Group exercise therapy for mobility and balance in people with multiple sclerosis

ISRCTN	ISRCTN78227711
DOI	https://doi.org/10.1186/ISRCTN78227711
Secondary identifying numbers	N/A

Submission date: 27/03/2008
Registration date: 17/10/2008
Last edited: 21/10/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Andrea Lowe-Strong
Scientific

Senior Lecturer
University of Ulster
Health and Rehabilitation Sciences Research Institute
Shore Road
Newtownabbey
Northern Ireland
BT37 0QB
United Kingdom

Phone	+44 (0)2890 368052
Email	a.lowe@ulster.ac.uk

Study information

Study design	Single-blind, randomised, single-centre trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Group exercise therapy for mobility and balance in people with multiple sclerosis: a randomised controlled trial
Study objectives	To determine whether group exercise therapy can improve mobility, balance, self-efficacy and quality of life in people with multiple sclerosis (MS).
Ethics approval(s)	NHS Office for Research Ethics Committees Northern Ireland (ORECNI), approved in 2007 (ref: 07/N1R01/5)
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/03/2008
Completion date	01/06/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	160
Key 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
Key exclusion criteria	1. The Expanded Disability Status Scale (EDSS) >7.00 2. Serious other medical or surgical condition
Date of first enrolment	01/03/2008
Date of final enrolment	01/06/2011

Locations

Countries of recruitment

Northern Ireland
United Kingdom

Study participating centre

Senior Lecturer

Northern Ireland
BT37 0QB
United Kingdom

Sponsor information

University of Ulster (UK)
University/education

c/o Mr Nick Curry
Research Governance Office
Shore Road
Newtownabbey
Northern Ireland
BT37 0QB
Northern Ireland
United Kingdom

Phone	+44 (0)28 90366629
Email	n.cury@ulster.ac.uk
Website	http://www.ulster.ac.uk
"ROR"	https://ror.org/01yp9g959

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Abstract results	Pilot study presented at 'World Physical Therapy ' Abstract can be found on page 325	02/06/2007		No	No