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 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 trial start date
01/03/2008
Overall trial end date
01/06/2011
Reason abandoned (if study stopped)
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
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
Basic results (scientific)
Publication list
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