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Intervenções de teste para mobilidade por meio de exercícios (TIME) (TIME)

1 de outubro de 2026 atualizado por: Christopher Sciamanna, MD, MPH, Milton S. Hershey Medical Center

PCORI-HA-2021C3-25041 Eficácia comparativa de exercícios breves de força e equilíbrio e exercícios de grupo domiciliares padrão para pacientes de cuidados primários com incapacidade de mobilidade

In this project, the team plans to test the impact of FAST, its brief home-based strength training program which includes performance goal setting, to a program for home (BAND TOGETHER) that is similar to one offered by Silver Sneakers, available online to millions of older adults, and includes strength, balance, and aerobic exercises. The team hypothesizes that the brief program (FAST) will improve leg function better than the standard program (BAND TOGETHER), by encouraging older adults to be more consistent with using it and to try harder when they do.

Visão geral do estudo

Descrição detalhada

One in four older adults, the fastest growing demographic group in the US, reports serious difficulty walking or climbing stairs. Older adults note that these walking difficulties "deprives you of your identity" and "affects my day to day life… I can't do very much work on my own." Walking difficulties impair people's quality of life more than depression, anxiety, or pain. Walking difficulties also increase the chances of future disability, death, and healthcare costs. Though strength training improves walking ability, fewer than one in five older adults do strength training enough to benefit. What is unknown is how to create a strength training program that improves the ability of older adults to walk and do other things they need and want to do and that older adults are willing to do.

One approach to designing a strength training program that has not been tried before is to make them shorter. In 2020, the project team set out to design a short strength training program that older adults could do at home that would improve their physical function and that they would consistently do. The program was called FAST (Functional Activity Strength Training) and, to make it more effective, the team set specific goals for how many additional repetitions each person should be able to do over 12 weeks. These goals were then mentioned repeatedly, and feedback was provided about how well people made progress toward these goals.

In the first study of FAST (FAST-1), 24 healthy older adults performed 30 seconds of squats and push-ups each day but received no personal supervision. Over six months, they performed the exercises on 73 percent of days, which led to large increases in the number of push-ups and squats they were able to do. In the second study of FAST (FAST-2), the team randomly assigned 97 older adults who had trouble walking, and those assigned to do 30 seconds each of chair stands and steps onto a stepper each day improved their ability to stand up from a chair and stand on one leg more than those who did not do the exercises.

In this project, the team plans to test the impact of FAST, its brief home-based strength training program which includes performance goal setting, to a program for home (BAND TOGETHER) that is similar to one offered by Silver Sneakers, available online to millions of older adults, and includes strength, balance, and aerobic exercises. The team hypothesizes that the brief program (FAST) will improve leg function better than the standard program (BAND TOGETHER), by encouraging older adults to be more consistent with using it and to try harder when they do.

This study will enroll 520 primary care patients who are at least 65 years of age and randomly assign them to have access to 12 months of daily FAST or three-times weekly BAND TOGETHER. Each program will be delivered via the internet and each patient will receive about 30 minutes per month of personal support. The study will enroll patients who have trouble walking, have access to the internet, can provide informed consent, and receive permission from their doctor. The study is designed to see whether patients who have access to FAST, after 12 months, have better walking ability, balance, and leg strength and can do their normal daily activities more easily and fall less often than patients who have access to BAND TOGETHER.

To help us understand how best to perform the study, as well as how best to share the results, the study team assembled a group of stakeholders that includes patients, primary care providers, fitness center directors, and people who work for insurance, public health, and senior services organizations. The team will bring those stakeholders together each year and consult them regularly to help make difficult decisions as they arise-decisions that may impact each group of stakeholders differently. Two patient partners will work with investigators to supervise the group of stakeholders and organize their feedback, structured as a public comment period, to help the research team make decisions that take into account the perspectives of all of the key groups of stakeholders involved in improving the physical function of older adults.

Tipo de estudo

Intervencional

Inscrição (Real)

702

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

    • Pennsylvania
      • Hershey, Pennsylvania, Estados Unidos, 17033
        • Penn State College of 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

65 anos e mais velhos (Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Age greater than or equal to 65
  • Self reported difficulty or inability to walk 1/4/ mile
  • Access to the Internet
  • Covid vaccination

Exclusion Criteria:

  • Chest pain on the PAR-Q
  • Participating in another research project involving physical activity, falls or weight loss
  • Planning to move or have surgery in the next 12 months
  • Cognitive impairment

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: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: FAST-BCT

FAST exercise intervention without behavior change techniques applied. Daily exercise intervention including functional resistance training and personalized coaching.

Daily exercise intervention including functional resistance exercises and personalized coaching.

Experimental: FAST+BCT

FAST exercise intervention with behavior change techniques applied. Daily exercise intervention including functional resistance training and personalized coaching with added reminders, education, goal setting, self monitoring, and feedback to encourage adherence and effort.

Daily exercise intervention including functional resistance exercises and personalized coaching.

Reminders, education, goal-setting, self-monitoring, and feedback used to encourage participants to increase effort and adherence

Comparador Ativo: BT-BCT

Band Together exercise intervention without behavior change techniques applied. 3 times weekly group exercise intervention held over Zoom featuring strength and balance exercises for 45 minutes.

3 times weekly group exercise over Zoom featuring strength and balance exercises for 45 minutes

Comparador Ativo: BT+BCT

Band Together exercise intervention with behavior change techniques applied. 3 times weekly group exercise intervention held over Zoom featuring strength and balance exercises for 45 minutes with added reminders, education, goal setting, self monitoring, and feedback to encourage adherence and effort.

Reminders, education, goal-setting, self-monitoring, and feedback used to encourage participants to increase effort and adherence

3 times weekly group exercise over Zoom featuring strength and balance exercises for 45 minutes

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Physical Function
Prazo: 12 Months

Patient-Reported Outcomes Measurement Scale (PROMIS-29). The minimum and maximum values are unable to do and without any difficulty, and a higher score means a better outcome.

12 Months

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Lower Extremity Performance
Prazo: 12 Months

Short Physical Performance Battery. The minimum value is a score of 0 points, the maximum value is a score of 16. A higher score means a better outcome.

12 Months
Dose Received
Prazo: Through study completion, an average of 1 year

Sessions completed per week (percent)

Through study completion, an average of 1 year
Effort (Rating of Perceived Exertion)
Prazo: Monthly up to 12 months

Rating of Perceived Exertion. The minimum value is 0 (at rest) and the maximum value is 10 (maximal). This is a purely subjective measure here a higher or lower score doesn't necessarily lead to a better outcome, but for our exercise study we have a target RPE of 5 for exercise.

Monthly up to 12 months
Gait Speed (10 meter walk test)
Prazo: 12 Months

Gait Speed (10 meter walk test). Participants undergo two trials (comfortable speed and fast speed), and an average of the two trials is used as the gait speed in m/s.

12 Months
Muscle Strength
Prazo: 12 Months

Upper and lower extremity strength

12 Months
Walking Ability
Prazo: 12 Months

6 Minute Walk Distance

12 Months
Fatigue, Pain
Prazo: 12 Months

Patient Reported Outcomes Measurement Scale (PROMIS-29). The minimum value for the fatigue scales is "not at all", the maximum value is "very much". A lower score means a better outcome. The minimum values for the pain scales are "not at all" and 0, the maximum values "very much" and 10. A lower value means a better outcome.

12 Months
Falls
Prazo: 12 Months

Percent experiencing a fall-related injury

12 Months
Physical Activity
Prazo: 12 months

Accelerometry over 7 days

12 months
Number of participants with a self-reported injury due to physical activities
Prazo: Monthly up to 12 months

Injuries due to physical activities

Monthly up to 12 months
Program Satisfaction
Prazo: Monthly up to 12 months

Net Promoter Score. The maximum value is 10 and the minimum value is 0. A higher value means a better outcome.

Monthly up to 12 months

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Body Weight (kg)
Prazo: 12 Months

Body Weight (kg)

12 Months
Height (cm)
Prazo: 12 Months

Height (cm)

12 Months
Sociodemographics, self-reported medical history and tobacco use
Prazo: Baseline

Age, gender, race and ethnicity, medical history, smoking status, and education

Baseline
Caregiving Status Questions (Receiving and Providing)
Prazo: Monthly up to 12 months

Giving and receiving caregiving, paid or unpaid, for personal care needs, such as eating, bathing, dressing, or getting around inside the home.

Monthly up to 12 months

Colaboradores e Investigadores

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

Publicações e links úteis

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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)

27 de julho de 2023

Conclusão Primária (Estimado)

1 de dezembro de 2026

Conclusão do estudo (Estimado)

1 de janeiro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

12 de janeiro de 2023

Enviado pela primeira vez que atendeu aos critérios de CQ

2 de fevereiro de 2023

Primeira postagem (Real)

13 de fevereiro de 2023

Atualizações de registro de estudo

Última Atualização Postada (Real)

5 de outubro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

1 de outubro de 2026

Última verificação

1 de outubro de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • HA-2021C3-25041
  • PCORI-HA-2021C3-25041 (Outro identificador: PCORI)

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

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