Core Stability Training in Multiple Sclerosis

NCT ID: NCT01414725

Last Updated: 2014-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-07-31

Brief Summary

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The primary purpose of this study is to determine whether a 12 week Pilates based core stability training programme is effective in improving balance, mobility and balance confidence in ambulant individuals with Multiple Sclerosis (MS).

Detailed Description

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The primary purpose of this study is to determine whether a 12 week Pilates based core stability training programme is effective in improving balance, mobility and balance confidence in ambulant individuals with Multiple Sclerosis (MS). The secondary aim is to determine the relative effectiveness of this 12 week Pilates based core stability training programme compared to a standardised physiotherapy exercise programme. Finally we intend to explore the underlying mechanisms of change associated with these exercise interventions by directly measuring changes in muscle thickness and activation in the deep abdominal core stabilising muscles of a sub-set of participants.

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Core Stability Training

Group Type EXPERIMENTAL

Core Stability Training

Intervention Type OTHER

Individualised face to face training sessions, delivered over 12 weeks, plus an individualised 15-minute daily home exercise programme will be provided. This will be undertaken by a neurological physiotherapist with experience in the delivery of core stability training to people with MS. Exercises will be progressed in response to the abilities of the individual. Each participant will receive a workbook with written and diagrammatic instructions describing their home exercise programme.

Relaxation

Group Type PLACEBO_COMPARATOR

Relaxation

Intervention Type OTHER

Three face to face individualised relaxation sessions, provided at 4 weekly intervals, plus a 15-minute home programme based around an audio relaxation CD. Weekly telephone contact / support will be provided.

Standard Physiotherapy Exercises

Group Type ACTIVE_COMPARATOR

Standard Physiotherapy Exercises

Intervention Type OTHER

Individualised face to face training sessions, delivered over 12 weeks, plus an individualised 15-minute daily home exercise programme will be provided. This will be undertaken by a neurological physiotherapist. The exercises will comprise a standardised programme of simple physiotherapy exercises which aim to improve trunk and pelvic stability, lower limb muscle length and strength, and balance and control of movement, as described by Barrett et al \[2009\]. Exercises will be progressed in response to the abilities of the individual. Each participant will receive a workbook with written and diagrammatic instructions describing their home exercise programme.

Interventions

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Standard Physiotherapy Exercises

Individualised face to face training sessions, delivered over 12 weeks, plus an individualised 15-minute daily home exercise programme will be provided. This will be undertaken by a neurological physiotherapist. The exercises will comprise a standardised programme of simple physiotherapy exercises which aim to improve trunk and pelvic stability, lower limb muscle length and strength, and balance and control of movement, as described by Barrett et al \[2009\]. Exercises will be progressed in response to the abilities of the individual. Each participant will receive a workbook with written and diagrammatic instructions describing their home exercise programme.

Intervention Type OTHER

Core Stability Training

Individualised face to face training sessions, delivered over 12 weeks, plus an individualised 15-minute daily home exercise programme will be provided. This will be undertaken by a neurological physiotherapist with experience in the delivery of core stability training to people with MS. Exercises will be progressed in response to the abilities of the individual. Each participant will receive a workbook with written and diagrammatic instructions describing their home exercise programme.

Intervention Type OTHER

Relaxation

Three face to face individualised relaxation sessions, provided at 4 weekly intervals, plus a 15-minute home programme based around an audio relaxation CD. Weekly telephone contact / support will be provided.

Intervention Type OTHER

Other Intervention Names

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Physiotherapy Physiotherapy Physiotherapy

Eligibility Criteria

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Inclusion Criteria

* Definite diagnosis of MS, according to McDonald's criteria
* Aged 18 years or over
* Able to walk independently with or without use of intermittent or constant unilateral assistance such as walking stick or orthotic brace

Exclusion Criteria

* In relapse or relapse in previous three months
* Any medical condition contra-indicating participation in core stability exercises
* Score \< 6 on the Abbreviated Mental Test, as an indicator of those whose cognitive difficulties could interfere with the informed consent process, or the ability to fully engage in the exercise programme.
* Current or recent (within past 6 months) participation in core stability exercises
* Current involvement in another interventional research study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Plymouth

OTHER

Sponsor Role lead

Responsible Party

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Jenny Freeman

Dr Jenny Freeman

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jennifer Freeman

Role: PRINCIPAL_INVESTIGATOR

University of Plymouth

Locations

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Merlin Centre, Bradbury House, Hewas water

St Austell, Cornwall, United Kingdom

Site Status

Devon NHS Trust

Newton Abbot, Devon, United Kingdom

Site Status

University Of Plymouth, School of Health Professions

Plymouth, Devon, United Kingdom

Site Status

Tavistock Community Hospital

Spring Hill, Tavistock, Devon, United Kingdom

Site Status

Lanarkshire NHS Trust

Cumbernauld, North Lanarkshire, United Kingdom

Site Status

South Tees NHS Trust

Middlesbrough, South Tees, United Kingdom

Site Status

University College London Hospital Trust

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Freeman JA, Gear M, Pauli A, Cowan P, Finnigan C, Hunter H, Mobberley C, Nock A, Sims R, Thain J. The effect of core stability training on balance and mobility in ambulant individuals with multiple sclerosis: a multi-centre series of single case studies. Mult Scler. 2010 Nov;16(11):1377-84. doi: 10.1177/1352458510378126. Epub 2010 Aug 10.

Reference Type BACKGROUND
PMID: 20699285 (View on PubMed)

Freeman J, Fox E, Gear M, Hough A. Pilates based core stability training in ambulant individuals with multiple sclerosis: protocol for a multi-centre randomised controlled trial. BMC Neurol. 2012 Apr 5;12:19. doi: 10.1186/1471-2377-12-19.

Reference Type BACKGROUND
PMID: 22480437 (View on PubMed)

Fox et al. (2013) Pilates based core stability training in ambulant individuals with multiple sclerosis: a multicentre, blinded, randomised, placebo controlled trial Way Ahead 2014;18(1):6-8 http://www.mstrust.org.uk/professionals/information/wayahead/articles/18012014_03.jsp

Reference Type BACKGROUND

Other Identifiers

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10/H0106/88

Identifier Type: -

Identifier Source: org_study_id

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