Community-based Exercise Therapies for Huntington's Disease
| ISRCTN | ISRCTN59910670 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59910670 |
| Protocol serial number | 9371 |
| Sponsor | Cardiff University (UK) |
| Funder | Wales Office of Research and Development for Health and Social Care (WORD) Grant Codes: HA09/028 |
- Submission date
- 21/04/2011
- Registration date
- 21/04/2011
- Last edited
- 18/11/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Katy DeBono
Scientific
Scientific
Department of Physiotherapy
Heath Park
Cardiff
CF14 4XN
United Kingdom
| debonok1@cardiff.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised interventional trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Can community supported exercise benefit subjective wellbeing, physical activity levels and abilities in people with Huntington's disease? A randomised feasibility study and process evaluation |
| Study acronym | COMMET-HD |
| Study objectives | Keeping physically active is known to result in considerable health benefits. We know that gym based exercises can be of benefit to physically able individuals as well as people with uncomplicated Long Term Neurological Conditions (LTNCs) such as Muscular Dystrophy, Parkinsons Disease, Motor Neurone Disease and Multiple Sclerosis. Little is known about ways to support and encourage involvement in regular exercise in the more complex LTNCs such as Huntingtons disease (HD), a progressive condition in which individuals suffer mobility deficits, cognitive decline, and psychiatric illness. This study aims to evaluate a gym-based supported exercise programme in terms of acceptability and potential benefit to people with HD. People with early stage HD will be provided with a graded exercise programme that will involve exercising three times a week for 3 months. One of the weekly sessions will take place in a gym based setting under supervision and the other two will be participant directed and focussed around a guided walking programme. We will record how often people do the prescribed exercise, how they feel about it and whether there are any changes in health and wellbeing. We then plan use to this and evidence from other LTNCs to help develop practical methods to improve uptake of exercise for people with complex LTNCs in community leisure facilities. |
| Ethics approval(s) | Medical Research Ethics Committee ref:10/WSE02/74; 22/12/2010 |
| Health condition(s) or problem(s) studied | Dementias and Neurodegenerative Diseases Research Network |
| Intervention | 1. Participants will be allocated to an intervention or a control group 2. Those allocated to the intervention group will be asked to exercise once a week in a community based gym under supervision of a member of the research team and to undertake an additional guided exercise session twice a week for the duration of the intervention. 3. The control group will be asked to continue as normal and will be offered the intervention at the end of the study provided results give no indication to questions 4. Follow Up Length: 9 month(s) |
| Intervention type | Other |
| Primary outcome measure(s) |
A number of outcomes that are representative of participation restriction, activity limitation as |
| Key secondary outcome measure(s) | |
| Completion date | 31/05/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 30 |
| Key inclusion criteria | 1. The diagnosis of Huntington's Disease (HD), confirmed by genetic testing and neurological examination (this is a routine requirement for any of the participants enrolled in the Registry study) 2. The ability to walk independently as primary means of mobility and willing to travel to the exercise centre for the intervention 3. The capacity to give informed consent 4. A total functional capacity (TFC) score of at least 7 5. A Unified Huntington's Disease Rating Scales (UHDRS) Transcranial Magnetic Stimulation (TMS) score of at least 5 6. Have maintained a stable medical regime for 4 weeks prior to initiation of study and are able to maintain a stable regime for the course of the study 7. Either gender |
| Key exclusion criteria | 1. Have a history of additional prior major neurological condition, such as stroke 2. Have an orthopaedic condition that independently limits mobility 3. Have cardiac precautions that would prevent the subject from completing the exercise programme or completing the full battery of outcome measures 4. Demonstrate uncontrolled psychiatric symptoms 5. Are pregnant 6. Demonstrate any contraindication to exercise |
| Date of first enrolment | 28/02/2011 |
| Date of final enrolment | 31/05/2011 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
Department of Physiotherapy
Cardiff
CF14 4XN
United Kingdom
CF14 4XN
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? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2012 | Yes | No | |
| Results article | results | 01/12/2013 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
