Task-related TRAINing in Huntingtons Disease
| ISRCTN | ISRCTN94284668 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN94284668 |
| Secondary identifying numbers | 12400 |
- Submission date
- 24/05/2012
- Registration date
- 24/05/2012
- Last edited
- 27/02/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Huntington's disease (HD) leads to loss of mobility, with individuals eventually requiring assistance with all activities of daily living. Our research has provided evidence that people with early stage HD can benefit from a physiotherapy-led home-based exercise programme, aimed at improving muscle strength, balance and overall fitness. While this research provides an important first step into the potential benefits of physiotherapy-related interventions for people with HD, further research in this area is needed. The purpose of this study is to evaluate the feasibility, acceptability and potential benefit of home-based physiotherapy targeted for people with early to mid-stage HD who currently receive no or minimal physiotherapy.
Who can participate?
We will recruit 30 people who have been diagnosed with HD and have difficulties with walking and/or balance.
What does the study involve?
Participants will be randomly allocated into either an intervention group, in which they receive a home-based physiotherapy programme, or a control group who will be asked to continue as normal. Participants will be assessed at the start of the study and after 8 and 16 weeks. The effectiveness of the programme will be assessed, including its effects on general physical functioning, walking ability and balance. In addition, each participant will set individual goals related to their functional abilities, in collaboration with a physiotherapist. If the programme is found to be beneficial and safe, the control group will be offered the intervention at the end of the study.
What are the possible benefits and risks of participating?
There may be no direct benefits to anyone taking part in this study. The study is being undertaken to find out whether or not the physiotherapy intervention is beneficial to people with HD. Participants will be helping to answer this question, which may be of benefit to people with HD in the future. The assessments are unlikely to cause any undue stress. Participant care and comfort will be ensured at all times. The proposed physiotherapy training is of low to moderate intensity and therefore poses minimal risk. It will not involve any heavy load bearing activities. If a participant has any specific problems or difficulties, they will be provided with a contact telephone number to speak to the research team. If necessary they will be seen at their HD clinic for review. Before and during the study they will also be given the opportunity to discuss any concerns with the researchers in private.
Where is the study run from?
The study is being organised by the School of Healthcare Studies, Cardiff University and has six study sites: Cardiff, Oxford, Manchester, Sheffield, Birmingham and London.
When is the study starting and how long is it expected to run for?
The study started in September 2012 and will finish in December 2013.
Who is funding the study?
Huntington’s Disease Association (UK).
Who is the main contact?
Katy Debono
Debonok1@cardiff.ac.uk
Contact information
Scientific
Cardiff University
Department of Physiotherapy
Heath Park
Cardiff
CF14 4XN
United Kingdom
| debonok1@cardiff.ac.uk |
Study information
| Study design | Randomised interventional trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Task-related TRAINing in Huntingtons Disease: a home-based intervention trial |
| Study acronym | TRAIN |
| Study hypothesis | The proposed trial will investigate the potential benefits of a physiotherapy programme for people with mid-stage Huntington's Disease (HD) who currently receive no or minimal physiotherapy input. We will recruit 30 individuals who have been diagnosed with HD. Participants will be randomly allocated into either a group in which they receive a home-based physiotherapy programme (called the intervention group), or a group who will be asked to continue as usual (control group). The trial will start after participants are recruited and consented. Participants will be assessed on enrolment into the trial. They will be randomly allocated their group immediately following the first (baseline) assessment. Those in the group which receive home-based physiotherapy programme will begin this within 2 weeks of the baseline assessment. They will be reassessed at 8 weeks following the start of the physiotherapy programme, and again at 16 weeks from the start of physiotherapy programme. These timescales mean that each participant will be involved in the trial for a minimum of 16 weeks and a maximum of 18 weeks (if there is a delay for anybody in the intervention group between enrolment and starting the physiotherapy programme). The effectiveness of the programme will be assessed using various measures, including general physical functioning, walking ability and balance. In addition, each participant will set individual goals related to their functional abilities, with the physiotherapist delivering the home-based programme. To maximise recruitment and ensure consistency of care, the control group will be offered the intervention at the end of the trial, provided that results so far give no reason to question safety or potential for benefit. If shown to be an acceptable and beneficial intervention, the results from the proposed trial could help to provide a structured framework to guide physiotherapy service delivery according to clinical need for people with HD. More details can be found at http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=12400 |
| Ethics approval(s) | South East Wales Research Ethics Committee, 16/05/2012, ref: 12WA0151 |
| Condition | Dementias and neurodegenerative diseases |
| Intervention | Home-based exercise programme: Physiotherapy exercise programme targeted at people with early / mid stage HD. The intervention group is an 8-week (2x/week) programme providing task-related training and functional activity exercise to improve sit to stand, balance and walking. |
| Intervention type | Behavioural |
| Primary outcome measure | Physical Performance Test measured at 0 weeks (baseline), 8 weeks and 16 weeks |
| Secondary outcome measures | 1. 30 second chair stand test measured at 0 weeks (baseline), 8 weeks and 16 weeks 2. 30-second chair stand test by the treating therapists measured at once a week 3. Depression will be quantified by the Hospital Anxiety and Depression Scale (HADS) at 0 weeks (baseline), 8 weeks and 16 weeks 4. Quality of life as measured by the Huntington's Disease Quality of Life Measure (HD-QOL) measured at 0 weeks (baseline), 8 weeks and 16 weeks 5. The Berg Balance Scale measured at 0 weeks (baseline), 8 weeks and 16 weeks 6. Timed Up and Go walking speed as measured by 10 m walk measured at 0 weeks (baseline), 8 weeks and 16 weeks |
| Overall study start date | 03/07/2012 |
| Overall study end date | 03/12/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 30; UK Sample Size: 30 |
| Participant inclusion criteria | 1. Diagnosis of manifest HD, confirmed by genetic testing 2. Self-reported or physician-reported difficulties with walking and/or balance 3. Between ages of 18 and 70 years 4. Capacity to give informed consent 5. Total functional capacity (TFC) of at least 4 6. Stable medication regime for 4 weeks prior to initiation of trial, and be able to maintain a stable regime for the course of trial 7. Enrolled on EHDN Registry/ENROLL study 8. Target Gender: Male & Female 9. Upper Age Limit 70 years 10. Lower Age Limit 18 years |
| Participant exclusion criteria | 1. History of prior neurological condition, such as stroke 2. Unable to understand or communicate in spoken English 3. Moderate to severe arthritis in the hips, knees or ankles, or orthopaedic condition that limits walking ability 4. Cardiac precautions that would prevent subject from completing the intervention or the full battery of outcomes 5. Currently in receipt of active physiotherapy input 6. Are currently involved in any interventional trial or within 2 months of completing an interventional trial 7. Are not enrolled (or interested in enrolling) on the EHDN Registry/ ENROLL study 8. Demonstrate uncontrolled psychiatric symptoms / have active psychosis |
| Recruitment start date | 03/07/2012 |
| Recruitment end date | 03/12/2013 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
CF14 4XN
United Kingdom
Sponsor information
University/education
Research and Commercial Division
30-36 Newport Road
Cardiff
CF24 0DE
Wales
United Kingdom
| Website | http://www.cardiff.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/03kk7td41 |
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 | 01/11/2014 | Yes | No |
