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Overcoming TWEAK Signaling to Restore Muscle and Mobility After Joint Replacement (TWEAK)

3 de julho de 2021 atualizado por: Marcas M. Bamman, PhD, University of Alabama at Birmingham
This single-blind, randomized, controlled trial is designed to test the effect of an intensive, 16 week exercise rehabilitation program (progressive resistance training + functional mobility training) vs. usual care on restoration of muscle mass and mobility after total hip (THA) or knee (TKA) arthroplasty in men and women with end-stage osteoarthritis. The molecular basis underlying the trial is the presence of significant muscle inflammation susceptibility in many of these individuals, and the expectation that the more intensive intervention will overcome this inflammatory burden to facilitate recovery.

Visão geral do estudo

Status

Concluído

Condições

Descrição detalhada

While elective total hip (THA) and knee (TKA) arthroplasty relieve pain and improve mobility function for thousands with end-stage osteoarthritis (OA), up to 35% endure persistent muscle atrophy and mobility limitations for several years that impact life quality, increase morbidity, and burden the healthcare system. Given that THA/TKA volumes are increasing exponentially with >1.1 million in the US annually, refractory mobility impairment is a major public health problem. Together, the available data raise two important knowledge gaps in THA/TKA rehabilitation: (i) poorly understood factors that limit responsiveness of a large number of patients to current usual care; and (ii) the absence of rehabilitation programs proven to overcome these limitations. The proposed project is designed to fill these gaps. The investigators' fundamental tenet is that restoration of mobility function following THA/TKA requires: (i) regeneration of surgically damaged muscle; and (ii) regrowth of muscles that have atrophied over years of OA and limited usage. The investigators suggest a major cause of muscle regeneration impairment in some individuals is what the investigators identified as muscle inflammation susceptibility (MuIS) - hyperactive inflammatory signaling in muscle of MuIS(+) individuals despite no systemic inflammation - which also manifests in isolated primary satellite cells and inhibits myogenesis in vitro, indicative of a true cellular phenotype beyond the niche. The investigators' preliminary findings in THA/TKA patients strongly suggest the tumor necrosis factor-like weak inducer of apoptosis (TWEAK) signaling pathway may be central to MuIS and impaired THA/TKA recovery, as high perioperative muscle TWEAK signaling in the ipsilateral thigh was the most sensitive indicator of impaired muscle protein synthesis and failed strength recovery after 8 wk of usual care. Progressive resistance exercise training (PRT) is a putative anabolic intervention that the investigators find consistently increases muscle mass to meet healthy standards in atrophied and mobility-impaired adults, by activating muscle protein synthesis and the myogenic activity of muscle satellite cells. Together, these findings raise the central hypothesis that PRT plus adjunctive functional mobility training (PRT+FM) after THA/TKA will more effectively restore muscle mass and mobility function to healthy standards than usual care and, because MuIS(+) are predicted to suffer failed muscle recovery and persistent dismobility under usual care, the impact of PRT+FM will be greatest in MuIS(+). The investigators will thoroughly test this hypothesis in a randomized controlled trial of 88 THA/TKA patients with the following aims. Aim 1: To determine the effects of 16 wk of PRT+FM vs. usual care after elective THA/TKA on muscle mass, performance, and mobility function. Aim 2: To determine whether MuIS status modifies the effects of PRT+FM or usual care after THA/TKA. Cellular and molecular mechanisms of muscle mass regulation will be studied in detail. Aim 3. To determine the long-term impact of 16 wk PRT+FM by re-assessing outcomes at 6 mo and 1 y. The investigators fully expect the novel findings to lead a paradigm shift in THA/TKA rehabilitation that will have a profound impact on a growing segment of the population.

Tipo de estudo

Intervencional

Inscrição (Real)

80

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • Alabama
      • Birmingham, Alabama, Estados Unidos, 35205
        • UAB Center for Exercise Medicine

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

40 anos a 80 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Between the ages 40 and 80 y.

    • Scheduled to undergo elective total hip or knee replacement specifically for the surgical indication of end-stage osteoarthritis.
    • First-time hip or knee replacement.
    • Capable of providing informed consent (cognitively intact if consenting to surgery).

Exclusion Criteria:

  • Any surgical indication other than first-time total joint replacement specifically for end-stage osteoarthritis.

    • Bilateral knee/ hip replacement
    • History of alcoholism or liver disease.
    • Any history of hypo- or hyper-coagulation disorders including subjects taking Coumadin.
    • Any individual with end-stage disease and/or a life expectancy less than one year.
    • Pregnancy.
    • Lactating Women.
    • Neurological, musculoskeletal, or other disorder that would preclude them from completing the exercise training intervention and all performance tests.
    • Uncontrolled hypertension, unstable or exercise-induced angina pectoris or myocardial ischemia, congestive heart failure.
    • Uncontrolled diabetes mellitus.
    • Any other condition or events considered exclusionary by the PIs and/or physician Co-Is.
    • Lidocaine allergy (1% lidocaine is the local anesthetic used during the muscle biopsy procedure).
    • Phenylketonuria (phenylalanine tracer for metabolic studies).
    • Currently receiving androgen (e.g., testosterone) or anabolic (e.g., growth hormone (GH), insulin-like growth factor-I (IGF-I)) therapy.
    • Body mass index ≥ 35.
    • History of lower body progressive resistance training within the past year.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: PRT + FM
Progressive resistance training + functional mobility training 3 d/wk x 16 wk
Supervised progressive resistance training + functional mobility training (PRT+FM) 3 days per week for 16 weeks post-surgery.
Post-surgical usual care activities including any prescribed physical therapy
Comparador Ativo: Usual Care
Post-surgical usual care including physical therapy
Post-surgical usual care activities including any prescribed physical therapy

