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The Effects of a 6-week Balance, Agility, Strengthening Exercise Class

19 de março de 2020 atualizado por: Karen Dobbin, University of Manitoba

The Effects of a 6-week Balance, Agility, Strengthening Exercise (BASE) Class on Balance Performance, Self-Efficacy, and Fear of Falling in Cancer Survivors

Cancer treatments can have a significant impact on a cancer survivor's function and independence, and these patients can have twice the incidence of falls than their cancer-free peers. Balance programs of varying lengths have shown to improve balance performance, increase self-efficacy and decrease fear of falling; however, there are limited intervention studies amongst cancer survivors, and none that examine the combination of balance performance, self-efficacy and fear of falling. It is believed that this study will show that a 6-week Balance, Agility, Strengthening Exercise (BASE) Class is a sufficient time frame to demonstrate a positive effect on balance performance, self-efficacy, and fear of failing in cancer survivors, and will add to the body of knowledge in this population.

Visão geral do estudo

Status

Desconhecido

Condições

Descrição detalhada

Objectives Given that this combination of outcomes have not been sufficiently measured in the cancer population, and most balance and agility training programs are 12 weeks or more in length, the objectives of this study is to determine the effects of a 6-week intervention, the Balance, Agility, Strengthening Exercise (BASE) Class, on the balance performance, self-efficacy, and the fear of falling in cancer survivors.

Methods This study is a 3 year exercise interventional study, with 20 participants per year. In year one of the study, 20 participants will be enrolled in a 6-week Balance, Agility, Strengthening Exercise (BASE) Class. The pre-program data collection will include: demographic data; initial intake examination utilizing standard physiotherapy assessment of range of motion, flexibility, and strength; use of validated balance performance tools; and validated self-report surveys for balance confidence, fear of falling, and quality of life. The participants will attend the BASE class twice weekly for 6-weeks. The post-program data collection is to include the same outcome measures.

Subsequent years will be an observational study of the same design, enrolling 20 participants in year 2 and 3 for a 6-week BASE class. A total of 60 participants will be recruited over 3 years providing adequate power to assess program efficacy. Based on the resources available, this study can only accommodate 20 participants per year and can only be conducted for a 6-week period each year of the study.

Participants and recruitment Posters and hand bills will be distributed and placed throughout CancerCare recruiting participants for the study (self-referral). In addition, hand bills will provided for oncologists, oncology nurses, and psychosocial clinicians to give to patients/potential participants within the clinical areas at CancerCare. After receiving the hand bill with the study description and information, potential participants can choose to phone or e-mail the PI to indicate their interest in the study. A phone interaction will take place between the PI and potential participant to determine if they meet the inclusion criteria. Once it is determined that they meet the inclusion criteria, an in-person meeting will be arranged and they will be provided with the study's objectives, risks and benefits, and the consent document. Time will be allowed for the potential participant to ask questions and to consider their enrollment in the study. After a thorough discussion and review of the documents, the potential participant will be asked to sign the consent form. If requested, a person will be allowed to take the consent form home for further consideration prior to signing.

Data collection Prior to the start of the BASE Class, an initial assessment will take place. This assessment will utilize standard physiotherapy assessment of range of motion, flexibility, and strength; use of validated balance performance tools; and validated self-report surveys for balance confidence, fear of falling, and quality of life.

Intervention:

The BASE class will run twice weekly for 1.5 hours each session over a 6-week period and will include a 10-minute warm-up, 30 minutes of static and dynamic balance exercises, 20 minutes of lower extremity strengthening exercises, and a 10-minute cool-down. There will be weekly falls prevention and mobility enhancement education provided during the class.

Statistical Analysis Pre-post paired comparisons will be conducted for each balance performance and self-reported questionnaire measure. A paired T-test or Wilcoxon signed ranks test will be performed according to the observed distributions.

Tipo de estudo

Intervencional

Inscrição (Antecipado)

60

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.

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

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • community-dwelling
  • ambulatory
  • diagnosed with hematological or solid cancer tumors (except brain tumors/brain metastases)
  • age >18 years
  • self-identified as experiencing impaired balance, and scoring less than 80% on the Activities-specific Balance Confidence Scale
  • able to communicate in English

Exclusion Criteria:

  • metastatic cancer
  • those unable to provide informed consent
  • those having previously received physiotherapy and exercise instruction from the principal investigator.

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: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Interventional
Balance, Agility, Strengthening Exercise (BASE) class intervention - a 6-week exercise class to determine the change in balance performance, fear of falling and self-efficacy
The BASE class will be conducted twice weekly for 1.5 hours each session over a 6-week period and will include a 10-minute warm-up, 30 minutes of static and dynamic balance exercises, 20 minutes of lower extremity strengthening exercises, and a 10-minute cool-down. There will be weekly falls prevention and mobility enhancement education provided during the class.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Balance Performance - miniBest
Prazo: 1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class
Mini-Balance Evaluation Systems Test is a 14-item balance scale covering a broad spectrum of performance tasks including dynamic body stability, transfers, gait, variation of support surfaces, and of visual conditions, obstacle negotiation, reactions to external forces and performance during dual-tasking.
1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class
Balance Performane - TUG
Prazo: 1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class
Timed Up and Go: a rise from a chair, 3-meter walk, turn and walk back to chair and sitting. Designed to measure mobility, balance, and locomotor performance; evaluates falls risk and basic functional mobility.
1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class
Balance Performance - Timed Unipedal Stance Test
Prazo: 1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class
A simple test for measuring static aspects of balance ability, measured in seconds with eyes open and eyes closed; useful when combined with other balance performance tests.
1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class
Balance Performance - 6-meter Gait Speed Test
Prazo: 1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class
A 6-meter walking test measured in meters/second; an indicator of walking ability, function, and mobility.
1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class
Balance Performance - Four Square Step Test
Prazo: 1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class
A timed measurement of stepping whilst changing direction to provide a measure of dynamic standing balance and mobility; stepping forwards, sideways, and backwards over obstacles in a specified sequence.
1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Self-report ABC Scale
Prazo: 1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class
Activities-specific Balance Confidence Scale is a 16-item self-report questionnaire examining a person's confidence in a broad range of activities with various difficulties; to assess balance confidence in ambulatory community-dwelling older adults
1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class
Self-report MFES
Prazo: 1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class
Modified Fall Efficacy Scale International is a 15 question self-rated scale assessing a person's confidence in performing activities in the home, plus additional items related to outdoor activities.
1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class
self-report Fear of Falling
Prazo: 1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class
A 14 item scale that examines fear of falling and the effect it has on participation in various activities
1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class
Self-report Quality of Life FACT-G
Prazo: 1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class
Functional Assessment of Cancer Therapy - General is a 27-item self-report instrument that consists of 4 sub-scales: physical well-being, social well-being, emotional well-being, and functional well-being to measure quality of life for cancer patients.
1-2 weeks prior to BASE Class, change from baseline 1-2 weeks post BASE Class

Colaboradores e Investigadores

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

Patrocinador

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 (Antecipado)

6 de abril de 2020

Conclusão Primária (Antecipado)

30 de junho de 2022

Conclusão do estudo (Antecipado)

1 de janeiro de 2023

Datas de inscrição no estudo

Enviado pela primeira vez

17 de março de 2020

Enviado pela primeira vez que atendeu aos critérios de CQ

19 de março de 2020

Primeira postagem (Real)

24 de março de 2020

Atualizações de registro de estudo

Última Atualização Postada (Real)

24 de março de 2020

Última atualização enviada que atendeu aos critérios de controle de qualidade

19 de março de 2020

Última verificação

1 de março de 2020

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • H2019:470

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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