Exercise Rehabilitation of Younger and Older People With Claudication

Intermittent Claudication Clinical Trial

Official title:

Exercise Rehabilitation of Younger and Older People With Claudication

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00654810
• Other study ID #: AG0097
• Secondary ID: K01AG000657
• Status: Completed
• Phase: N/A
• First received: April 7, 2008
• Last updated: April 7, 2008
• Start date: February 1994
• Est. completion date: January 2000

Study information

• Verified date: April 2008
• Source: National Institute on Aging (NIA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: January 2000
• Est. primary completion date: January 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intermittent Claudication

Intervention

Behavioral:
• Walking Exercise
Intermittent treadmill walking to near maximal claudication pain three days per week

Locations

Country	Name	City	State
United States	Baltimore VA Medical Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the walking distance to onset of leg pain, and the change in walking distance to maximal leg pain.		6 months	No
Secondary	Changes in cardiopulmonary function, calf muscle circulation, and health-related quality of life.		6 months	No