- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02115
- Reclutamento
- Brigham and Women's Hospital
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Contatto:
- Jessica Milian, BA
- Numero di telefono: 617-732-6320
- Email: jmilian@partners.org
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Investigatore principale:
- Reena Pande, MD
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Comparatore attivo: 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.
|
Comparatore attivo: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
Expression of genes regulating skeletal muscle metabolism
Lasso di tempo: 3 months
|
3 months
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
Additional measures include skeletal muscle glucose uptake, measures of functional capacity, leg blood flow, and quality of life.
Lasso di tempo: 3 months
|
3 months
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Reena Pande, MD, Brigham and Women's Hospital
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2010p001107RP
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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