- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00827827
Strength Training for Skeletal Muscle Adaptation After Stroke
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
This study investigates the hypothesis that a novel, high intensity, high repetition ST program will improve abnormalities in paretic and non-paretic leg muscle volume and composition compared to an attention-matched control regimen of supervised stretching over a 3-month intervention period in those disabled by stroke. The investigators further hypothesize that ST-induced skeletal muscle adaptation will translate into improved insulin sensitivity, strength, and function in this population. The specific objectives are to: 1) Determine the effects ST compared to a control intervention on paretic and non-paretic abnormalities in skeletal muscle volume, intramuscular fat, muscle fiber distribution, muscle capillary density, and muscle inflammation in chronically disabled stroke survivors. 2) Determine the effects ST compared to a control intervention on insulin sensitivity in stroke survivors, and whether structural and cellular skeletal muscle mechanisms contribute to improvements in insulin sensitivity after ST. 3) Determine the effects ST compared to a control intervention on physical function (strength, walking speed and balance) in stroke survivors, and whether structural skeletal muscle mechanisms predict ST-induced functional improvement.
The project design consists of 4 phases over 5 months for stroke participants enrolled in either of the two intervention arms (ST vs. CONTROL). During phase 1 the investigators will screen and consent chronic stroke patients with residual gait deficits. Phase 2 (3 weeks) will consist of baseline testing that includes dual energy X-ray absorptiometry (DEXA) scanning, bilateral CT scanning of the legs, bilateral vastus lateralis muscle biopsies, strength testing, timed walks, balance measurements, oral glucose tolerance testing, and hyperglycemic clamp testing. Following completion of baseline testing, volunteers are to be randomized to ST or the CONTROL group. Phase 3 (Intervention Phase, 3 months) will begin with 2 sessions of acclimatization for those assigned to the ST group. ST will then be progressed to 2 sets of 20 repetitions on each leg on each machine (Keiser Leg Press, Leg Extension, Leg Curl) with gradual increases in resistance over 3 months. Those in the CONTROL group will receive equal exposure to health care personnel in the Baltimore VA Exercise facility, performing a full battery of upper and lower body passive and active stretching exercises at each intervention session. In Phase 4 all baseline testing and laboratory analyses will be repeated.
Developing evidence-based therapies to combat skeletal muscle deterioration is highly relevant for chronically disabled stoke survivors. There is mounting evidence that current models of post-stroke rehabilitation are not optimal for maximizing recovery of muscle mass, strength, and metabolic health. The proposed research will develop new insight into the utility of progressive ST for reversing detrimental changes to gross muscle composition, muscle molecular phenotype, muscle inflammation, and muscle capillarization. Changes to any or all of these muscle parameters should have measurable impact on both whole body insulin sensitivity and function. Collectively, the results from this trial may change the current standard of care for stroke survivors by providing evidenced reasons for augmenting physical therapists' treatments, allowing more intense and diverse therapy sessions for maintenance of skeletal muscle.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Maryland
-
Baltimore, Maryland, Stati Uniti, 21201
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Stroke greater than 6 months prior with residual hemiparetic gait in women or men aged 40-85 years
- Completion of all regular post-stroke physical therapy
- Adequate language and neurocognitive function to participate in testing and training and to give adequate informed consent
Exclusion Criteria:
- Alcohol consumption greater than 3 oz. liquor, or 3 x 4 oz glasses of wine, or 3 x 12 oz. beers per day, by self-report
clinical history of:
- unstable angina
- recent (less than 3 months) myocardial infarction or congestive heart failure (NYHA category II)
- hemodynamically significant valvular dysfunction
- peripheral arterial occlusive disease (PAOD) with claudication
- major orthopedic, chronic pain, or non-stroke neuromuscular disorders restricting exercise
- pulmonary or renal failure
- poorly controlled hypertension (greater than 190/110)
- recent hospitalization for severe disease or surgery
- severe or global receptive aphasia which confounds reliable testing and training
- Allergy to lidocaine
- Known muscle disorder
- Taking Coumadin or Lovenox (contraindication for muscle biopsies)
- Dementia
- Untreated major depression
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 |
---|---|
Sperimentale: Arm 1
Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl).
Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour.
Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.
|
3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour.
|
Comparatore attivo: Arm 2
Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week).
Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.
|
3x per week upper and lower body stretching mixed with active and passive range of motion exercises
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Change in 1-repetition Maximum (RM) Muscle Strength (Leg Press, Paretic Side)
Lasso di tempo: Baseline, 3 months
|
Baseline, 3 months
|
|
Change in 1-RM Muscle Strength (Leg Press, Non-Paretic Side)
Lasso di tempo: Baseline, 3 months
|
Baseline, 3 months
|
|
Change in 1-RM Muscle Strength (Leg Extension, Paretic Side)
Lasso di tempo: Baseline, 3 Months
|
Baseline, 3 Months
|
|
Change in 1-RM Muscle Strength (Leg Extension, Non-Paretic Side)
Lasso di tempo: Baseline, 3 Months
|
Baseline, 3 Months
|
|
Change in Leg Muscle Endurance (Paretic Side)
Lasso di tempo: Baseline, 3 Months
|
Tests how training impacts the total number of submaximal repetitions a participant can perform according to standardized cadence (at the same absolute level of resistance, pre and post).
