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Exercise for Elderly Peripheral Revascularized Patients

Primary Purpose

Peripheral Artery Disease, Intermittent Claudication

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Treadmill exercise
Sponsored by
National Institute on Aging (NIA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Artery Disease focused on measuring functional ability, gait, musculoskeletal disorder therapy, peripheral blood vessel disorder

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • General Clinical Research Center, University of Oklahoma Health Sciences Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Change in the walking distance to onset of leg pain, and the change in walking distance to maximal leg pain

Secondary Outcome Measures

Changes in walking efficiency, calf muscle circulation, and cardiopulmonary function.

Full Information

First Posted
April 24, 2008
Last Updated
April 24, 2008
Sponsor
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT00667290
Brief Title
Exercise for Elderly Peripheral Revascularized Patients
Official Title
Exercise for Elderly Peripheral Revascularized Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
July 2000 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Artery Disease, Intermittent Claudication
Keywords
functional ability, gait, musculoskeletal disorder therapy, peripheral blood vessel disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Treadmill exercise
Intervention Description
Graded treadmill walking 3 times per week for 3 months
Primary Outcome Measure Information:
Title
Change in the walking distance to onset of leg pain, and the change in walking distance to maximal leg pain
Secondary Outcome Measure Information:
Title
Changes in walking efficiency, calf muscle circulation, and cardiopulmonary function.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew W. Gardner, PhD
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
Facility Information:
Facility Name
General Clinical Research Center, University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73117
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
7674529
Citation
Gardner AW, Poehlman ET. Exercise rehabilitation programs for the treatment of claudication pain. A meta-analysis. JAMA. 1995 Sep 27;274(12):975-80.
Results Reference
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PubMed Identifier
11454114
Citation
Gardner AW, Katzel LI, Sorkin JD, Bradham DD, Hochberg MC, Flinn WR, Goldberg AP. Exercise rehabilitation improves functional outcomes and peripheral circulation in patients with intermittent claudication: a randomized controlled trial. J Am Geriatr Soc. 2001 Jun;49(6):755-62. doi: 10.1046/j.1532-5415.2001.49152.x.
Results Reference
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PubMed Identifier
12042688
Citation
Gardner AW, Katzel LI, Sorkin JD, Goldberg AP. Effects of long-term exercise rehabilitation on claudication distances in patients with peripheral arterial disease: a randomized controlled trial. J Cardiopulm Rehabil. 2002 May-Jun;22(3):192-8. doi: 10.1097/00008483-200205000-00011.
Results Reference
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PubMed Identifier
14981444
Citation
Gardner AW, Killewich LA, Montgomery PS, Katzel LI. Response to exercise rehabilitation in smoking and nonsmoking patients with intermittent claudication. J Vasc Surg. 2004 Mar;39(3):531-8. doi: 10.1016/j.jvs.2003.08.037.
Results Reference
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PubMed Identifier
16242558
Citation
Gardner AW, Montgomery PS, Flinn WR, Katzel LI. The effect of exercise intensity on the response to exercise rehabilitation in patients with intermittent claudication. J Vasc Surg. 2005 Oct;42(4):702-9. doi: 10.1016/j.jvs.2005.05.049.
Results Reference
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Exercise for Elderly Peripheral Revascularized Patients

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