Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000218099
Ethics application status
Approved
Date submitted
25/01/2010
Date registered
17/03/2010
Date last updated
11/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of environmental enrichment on clinical measures of disease progression and quality of life for patients with Huntington's disease.
Scientific title
Among patients with Huntington's disease, does environmental enrichment affect clinical measures of disease progression and quality of life.
Secondary ID [1] 1313 0
Nil.
Universal Trial Number (UTN)
U1111-1113-4158
Trial acronym
HEROs
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Huntington's disease 256620 0
Condition category
Condition code
Neurological 256788 256788 0 0
Neurodegenerative diseases
Human Genetics and Inherited Disorders 256790 256790 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Environmental enrichment; a 9 month cognitive and physical stimulation intervention (occupational therapy, physical exercise) to directly target affected brain regions. Participants will be randomly allocated into two cohorts: one group will receive the environmental enrichment intervention and the other group will not. Carers (healthy volunteers) will also be recruited to assist with participant compliance and to complete questionnaires regarding the participant. Carers of participants who undertake the environmental enrichment intervention may also voluntarily undertake the exercise regimen and therefore may act as a control group for the exercise-related measures such as balance tests, and questionnaires.

The Occupational Therapy intervention will be client centered and delivered using the group and individual model. The model of service delivery will be guided by the Goal Attainment scale which will support the assessment of individual needs and goals. Each participant will work individually with their therapist to achieve this. The Goal Attainment Scale will be used to measure outcomes specific to the Occupational Therapy Intervention.

The exercise intervention will involve one session per week of approximately 60 minutes duration at an exercise clinic. Sessions will commence with a 10 minute warm-up period and finish with a 5 minute cool-down period consisting of low-level aerobic exercise on cycle ergometers and stretching. All exercise sessions will be conducted in small groups of up to 10 participants, with participants exercising in pairs under direct supervision to ensure correct technique and minimise the risk of injury. In order to minimise the possibility of boredom and overreaching, the exercise programs will be periodized by cycling with an emphasis on intensity and volume. All participants will be asked to maintain otherwise customary physical activity and dietary patterns throughout the intervention period.

There will be two main components to the exercise program.
1) Resistance training, to provide optimal stimulus to enhance neuromuscular strength, including 6 exercises each session targeting major upper and lower body muscle groups, modified to suit people with Huntington's disease. Repetition maximums will be set per individual and participants will be encouraged to exceed this to ensure a progressive nature to the training program, with an inter-set rest period of 3 minutes.
2) Aerobic training will provide optimal stimulus to enhance the cardiorespiratory capacity while maintaining a healthy level of body fat and cardiovascular and metabolic risk. Participants will be encouraged to accumulate 150 minutes per week of continuous or intermittent exercise with a target heart rate of 60-85% of maximum. Activities in the exercise clinic will include cycling, treadmill, cross trainer and rowing ergometer exercise supplemented with other activities in and around the home and community (eg walking, swimming).

At the end of the 9 month intervention period, participants in the control group and intervention groups will be offered the opportunity to participate in another 9 month intervention.
Intervention code [1] 255873 0
Treatment: Other
Intervention code [2] 255923 0
Rehabilitation
Intervention code [3] 255924 0
Lifestyle
Comparator / control treatment
No treatment
Control group
Active

