Active for Life Assisted Living Feasibility and Acceptability Study
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Sedentary behavior (SB) is an emerging health risk, especially for older adults, as it is associated with chronic disease, loss of function, and increased disability and frailty. Older adults in assisted living (AL) are less active than their peers living independently. Recent evidence demonstrates there are substantial health benefits from light physical activity (LPA) and the newly published Physical Activity Guidelines for Americans recommends that older adults replace SB with LPA. An intervention to increase LPA and reduce SB has potential to reduce health risks, slow functional decline and frailty, and delay residents' needs for higher-level care such as a nursing home. We propose to test the feasibility and acceptability of a self-efficacy based intervention, "Active for Life," with the goal of increasing PA and decreasing SB of AL residents.
Active for Life is a 12 week intervention. Key components include (a) exercise with functional circuit training (FCT), walking, and stretching, (b) a behavioral component with a structured self-efficacy enhancing intervention that includes self-regulation strategies, and (c) education that addresses principles of exercise, the distinct health benefits of LPA, the negative consequences of too much sedentary time, and strategies for overcoming barriers to physical activity. It is important to test the feasibility and acceptability of the intervention for AL residents because this population will be more frail than previously tested populations. The intervention has been modified to be appropriate for AL residents based on guidance from AL experts and individual interviews conducted with AL residents. We will enroll 27 participants from approximately four AL facilities. Outcomes will be measured at baseline and at conclusion of the intervention. The primary outcomes are feasibility and acceptability of the intervention, but we will also examine preliminary evidence of outcome measures of objectively-measured sedentary behavior and physical activity, self-efficacy for exercise, value of physical activity, self-rated health, physical function, anxiety, depression, pain interference, and fatigue. This study is innovative because there are no well-established evidence-based interventions to promote PA in the AL setting and none that focus on increasing LPA and decreasing SB.
Tipo de estudo
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109
- University of Michigan School of Nursing
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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:
- Residing in assisted living facility
- Inactive (performing moderate level activities for less than 30 min./day, 5 day/week or not performing muscle strengthening activities twice/week) or a desire to increase physical activity
- Score of at least 3 on the Mini-Cog cognitive screening
Exclusion Criteria:
- Mobility issues that prevent participation in PA, such as if they rely on a wheelchair or motorized scooter (not excluded if they require an assistive device such as a cane or walker)
- Hospitalization in the previous month
- Skin on the thigh where ActivPAL monitor would be placed is not intact (has lesions, signs of infection, rash, or skin breakdown)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Active for Life
The Active Life intervention includes structured walking, functional circuit training, stretching and behavior/educational components.
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Each intervention session will take place within the assisted living facility twice a week for 12 weeks. Sessions will begin with 5-10 minutes of walking in the hallway. Participants will be encouraged to walk at their own pace and allowed to take breaks if needed. Next, behavioral strategies based on the construct of self-efficacy from social cognitive theory and education about physical activity will be delivered. This component is scheduled between the walking and circuit training, lasts 15-20 minutes, and serves as a rest period. Circuit training will focus on strength and balance. Approximately 8 exercise stations will be set up, and the exercises performed at each station will be changed approximately every 4 weeks. The circuit training will last ~30-40 minutes, with participants moving from one station to the next at their own pace and taking breaks in between. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Feasibility: Number of participants screened
Prazo: After completion of the 12 week intervention
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Several measures will be used to describe the feasibility of the intervention.
We will calculate how many participants volunteered to be screened for participation in the study.
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After completion of the 12 week intervention
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Feasibility: Number of participants eligible
Prazo: After completion of the 12 week intervention
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Several measures will be used to describe the feasibility of the intervention.
We will calculate how many participants met eligibility criteria for study participation.
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After completion of the 12 week intervention
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Feasibility: Numbers of participants ineligible by each eligibility criterion
Prazo: After completion of the 12 week intervention
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Several measures will be used to describe the feasibility of the intervention.
We will summarize reasons that participants were ineligible for study participation by adding up the number of people who don't meet each specific eligibility criterion.
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After completion of the 12 week intervention
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Feasibility: Number of participants who enroll
Prazo: After completion of the 12 week intervention
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Several measures will be used to describe the feasibility of the intervention.
We will calculate how many eligible participants decide to enroll in the study.
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After completion of the 12 week intervention
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Feasibility: Length of time for recruitment activities
Prazo: After completion of the 12 week intervention
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Several measures will be used to describe the feasibility of the intervention.
We will calculate how much time is spent to recruit the study sample.
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After completion of the 12 week intervention
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Feasibility: Percentage of activity sessions attended by participants
Prazo: After completion of the 12 week intervention
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Several measures will be used to describe the feasibility of the intervention.
We will calculate the percentage of activity sessions that participants attended.
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After completion of the 12 week intervention
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Feasibility: Participant retention rates
Prazo: After completion of the 12 week intervention
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Several measures will be used to describe the feasibility of the intervention.
We will calculate retention rates of how many participants started and how many completed the study.
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After completion of the 12 week intervention
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Feasibility: Documentation of stated reasons for participant dropout
Prazo: After completion of the 12 week intervention
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Several measures will be used to describe the feasibility of the intervention.
