Clinical trial NCT00654810: Exercise Rehabilitation of Younger and Older People With Claudication
Official title: Exercise Rehabilitation of Younger and Older People With Claudication
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intermittent Claudication
Keywords: functional ability
gait
musculoskeletal disorder therapy
peripheral blood vessel disorder
Lead sponsor: National Institute on Aging (NIA)
Sponsor class: NIH
First posted: 2008-04-09
Enrollment: 64
Sex: ALL
Minimum age (years): 45
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in the walking distance to onset of leg pain, and the change in walking distance to maximal leg pain.
timeFrame: 6 months
Secondary outcomes:
measure: Changes in cardiopulmonary function, calf muscle circulation, and health-related quality of life.
timeFrame: 6 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Baltimore VA Medical Center
state: Maryland
Study officials:
affiliation: University of Oklahoma
name: Andrew W. Gardner, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.