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- Klinische proef NCT01231360
The Effect of Exercise Training on Skeletal Muscle Metabolism in Peripheral Artery Disease (PAD)
The Effect of Exercise Training on Skeletal Muscle Metabolism in Peripheral Artery Disease
Specific Aim 1: To test the hypothesis that subjects with PAD and intermittent claudication have altered expression of genes that regulate skeletal muscle metabolism.
Specific Aim 2: To test the hypothesis that exercise training improves calf skeletal muscle insulin resistance and genes that regulate skeletal muscle metabolic function in PAD patients with intermittent claudication.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
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Massachusetts
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Boston, Massachusetts, Verenigde Staten, 02115
- Werving
- Brigham and Women's Hospital
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Contact:
- Jessica Milian, BA
- Telefoonnummer: 617-732-6320
- E-mail: jmilian@partners.org
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Hoofdonderzoeker:
- Reena Pande, MD
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- claudication symptoms
- ABI ≤ 0.9 in the symptomatic leg
Exclusion Criteria:
- diabetes
- impaired fasting glucose
- peripheral vascular intervention within the prior six months
- recent unstable angina
- myocardial infarction or stroke within the prior six months
- changes to their HMG-CoA reductase inhibitor (statin)within the past three months
- changes to pentoxifylline and/or cilostazol regimen within the past three months or anticipated to be necessary during the study
- are on Coumadin
- exercise limitations for reasons other than intermittent claudication (such as congestive heart failure, angina, chronic lung disease, or other disorders affecting the limb such as arthritis or neuropathy)
- rest pain or ulcers due to critical limb ischemia
- lower extremity amputation
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Actieve vergelijker: Exercise Training
Subjects randomized to exercise training will participate in a three-month treadmill exercise program in 1-hour training sessions three times per week as previously described.
After a 5-minute warm-up period, exercise is initiated at a low workload of 2 mph at 0% grade.
Subjects walk until moderate claudication severity develops, and then rest until the discomfort resolves, repeating until the total exercise period is completed.
The intensity of the treadmill exercise is increased as tolerated by increasing walking speed by 0.5-1 mph and/or grade by 1-2%.
Subjects are encouraged to continue the walking program at home for at least 30 minutes on two separate occasions each week.
|
Subjects randomized to exercise training will participate in a three-month treadmill exercise program in 1-hour training sessions three times per week as previously described.
After a 5-minute warm-up period, exercise is initiated at a low workload of 2 mph at 0% grade.
Subjects walk until moderate claudication severity develops, and then rest until the discomfort resolves, repeating until the total exercise period is completed.
The intensity of the treadmill exercise is increased as tolerated by increasing walking speed by 0.5-1 mph and/or grade by 1-2%.
Subjects are encouraged to continue the walking program at home for at least 30 minutes on two separate occasions each week.
|
Actieve vergelijker: Normal routine
Subjects randomized to the routine activity control group will be asked to keep a log of their daily activities and return to the Vascular Research Center at weeks 4, 8, and 12 at which time they will be asked to return their log and undergo repeat treadmill testing and complete the 6 minute walk test.
|
Subjects randomized to the routine activity control group will be asked to keep a log of their daily activities and return to the Vascular Research Center at weeks 4, 8, and 12 at which time they will be asked to return their log and undergo repeat treadmill testing and complete the 6 minute walk test.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Expression of genes regulating skeletal muscle metabolism
Tijdsspanne: 3 months
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3 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Additional measures include skeletal muscle glucose uptake, measures of functional capacity, leg blood flow, and quality of life.
Tijdsspanne: 3 months
|
3 months
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Reena Pande, MD, Brigham and Women's Hospital
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2010p001107RP
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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