Exercise Rehabilitation of Younger and Older People With Claudication

Not Applicable

Completed

• Conditions: Intermittent Claudication
• Interventions: Behavioral: Walking Exercise

• Registration Number: NCT00654810
• Lead Sponsor: National Institute on Aging (NIA)

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 Timeline

• Study Start: 1994-02
• Primary Completion: 2000-01
• Study Completion: 2000-01
• Status Verified: 2008-04
• Study First Submitted: 2008-04-07
• Study First Submitted QC: 2008-04-07
• Last Update Submitted: 2008-04-07
• Study First Posted: 2008-04-09
• Last Update Posted: 2008-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Walking Exercise	Low intensity group (40% of maximal exercise capacity)
2	Walking Exercise	High intensity group (80% of maximal exercise capacity)

Primary Outcome Measures

Name	Time	Method
Change in the walking distance to onset of leg pain, and the change in walking distance to maximal leg pain.	6 months

Secondary Outcome Measures

Name	Time	Method
Changes in cardiopulmonary function, calf muscle circulation, and health-related quality of life.	6 months

Trial Locations

Locations (1)

Baltimore VA Medical Center; 🇺🇸 Baltimore, Maryland, United States