- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00667290
Exercise for Elderly Peripheral Revascularized Patients
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Peripheral arterial disease (PAD) patients with critical limb-threatening ischemia have improved peripheral circulation following infrainguinal revascularization. Despite this hemodynamic benefit, little change in functional status occurs, and many patients have residual ambulatory dysfunction. The lack of functional improvement in revascularized patients may be due to extreme physical deconditioning secondary to their pre-existing critical limb-threatening ischemia. Therefore, we hypothesize that a program of aerobic exercise training is necessary to optimize ambulation, free-living daily physical activity, and health-related quality of life through the mechanisms of improved walking economy, peripheral circulation, and cardiopulmonary function.
This is a prospective, randomized controlled clinical trial comparing an exercise group undergoing a program of graded treadmill walking, and a non-exercise control group. Eighty PAD patients will be randomized into either the exercise group (N = 40) or the non-exercise control group (N = 40) following successful lower extremity arterial bypass or angioplasty. The 3-month exercise program will consist of graded treadmill walking 3 times per week with progressive increments in exercise duration from 15 to 40 minutes, and progressive increments in exercise intensity from 50 to 80% of exercise capacity.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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-
Oklahoma
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Oklahoma City, Oklahoma, Förenta staterna, 73117
- General Clinical Research Center, University of Oklahoma Health Sciences Center
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- lower extremity arterial bypass at least 3 months prior to screening
- infrainguinal percutaneous transluminal angioplasty (PTLA) at least 2 weeks prior to screening
Exclusion Criteria:
- 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)
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 1
|
Graded treadmill walking 3 times per week for 3 months
|
Inget ingripande: 2
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Vad mäter studien?
Primära resultatmått
Resultatmått |
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Change in the walking distance to onset of leg pain, and the change in walking distance to maximal leg pain
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Sekundära resultatmått
Resultatmått |
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Changes in walking efficiency, calf muscle circulation, and cardiopulmonary function.
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Samarbetspartners och utredare
Utredare
- Huvudutredare: Andrew W. Gardner, PhD, University of Oklahoma
Publikationer och användbara länkar
Allmänna publikationer
- 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. doi: 10.1046/j.1532-5415.2001.49152.x.
- 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.
- 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.
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- AG0098
- R01AG016685 (U.S.S. NIH-anslag/kontrakt)
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Kristie BjornsonUniversity of Washington; Louisiana State University Health Sciences Center...Rekrytering
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Assaf-Harofeh Medical CenterBen-Gurion University of the NegevOkänd
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