Group exercise therapy for mobility and balance in people with multiple sclerosis
| ISRCTN | ISRCTN78227711 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78227711 |
| Protocol serial number | N/A |
| Sponsor | University of Ulster (UK) |
| Funder | The Research and Development Office, Northern Ireland Health and Social Services Central Services Agency (United Kingdom) (grant ref: RRG 8.5-RRG/3277/05) |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
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 |
|---|---|
| a.lowe@ulster.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-blind, randomised, single-centre trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
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. |
| Key secondary outcome measure(s) |
The following will be assessed at baseline, immediately after the 6 weeks of intervention, and 3 and 6 months following discharge from the intervention: |
| Completion date | 01/06/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- Northern Ireland
Study participating centre
BT37 0QB
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