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in unilateral (surgical) thigh muscle mass (unit of measure = grams)
Prazo: Pre-surgery to 16 weeks post-surgery
Primary muscle mass outcome of Aim 1
Pre-surgery to 16 weeks post-surgery
Change in unilateral (surgical) knee extension power (unit of measure = watts)
Prazo: Pre-surgery to 16 weeks post-surgery
Primary functional outcome of Aim 1
Pre-surgery to 16 weeks post-surgery
Change in short physical performance battery (SPPB) (unit of measure = score)
Prazo: From 16 weeks post-surgery to 26 and 52 weeks post-surgery
Primary outcome of Aim 3
From 16 weeks post-surgery to 26 and 52 weeks post-surgery
Muscle inflammation susceptibility (MuIS) status (unit of measure = relative value)
Prazo: At the time of surgery
Primary outcome of Aim 2: Muscle inflammation susceptibility (MuIS) defined by TWEAK receptor gene expression
At the time of surgery

Medidas de resultados secundários

Medida de resultado
Prazo
Change in muscle fiber size (unit of measure = micrometers squared)
Prazo: From the time of surgery to 16 weeks post-surgery
From the time of surgery to 16 weeks post-surgery
Change in unilateral (surgical) knee extension isometric strength (unit of measure = Newton-meters)
Prazo: Pre-surgery to 16 weeks post-surgery
Pre-surgery to 16 weeks post-surgery
Change in maximum 10-meter gait speed (unit of measure = meters per second)
Prazo: Pre-surgery to 16 weeks post-surgery
Pre-surgery to 16 weeks post-surgery

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Change in free-living physical activity (unit of measure = steps per day)
Prazo: Pre-surgery to 8, 16, 26, and 52 weeks post-surgery
Via wearable technology (i.e. step counter)
Pre-surgery to 8, 16, 26, and 52 weeks post-surgery
Change in self-reported health status (unit of measure = score)
Prazo: Pre-surgery to 1, 8, 16, 26, and 52 weeks post-surgery
Via Short Form-36v2 Health Survey (SF-36v2)
Pre-surgery to 1, 8, 16, 26, and 52 weeks post-surgery
Change in cellular and molecular markers (unit of measure = arbitrary units)
Prazo: From the time of surgery to 16 weeks post-surgery
Experiments using muscle tissue and primary muscle satellite cells collected from surgical and contralateral limbs.
From the time of surgery to 16 weeks post-surgery
Change in fatigue (unit of measure = score)
Prazo: Pre-surgery to 1, 8, 16, 26, and 52 weeks post-surgery
Via Patient Reported Outcomes Measurement Information System (PROMIS)
Pre-surgery to 1, 8, 16, 26, and 52 weeks post-surgery
Change in pain (unit of measure = score)
Prazo: Pre-surgery to 1, 8, 16, 26, and 52 weeks post-surgery
Via Patient Reported Outcomes Measurement Information System (PROMIS)
Pre-surgery to 1, 8, 16, 26, and 52 weeks post-surgery
Change in depression (unit of measure = score)
Prazo: Pre-surgery to 1, 8, 16, 26, and 52 weeks post-surgery
Beck Depression Inventory (BDI II)
Pre-surgery to 1, 8, 16, 26, and 52 weeks post-surgery
Change in fatigue severity (unit of measure = score)
Prazo: Pre-surgery to 1, 8, 16, 26, and 52 weeks post-surgery
Fatigue Severity Scale (FSS)
Pre-surgery to 1, 8, 16, 26, and 52 weeks post-surgery

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Marcas M Bamman, PhD, University of Alabama at Birmingham
  • Investigador principal: S Louis Bridges, MD, PhD, University of Alabama at Birmingham

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de outubro de 2015

Conclusão Primária (Real)

1 de setembro de 2020

Conclusão do estudo (Real)

28 de fevereiro de 2021

Datas de inscrição no estudo

Enviado pela primeira vez

5 de agosto de 2015

Enviado pela primeira vez que atendeu aos critérios de CQ

10 de dezembro de 2015

Primeira postagem (Estimativa)

11 de dezembro de 2015

Atualizações de registro de estudo

Última Atualização Postada (Real)

7 de julho de 2021

Última atualização enviada que atendeu aos critérios de controle de qualidade

3 de julho de 2021

Última verificação

1 de julho de 2021

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • R01HD084124 (Concessão/Contrato do NIH dos EUA)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

INDECISO

Descrição do plano IPD

Data might be provided on written request in aggregate form.

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