Exercise Rehabilitation of Younger and Older People With Claudication - Tabular View

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Exercise Rehabilitation of Younger and Older People With Claudication

This study has been completed.
Information provided by National Institute on Aging (NIA)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Exercise Rehabilitation of Younger and Older People With Claudication

Official Title ^†

Exercise Rehabilitation of Younger and Older People With Claudication

Brief Summary

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.

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.

Study Phase

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study

Primary Outcome Measure ^†

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 Measure ^†

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

Condition ^†

Intermittent Claudication

Intervention ^†

Behavioral: Walking Exercise

MEDLINE PMIDs

16242558, 11034229, 7674529, 11454114, 12042688, 14981444

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

Start Date ^†

February 1994

Completion Date

January 2000

Eligibility 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

Gender

Both

Ages

45 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00654810

Organization ID

AG0097

Secondary IDs ^††

K01-AG-00657

Study Sponsor ^†

National Institute on Aging (NIA)

Collaborators ^††

Investigators ^†

Principal Investigator:

Andrew W. Gardner, PhD

University of Oklahoma

Information Provided By

National Institute on Aging (NIA)

Verification Date

April 2008

First Received Date ^†

April 7, 2008

Last Updated Date

April 7, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.