Community-based Exercise Therapies for Huntington's Disease

ISRCTN ISRCTN59910670
DOI https://doi.org/10.1186/ISRCTN59910670
Secondary identifying numbers 9371
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

Not provided at time of registration

Contact information

Ms Katy DeBono
Scientific

Department of Physiotherapy
Heath Park
Cardiff
CF14 4XN
United Kingdom

debonok1@cardiff.ac.uk

Study information

Study designRandomised interventional trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleCan 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 acronymCOMMET-HD
Study hypothesisKeeping 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,
Parkinson’s 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 Huntington’s 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
ConditionDementias and Neurodegenerative Diseases Research Network
Intervention1. 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 typeOther
Primary outcome measureA number of outcomes that are representative of participation restriction, activity limitation as
Secondary outcome measures
Overall study start date28/02/2011
Overall study end date31/05/2011

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsPlanned Sample Size: 30; UK Sample Size: 30; Description: Thirty patients with early stage HD will be recruited to the study. Fifteen will be randomised to each arm of the study.
Participant inclusion criteria1. 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
Participant exclusion criteria1. 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
Recruitment start date28/02/2011
Recruitment end date31/05/2011

Locations

Countries of recruitment

  • United Kingdom
  • Wales

Study participating centre

Department of Physiotherapy
Cardiff
CF14 4XN
United Kingdom

Sponsor information

Cardiff University (UK)
University/education

7th Floor
30-36 Newport Road
Cardiff
CF24 0DE
Wales
United Kingdom

ROR logo https://ror.org/03kk7td41

Funders

Funder type

Government

Wales Office of Research and Development for Health and Social Care (WORD) Grant Codes: HA09/028

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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
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