Multiple SclerosisNCT03136744
Reducing Sedentary Behaviour: A Novel Opportunity for Managing Comorbidity in MS?
A study testing Sit Less with MS in people with Multiple Sclerosis, run by University of Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Sit Less with MS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 3 Feb 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- other neurological problems besides MS or medically unstable to engage in the program.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Sit Less with MS
- Keywords
- Sedentary behaviour, Co-morbidity, Intervention
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sit Less with MSBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Sit Less with MS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of sedentary interruptions per day
Change in number of sedentary breaks from baseline to post-intervention and follow-up
Measured: 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
Measured: Baseline (week 0), post-intervention (week 16), and follow-up (week 24)
Secondary outcomes (12)
Patient Determined Disease Steps (PDDS)
The PDDS will be used to track patient-reported impairment level from baseline to post-intervention and follow-up
Measured: Baseline (week 0), post-intervention (week 16), and follow-up (week 24)
Fatigue Severity Scale (FSS)
The FSS will be used to track patient-reported fatigue level from baseline to post-intervention and follow-up
Measured: Baseline (week 0), post-intervention (week 16), and follow-up (week 24)
Modified Fatigue Impact Scale
The Modified Fatigue Impact Scale will be used to track the impact of fatigue from baseline to post-intervention and follow-up
Measured: Baseline (week 0), post-intervention (week 16), and follow-up (week 24)
Symbol Digit Modality Test
The Symbol Digit Modality Test will be used to monitor cognitive status from baseline to post-intervention and follow-up
Measured: Baseline (week 0), post-intervention (week 16), and follow-up (week 24)
Hospital Anxiety and Depression Scale
The Hospital Anxiety and Depression Scale will be used to monitor level of depression from baseline to post-intervention and follow-up
Measured: Baseline (week 0), post-intervention (week 16), and follow-up (week 24)
Short Form McGill Pain Questionnaire
The Short Form McGill Pain Questionnaire will be used to monitor level of pain from baseline to post-intervention and follow-up
Measured: Baseline (week 0), post-intervention (week 16), and follow-up (week 24)
Pittsburgh Sleep Quality Questionnaire
The Pittsburgh Sleep Quality Questionnaire will be used to monitor sleep quality from baseline to post-intervention and follow-up
Measured: Baseline (week 0), post-intervention (week 16), and follow-up (week 24)
Godin-Shephard Leisure-Time Physical Activity Questionnaire
The Godin-Shephard Leisure-Time Physical Activity Questionnaire will be used to track self-reported physical activity level from baseline to post-intervention and follow-up
Measured: Baseline (week 0), post-intervention (week 16), and follow-up (week 24)
6-minute Walk Test
The 6-minute Walk test will be used to measure endurance from baseline to post-intervention and follow-up
Measured: Baseline (week 0), post-intervention (week 16), and follow-up (week 24)
10-meter Walk test
The 10-meter Walk test will be used to assess gait speed from baseline to post-intervention and follow-up
Measured: Baseline (week 0), post-intervention (week 16), and follow-up (week 24)
Short Physical Performance Battery
The Short Physical Performance Battery will be monitor balance, walking speed, and function from baseline to post-intervention and follow-up
Measured: Baseline (week 0), post-intervention (week 16), and follow-up (week 24)
Quality of Life (SF-36) Questionnaire
The Quality of Life (SF-36) Questionnaire will be used to monitor patient-reported quality of life from baseline to post-intervention and follow-up
Measured: Baseline (week 0), post-intervention (week 16), and follow-up (week 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study start3 Feb 2018
- Primary completion12 Jun 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Innovates Health Solutions
- Responsible party
- Sponsor
- Investigators
- Patricia Manns, PhD, Principal investigator, University of AlbertaRobert Motl, PhD, Principal investigator, University of Alabama at BirminghamSaeideh Aminian, PhD, Study director, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03136744
- Sponsor's protocol ID
- RES0026185
- Status last verified
- Feb 2020
- First submitted
- 24 Apr 2017
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participants de-identified data may be shared with our co-PI, Dr. Motl, with University of Alabama at Birmingham
Publications
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.
PubMed 18252901Healy 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.
PubMed 21224291Owen 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.
PubMed 20577058van 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.
PubMed 22450936Mehrabani 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.
PubMed 34433359Aminian 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.
PubMed 30940762
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Sedentary Behaviour: A Novel Opportunity for Managing Comorbidity in MS?
- ClinicalTrials.gov ID
- NCT03136744
- Acronym / sponsor ID
- RES0026185
- Conditions
- Multiple Sclerosis
- Keywords
- Sedentary behaviour, Co-morbidity, Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Alberta Innovates Health Solutions
- Study start
- 3 Feb 2018 (actual)
- Primary completion
- 12 Jun 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 2 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sit Less with MS | Experimental | Behavioral: Sit Less with MSThe 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (1 listed)
- other neurological problems besides MS or medically unstable to engage in the program.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sit Less with MSThe 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. | Behavioural | Sit Less with MS |
Primary outcome
Number of sedentary interruptions per day
Time frame: Baseline (week 0), post-intervention (week 16), and follow-up (week 24)
Change in number of sedentary breaks from baseline to post-intervention and follow-up
Average sedentary time per day
Time frame: Baseline (week 0), post-intervention (week 16), and follow-up (week 24)
Change in sedentary time from baseline to post-intervention and follow-up
12 secondary outcomes
Patient Determined Disease Steps (PDDS)
Time frame: Baseline (week 0), post-intervention (week 16), and follow-up (week 24)
Fatigue Severity Scale (FSS)
Time frame: Baseline (week 0), post-intervention (week 16), and follow-up (week 24)
Modified Fatigue Impact Scale
Time frame: Baseline (week 0), post-intervention (week 16), and follow-up (week 24)
Symbol Digit Modality Test
Time frame: Baseline (week 0), post-intervention (week 16), and follow-up (week 24)
Hospital Anxiety and Depression Scale
Time frame: Baseline (week 0), post-intervention (week 16), and follow-up (week 24)
Short Form McGill Pain Questionnaire
Time frame: Baseline (week 0), post-intervention (week 16), and follow-up (week 24)
Pittsburgh Sleep Quality Questionnaire
Time frame: Baseline (week 0), post-intervention (week 16), and follow-up (week 24)
Godin-Shephard Leisure-Time Physical Activity Questionnaire
Time frame: Baseline (week 0), post-intervention (week 16), and follow-up (week 24)
6-minute Walk Test
Time frame: Baseline (week 0), post-intervention (week 16), and follow-up (week 24)
10-meter Walk test
Time frame: Baseline (week 0), post-intervention (week 16), and follow-up (week 24)
Short Physical Performance Battery
Time frame: Baseline (week 0), post-intervention (week 16), and follow-up (week 24)
Quality of Life (SF-36) Questionnaire
Time frame: Baseline (week 0), post-intervention (week 16), and follow-up (week 24)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 18252901Healy 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.
- Background: PubMed 21224291Healy 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.
- Background: PubMed 20577058Owen 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.
- Background: PubMed 22450936van 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.
- Derived from this study: PubMed 34433359Mehrabani 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.
- Derived from this study: PubMed 30940762Aminian 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.
- Individual participant dataSharing planned: Yes. Participants de-identified data may be shared with our co-PI, Dr. Motl, with University of Alabama at Birmingham
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Manns, PhD principal investigator
University of Alberta
Robert Motl, PhD principal investigator
University of Alabama at Birmingham
Saeideh Aminian, PhD study director
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sit Less with MS in people with Multiple Sclerosis, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of sedentary interruptions per day (time frame: Baseline (week 0), post-intervention (week 16), and follow-up (week 24)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03136744, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024; AzTrials last refreshed its copy on 30 Oct 2026.