Supporting activity engagement in people with Huntington's disease

ISRCTN	ISRCTN65378754
DOI	https://doi.org/10.1186/ISRCTN65378754
Protocol serial number	16354
Sponsor	Cardiff University (UK)
Funder	National Institute of Social Care and Health Research; Grant Codes: SPON 1249-13

Submission date: 13/03/2014
Registration date: 13/03/2014
Last edited: 21/02/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Huntington's disease (HD) is an inherited nervous-system-related disease, which over time causes problems with movement, thinking and behaviour and ultimately difficulties in undertaking usual activities of daily living. We know that keeping active (both physically and socially) is important for any person who suffers with a long-term health condition. This can become very difficult for people with HD given the complex and varied problems that they are faced with on a daily basis. This study aims to analyse two different home-based programmes that have been specifically developed for people with HD, each of which has different attributes, either social or physical.

Who can participate?
People with HD can participate in this study.

What does the study involve?
Participants will be asked to attend three research assessments (focussing on movement, thinking and activities of daily living) over a 6-month period at their local HD clinics. After the first assessment, they will be randomly allocated to one of two programmes that will be based in the home. In between the second and third assessment, all participants will continue with their normal activities. At the end of the study, each participant will be offered a brief version of the other programme.

What are the possible benefits and risks of participating?
There may, or may not be, direct benefits to anyone taking part in this study. The study is being undertaken to find out whether or not the activity programmes are beneficial to people with HD. By taking part, participants will be helping us to answer this question, which may be of benefit to people with HD in the future. The assessments and interventions are unlikely to cause any undue stress and there are no clear risks assoicated with participating in the study.

Where is the study run from?
The study is managed by the South East Wales Trials Unit, based in Cardiff. Participants are being recruited from the following sites in the UK:
1. Ashgrove House, NHS Grampian, Aberdeen
2. The Barberry, Birmingham and Solihull Mental Health Foundation NHS Trust, Birmingham
3. Southampton General Hospital, University Hospital Southampton NHS Foundation Trust, Southampton
4. Southmead Hospital, North Bristol NHS Trust, Bristol
5. St Mary's Hospital, Central Manchester University Hospitals NHS Foundation Trust, Manchester
6. Sheffield Clinical Genetics Service, Sheffield Children's NHS Foundation Trust, Sheffield
7. The Bennett Centre, North Staffordshire Combined Healthcare NHS Trust, Stoke-on-Trent
8. Cardiff University, Cardiff

When is the study starting and how long is it expected to run for?
May 2014 to March 2016

Who is funding the study?
National Institute for Health and Social Care Research (UK)

