Condition category
Mental and Behavioural Disorders
Date applied
21/04/2011
Date assigned
21/04/2011
Last edited
18/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Katy DeBono

ORCID ID

Contact details

Department of Physiotherapy
Heath Park
Cardiff
CF14 4XN
United Kingdom
debonok1@cardiff.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

9371

Study information

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

Acronym

COMMET-HD

Study hypothesis

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,
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

Medical Research Ethics Committee ref:10/WSE02/74; 22/12/2010

Study design

Randomised interventional trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Phase I

Drug names

Primary outcome measures

A number of outcomes that are representative of participation restriction, activity limitation as

Secondary outcome measures

Overall trial start date

28/02/2011

Overall trial end date

31/05/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned 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 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

Recruitment start date

28/02/2011

Recruitment end date

31/05/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Physiotherapy
Cardiff
CF14 4XN
United Kingdom

Sponsor information

Organisation

Cardiff University (UK)

Sponsor details

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

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

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

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

Results - basic reporting

Publication summary

1. 2012 results in: http://jnnp.bmj.com/content/83/Suppl_1/A58.2.abstract
2. 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24232362

Publication citations

  1. Results

    Busse M, Quinn L, Debono K, Jones K, Collett J, Playle R, Kelly M, Simpson S, Backx K, Wasley D, Dawes H, Rosser A, , A randomized feasibility study of a 12-week community-based exercise program for people with Huntington's disease., J Neurol Phys Ther, 2013, 37, 4, 149-158, doi: 10.1097/NPT.0000000000000016.

Additional files

Editorial Notes