Exercise Rehabilitation of Younger and Older People With Claudication

National Institutes of Health (NIH)

Status: Completed

Conditions: Intermittent Claudication

Treatments: Behavioral: Walking Exercise

Study type: Interventional

Funder types: NIH

Identifiers

NCT00654810

AG0097

K01AG000657 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 45 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

64 participants in 2 patient groups

1

Experimental group

Description:

Low intensity group (40% of maximal exercise capacity)

Treatment:

Behavioral: Walking Exercise

2

Experimental group

Description:

High intensity group (80% of maximal exercise capacity)

Treatment:

Behavioral: Walking Exercise