|
Baseline, 3 Months
|
Change in Leg Muscle Endurance (Non-Paretic Side)
Lasso di tempo: Baseline, 3 months
|
Tests how training impacts the total number of submaximal repetitions a participant can perform according to standardized cadence (at the same absolute level of resistance, pre and post).
|
Baseline, 3 months
|
Change in 6-minute Walk Distance
Lasso di tempo: Baseline, 3 Months
|
Baseline, 3 Months
|
|
Change in 10 Meter Walking Speed (Self-Selected)
Lasso di tempo: Baseline, 3 months
|
Baseline, 3 months
|
|
Change in 10 Meter Walking Speed (Fastest)
Lasso di tempo: Baseline, 3 Months
|
Baseline, 3 Months
|
|
Change in Peak Aerobic Capacity (VO2 Peak)
Lasso di tempo: Baseline, 3 Months
|
Baseline, 3 Months
|
|
Change in Berg Balance Scale
Lasso di tempo: Baseline, 3 months
|
This measure is a 14 item scale, with each item scored (0-4) and summed for a maximum score of 56 points.
Range is 0-56 and higher values represent a better outcome.
|
Baseline, 3 months
|
Change in Paretic Limb Step Time (Self-Selected)
Lasso di tempo: Baseline, 3 months
|
This and other measures come from Instrumented Walkway (Gait Rite)
|
Baseline, 3 months
|
Change in Paretic Limb Step Time (Fastest)
Lasso di tempo: Baseline, 3 Months
|
This and other measures come from Instrumented Walkway (Gait Rite)
|
Baseline, 3 Months
|
Change in Non-Paretic Limb Step Time (Self-Selected)
Lasso di tempo: Baseline, 3 months
|
This and other measures come from Instrumented Walkway (Gait Rite)
|
Baseline, 3 months
|
Change in Non-Paretic Limb Step Time (Fastest)
Lasso di tempo: Baseline, 3 Months
|
This and other measures come from Instrumented Walkway (Gait Rite)
|
Baseline, 3 Months
|
Change in Paretic Limb Step Length (Self-Selected)
Lasso di tempo: Baseline, 3 Months
|
This and other measures come from Instrumented Walkway (Gait Rite)
|
Baseline, 3 Months
|
Change in Paretic Limb Step Length (Fastest)
Lasso di tempo: Baseline, 3 months
|
This and other measures come from Instrumented Walkway (Gait Rite)
|
Baseline, 3 months
|
Change in Non-Paretic Limb Step Length (Self-Selected)
Lasso di tempo: Baseline, 3 Months
|
This and other measures come from Instrumented Walkway (Gait Rite)
|
Baseline, 3 Months
|
Change in Non-Paretic Limb Step Length (Fastest)
Lasso di tempo: Baseline, 3 Months
|
This and other measures come from Instrumented Walkway (Gait Rite)
|
Baseline, 3 Months
|
Collaboratori e investigatori
Pubblicazioni e link utili
Pubblicazioni generali
- Ivey FM, Prior SJ, Hafer-Macko CE, Katzel LI, Macko RF, Ryan AS. Strength Training for Skeletal Muscle Endurance after Stroke. J Stroke Cerebrovasc Dis. 2017 Apr;26(4):787-794. doi: 10.1016/j.jstrokecerebrovasdis.2016.10.018. Epub 2016 Nov 16.
- Ivey FM, Ryan AS. Resistive training improves insulin sensitivity after stroke. J Stroke Cerebrovasc Dis. 2014 Feb;23(2):225-9. doi: 10.1016/j.jstrokecerebrovasdis.2012.12.014. Epub 2013 Jan 22.
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
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 (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- B6737-R
- H30631 (Altro identificatore: Baltimore VAMC)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
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 .
Prove cliniche su Exercise- Strength Training
-
Nottingham University Hospitals NHS TrustCompletato
-
Gallaudet UniversityDepartment of Health and Human ServicesReclutamentoPerdita dell'udito | SorditàStati Uniti
-
Stanford UniversityCompletatoSindrome da deficit di attenzione e iperattivitàStati Uniti
-
NYU Langone HealthReclutamento
-
KTO Karatay UniversityCompletatoIctus | Riabilitazione dell'ictusTacchino
-
University of Maryland, College ParkNational Institutes of Health (NIH); National Institute on Aging (NIA)ReclutamentoDisturbi percettivi uditivi | Problemi di invecchiamentoStati Uniti
-
Université de MontréalFonds de la Recherche en Santé du QuébecCompletato
-
Gia Dinh People HospitalNon ancora reclutamentoCompromissione cognitiva lieve | Prevenzione della demenza
-
AccareCompletatoSintomi comportamentali | Comportamento problema | ADHD | Problema di comportamento del bambino | ADHD Tipo prevalentemente disattento | ADHD - Tipo combinato | Problema di comportamento | Comportamento dirompente | Problema comportamentale | ADHD, tipo prevalentemente iperattivo-impulsivoOlanda
-
University of FloridaCompletatoApnea notturna, ostruttiva | RussareStati Uniti