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Clinical Trials/NCT00654810
NCT00654810
Completed
N/A

Exercise Rehabilitation of Younger and Older People With Claudication

National Institute on Aging (NIA)1 site in 1 country64 target enrollmentFebruary 1994

Overview

Phase
N/A
Intervention
Not specified
Conditions
Intermittent Claudication
Sponsor
National Institute on Aging (NIA)
Enrollment
64
Locations
1
Primary Endpoint
Change in the walking distance to onset of leg pain, and the change in walking distance to maximal leg pain.
Status
Completed
Last Updated
18 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1994
End Date
January 2000
Last Updated
18 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
National Institute on Aging (NIA)

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

Outcomes

Primary Outcomes

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

Time Frame: 6 months

Secondary Outcomes

  • Changes in cardiopulmonary function, calf muscle circulation, and health-related quality of life.(6 months)

Study Sites (1)

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