Condition category
Mental and Behavioural Disorders
Date applied
24/05/2012
Date assigned
24/05/2012
Last edited
27/02/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Ms Katy DeBono

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

12400

Study information

Scientific title

Task-related TRAINing in Huntingtons Disease: a home-based intervention trial

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

South East Wales Research Ethics Committee, 16/05/2012, ref: 12WA0151

Study design

Randomised interventional trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

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

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

Phase

Drug names

Primary outcome measures

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 trial start date

03/07/2012

Overall trial end date

03/12/2013

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 30; UK Sample Size: 30

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

Trial participating centre

Cardiff University
Cardiff
CF14 4XN
United Kingdom

Sponsor information

Organisation

Cardiff University (UK)

Sponsor details

Research and Commercial Division
30-36 Newport Road
Cardiff
CF24 0DE
United Kingdom

Sponsor type

University/education

Website

http://www.cardiff.ac.uk/

Funders

Funder type

Charity

Funder name

Huntington’s Disease Association (UK)

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

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25012999

Publication citations

Additional files

Editorial Notes