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

NCT02301442 | Completed

• 1 other identifier: ULimerick
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Change in walking mobility from 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.

  Weeks 1 to 36

Secondary Outcomes (7)

• Change in lower limb functional muscle strength from weeks 1 to 36

  Weeks 1 to 36

• Change in aerobic fitness from weeks 1 to 36

  Weeks 1 to 36

• Change in anxiety and depression from weeks 1 to 36

  Weeks 1 to 36

• Change in cognitive processing from weeks 1 to 36

  Weeks 1 to 36

• Change in physical activity levels from weeks 1 to 36

  Weeks 1 to 36

Other Outcomes (2)

• Adherence to the intervention

  Week 12

• Change in Social Cognitive Theory domains from weeks 1 to 36

  Weeks 1 to 36

Study Arms (2)

Exercise + behaviour change intervention

EXPERIMENTAL

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

Exercise + control education

ACTIVE COMPARATOR

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

Interventions

Exercise + behaviour change intervention BEHAVIORAL

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.

Exercise + behaviour change intervention

Exercise + control education BEHAVIORAL

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.

Exercise + control education

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Limerick: lead

Study Sites (1)

Department of Clinical Therapies, University of Limerick

Limerick, Munster, Ireland

Location

Related Publications (3)

• Hayes S, Uszynski MK, Motl RW, Gallagher S, Larkin A, Newell J, Scarrott C, Coote S. Randomised controlled pilot trial of an exercise plus behaviour change intervention in people with multiple sclerosis: the Step it Up study. BMJ Open. 2017 Oct 12;7(10):e016336. doi: 10.1136/bmjopen-2017-016336.

  PMID: 29025830 DERIVED

• Coote S, Uszynski M, Herring MP, Hayes S, Scarrott C, Newell J, Gallagher S, Larkin A, Motl RW. Effect of exercising at minimum recommendations of the multiple sclerosis exercise guideline combined with structured education or attention control education - secondary results of the step it up randomised controlled trial. BMC Neurol. 2017 Jun 24;17(1):119. doi: 10.1186/s12883-017-0898-y.

  PMID: 28646860 DERIVED

• Coote S, Gallagher S, Msetfi R, Larkin A, Newell J, Motl RW, Hayes S. A randomised controlled trial of an exercise plus behaviour change intervention in people with multiple sclerosis: the step it up study protocol. BMC Neurol. 2014 Dec 21;14:241. doi: 10.1186/s12883-014-0241-9.

  PMID: 25528262 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Susan Coote, PhD

  University of Limerick

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2014
• First Posted: November 26, 2014
• Study Start: September 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: May 13, 2016

Record last verified: 2016-05

Locations

IE (1)