Exercise for Elderly Peripheral Revascularized Patients
|Peripheral Artery Disease Intermittent Claudication||Behavioral: Treadmill exercise|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Exercise for Elderly Peripheral Revascularized Patients|
- Change in the walking distance to onset of leg pain, and the change in walking distance to maximal leg pain
- Changes in walking efficiency, calf muscle circulation, and cardiopulmonary function.
|Study Start Date:||July 2000|
|Study Completion Date:||June 2007|
|Primary Completion Date:||June 2007 (Final data collection date for primary outcome measure)|
Behavioral: Treadmill exercise
Graded treadmill walking 3 times per week for 3 months
|No Intervention: 2|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00667290
|United States, Oklahoma|
|General Clinical Research Center, University of Oklahoma Health Sciences Center|
|Oklahoma City, Oklahoma, United States, 73117|
|Principal Investigator:||Andrew W. Gardner, PhD||University of Oklahoma|