Exercise for Elderly Peripheral Revascularized Patients
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|ClinicalTrials.gov Identifier: NCT00667290|
Recruitment Status : Completed
First Posted : April 28, 2008
Last Update Posted : April 28, 2008
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Artery Disease Intermittent Claudication||Behavioral: Treadmill exercise||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Exercise for Elderly Peripheral Revascularized Patients|
|Study Start Date :||July 2000|
|Actual Primary Completion Date :||June 2007|
|Actual Study Completion Date :||June 2007|
Behavioral: Treadmill exercise
Graded treadmill walking 3 times per week for 3 months
|No Intervention: 2|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|