We will document stated reasons for dropout from the study as much as we are able.
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After completion of the 12 week intervention
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Feasibility: Injuries and adverse events
Prazo: After completion of the 12 week intervention
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Several measures will be used to describe the feasibility of the intervention.
We will summarize any adverse events/injuries that occur during the study.
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After completion of the 12 week intervention
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Feasibility: Rates of missing or unusable data
Prazo: After completion of the 12 week intervention
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Several measures will be used to describe the feasibility of the intervention.
We will summarize how much data are missing from baseline, mid-intervention, and post-intervention data collections.
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After completion of the 12 week intervention
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Feasibility: Time required to complete outcome measures
Prazo: After completion of the 12 week intervention
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Several measures will be used to describe the feasibility of the intervention.
We will keep record of how long each data collection session takes and calculate average length of data collection at both baseline and post-intervention.
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After completion of the 12 week intervention
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Acceptability: Exit interviews
Prazo: After completion of the 12 week intervention
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Semi-structured exit interviews will ask questions related to acceptability of the intervention, such as how participants felt about the overall intervention and its specific components, whether the time commitment was reasonable, whether assisted living staff were supportive of their participation and goals, and any suggestions for future improvements.
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After completion of the 12 week intervention
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Acceptability: Final acceptability scale
Prazo: After completion of the 12 week intervention
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This scale consists of 13 questions related to participants' overall satisfaction with the intervention and its components.
Higher score indicates greater intervention acceptability.
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After completion of the 12 week intervention
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Time spent in sedentary behavior and physical activity
Prazo: 7 days of data are gathered at baseline at after the 12 week intervention.
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ActivPAL monitor will measure time spent sitting/lying, standing, and stepping for 7 consecutive days at each measurement.
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7 days of data are gathered at baseline at after the 12 week intervention.
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Self-efficacy for exercise
Prazo: Measured at baseline, three weeks, and after 12 week intervention.
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Exercise self-efficacy- 9 items.
Potential range of scores is 0 to 90.
Higher score indicates higher self-efficacy for exercise.
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Measured at baseline, three weeks, and after 12 week intervention.
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Value of Physical Activity
Prazo: Measured at baseline and after 12 week intervention.
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Single item asking "How important is physical activity in your life?" with a Likert response scale ranging from 1 to 5. Higher score will indicate greater importance of physical activity
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Measured at baseline and after 12 week intervention.
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Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health
Prazo: Measured at baseline and after 12 week intervention.
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Physical, social, and mental health- 10 items.
Scores are calculated as T-scores with a mean = 50 and standard deviation = 10.
Low scores indicate low global health and higher scores indicate higher global health.
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Measured at baseline and after 12 week intervention.
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PROMIS Physical Functioning
Prazo: Measured at baseline and after 12 week intervention.
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Physical function scale- measured with computer adaptive testing.
Scores are calculated as T-scores with a mean = 50 and standard deviation = 10.
Low scores indicate low physical function and higher scores indicate higher physical function.
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Measured at baseline and after 12 week intervention.
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PROMIS Anxiety
Prazo: Measured at baseline and after 12 week intervention.
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General experience with anxious moods- measured with computer adaptive testing.
Scores are calculated as T-scores with a mean = 50 and standard deviation = 10.
Low scores indicate low anxiety and higher scores indicate higher anxiety.
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Measured at baseline and after 12 week intervention.
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PROMIS Depression
Prazo: Measured at baseline and after 12 week intervention.
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General experience with depressed moods- measured with computer adaptive testing.
Scores are calculated as T-scores with a mean = 50 and standard deviation = 10.
Low scores indicate low depression and higher scores indicate higher depression.
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Measured at baseline and after 12 week intervention.
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PROMIS Fatigue
Prazo: Measured at baseline and after 12 week intervention.
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General experience of fatigue- measured with computer adaptive testing.
Scores are calculated as T-scores with a mean = 50 and standard deviation = 10.
Low scores indicate low fatigue and higher scores indicate higher fatigue.
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Measured at baseline and after 12 week intervention.
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PROMIS Pain Interference
Prazo: Measured at baseline and after 12 week intervention.
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Extent to which pain interferes with functioning- measured with computer adaptive testing.
Scores are calculated as T-scores with a mean = 50 and standard deviation = 10.
Low scores indicate low pain interference and higher scores indicate higher pain interference.
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Measured at baseline and after 12 week intervention.
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Positive and Negative Social Influences on PA in Older Adults
Prazo: Measured at baseline and after 12 week intervention.
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Support from family and friends for being physically active.
The questionnaire has 27 items (15 items describing positive social influence and 12 items describing negative social influence).
The potential range of scores for positive social influence is 0 to 180 and the potential range of scores for negative social influence is 0 to 144.
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Measured at baseline and after 12 week intervention.
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Acceptability: Mid-point acceptability scale
Prazo: Measured at 6-weeks (mid-point of intervention)
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This scale consists of 3 questions related to acceptability of intervention delivery.
Higher score indicates greater intervention acceptability.
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Measured at 6-weeks (mid-point of intervention)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Janet L Larson, PhD, RN, University of Michigan School of Nursing
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Antecipado)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
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
Outros números de identificação do estudo
- HUM00175558
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