, or liver disease
Current use of pentoxifylline or cilostazol medications for the treatment of intermittent claudication

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00654810

Locations

United States, Maryland
Baltimore VA Medical Center
Baltimore, Maryland, United States, 21201

Sponsors and Collaborators

National Institute on Aging (NIA)

Investigators

Principal Investigator:

Andrew W. Gardner, PhD

University of Oklahoma

More Information

Publications:

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.

Gardner AW, Katzel LI, Sorkin JD, Killewich LA, Ryan A, Flinn WR, Goldberg AP. Improved functional outcomes following exercise rehabilitation in patients with intermittent claudication. J Gerontol A Biol Sci Med Sci. 2000 Oct;55(10):M570-7.

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Gardner AW, Montgomery PS, Parker DE. Optimal exercise program length for patients with claudication. J Vasc Surg. 2012 May;55(5):1346-54. Epub 2012 Mar 28.

Responsible Party:	Andrew W. Gardner, PhD, University of Oklahoma Health Sciences Center
ClinicalTrials.gov Identifier:	NCT00654810 History of Changes
Other Study ID Numbers:	AG0097, K01-AG-00657
Study First Received:	April 7, 2008
Last Updated:	April 7, 2008
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Aging (NIA):

functional ability
gait
musculoskeletal disorder therapy
peripheral blood vessel disorder

Additional relevant MeSH terms:

Intermittent Claudication
Arteriosclerosis
Arterial Occlusive Diseases

Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013