Clinical trial NCT03136744: Reducing Sedentary Behaviour: A Novel Opportunity for Managing Comorbidity in MS?
Official title: Reducing Sedentary Behaviour: A Novel Opportunity for Managing Comorbidity in MS?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Sedentary behaviour
Co-morbidity
Intervention
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Alberta Innovates Health Solutions
First posted: 2017-05-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Detailed description: Background: The health risks of sedentary behaviour or 'sitting too much' for the general population are receiving widespread media attention, with bylines that include, "comfy chairs are killing us very softly" or "don't just sit there!" Others have suggested that sitting is the new smoking! This media attention reflects the exponential growth of research on sedentary behaviour in the last 10 years \[1-4\]. The investigators believe that learning more about sedentary behaviour and its health risks may be particularly relevant for those with multiple sclerosis (MS). People with MS are substantially less active than persons without MS and have co-morbidities such as walking disability and fatigue that may make achieving the 'typical' moderate to vigorous intensity exercise targets very difficult. The investigators will test a new approach to activity promotion that focuses on reducing sedentary behaviour and moving more during the day. This approach is likely to be more feasible and lead to more sustainable activity behaviour change in persons with MS. It's broad applicability - to persons with MS who move well, to those who need help to walk, and perhaps only walk at home - is a major strength of this new approach. In the end, if found to be effective, it could mean that a large majority of those with MS could receive the benefits of activity that they may be missing out on if only the usual moderate to vigorous activity programme is recommended.

Purpose: The purpose of this project is to test the feasibility of a sedentary behaviour intervention program on reducing sedentary behaviour and improving co-morbidities such as walking disability and fatigue in people with MS.

Methods: Forty persons with MS will be recruited from the community (mostly from Edmonton through our collaboration with the MS Society of Alberta) and the MS Clinic (University of Alberta Campus). The participants will be involved with the study for 24 weeks, including a 16-week intervention and an 8-week follow-up. The intervention includes two 8-week stages; 1) Sit Less Stage- Interruptions to prolonged sitting, and 2) Move More Stage- Reduction in total sitting time through replacing sitting with light physical activities.

Baseline testing will consist of demographic, anthropometric, impairment and functional testing. Subsequently, participants will be set up with an activity monitor (ActivPAL) to wear for 7 days. All outcomes, including those from the ActivPAL, will be assessed at three-time points: Baseline (Week 0), Post-intervention (Week 16), and Follow-up (Week 24). However, at mid-intervention (Week 8), data will be collected only from the ActivPAL activity monitor. A log book will be used by participants to record their wake-time and sleep-time and times when they didn't wear the monitor.

Intervention: Once baseline testing is completed, in the first week of intervention a Fitbit monitor will be attached to each participant's waist, and the participants will be asked to do the activities that they normally do every day. This information will be used to determine usual activity behaviour. Also, participants will be asked to wear the Fitbit throughout the entire 16 weeks of the intervention. A program manual will be provided to the participants to guide them throughout the 16 weeks of the intervention. In addition to the program manual, participants will receive (via email) a weekly newsletter that emphasises an aspect of behaviour change from social cognitive theory and Skype chats will be conducted as well.

Analysis: Most of the feasibility outcomes will be descriptive related to recruitment (e.g., number of participants enrolled/number of participants approached) and adherence to the intervention. Descriptive statistics (mean, SD) will be used to characterize the sample. A two-way mixed factor ANOVA will be used to determine whether there are main (time, level of disability) and/or interaction effects for two primary sedentary behaviour outcomes - the average number of sedentary interruptions, and average sedentary time per day. Effect sizes will be calculated for each of the sedentary behaviour and the co-morbidity outcomes. Where clinically meaningful change benchmarks are available, we will determine if changes achieved from the intervention were clinically significant.

Eligibility criteria: Inclusion Criteria

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Number of sedentary interruptions per day
timeFrame: Baseline (week 0), post-intervention (week 16), and follow-up (week 24)
measure: Average sedentary time per day
timeFrame: Baseline (week 0), post-intervention (week 16), and follow-up (week 24)
Secondary outcomes:
measure: Patient Determined Disease Steps (PDDS)
timeFrame: Baseline (week 0), post-intervention (week 16), and follow-up (week 24)
measure: Fatigue Severity Scale (FSS)
timeFrame: Baseline (week 0), post-intervention (week 16), and follow-up (week 24)
measure: Modified Fatigue Impact Scale
timeFrame: Baseline (week 0), post-intervention (week 16), and follow-up (week 24)
measure: Symbol Digit Modality Test
timeFrame: Baseline (week 0), post-intervention (week 16), and follow-up (week 24)
measure: Hospital Anxiety and Depression Scale
timeFrame: Baseline (week 0), post-intervention (week 16), and follow-up (week 24)
measure: Short Form McGill Pain Questionnaire
timeFrame: Baseline (week 0), post-intervention (week 16), and follow-up (week 24)
measure: Pittsburgh Sleep Quality Questionnaire
timeFrame: Baseline (week 0), post-intervention (week 16), and follow-up (week 24)
measure: Godin-Shephard Leisure-Time Physical Activity Questionnaire
timeFrame: Baseline (week 0), post-intervention (week 16), and follow-up (week 24)
measure: 6-minute Walk Test
timeFrame: Baseline (week 0), post-intervention (week 16), and follow-up (week 24)
measure: 10-meter Walk test
timeFrame: Baseline (week 0), post-intervention (week 16), and follow-up (week 24)
measure: Short Physical Performance Battery
timeFrame: Baseline (week 0), post-intervention (week 16), and follow-up (week 24)
measure: Quality of Life (SF-36) Questionnaire
timeFrame: Baseline (week 0), post-intervention (week 16), and follow-up (week 24)
Other outcomes:
measure: Recruitment rate
timeFrame: Follow-up (Week 24)
measure: Proportion of participants who completed the program [Adherence]
timeFrame: Follow-up (week 24)
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Patricia Manns, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: Robert Motl, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alberta
name: Saeideh Aminian, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.