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Completed

NCT Number: NCT02980744

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta

Edmonton, Alberta, T6G 2G4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sedentary Behaviour Intervention

Behavioral

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.

Primary outcomes

  1. Reach

    Time frame: Follow-up (week 16)

    Number enrolled divided by number eligible

  2. Retention

    Time frame: Follow-up (week 16)

    Percentage of those enrolled who completed the program

  3. Satisfaction with program

    Time frame: Post-intervention (week 9)

    Post-intervention interviews will be conducted to assess satisfaction with the program, participants' satisfaction as a percentage will be determined.

Secondary outcomes

  1. Change in sedentary time

    Time frame: 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

  2. Change in standing time

    Time frame: 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

  3. Change in stepping time

    Time frame: 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

  4. Change in number of sit-to-stand transitions

    Time frame: 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

  5. Change in resting blood pressure

    Time frame: 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

  6. Change in waist circumference

    Time frame: 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

  7. Change in gait speed

    Time frame: 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

  8. Change in self-efficacy scale

    Time frame: 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

  9. Change in Quality-of-Life scale

    Time frame: 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

  10. Change in lower extremity impairment

    Time frame: 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

  11. Change in cognitive scale

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Alberta Innovates Health Solutions
  • Glenrose Foundation

Registry information

Official study title

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

Acronym: STUFFS

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Dec 2, 2016
Registry last updated
Feb 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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