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Strength Training for Skeletal Muscle Adaptation After Stroke

7 juni 2018 bijgewerkt door: 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.

Studie Overzicht

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

38

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • Maryland
      • Baltimore, Maryland, Verenigde Staten, 21201
        • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

40 jaar tot 85 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

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
Experimenteel: 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.
Actieve vergelijker: 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

Wat meet het onderzoek?

Primaire uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 april 2009

Primaire voltooiing (Werkelijk)

31 augustus 2013

Studie voltooiing (Werkelijk)

6 juni 2018

Studieregistratiedata

Eerst ingediend

22 januari 2009

Eerst ingediend dat voldeed aan de QC-criteria

22 januari 2009

Eerst geplaatst (Schatting)

23 januari 2009

Updates van studierecords

Laatste update geplaatst (Werkelijk)

9 juli 2018

Laatste update ingediend die voldeed aan QC-criteria

7 juni 2018

Laatst geverifieerd

1 juni 2018

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • B6737-R
  • H30631 (Andere identificatie: Baltimore VAMC)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

Nee

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

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