Peripheral Artery Disease, Intermittent Claudication
Conditions
Keywords
functional ability, gait, musculoskeletal disorder therapy, peripheral blood vessel disorder
Brief summary
The purpose of this study is (1) to determine whether a 3-month exercise rehabilitation program will improve claudication distances, free-living daily physical activity, and health-related quality of life of older, revascularized patients with peripheral arterial disease, and (2) to determine whether the primary mechanisms by which exercise rehabilitation affects the above functional outcomes are through alterations in walking efficiency, peripheral circulation, and cardiopulmonary function.
Detailed description
Peripheral arterial disease (PAD) patients with critical limb-threatening ischemia have improved peripheral circulation following infrainguinal revascularization. Despite this hemodynamic benefit, little change in functional status occurs, and many patients have residual ambulatory dysfunction. The lack of functional improvement in revascularized patients may be due to extreme physical deconditioning secondary to their pre-existing critical limb-threatening ischemia. Therefore, we hypothesize that a program of aerobic exercise training is necessary to optimize ambulation, free-living daily physical activity, and health-related quality of life through the mechanisms of improved walking economy, peripheral circulation, and cardiopulmonary function. This is a prospective, randomized controlled clinical trial comparing an exercise group undergoing a program of graded treadmill walking, and a non-exercise control group. Eighty PAD patients will be randomized into either the exercise group (N = 40) or the non-exercise control group (N = 40) following successful lower extremity arterial bypass or angioplasty. The 3-month exercise program will consist of graded treadmill walking 3 times per week with progressive increments in exercise duration from 15 to 40 minutes, and progressive increments in exercise intensity from 50 to 80% of exercise capacity.
Interventions
BEHAVIORALTreadmill exercise
Graded treadmill walking 3 times per week for 3 months
Sponsors
National Institute on Aging (NIA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* lower extremity arterial bypass at least 3 months prior to screening * infrainguinal percutaneous transluminal angioplasty (PTLA) at least 2 weeks prior to screening
Exclusion criteria
* persistent rest pain due to (peripheral artery disease (PAD) (Fontaine Stage III for PAD), * persistent tissue loss due to PAOD (Fontaine Stage IV for PAD), * medical conditions that are contraindicative for exercise according to the American College of Sports Medicine (e.g., acute myocardial infarction, unstable angina, etc.) * cognitive dysfunction (mini-mental state examination score of less than 24)
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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in walking efficiency, calf muscle circulation, and cardiopulmonary function. | — |
Countries
United States
Outcome results
None listed