Who is the main contact?
Dr Monica Busse
busseme@cardiff.ac.uk

Contact information

Dr Monica Busse
Scientific

Heath Park
Cardiff
CF14 4XN
United Kingdom

ORCID ID	0000-0002-5331-5909
Email	busseme@cardiff.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised; Interventional; Design type: Process of Care
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Supporting activity ENGAGEment in people with Huntington's Disease: a phase II evaluation
Study acronym	ENGAGE-HD
Study objectives	The main objective of the trial is to evaluate the feasibility, acceptability and potential benefit of a home-based physical activity intervention programme targeted for people with early-mid stage HD when compared to an equivalent contact time social interaction intervention.
Ethics approval(s)	South East Wales Research Ethics Committee B, 26/02/2014; ref. 14/WA/0034
Health condition(s) or problem(s) studied	Topic: Dementias and Neurodegenerative Diseases Research Network; Subtopic: Huntingtons Disease; Disease: Huntington's disease
Intervention	ENGAGE-HD: Participants enrolled in the ENGAGE-HD Physical Activity Intervention will receive 6 home visits and interim phone calls over a course of 16 weeks (weeks 1, 2, 3, 6, 10 and 14). They will be supported in developing an individualized lifestyle approach to enhancing physical activity through interactions with trained physical activity coaches along with resources that include a.purpose development workbook and an exercise DVD. The alternate intervention is a social contact intervention. A minimisation technique will be used for randomisation to allow for balancing of a range of important variables.
Intervention type	Behavioural
Primary outcome measure(s)	Current primary outcome measures as of 09/12/2014: The primary feasibility outcome will include an evaluation of eligibility, recruitment and retention rates (in line with CONSORT recommendations) as well as monitoring of completion of outcome measures and assessments. Previous primary outcome measures: Physical Performance Test; Timepoint(s): baseline, 16 weeks and 24 weeks
Key secondary outcome measure(s)	Added 09/12/2014: A range of secondary measures will be explored in terms of short-term benefit (timepoints: baseline, 16 weeks and 24 weeks). The main assessment of short-term benefit will be provided by the Physical Performance Test (PPT) Added 13/03/2017: Measures of participation and health: 1. Individualised quality of life, measured using the schedule for the evaluation of individual quality of life—direct weighting (SEIQoL-DW) at follow up assessment (week +26) 2. Self-efficacy, measured using the Lorig self-efficacy scale at baseline (week 0), primary outcome assessment (week +16), follow up assessment (week +26) 3. Health service use, measured using the Client Services Receipt Inventory at baseline (week 0), primary outcome assessment (week +16), follow up assessment (week +26) 4. Health utility, measured using EQ-5D-5L and ICE-CAP-A at baseline (week 0), primary outcome assessment (week +16), follow up assessment (week +26) Measures of activity: 1. Functional activity, measured using the Physical Performance Test (PPT) at baseline (week 0), primary outcome assessment (week +16), follow up assessment (week +26) 2. Usual pattern of mobility, measured using the Life Space Assessment at baseline (week 0), follow up assessment (week +26) 3. Physical activity, measured using the International Physical Activity Questionnaire (Short Form) at baseline (week 0), follow up assessment (week +26) 4. Walking ability, measured using the six minute walk test and the Timed Up and Go Test at baseline (week 0), primary outcome assessment (week +16), follow up assessment (week +26) 5. Self-reported falls, including the frequency, circumstance and severity of any falls at baseline (week 0), primary outcome assessment (week +16), follow up assessment (week +26) Measures of body function: 1. Disease-specific clinical measure of motor impairment, measured using the Unified Huntington Disease Rating Scale (UHDRS) modified motor scale at baseline (week 0), primary outcome assessment (week +16), follow up assessment (week +26) 2. Cognitive impairment, measured using the Symbol Digit Modality Test (SDMT) and Category Verbal Fluency at baseline (week 0), primary outcome assessment (week +16), follow up assessment (week +26) 3. Lower extremity strength and endurance, measured using the Timed 15 Repetition Chair Stand Test (15RCST) at baseline (week 0), primary outcome assessment (week +16), follow up assessment (week +26) Behavioural outcomes: 1. Measures of autonomy/supportive interactions, measured using the PAS Healthcare Climate Questionnaire at primary outcome assessment (week +16)
Completion date	31/03/2016

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	62
Key inclusion criteria	Current inclusion criteria as of 14/10/2014: 1. Diagnosis of manifest HD, confirmed by genetic testing 2. Self-reported or physician-reported difficulties with walking and/or balance (but still able to walk with minimal assistance) 3. Above the age of 18 4. Stable medication regime for 4 weeks prior to initiation of trial, and anticipated to be able to maintain a stable regime for the course of trial 5. Enrolled on EHDN Registry/ENROLL-HD study [or if not enrolled, that the clinician is able to provide a recent specialist HD clinical assessment that includes a UHDRS TMS score, full medical history and a record of the CAG length (longer allele)] Previous inclusion criteria: 1. Diagnosis of manifest HD, confirmed by genetic testing 2. Self-reported or physician-reported difficulties with walking and/or balance (but still able to walk with minimal assistance) 3. Above the age of 18 4. Stable medication regime for 4 weeks prior to initiation of trial, and anticipated to be able to maintain a stable regime for the course of trial 5. Enrolled on EHDN Registry/ENROLL-HD study
Key exclusion criteria	1. Any physical or psychiatric condition that would prohibit the participant from completing the intervention or the full battery of assessments 2. Unable to understand or communicate in spoken English 3. Currently involved in any interventional trial or within 4 weeks of completing an interventional trial
Date of first enrolment	23/06/2014
Date of final enrolment	21/08/2015

Locations

Countries of recruitment

United Kingdom
Wales

Study participating centres

Cardiff University

Cardiff
CF10 3XQ
United Kingdom

Ashgrove House

NHS Grampian
Aberdeen
-
United Kingdom

The Barberry

Birmingham and Solihull Mental Health Foundation NHS Trust
Birmingham
-
United Kingdom

Southampton General Hospital

University Hospital Southampton NHS Foundation Trust
Southampton
-
United Kingdom

Southmead Hospital

North Bristol NHS Trust
Bristol
-
United Kingdom

St Mary's Hospital

Central Manchester University Hospitals NHS Foundation Trust
Manchester
-
United Kingdom

Sheffield Clinical Genetics Service

Sheffield Children's NHS Foundation Trust
Sheffield
-
United Kingdom

The Bennett Centre

North Staffordshire Combined Healthcare NHS Trust
Stoke-on-Trent
-
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan	The datasets generated during and/or analysed during the current study are not expected to be made available so as to protect the identity of participants with a rare disease.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	17/11/2016		Yes	No
Protocol article	protocol	12/12/2014		Yes	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

21/02/2018: Publication reference added.