NCT00654810

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 1994

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

February 1, 1994

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2000

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2000

Completed
8.3 years until next milestone

First Submitted

Initial submission to the registry

April 7, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 9, 2008

Completed
Last Updated

April 9, 2008

Status Verified

April 1, 2008

Enrollment Period

5.9 years

First QC Date

April 7, 2008

Last Update Submit

April 7, 2008

Conditions

Intermittent 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.

    6 months

Secondary Outcomes (1)

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

    6 months

Study Arms (2)

1

EXPERIMENTAL

Low intensity group (40% of maximal exercise capacity)

Behavioral: Walking Exercise

2

EXPERIMENTAL

High intensity group (80% of maximal exercise capacity)

Behavioral: Walking Exercise

Interventions

Walking ExerciseBEHAVIORAL

Intermittent treadmill walking to near maximal claudication pain three days per week

12

Eligibility Criteria

Age45 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baltimore VA Medical Center

Baltimore, Maryland, 21201, United States

Location

Related Publications (7)

  • 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: 16242558RESULT

  • 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.

    PMID: 11034229RESULT

  • 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.

    PMID: 22459748DERIVED

MeSH Terms

Conditions

Intermittent ClaudicationPeripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Peripheral Arterial DiseaseVascular 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
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

April 7, 2008

First Posted

April 9, 2008

Study Start

February 1, 1994

Primary Completion

January 1, 2000

Study Completion

January 1, 2000

Last Updated

April 9, 2008

Record last verified: 2008-04

Locations

US(1)