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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Sedentary behaviour intervention
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stroke focused on measuring Stroke, Sedentary behaviour, Intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alberta

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

STUFFS

Arm Description

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.

Outcomes

Primary Outcome Measures

Reach
Number enrolled divided by number eligible
Retention
Percentage of those enrolled who completed the program
Satisfaction with program
Post-intervention interviews will be conducted to assess satisfaction with the program, participants' satisfaction as a percentage will be determined.

Secondary Outcome Measures

Change in sedentary time
To assess change in accelerometer-derived sedentary time from baseline to post-intervention and follow-up periods
Change in standing time
To assess change in accelerometer-derived standing time from baseline to post-intervention and follow-up periods
Change in stepping time
To assess change in accelerometer-derived stepping time from baseline to post-intervention and follow-up periods
Change in number of sit-to-stand transitions
To assess change in accelerometer-derived number of sit-to-stand transitions from baseline to post-intervention and follow-up periods
Change in resting blood pressure
To assess change in systolic and diastolic blood pressure from baseline to post-intervention and follow-up periods
Change in waist circumference
To assess change in waist circumference from baseline to post-intervention and follow-up periods
Change in gait speed
To assess change in walking speed from baseline to post-intervention and follow-up periods
Change in self-efficacy scale
To assess change in self-efficacy using Multidimensional Self-Efficacy Scale (MSES) over time from baseline to post-intervention and follow-up periods
Change in Quality-of-Life scale
To assess change in quality of life using Stroke Impact Scale from baseline to post-intervention and follow-up
Change in lower extremity impairment
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
Change in cognitive scale
To assess change in cognition using Montreal Cognitive Assessment scale from baseline to post-intervention and follow-up periods

Full Information

First Posted
November 25, 2016
Last Updated
February 16, 2018
Sponsor
University of Alberta
Collaborators
Alberta Innovates Health Solutions, Glenrose Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02980744
Brief Title
A Home-based Intervention to Reduce Sedentary Behaviour and Improve Function After Stroke
Acronym
STUFFS
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
Collaborators
Alberta Innovates Health Solutions, Glenrose Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Sedentary behaviour, Intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
STUFFS
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Sedentary behaviour intervention
Intervention Description
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 Outcome Measure Information:
Title
Reach
Description
Number enrolled divided by number eligible
Time Frame
Follow-up (week 16)
Title
Retention
Description
Percentage of those enrolled who completed the program
Time Frame
Follow-up (week 16)
Title
Satisfaction with program
Description
Post-intervention interviews will be conducted to assess satisfaction with the program, participants' satisfaction as a percentage will be determined.
Time Frame
Post-intervention (week 9)
Secondary Outcome Measure Information:
Title
Change in sedentary time
Description
To assess change in accelerometer-derived sedentary time from baseline to post-intervention and follow-up periods
Time Frame
baseline - week 0 (within one month of discharge from inpatient rehab), week 9 (post-intervention), week 16 (follow-up)
Title
Change in standing time
Description
To assess change in accelerometer-derived standing time from baseline to post-intervention and follow-up periods
Time Frame
baseline - week 0 (within one month of discharge from inpatient rehab), week 9 (post-intervention), week 16 (follow-up)
Title
Change in stepping time
Description
To assess change in accelerometer-derived stepping time from baseline to post-intervention and follow-up periods
Time Frame
baseline - week 0 (within one month of discharge from inpatient rehab), week 9 (post-intervention), week 16 (follow-up)
Title
Change in number of sit-to-stand transitions
Description
To assess change in accelerometer-derived number of sit-to-stand transitions from baseline to post-intervention and follow-up periods
Time Frame
baseline - week 0 (within one month of discharge from inpatient rehab), week 9 (post-intervention), week 16 (follow-up)
Title
Change in resting blood pressure
Description
To assess change in systolic and diastolic blood pressure from baseline to post-intervention and follow-up periods
Time Frame
baseline - week 0 (within one month of discharge from inpatient rehab), week 9 (post-intervention), week 16 (follow-up)
Title
Change in waist circumference
Description
To assess change in waist circumference from baseline to post-intervention and follow-up periods
Time Frame
baseline - week 0 (within one month of discharge from inpatient rehab), week 9 (post-intervention), week 16 (follow-up)
Title
Change in gait speed
Description
To assess change in walking speed from baseline to post-intervention and follow-up periods
Time Frame
baseline - week 0 (within one month of discharge from inpatient rehab), week 9 (post-intervention), week 16 (follow-up)
Title
Change in self-efficacy scale
Description
To assess change in self-efficacy using Multidimensional Self-Efficacy Scale (MSES) over time from baseline to post-intervention and follow-up periods
Time Frame
baseline - week 0 (within one month of discharge from inpatient rehab), week 9 (post-intervention), week 16 (follow-up)
Title
Change in Quality-of-Life scale
Description
To assess change in quality of life using Stroke Impact Scale from baseline to post-intervention and follow-up
Time Frame
baseline - week 0 (within one month of discharge from inpatient rehab), week 9 (post-intervention), week 16 (follow-up)
Title
Change in lower extremity impairment
Description
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
Time Frame
baseline - week 0 (within one month of discharge from inpatient rehab), week 9 (post-intervention), week 16 (follow-up)
Title
Change in cognitive scale
Description
To assess change in cognition using Montreal Cognitive Assessment scale from baseline to post-intervention and follow-up periods
Time Frame
baseline - week 0 (within one month of discharge from inpatient rehab), week 9 (post-intervention), week 16 (follow-up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia Manns, PT, PhD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Victor Ezeugwu, PT, MSc
Organizational Affiliation
University of Alberta
Official's Role
Study Director
Facility Information:
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2G4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data related to activPAL sedentary and activity monitoring might be shared with supervisors and other researchers
Citations:
PubMed Identifier
26205371
Citation
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Results Reference
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PubMed Identifier
25535808
Citation
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Results Reference
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PubMed Identifier
25220942
Citation
Tieges Z, Mead G, Allerhand M, Duncan F, van Wijck F, Fitzsimons C, Greig C, Chastin S. Sedentary behavior in the first year after stroke: a longitudinal cohort study with objective measures. Arch Phys Med Rehabil. 2015 Jan;96(1):15-23. doi: 10.1016/j.apmr.2014.08.015. Epub 2014 Sep 16.
Results Reference
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PubMed Identifier
18948606
Citation
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Gowland C, Stratford P, Ward M, Moreland J, Torresin W, Van Hullenaar S, Sanford J, Barreca S, Vanspall B, Plews N. Measuring physical impairment and disability with the Chedoke-McMaster Stroke Assessment. Stroke. 1993 Jan;24(1):58-63. doi: 10.1161/01.str.24.1.58.
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A Home-based Intervention to Reduce Sedentary Behaviour and Improve Function After Stroke

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