Condition category
Nervous System Diseases
Date applied
27/03/2008
Date assigned
17/10/2008
Last edited
21/10/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Andrea Lowe-Strong

ORCID ID

Contact details

Senior Lecturer
University of Ulster
Health and Rehabilitation Sciences Research Institute
Shore Road
Newtownabbey
Northern Ireland
BT37 0QB
United Kingdom
+44 (0)2890 368052
a.lowe@ulster.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Group exercise therapy for mobility and balance in people with multiple sclerosis: a randomised controlled trial

Acronym

Study hypothesis

To determine whether group exercise therapy can improve mobility, balance, self-efficacy and quality of life in people with multiple sclerosis (MS).

Ethics approval

NHS Office for Research Ethics Committees Northern Ireland (ORECNI), approved in 2007 (ref: 07/N1R01/5)

Study design

Single-blind, randomised, single-centre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Multiple sclerosis with balance and mobility problems

Intervention

The exercise group will attend an exercise class twice per week for 6 weeks. The exercises will consist of 8 different stations and will be staged according to ability. Each class will last approximately 90 minutes with 10 minutes warm up, 3 minutes per exercise, 3 minutes rest in between and a cool down period/discussion time at the end.

There is no intervention for the control group. At the end of the study period they will be offered 1-2 workshops (as necessary) at the end of the trial to teach them the exercises that were offered to the experimental group.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Rivermead Mobility Index, assessed at baseline, immediately after the 6 weeks of intervention, and 3 and 6 months following discharge from the intervention. Analysis will be conducted on an intention to treat basis.

Secondary outcome measures

The following will be assessed at baseline, immediately after the 6 weeks of intervention, and 3 and 6 months following discharge from the intervention:
1. Berg Balance Scale
2. The Multiple Sclerosis Impact Scale (MSIS-29)
3. Multiple Sclerosis Walking Scale-12
4. Barthel Index
5. MS Self-efficacy Scale

Analysis will be conducted on an intention to treat basis.

Overall trial start date

01/03/2008

Overall trial end date

01/06/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Confirmed diagnosis of MS
2. Male or female, over 18 years of age
3. In a stable phase of their MS
4. Cognitively they must have a Score of 6 or more in the 10-point mini mental score (Hodkinson, 1972)
5. A minimum score of 14 on the Rivermead Mobility Index

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

160

Participant exclusion criteria

1. The Expanded Disability Status Scale (EDSS) >7.00
2. Serious other medical or surgical condition

Recruitment start date

01/03/2008

Recruitment end date

01/06/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Senior Lecturer
Northern Ireland
BT37 0QB
United Kingdom

Sponsor information

Organisation

University of Ulster (UK)

Sponsor details

c/o Mr Nick Curry
Research Governance Office
Shore Road
Newtownabbey
Northern Ireland
BT37 0QB
United Kingdom
+44 (0)28 90366629
n.cury@ulster.ac.uk

Sponsor type

University/education

Website

http://www.ulster.ac.uk

Funders

Funder type

Government

Funder name

The Research and Development Office, Northern Ireland Health and Social Services Central Services Agency (United Kingdom) (grant ref: RRG 8.5-RRG/3277/05)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Pilot study presented at 'World Physical Therapy 2007' : http://www.physiotherapyjournal.com/issues/contents?issue_key=S0031-9406(07)X6001-2
Abstract can be found on page 325

Publication citations

Additional files

Editorial Notes