Reducing Sedentary Behaviour: A Novel Opportunity for Managing Comorbidity in MS?

NCT03136744 | Completed

• 1 other identifier: RES0026185
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Activity recommendations for the general population and those with multiple sclerosis (MS) focus on the promotion of activity that has a moderate intensity - in other words, activity intense enough to breathe heavily and sweat. Most adults do not achieve the recommended 150 minutes of moderate-intensity activity per week. Even fewer persons with MS meet the recommendations. Those with MS often have problems with walking and fatigue, thus it is not difficult to understand that moderate intensity activity is challenging. Our study will test the feasibility of a new approach focusing on activity over the whole day - promoting light activity such as standing or walking around the house while reducing prolonged sitting (sedentary behaviour). This approach is supported by research evidence showing that too much sedentary time, especially prolonged bouts of sitting, is associated with health risk factors such as obesity and cholesterol level. Recent work with persons with MS confirms that prolonged sitting is a problem for this population and emphasises the potential importance of this approach. This study tests the feasibility of an internet-based intervention designed to decrease sedentary behaviour and to increase upright time in people with MS.

Conditions

Multiple Sclerosis

Keywords

Sedentary behaviour; Co-morbidity; Intervention

Outcome Measures

Primary Outcomes (2)

• Number of sedentary interruptions per day

  Change in number of sedentary breaks from baseline to post-intervention and follow-up

  Baseline (week 0), post-intervention (week 16), and follow-up (week 24)

• Average sedentary time per day

  Change in sedentary time from baseline to post-intervention and follow-up

  Baseline (week 0), post-intervention (week 16), and follow-up (week 24)

Secondary Outcomes (12)

• Patient Determined Disease Steps (PDDS)

  Baseline (week 0), post-intervention (week 16), and follow-up (week 24)

• Fatigue Severity Scale (FSS)

  Baseline (week 0), post-intervention (week 16), and follow-up (week 24)

• Modified Fatigue Impact Scale

  Baseline (week 0), post-intervention (week 16), and follow-up (week 24)

• Symbol Digit Modality Test

  Baseline (week 0), post-intervention (week 16), and follow-up (week 24)

• Hospital Anxiety and Depression Scale

  Baseline (week 0), post-intervention (week 16), and follow-up (week 24)

Other Outcomes (2)

• Recruitment rate

  Follow-up (Week 24)

• Proportion of participants who completed the program [Adherence]

  Follow-up (week 24)

Study Arms (1)

Sit Less with MS

EXPERIMENTAL

The Sit Less with MS program is based on Social Cognitive Theory (SCT) and consists of strategies that will enable people with MS to 'sit less' by frequently interrupting sitting and 'move more' by replacing sitting with light-intensity activity during waking hours.

Behavioral: Sit Less with MS

Interventions

Sit Less with MS BEHAVIORAL

The Sit Less with MS intervention has a total duration of 16 weeks and consists of two stages: sit less and move more stages. During the first stage (sit less), we will conduct coaching sessions with participants every week and the focus will be on interrupting their sitting time every 30 minutes. Facebook and Twitter will be also used to provide information and supplement coaching sessions. During the second stage, the focus will be on encouraging the participants to move more by replacing sitting with light intensity activities frequently throughout waking hours.

Sit Less with MS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• confirmed diagnosis of MS of at least one-year duration.
• Expanded Disability Status Scale (EDSS) scores between 1 and 6.5.
• stable in terms of disease modifying drugs and rehabilitation over the previous 6 months.
• relapse free within the previous 3 months.
• physically inactive, defined as insufficiently active by Godin-Shephard Leisure-Time Physical Activity Questionnaire.
• able to walk with or without a walking aid for 10 meters.

You may not qualify if:

• other neurological problems besides MS or medically unstable to engage in the program.

Sponsors & Collaborators

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

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2G4, Canada

Location

Related Publications (6)

• Healy GN, Dunstan DW, Salmon J, Cerin E, Shaw JE, Zimmet PZ, Owen N. Breaks in sedentary time: beneficial associations with metabolic risk. Diabetes Care. 2008 Apr;31(4):661-6. doi: 10.2337/dc07-2046. Epub 2008 Feb 5.

  PMID: 18252901 BACKGROUND

• Healy GN, Matthews CE, Dunstan DW, Winkler EA, Owen N. Sedentary time and cardio-metabolic biomarkers in US adults: NHANES 2003-06. Eur Heart J. 2011 Mar;32(5):590-7. doi: 10.1093/eurheartj/ehq451. Epub 2011 Jan 11.

  PMID: 21224291 BACKGROUND

• Owen N, Healy GN, Matthews CE, Dunstan DW. Too much sitting: the population health science of sedentary behavior. Exerc Sport Sci Rev. 2010 Jul;38(3):105-13. doi: 10.1097/JES.0b013e3181e373a2.

  PMID: 20577058 BACKGROUND

• van der Ploeg HP, Chey T, Korda RJ, Banks E, Bauman A. Sitting time and all-cause mortality risk in 222 497 Australian adults. Arch Intern Med. 2012 Mar 26;172(6):494-500. doi: 10.1001/archinternmed.2011.2174.

  PMID: 22450936 BACKGROUND

• Mehrabani G, Aminian S, Norton S, Motl RW, Manns PJ. Preliminary efficacy of the "SitLess with MS" intervention for changing sedentary behaviour, symptoms, and physical performance in multiple sclerosis. Disabil Rehabil. 2022 Oct;44(21):6374-6381. doi: 10.1080/09638288.2021.1966520. Epub 2021 Aug 25.

  PMID: 34433359 DERIVED

• Aminian S, Motl RW, Rowley J, Manns PJ. Management of multiple sclerosis symptoms through reductions in sedentary behaviour: protocol for a feasibility study. BMJ Open. 2019 Apr 1;9(4):e026622. doi: 10.1136/bmjopen-2018-026622.

  PMID: 30940762 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Patricia Manns, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Robert Motl, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• Saeideh Aminian, PhD

  University of Alberta

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: April 24, 2017
• First Posted: May 2, 2017
• Study Start: February 3, 2018
• Primary Completion: June 12, 2019
• Study Completion: December 31, 2019
• Last Updated: September 19, 2024

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Data will be available for sharing after study completion by April 30, 2019.
• Access Criteria: Participants data will be de-identified prior to sharing with our co-PI, Dr. Motl with University of Alabama at Birmingham.

Locations

CA (1)