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Step it Up: An Exercise and Behaviour Change Programme for People With Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT02301442
Recruitment Status : Completed
First Posted : November 26, 2014
Last Update Posted : May 13, 2016
Sponsor:
Information provided by (Responsible Party):
University of Limerick

Brief Summary:
Exercise has consistently yielded short-term, positive effects on health outcomes in people with multiple sclerosis (MS). However, these effects have not been maintained in the long-term. Behaviour change interventions aim to promote long-term positive lifestyle change. This study, namely, "Step it Up" will compare the effectiveness of an exercise plus Social Cognitive Theory (SCT)-based behaviour change intervention with an exercise plus control education intervention on walking mobility among people with MS.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Behavioral: Exercise + behaviour change intervention Behavioral: Exercise + control education Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial of an Exercise Plus Behaviour Change Intervention in People With MS: the "Step it Up" Study Protocol
Study Start Date : September 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise + behaviour change intervention
This arm of the trial includes assessments at weeks 0, 12, 24 and 36. A 10-week exercise + behaviour change intervention will be delivered by physiotherapists between weeks 1 and 11.
Behavioral: Exercise + behaviour change intervention
In addition to the same exercise intervention as the control group, this group will receive a behaviour change intervention. This will be delivered after each exercise session and will incorporate the elements: self-efficacy, outcome expectations, impediments and goal-setting. On the weeks when the participants do not attend group sessions, they will receive telephone calls from physiotherapists. This will consist of guided conversations that consider content delivered in previous sessions.

Active Comparator: Exercise + control education
This arm of the trial includes assessments at weeks 0, 12, 24 and 36. A 10-week exercise + control education intervention will be delivered by physiotherapists between weeks 1 and 11.
Behavioral: Exercise + control education
The control group will receive exercise and education components. The exercise intervention includes aerobic & strengthening components and are in line with MS exercise guidelines (Latimer-Cheung et al 2013). The aerobic activity is walking, measured using pedometers & exercise logs. The strengthening programme consists of 10 exercises targeting major muscle groups for the upper and lower extremities using elastic resistance band. Over the 10-week programme participants will attend 6 group exercise class, supplemented with telephone calls in the weeks without classes. After each group exercise class this group will receive an education session about the following: diet, vitamin D, sleep, temperature and hydration, and immunisations and vaccinations.




Primary Outcome Measures :
  1. Change in walking mobility from weeks 1 to 36 [ Time Frame: Weeks 1 to 36 ]
    Change in walking mobility will be measured using the Timed up and Go test, the Six Minute Walk Test and the Multiple Sclerosis Walking Scale-12. These measures will be completed at weeks 1, 12, 24 and 36. The primary outcome will be the change over time from week 1 to week 36.


Secondary Outcome Measures :
  1. Change in lower limb functional muscle strength from weeks 1 to 36 [ Time Frame: Weeks 1 to 36 ]
    Change in lower limb muscle strength will be measured using the 5 times sit to stand test. This measure will be completed at weeks 1, 12, 24 and 36.

  2. Change in aerobic fitness from weeks 1 to 36 [ Time Frame: Weeks 1 to 36 ]
    Change in aerobic fitness will be measured using the Modified Canadian Aerobic Fitness Test. This measure will be completed at weeks 1, 12, 24 and 36.

  3. Change in anxiety and depression from weeks 1 to 36 [ Time Frame: Weeks 1 to 36 ]
    Change in anxiety and depression will be measured using the Hospital Anxiety and Depression Scale. This measure will be completed at weeks 1, 12, 24 and 36.

  4. Change in cognitive processing from weeks 1 to 36 [ Time Frame: Weeks 1 to 36 ]
    Change in cognitive processing will be measured using the Symbol Digit Modalities Test. This measure will be completed at weeks 1, 12, 24 and 36.

  5. Change in physical activity levels from weeks 1 to 36 [ Time Frame: Weeks 1 to 36 ]
    Change in phyiscal activity levels will be measured using the Godin Leisure-Time Exercise Questionnaire, the International Physical Activity Questionnaire and an objective measure of physical activity- the SenseWear Arm band accelerometer. These measures will be completed at weeks 1, 12, 24 and 36.

  6. Change in self-reported fatigue from weeks 1 to 36 [ Time Frame: Weeks 1 to 36 ]
    Change in self-reported fatigue will be measured using the Modified Fatigue Impact Scale. This measure will be completed at weeks 1, 12, 24 and 36.

  7. Change in self-reported impact of MS from weeks 1 to 36 [ Time Frame: Weeks 1 to 36 ]
    Change in self-reported impact of MS will be measured using the Multiple Sclerosis Impact Scale-29. This measure will be completed at weeks 1, 12, 24 and 36.


Other Outcome Measures:
  1. Adherence to the intervention [ Time Frame: Week 12 ]
    Participants adherence to the intervention will be measured at week 12 (post-intervention) using self-report (participant-reported) exercise logs and adherence logs recorded by the trial interventionalists.

  2. Change in Social Cognitive Theory domains from weeks 1 to 36 [ Time Frame: Weeks 1 to 36 ]
    Change in Social Cognitive Theory domains will be measured using the Exercise Self-Efficacy Scale, the Exercise Goal Setting scale, the Multidimensional Outcomes Expectations for Exercise Scale and the Social Provisions Scale. These measures will be completed at weeks 1, 12, 24 and 36.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Physician-confirmed formal diagnosis of MS
  • Patient Determined Disease Steps score of 0-3
  • A sedentary lifestyle (< 30 minutes of moderate to strenuous exercise one day or more per week over the last six months)
  • Willing to give written informed consent.

Exclusion Criteria:

  • Pregnancy
  • MS relapse in the last 12 weeks
  • Changes to MS medication or steroid treatment in the last 12 weeks.

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): NCT02301442


Locations
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Ireland
Department of Clinical Therapies, University of Limerick
Limerick, Munster, Ireland
Sponsors and Collaborators
University of Limerick
Investigators
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Principal Investigator: Susan Coote, PhD University of Limerick

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Limerick
ClinicalTrials.gov Identifier: NCT02301442     History of Changes
Other Study ID Numbers: ULimerick
First Posted: November 26, 2014    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
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Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases