Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Strength Training for Skeletal Muscle Adaptation After Stroke

7 juin 2018 mis à jour par: VA Office of Research and Development
Chronically disabled stroke survivors experience accelerated skeletal muscle atrophy and other detrimental changes to muscle and surrounding tissues on the paretic side. This unilateral tissue-level damage contributes to worsening disability and insulin resistance. This VA Merit Award will advance the investigators' understanding of the potential for strength training (ST) to reverse stroke-related muscle abnormalities to improve metabolic health, strength, and function. It will be the first study to thoroughly investigate the effects of ST on muscle atrophy, intramuscular fat, muscle fiber characteristics, capillary density and insulin sensitivity after stroke.

Aperçu de l'étude

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

38

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Maryland
      • Baltimore, Maryland, États-Unis, 21201
        • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

40 ans à 85 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Comparateur actif: 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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in 1-repetition Maximum (RM) Muscle Strength (Leg Press, Paretic Side)
Délai: Baseline, 3 months
Baseline, 3 months
Change in 1-RM Muscle Strength (Leg Press, Non-Paretic Side)
Délai: Baseline, 3 months
Baseline, 3 months
Change in 1-RM Muscle Strength (Leg Extension, Paretic Side)
Délai: Baseline, 3 Months
Baseline, 3 Months
Change in 1-RM Muscle Strength (Leg Extension, Non-Paretic Side)
Délai: Baseline, 3 Months
Baseline, 3 Months
Change in Leg Muscle Endurance (Paretic Side)
Délai: 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)
Délai: 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
Délai: Baseline, 3 Months
Baseline, 3 Months
Change in 10 Meter Walking Speed (Self-Selected)
Délai: Baseline, 3 months
Baseline, 3 months
Change in 10 Meter Walking Speed (Fastest)
Délai: Baseline, 3 Months
Baseline, 3 Months
Change in Peak Aerobic Capacity (VO2 Peak)
Délai: Baseline, 3 Months
Baseline, 3 Months
Change in Berg Balance Scale
Délai: 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)
Délai: Baseline, 3 months
This and other measures come from Instrumented Walkway (Gait Rite)
Baseline, 3 months
Change in Paretic Limb Step Time (Fastest)
Délai: 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)
Délai: Baseline, 3 months
This and other measures come from Instrumented Walkway (Gait Rite)
Baseline, 3 months
Change in Non-Paretic Limb Step Time (Fastest)
Délai: Baseline, 3 Months
This and other measures come from Instrumented Walkway (Gait Rite)
Baseline, 3 Months
Change in Paretic Limb Step Length (Self-Selected)
Délai: Baseline, 3 Months
This and other measures come from Instrumented Walkway (Gait Rite)
Baseline, 3 Months
Change in Paretic Limb Step Length (Fastest)
Délai: 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)
Délai: Baseline, 3 Months
This and other measures come from Instrumented Walkway (Gait Rite)
Baseline, 3 Months
Change in Non-Paretic Limb Step Length (Fastest)
Délai: Baseline, 3 Months
This and other measures come from Instrumented Walkway (Gait Rite)
Baseline, 3 Months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 avril 2009

Achèvement primaire (Réel)

31 août 2013

Achèvement de l'étude (Réel)

6 juin 2018

Dates d'inscription aux études

Première soumission

22 janvier 2009

Première soumission répondant aux critères de contrôle qualité

22 janvier 2009

Première publication (Estimation)

23 janvier 2009

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

9 juillet 2018

Dernière mise à jour soumise répondant aux critères de contrôle qualité

7 juin 2018

Dernière vérification

1 juin 2018

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

Non

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner