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

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ClinicalTrials.gov Identifier: NCT03136744
Recruitment Status : Completed
First Posted : May 2, 2017
Last Update Posted : February 24, 2020
Sponsor:
Collaborator:
Alberta Innovates Health Solutions
Information provided by (Responsible Party):
University of Alberta

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.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Behavioral: Sit Less with MS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Reducing Sedentary Behaviour: A Novel Opportunity for Managing Comorbidity in MS?
Actual Study Start Date : February 3, 2018
Actual Primary Completion Date : June 12, 2019
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sit Less with MS
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
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.




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Patient Determined Disease Steps (PDDS) [ Time Frame: Baseline (week 0), post-intervention (week 16), and follow-up (week 24) ]
    The PDDS will be used to track patient-reported impairment level from baseline to post-intervention and follow-up

  2. Fatigue Severity Scale (FSS) [ Time Frame: Baseline (week 0), post-intervention (week 16), and follow-up (week 24) ]
    The FSS will be used to track patient-reported fatigue level from baseline to post-intervention and follow-up

  3. Modified Fatigue Impact Scale [ Time Frame: Baseline (week 0), post-intervention (week 16), and follow-up (week 24) ]
    The Modified Fatigue Impact Scale will be used to track the impact of fatigue from baseline to post-intervention and follow-up

  4. Symbol Digit Modality Test [ Time Frame: Baseline (week 0), post-intervention (week 16), and follow-up (week 24) ]
    The Symbol Digit Modality Test will be used to monitor cognitive status from baseline to post-intervention and follow-up

  5. Hospital Anxiety and Depression Scale [ Time Frame: Baseline (week 0), post-intervention (week 16), and follow-up (week 24) ]
    The Hospital Anxiety and Depression Scale will be used to monitor level of depression from baseline to post-intervention and follow-up

  6. Short Form McGill Pain Questionnaire [ Time Frame: Baseline (week 0), post-intervention (week 16), and follow-up (week 24) ]
    The Short Form McGill Pain Questionnaire will be used to monitor level of pain from baseline to post-intervention and follow-up

  7. Pittsburgh Sleep Quality Questionnaire [ Time Frame: Baseline (week 0), post-intervention (week 16), and follow-up (week 24) ]
    The Pittsburgh Sleep Quality Questionnaire will be used to monitor sleep quality from baseline to post-intervention and follow-up

  8. Godin-Shephard Leisure-Time Physical Activity Questionnaire [ Time Frame: Baseline (week 0), post-intervention (week 16), and follow-up (week 24) ]
    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

  9. 6-minute Walk Test [ Time Frame: Baseline (week 0), post-intervention (week 16), and follow-up (week 24) ]
    The 6-minute Walk test will be used to measure endurance from baseline to post-intervention and follow-up

  10. 10-meter Walk test [ Time Frame: Baseline (week 0), post-intervention (week 16), and follow-up (week 24) ]
    The 10-meter Walk test will be used to assess gait speed from baseline to post-intervention and follow-up

  11. Short Physical Performance Battery [ Time Frame: Baseline (week 0), post-intervention (week 16), and follow-up (week 24) ]
    The Short Physical Performance Battery will be monitor balance, walking speed, and function from baseline to post-intervention and follow-up

  12. Quality of Life (SF-36) Questionnaire [ Time Frame: Baseline (week 0), post-intervention (week 16), and follow-up (week 24) ]
    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


Other Outcome Measures:
  1. Recruitment rate [ Time Frame: Follow-up (Week 24) ]
    Number of participants enrolled out of total number approached

  2. Proportion of participants who completed the program [Adherence] [ Time Frame: Follow-up (week 24) ]
    Proportion of participants who completed the program



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03136744


Locations
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Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2G4
Sponsors and Collaborators
University of Alberta
Alberta Innovates Health Solutions
Investigators
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Principal Investigator: Patricia Manns, PhD University of Alberta
Principal Investigator: Robert Motl, PhD University of Alabama at Birmingham
Study Director: Saeideh Aminian, PhD University of Alberta
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT03136744    
Other Study ID Numbers: RES0026185
First Posted: May 2, 2017    Key Record Dates
Last Update Posted: February 24, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Participants de-identified data may be shared with our co-PI, Dr. Motl, with University of Alabama at Birmingham
Supporting Materials: Clinical Study Report (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Alberta:
Sedentary behaviour
Co-morbidity
Intervention
Additional relevant MeSH terms:
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Multiple Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases