NCT00667290

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2000

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2000

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 28, 2008

Completed
Last Updated

April 28, 2008

Status Verified

April 1, 2008

Enrollment Period

6.9 years

First QC Date

April 24, 2008

Last Update Submit

April 24, 2008

Conditions

Peripheral Artery DiseaseIntermittent Claudication

Keywords

functional abilitygaitmusculoskeletal disorder therapyperipheral blood vessel disorder

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Study Arms (2)

1

EXPERIMENTAL
Behavioral: Treadmill exercise

2

NO INTERVENTION

Interventions

Treadmill exerciseBEHAVIORAL

Graded treadmill walking 3 times per week for 3 months

1

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • lower extremity arterial bypass at least 3 months prior to screening
  • infrainguinal percutaneous transluminal angioplasty (PTLA) at least 2 weeks prior to screening

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Clinical Research Center, University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73117, United States

Location

Related Publications (5)

  • Gardner AW, Poehlman ET. Exercise rehabilitation programs for the treatment of claudication pain. A meta-analysis. JAMA. 1995 Sep 27;274(12):975-80.

    PMID: 7674529BACKGROUND

  • 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.

    PMID: 11454114BACKGROUND

  • 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.

    PMID: 12042688BACKGROUND

  • 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.

    PMID: 14981444BACKGROUND

  • 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.

    PMID: 16242558BACKGROUND

MeSH Terms

Conditions

Peripheral Arterial DiseaseIntermittent ClaudicationPeripheral Vascular Diseases

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Andrew W. Gardner, PhD

    University of Oklahoma

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

April 24, 2008

First Posted

April 28, 2008

Study Start

July 1, 2000

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

April 28, 2008

Record last verified: 2008-04

Locations

US(1)