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A Home-based Intervention to Reduce Sedentary Behaviour and Improve Function After Stroke (STUFFS)

16 de fevereiro de 2018 atualizado por: University of Alberta

The Feasibility of a Home-based Transition Intervention to Reduce Sedentary Behaviour and Improve Function Within the First Six Months After Stroke: STand Up Frequently From Stroke Trial

The traditional approach to physical activity promotion in people with stroke has always emphasized activities of a moderate-to-vigorous intensity (i.e. moving enough to breathe fast and break a sweat). For many people with stroke who often have difficulty with walking, achieving that intensity of activity is difficult. The result is that people with stroke spend over 80% of their day in sedentary behaviours (too much sitting). A growing body of research shows that too much sitting has negative effects on health including larger waist circumference, unhealthy levels of blood glucose and insulin, heart disease, lower levels of functioning, and premature death.

This project tests a new approach to activity promotion that focuses on increasing light-intensity activity throughout the whole day while reducing sitting time. The new intervention is titled "STand Up Frequently From Stroke (STUFFS)" and is aimed at increasing self-confidence among people with stroke to sit less, stand up and walk around at frequent intervals during the day. Studies in the general population have shown that standing up and walking around frequently are beneficially associated with health indicators (lower waist circumference, lower blood fat and glucose levels). Encouraging people with stroke to reduce sitting and increase light-intensity activities appears feasible and sustainable and might be a first step to increase their daily energy expenditure.

Visão geral do estudo

Status

Concluído

Condições

Descrição detalhada

Background: Stroke is a leading cause of adult disability among Canadians, with about 405,000 individuals living with the effects of stroke and this number is expected to rise by 80% in the next 20 years [1]. Guidelines on activity promotion in people with stroke emphasize the attainment of 150 minutes of moderate-to-vigorous intensity activity per week [2].

Moving fast enough to 'break a sweat' is challenging for people with stroke who often have mobility deficits. Stroke survivors spend over 80% of their day in sedentary behaviours (too much sitting) [3-5]. Accumulating evidence indicates that sedentary behaviour has deleterious effects on health, regardless of exercise levels [6]. Targeting sedentary behaviour might be a feasible and sustainable way to change activity behaviour in people with stroke.

Purpose: This research aims to test the feasibility of a social cognitive theory-based intervention to reduce sedentary behaviour and improve light-intensity activity (such as standing and walking around frequently). The focus is on improving activity behaviour and will allow a systematic and staged reduction of contact with organised hospital care.

Methodological approach: Thirty-five persons with stroke will be enrolled. Outcomes including sedentary behaviour, physical activity and function will be measured at baseline (week 0), post-intervention (week 9) and follow-up (week 16). Activity behaviour (i.e. time sedentary, standing, and stepping) will be recorded for 7 days at each time point using activPAL activity monitor, validated in people with stroke [7]. Impairment from stroke will be assessed using Chedoke McMaster Stroke Assessment, which is a valid and reliable tool to measure impairment after stroke [8]. Cognitive status will be assessed using Montreal Cognitive Assessment scale, validated in stroke [9].

At the end of the intervention, feasibility outcomes such as reach (number enrolled / number eligible), retention (% enrolled who complete study), and satisfaction (exit interviews) with the program will be determined. Changes in sedentary, physical activity and functional outcomes across time (weeks 0, 9 and 16) will be tested.

Intervention: For the intervention, output from baseline activity monitoring (using activPAL activity monitor) will provide data on usual activity behaviour. Action plans targeting areas of high sedentary behaviour throughout the day will be developed. A wrist-worn activity Misfit monitor - a motivational tool that will track adherence to the intervention will be used throughout the intervention period (i.e. 8 weeks). This device provides activity feedback for the user in real time. A checklist will be used to address: 1) use of walking aids; 2) incidence of falls; 3) review and progression of home exercise program; and 4) quality of walking.

Analysis: Descriptive statistics will be used to summarize baseline data. Feasibility measurements (reach, retention, and satisfaction) will be evaluated as percentages. Changes in activity and functional outcomes across time (weeks 0, 9 and 16) will be tested using repeated measures analysis of variance (ANOVA). All analysis will be done with STATA and significance level set at P < 0.05.

Tipo de estudo

Intervencional

Inscrição (Real)

34

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

    • Alberta
      • Edmonton, Alberta, Canadá, T6G 2G4
        • University of Alberta

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:

  • ischemic or hemorrhagic stroke
  • within 1 month of discharge from hospital
  • able to stand up from a chair with or without gait aid and walk at least 5 metres
  • able to understand 2-step commands

Exclusion Criteria:

  • Have other neurological problems besides stroke or medically unstable.

