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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
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Peripheral Artery Disease Intermittent Claudication Behavioral: Treadmill exercise

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Exercise for Elderly Peripheral Revascularized Patients
Study Start Date : July 2000
Primary Completion Date : June 2007
Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Behavioral: Treadmill exercise
Graded treadmill walking 3 times per week for 3 months
No Intervention: 2


Outcome Measures

Primary Outcome Measures :
  1. Change in the walking distance to onset of leg pain, and the change in walking distance to maximal leg pain

Secondary Outcome Measures :
  1. Changes in walking efficiency, calf muscle circulation, and cardiopulmonary function.

Eligibility Criteria

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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations

Information from the National Library of Medicine

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


Locations
United States, Oklahoma
General Clinical Research Center, University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73117
Sponsors and Collaborators
National Institute on Aging (NIA)
Investigators
Principal Investigator: Andrew W. Gardner, PhD University of Oklahoma
More Information

Publications:
Responsible Party: Andrew W. Gardner, PhD, CMRI Hobbs-Recknagel Professor, University of Oklahoma Health Sciences Center
ClinicalTrials.gov Identifier: NCT00667290     History of Changes
Other Study ID Numbers: AG0098
R01AG016685 ( U.S. NIH Grant/Contract )
First Posted: April 28, 2008    Key Record Dates
Last Update Posted: April 28, 2008
Last Verified: April 2008

Keywords provided by National Institute on Aging (NIA):
functional ability
gait
musculoskeletal disorder therapy
peripheral blood vessel disorder

Additional relevant MeSH terms:
Peripheral Arterial Disease
Intermittent Claudication
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases
Signs and Symptoms