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Exercise Rehabilitation of Younger and Older People With Claudication

Primary Purpose

Intermittent Claudication

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Walking 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 Intermittent Claudication focused on measuring functional ability, gait, musculoskeletal disorder therapy, peripheral blood vessel disorder

Eligibility Criteria

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

Inclusion Criteria:

  • History of intermittent claudication
  • Exercise tolerance limited by intermittent claudication during a screening treadmill test
  • Ankle/brachial index (ABI) at rest less than 0.90
  • Live independently at home

Exclusion Criteria:

  • Absence of PAD (peripheral artery disease)
  • Asymptomatic PAD (Fontaine stage I)
  • Rest pain PAD (Fontaine stage III)
  • Exercise tolerance limited by factors other than claudication (e.g., coronary artery disease, dyspnea, poorly controlled blood pressure)
  • Active cancer, renal disease, or liver disease
  • Current use of pentoxifylline or cilostazol medications for the treatment of intermittent claudication

Sites / Locations

  • Baltimore VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

Low intensity group (40% of maximal exercise capacity)

High intensity group (80% of maximal exercise capacity)

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 cardiopulmonary function, calf muscle circulation, and health-related quality of life.

Full Information

First Posted
April 7, 2008
Last Updated
April 7, 2008
Sponsor
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT00654810
Brief Title
Exercise Rehabilitation of Younger and Older People With Claudication
Official Title
Exercise Rehabilitation of Younger and Older People With Claudication
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
February 1994 (undefined)
Primary Completion Date
January 2000 (Actual)
Study Completion Date
January 2000 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to examine the effect of age and the effect of exercise intensity of rehabilitation programs on claudication pain symptoms and leg circulation of younger and older patients with intermittent claudication.
Detailed Description
Thirty-one patients randomized to low-intensity exercise rehabilitation and 33 patients randomized to high-intensity exercise rehabilitation completed the study. The 6-month exercise rehabilitation programs consisted of intermittent treadmill walking to near maximal claudication pain three days per week at either 40% (low-intensity group) or 80% (high-intensity group) of maximal exercise capacity. Total work performed in the two training regimens was similar by having the patients in the low-intensity group exercise for a longer duration than patients in the high-intensity group. Measurements of physical function, peripheral circulation, and health-related quality of life were obtained on each patient before and after the rehabilitation programs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Outcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Low intensity group (40% of maximal exercise capacity)
Arm Title
2
Arm Type
Experimental
Arm Description
High intensity group (80% of maximal exercise capacity)
Intervention Type
Behavioral
Intervention Name(s)
Walking Exercise
Intervention Description
Intermittent treadmill walking to near maximal claudication pain three days per week
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Changes in cardiopulmonary function, calf muscle circulation, and health-related quality of life.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: History of intermittent claudication Exercise tolerance limited by intermittent claudication during a screening treadmill test Ankle/brachial index (ABI) at rest less than 0.90 Live independently at home Exclusion Criteria: Absence of PAD (peripheral artery disease) Asymptomatic PAD (Fontaine stage I) Rest pain PAD (Fontaine stage III) Exercise tolerance limited by factors other than claudication (e.g., coronary artery disease, dyspnea, poorly controlled blood pressure) Active cancer, renal disease, or liver disease Current use of pentoxifylline or cilostazol medications for the treatment of intermittent claudication
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
Baltimore VA Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
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
background
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
background
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
background
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
background
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
result
PubMed Identifier
11034229
Citation
Gardner AW, Katzel LI, Sorkin JD, Killewich LA, Ryan A, Flinn WR, Goldberg AP. Improved functional outcomes following exercise rehabilitation in patients with intermittent claudication. J Gerontol A Biol Sci Med Sci. 2000 Oct;55(10):M570-7. doi: 10.1093/gerona/55.10.m570.
Results Reference
result
PubMed Identifier
22459748
Citation
Gardner AW, Montgomery PS, Parker DE. Optimal exercise program length for patients with claudication. J Vasc Surg. 2012 May;55(5):1346-54. doi: 10.1016/j.jvs.2011.11.123. Epub 2012 Mar 28.
Results Reference
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Exercise Rehabilitation of Younger and Older People With Claudication

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