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

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: STUFFS
Participants will undergo a sedentary behaviour intervention which includes breaking up prolonged sitting by standing and walking around for 5 minutes every half-hour, standing and walking during television commercial breaks, doing 2 sets of 10 sit-to-stand transitions three times per day, and going to the kitchen to grab some drink every hour. A wrist-worn Misfit activity monitor - a motivational tool that will track adherence to the intervention will be used throughout the intervention period (i.e. 8 weeks). This device which is commercially available provides activity feedback for the user in real time.
The intervention is based on socio-cognitive theory and focuses on building and increasing confidence (self-efficacy) to make a behaviour change. Output from the activity monitor (i.e. activPAL) will provide visual feedback of usual activity. Action plans targeting areas of high sedentary behaviour will be developed. A wrist-worn Misfit activity monitor is used as a self-monitoring tool throughout the intervention. This commercially available device provides activity information in real time, and sets daily targets for physical activity. A checklist will be used to address: 1) use of walking aids; 2) incidence of falls; 3) review and progression of home exercise program; and 4) quality of walking. The intervention visits will be conducted by a physical therapist.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Reach
Prazo: Follow-up (week 16)
Number enrolled divided by number eligible
Follow-up (week 16)
Retention
Prazo: Follow-up (week 16)
Percentage of those enrolled who completed the program
Follow-up (week 16)
Satisfaction with program
Prazo: Post-intervention (week 9)
Post-intervention interviews will be conducted to assess satisfaction with the program, participants' satisfaction as a percentage will be determined.
Post-intervention (week 9)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in sedentary time
Prazo: baseline - week 0 (within one month of discharge from inpatient rehab), week 9 (post-intervention), week 16 (follow-up)
To assess change in accelerometer-derived sedentary time from baseline to post-intervention and follow-up periods
baseline - week 0 (within one month of discharge from inpatient rehab), week 9 (post-intervention), week 16 (follow-up)
Change in standing time
Prazo: baseline - week 0 (within one month of discharge from inpatient rehab), week 9 (post-intervention), week 16 (follow-up)
To assess change in accelerometer-derived standing time from baseline to post-intervention and follow-up periods
baseline - week 0 (within one month of discharge from inpatient rehab), week 9 (post-intervention), week 16 (follow-up)
Change in stepping time
Prazo: baseline - week 0 (within one month of discharge from inpatient rehab), week 9 (post-intervention), week 16 (follow-up)
To assess change in accelerometer-derived stepping time from baseline to post-intervention and follow-up periods
baseline - week 0 (within one month of discharge from inpatient rehab), week 9 (post-intervention), week 16 (follow-up)
Change in number of sit-to-stand transitions
Prazo: baseline - week 0 (within one month of discharge from inpatient rehab), week 9 (post-intervention), week 16 (follow-up)
To assess change in accelerometer-derived number of sit-to-stand transitions from baseline to post-intervention and follow-up periods
baseline - week 0 (within one month of discharge from inpatient rehab), week 9 (post-intervention), week 16 (follow-up)
Change in resting blood pressure
Prazo: baseline - week 0 (within one month of discharge from inpatient rehab), week 9 (post-intervention), week 16 (follow-up)
To assess change in systolic and diastolic blood pressure from baseline to post-intervention and follow-up periods
baseline - week 0 (within one month of discharge from inpatient rehab), week 9 (post-intervention), week 16 (follow-up)
Change in waist circumference
Prazo: baseline - week 0 (within one month of discharge from inpatient rehab), week 9 (post-intervention), week 16 (follow-up)
To assess change in waist circumference from baseline to post-intervention and follow-up periods
baseline - week 0 (within one month of discharge from inpatient rehab), week 9 (post-intervention), week 16 (follow-up)
Change in gait speed
Prazo: baseline - week 0 (within one month of discharge from inpatient rehab), week 9 (post-intervention), week 16 (follow-up)
To assess change in walking speed from baseline to post-intervention and follow-up periods
baseline - week 0 (within one month of discharge from inpatient rehab), week 9 (post-intervention), week 16 (follow-up)
Change in self-efficacy scale
Prazo: baseline - week 0 (within one month of discharge from inpatient rehab), week 9 (post-intervention), week 16 (follow-up)
To assess change in self-efficacy using Multidimensional Self-Efficacy Scale (MSES) over time from baseline to post-intervention and follow-up periods
baseline - week 0 (within one month of discharge from inpatient rehab), week 9 (post-intervention), week 16 (follow-up)
Change in Quality-of-Life scale
Prazo: baseline - week 0 (within one month of discharge from inpatient rehab), week 9 (post-intervention), week 16 (follow-up)
To assess change in quality of life using Stroke Impact Scale from baseline to post-intervention and follow-up
baseline - week 0 (within one month of discharge from inpatient rehab), week 9 (post-intervention), week 16 (follow-up)
Change in lower extremity impairment
Prazo: baseline - week 0 (within one month of discharge from inpatient rehab), week 9 (post-intervention), week 16 (follow-up)
To assess change in lower extremity impairment using Chedoke McMaster Stroke Assessment for leg and foot over time from baseline to post-intervention and follow-up periods
baseline - week 0 (within one month of discharge from inpatient rehab), week 9 (post-intervention), week 16 (follow-up)
Change in cognitive scale
Prazo: baseline - week 0 (within one month of discharge from inpatient rehab), week 9 (post-intervention), week 16 (follow-up)
To assess change in cognition using Montreal Cognitive Assessment scale from baseline to post-intervention and follow-up periods
baseline - week 0 (within one month of discharge from inpatient rehab), week 9 (post-intervention), week 16 (follow-up)

Colaboradores e Investigadores

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

Patrocinador

Investigadores

  • Investigador principal: Patricia Manns, PT, PhD, University of Alberta
  • Diretor de estudo: Victor Ezeugwu, PT, MSc, University of Alberta

Publicações e links úteis

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Publicações Gerais

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

1 de agosto de 2016

Conclusão Primária (Real)

1 de agosto de 2017

Conclusão do estudo (Real)

1 de janeiro de 2018

Datas de inscrição no estudo

Enviado pela primeira vez

25 de novembro de 2016

Enviado pela primeira vez que atendeu aos critérios de CQ

29 de novembro de 2016

Primeira postagem (Estimativa)

2 de dezembro de 2016

Atualizações de registro de estudo

Última Atualização Postada (Real)

20 de fevereiro de 2018

Última atualização enviada que atendeu aos critérios de controle de qualidade

16 de fevereiro de 2018

Última verificação

1 de fevereiro de 2018

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

Data related to activPAL sedentary and activity monitoring might be shared with supervisors and other researchers

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