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

NCT02980744 | Completed

• 1 other identifier: Pro00053129
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Stroke; Sedentary behaviour; Intervention

Outcome Measures

Primary Outcomes (3)

• Reach

  Number enrolled divided by number eligible

  Follow-up (week 16)

• Retention

  Percentage of those enrolled who completed the program

  Follow-up (week 16)

• Satisfaction with program

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

  Post-intervention (week 9)

Secondary Outcomes (11)

• Change in sedentary time

  baseline - week 0 (within one month of discharge from inpatient rehab), week 9 (post-intervention), week 16 (follow-up)

• Change in standing time

  baseline - week 0 (within one month of discharge from inpatient rehab), week 9 (post-intervention), week 16 (follow-up)

• Change in stepping time

  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

  baseline - week 0 (within one month of discharge from inpatient rehab), week 9 (post-intervention), week 16 (follow-up)

• Change in resting blood pressure

  baseline - week 0 (within one month of discharge from inpatient rehab), week 9 (post-intervention), week 16 (follow-up)

Study Arms (1)

STUFFS

EXPERIMENTAL

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.

Behavioral: Sedentary behaviour intervention

Interventions

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.

STUFFS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Have other neurological problems besides stroke or medically unstable.

Sponsors & Collaborators

• University of Alberta: lead
• Alberta Innovates Health Solutions: collaborator
• Glenrose Foundation: collaborator

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2G4, Canada

Location

Related Publications (11)

• Krueger H, Koot J, Hall RE, O'Callaghan C, Bayley M, Corbett D. Prevalence of Individuals Experiencing the Effects of Stroke in Canada: Trends and Projections. Stroke. 2015 Aug;46(8):2226-31. doi: 10.1161/STROKEAHA.115.009616.

  PMID: 26205371 BACKGROUND

• Coutts SB, Wein TH, Lindsay MP, Buck B, Cote R, Ellis P, Foley N, Hill MD, Jaspers S, Jin AY, Kwiatkowski B, MacPhail C, McNamara-Morse D, McMurtry MS, Mysak T, Pipe A, Silver K, Smith EE, Gubitz G; Heart, and Stroke Foundation Canada Canadian Stroke Best Practices Advisory Committee. Canadian Stroke Best Practice Recommendations: secondary prevention of stroke guidelines, update 2014. Int J Stroke. 2015 Apr;10(3):282-91. doi: 10.1111/ijs.12439. Epub 2014 Dec 23.

  PMID: 25535808 BACKGROUND

• 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.

  PMID: 25220942 BACKGROUND

• Rand D, Eng JJ, Tang PF, Jeng JS, Hung C. How active are people with stroke?: use of accelerometers to assess physical activity. Stroke. 2009 Jan;40(1):163-8. doi: 10.1161/STROKEAHA.108.523621. Epub 2008 Oct 23.

  PMID: 18948606 BACKGROUND

• Paul L, Brewster S, Wyke S, Gill JM, Alexander G, Dybus A, Rafferty D. Physical activity profiles and sedentary behaviour in people following stroke: a cross-sectional study. Disabil Rehabil. 2016;38(4):362-7. doi: 10.3109/09638288.2015.1041615. Epub 2015 May 4.

  PMID: 25936730 BACKGROUND

• Biswas A, Oh PI, Faulkner GE, Bajaj RR, Silver MA, Mitchell MS, Alter DA. Sedentary time and its association with risk for disease incidence, mortality, and hospitalization in adults: a systematic review and meta-analysis. Ann Intern Med. 2015 Jan 20;162(2):123-32. doi: 10.7326/M14-1651.

  PMID: 25599350 BACKGROUND

• Taraldsen K, Askim T, Sletvold O, Einarsen EK, Bjastad KG, Indredavik B, Helbostad JL. Evaluation of a body-worn sensor system to measure physical activity in older people with impaired function. Phys Ther. 2011 Feb;91(2):277-85. doi: 10.2522/ptj.20100159. Epub 2011 Jan 6.

  PMID: 21212377 BACKGROUND

• 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.

  PMID: 8418551 BACKGROUND

• Xu Q, Cao WW, Mi JH, Yu L, Lin Y, Li YS. Brief screening for mild cognitive impairment in subcortical ischemic vascular disease: a comparison study of the Montreal Cognitive Assessment with the Mini-Mental State Examination. Eur Neurol. 2014;71(3-4):106-14. doi: 10.1159/000353988. Epub 2013 Dec 10.

  PMID: 24335198 BACKGROUND

• Ezeugwu VE, Manns PJ. Using Intervention Mapping to develop and implement a home-based sedentary behavior change intervention after stroke. Transl Behav Med. 2020 Feb 3;10(1):87-95. doi: 10.1093/tbm/iby128.

  PMID: 30566661 DERIVED

• Ezeugwu VE, Manns PJ. The Feasibility and Longitudinal Effects of a Home-Based Sedentary Behavior Change Intervention After Stroke. Arch Phys Med Rehabil. 2018 Dec;99(12):2540-2547. doi: 10.1016/j.apmr.2018.06.014. Epub 2018 Jul 5.

  PMID: 29981314 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Patricia Manns, PT, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Victor Ezeugwu, PT, MSc

  University of Alberta

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2016
• First Posted: December 2, 2016
• Study Start: August 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: January 1, 2018
• Last Updated: February 20, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)