| April 7, 2008 |
| April 7, 2008 |
| February 1994 |
| January 2000 (final data collection date for primary outcome measure) |
| Change in the walking distance to onset of leg pain, and the change in walking distance to maximal leg pain. [ Time Frame: 6 months ] [ Designated as safety issue: No ] |
| Same as current |
| No Changes Posted |
| Changes in cardiopulmonary function, calf muscle circulation, and health-related quality of life. [ Time Frame: 6 months ] [ Designated as safety issue: No ] |
| Same as current |
| |
| Exercise Rehabilitation of Younger and Older People With Claudication |
| Exercise Rehabilitation of Younger and Older People With Claudication |
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. |
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. |
| |
| Interventional |
| Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study |
| Intermittent Claudication |
| Behavioral: Walking Exercise |
- Experimental: Low intensity group (40% of maximal exercise capacity)
- Experimental: High intensity group (80% of maximal exercise capacity)
|
- 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.
- 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.
- Gardner AW, Poehlman ET. Exercise rehabilitation programs for the treatment of claudication pain. A meta-analysis. JAMA. 1995 Sep 27;274(12):975-80.
- 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.
- 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.
- 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.
|
| |
| Completed |
| 64 |
| January 2000 |
| January 2000 (final data collection date for primary outcome measure) |
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
|
| Both |
| 45 Years to 90 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00654810 |
| Andrew W. Gardner, PhD, University of Oklahoma Health Sciences Center |
| AG0097, K01-AG-00657 |
| National Institute on Aging (NIA) |
|
| Principal Investigator: |
Andrew W. Gardner, PhD |
University of Oklahoma |
|
|
| National Institute on Aging (NIA) |
| April 2008 |
