Clinical Trials

Project GEMS+: Guidelines for Exercise in MS plus

Type of Study/Intervention

Allied Health - Exercise

Recruitment Status

Recruiting

Form of MS

Relapsing remitting MS, Secondary progressive MS, Primary progressive MS

Brief summary

Multiple Sclerosis is a chronic disease of the central nervous system with an estimated 23,000 people in Australia affected with the disease. Exercise based physical activity offers benefit in managing many symptoms of MS such as mobility impairment, fatigue and depression.

A home-based exercise programme will be delivered to persons with MS for up to 5 months as part of a randomised controlled study. The exercise programme will be incrementally progressed to maximise participant success and adherence The programme will include 2 sessions of aerobic walking and 2 sessions of resistance training per week.

We will supervise participants via; Text message to encourage exercise, and telephone or internet video-calls to supervise resistance training.

We aim to recruit 32 participants with MS. Participants will be randomly allocated to receive the intervention or be assigned to the usual care group, during the study duration the usual care group will be asked to continue with their normal behaviour.

The aim of this study is to assess the feasibility of the study plan. As such we will focus on the process (e.g., rates of recruitment, adherence, and retention), resources (e.g., researcher contact time, monetary cost and equipment requirements per stage of the research), management (e.g., research preparation, researcher capacity, and expertise strengths and weakness), and science (e.g., safety, burden, participant feedback and efficacy/outcome).

Inclusion criteria

Participants who meet the following criteria will be included: (a) age
≥18 years; (b) diagnosis of MS; (c) Patient Determined Disability Steps (PDDS) scale [26] score ≤ 4.0 (i.e., mild or moderate disability consistent with the recommendations in the guidelines for exercise in MS); (d) relapse free in past 30 days; (e) willing and able to participate in a 5-month home-based exercise program and a 6 month follow-up; and (f) exercisers (operationalised to be engaging in 30 or more minutes of moderate intensity exercise 2+ days/week and 30 or more minutes or more of resistance training on 2+ days/week)

Exclusion criteria

Those who do not meet the above inclusion criteria will not be able to take part in the study.

Anticipated start date

Already started.

Region

NSW, SA, VIC, QLD, WA, TAS

Further details

Further details can be found here:

https://bit.ly/GEMS-MU2

There is also information on the ANZCTR website.

Ethics approval

Yes

Last updated

04/05/2020

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