Workout on Wheels Internet Intervention (WOWii)
Project Workout on Wheels Internet Intervention (WOWii): Summative Evaluation With Randomized Clinical Trial
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
This study will gather empirical evidence of the effectiveness of WOWii intervention in promoting changes in exercise behavior, fitness, and perceptions of exercise over the 16 week intervention as well as 2 months later for individuals living with SCI. The study staff will assess effectiveness by measuring participants (a) time spent each week doing aerobic exercise by self-report and objective monitoring, (b) aerobic capacity to assess fitness changes, and (c) self-reported perceptions of exercise barriers and self-efficacy at baseline, 4 months, and 6 months.
Participants will be randomly assigned to an experimental (WOWii) or a wait-list control group in one of four cohorts over a two-year period. This was an effective strategy in our previous trial in helping us achieve the full sample size. We will use a blocked randomization procedure to assure equal distribution of those with paraplegia and tetraplegia. Four cohorts will be enrolled over two years, with each having up to 36 people. This allows for up to 18 participants in the experimental and control groups, which permits us to offer two different time options for participants to attend the weekly meetings, as our video conferencing software allows up to 10 people to participate in the group video chat. Each cohort will be divided into two groups of 18 study participants as experimental and wait-list control groups. The experimental group will be divided into two groups of nine participants. Each cohort will begin the intervention at the same time and attend weekly calls together. All participants will undergo a pre-screen assessment which includes eligibility assessment. Participants will undergo 2 in-person fitness testing assessments at baseline at the end of the 16 week internet intervention with online meetings, before or during which they will complete an online survey and follow. A third follow up assessment will be conducted as an online survey at 6 months, which is 2 months after the intervention is complete, and an exit survey will be conducted individually over the phone after within one week of completing the final online survey. The wait-list control group will be offered the intervention at the end of the 6 month period. Due to low enrollment numbers, we will likely add a 5th cohort for enrollment.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Texas
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Dallas, Texas, Estados Unidos, 75246
- Baylor Institute for Rehabilitation
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Between the ages of 18 - 70 years old;
- Have SCI > 6 months with the ability to use arms enough for arm-based exercise and requires wheelchair use;
- Have access to a computer with internet access or if they do not have computer/internet access, have experience using a computer and going online;
- Obtain physician signed approval to participate in the exercise study; and
- Not be currently physically active, based on responses to the 7-item Behavioral Risk Factor Surveillance physical activity survey.
Exclusion Criteria:
- Not receive physician approval to begin an exercise program;
- Have participated in the previous pilot studies; and
- Unable to read the English language.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Intervenção
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Participants will self-monitor their exercise on the WOWii website, which has a page to record the type, duration, and intensity of daily exercise bouts. Two devices will track participants' exercise, a Polar heart rate monitor (RS300X, Polar®), which will provide data on the day, duration, and intensity (average and maximum) of aerobic activity and an ActiGraph accelerometer (model GT3X), which detects movement in three planes to indicate frequency and intensity of movement throughout the day. Experimental participants will be provided a Polar heart rate monitor to wear during each exercise bout for the entire length of the 6-month study, and exercise data will be collected weekly. Physiological outcomes on fitness will be assessed by measuring weight and aerobic capacity in a Cardiopulmonary Lab by a doctoral-trained physical therapist. Participants will complete surveys to report on their exercise self-efficacy and perceived barriers. |
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Sem intervenção: Wait-List Control
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in aerobic exercise (Participant adoption)
Prazo: 16 weeks
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minutes per week measured by Polar activity tracker (objective)
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16 weeks
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Aerobic exercise maintenance
Prazo: 16 weeks
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minutes per week measured by Polar activity tracker (objective)
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16 weeks
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Change in aerobic exercise (Participant adoption)
Prazo: Baseline & 16 weeks
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minutes per week measured by The International Physical Activity Questionnaire (IPAQ) (subjective)
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Baseline & 16 weeks
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Aerobic exercise maintenance
Prazo: 16 weeks
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minutes per week measured by The International Physical Activity Questionnaire (IPAQ) (subjective)
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16 weeks
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in aerobic fitness
Prazo: Baseline & 16 weeks
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peak V02 using continuous, graded arm crank protocol
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Baseline & 16 weeks
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Exercise Self-Efficacy
Prazo: 16 weeks
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health promotion scale with exercise subscale Self Rated Abilities for Health Practices Scale (SRAHP)
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16 weeks
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Change in perceived exercise barriers
Prazo: Baseline & 16 weeks
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Change in summary score of barriers on The Barriers to Health Activities among Disabled Persons scale (BHADP) from baseline to 16 weeks
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Baseline & 16 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Katherine Froehlich-Grobe, Ph.D., Baylor Institute for Rehabilitation
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 016-093
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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