Exercise Rehabilitation of Younger and Older People With Claudication

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00654810

Enrollment

Registered

2008-04-09

Start date

1994-02-28

Completion date

2000-01-31

Last updated

2008-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intermittent Claudication

Keywords

functional ability, gait, musculoskeletal disorder therapy, peripheral blood vessel disorder

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.

Interventions

BEHAVIORALWalking Exercise

Intermittent treadmill walking to near maximal claudication pain three days per week

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

45 Years to 90 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026