Outcomes
Primary outcome [1] 257654 0
Changes to cognitive function as assessed by various cognitive measurement instruments, including neurological examination, United Huntington's Disease Rating Scale, Hopkins Verbal Learning Test, Delis-Kaplan Executive Function Scale (DKEFS) Trail Making Trials, Huntington's Disease (HD) Quality of Life Battery for Carers, Short Form 36 (SF-36) Health Survey Questionnaire and Beck Depression Inventory.
Timepoint [1] 257654 0
At baseline, at 12 months (no intervention), at 12 months (9 months of intervention) and at 23 months (9 or 18 months of intervention).
Primary outcome [2] 257655 0
Brain volume as assessed by Magenetic Resonance Imaging (MRI) scan. Brain activity as assessed by functional MRI scans. Brain integrity as assessed by Diffusion Tensor Imaging.
Timepoint [2] 257655 0
At baseline, at 12 months (no intervention), at 12 months (9 months of intervention) and at 23 months (9 or 18 months of intervention).
Secondary outcome [1] 262931 0
Body composition (bone mineral density/fat/muscle composition) as assessed by Dual Energy X-ray Absorptiometry (DEXA) scan.
Timepoint [1] 262931 0
At baseline, at 12 months (no intervention), at 12 months (9 months of intervention) and at 23 months (9 or 18 months of intervention).
Secondary outcome [2] 262932 0
Balance capacity as assessed by balance tests.
Timepoint [2] 262932 0
At baseline, at 12 months (no intervention), at 12 months (9 months of intervention) and at 23 months (9 or 18 months of intervention).
Secondary outcome [3] 262933 0
Alteration to physiological concentrations of biochemical markers related to the disease, including salivary cortisol levels and blood insulin/c-peptide and glucose levels.
Timepoint [3] 262933 0
At baseline, at 12 months (no intervention), at 12 months (9 months of intervention) and at 23 months (9 or 18 months of intervention).

Eligibility
Key inclusion criteria
Patients must be diagnosed with Huntington's disease, and be capable of participating in the exercise intervention. Where possible, carers (healthy volunteers) will be recruited.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Asymptomatic or gene-positive individuals that have not been diagnosed with Huntington's disease. Inability to participate in the exercise intervention.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects will be allocated into two equal groups based on baseline cognitive and motor scores. The group to receive the intervention will be randomly assigned by coin toss.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random assignation of group to receive the intervention will be by coin toss.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256357 0
Charities/Societies/Foundations
Name [1] 256357 0
Lotterywest (Research Grant)
Country [1] 256357 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
270 Joondalup Drive
Joondalup WA 6027
Country
Australia
Secondary sponsor category [1] 251695 0
Other Collaborative groups
Name [1] 251695 0
Neurosciences Unit (Department of Health),
Address [1] 251695 0
Cnr Mooro Drive & John XXIII Venue,
Mt Claremont WA 6010
Country [1] 251695 0
Australia
Other collaborator category [1] 1060 0
Individual
Name [1] 1060 0
Dr Roger Barker,
Address [1] 1060 0
Centre for Brain Repair,
Cambridge University,
ED Adrian Building,
Forvie Site,
Robinson Way,
Cambridge CB2 OPY UK
Country [1] 1060 0
United Kingdom
Other collaborator category [2] 1061 0
Individual
Name [2] 1061 0
Dr Anthony Hannan
Address [2] 1061 0
Howard Florey Institute,
University of Melbourne,
Parkville Victoria 3010
Country [2] 1061 0
Australia
Other collaborator category [3] 1062 0
Other Collaborative groups
Name [3] 1062 0
The Brightwater Group
Address [3] 1062 0
Level 3/55 Scarborough Beach Road,
Osborne Park WA 6017
Country [3] 1062 0
Australia
Other collaborator category [4] 1063 0
Other Collaborative groups
Name [4] 1063 0
Huntington's WA Inc
Address [4] 1063 0
The Niche,
11 Aberdare Road,
Nedlands WA 6009
Country [4] 1063 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258431 0
Edith Cowan University Human Research Ethics Committee
Ethics committee address [1] 258431 0
270 Joondalup Drive,
Joondalup WA 6027
Ethics committee country [1] 258431 0
Australia
Date submitted for ethics approval [1] 258431 0
Approval date [1] 258431 0
27/11/2009
Ethics approval number [1] 258431 0
4229
Ethics committee name [2] 258432 0
Department of Health/North Metropolitan Area Mental Health Services
Ethics committee address [2] 258432 0
Graylands Hospital,
Brockway Road,
Mt Claremont WA 6010
Ethics committee country [2] 258432 0
Australia
Date submitted for ethics approval [2] 258432 0
Approval date [2] 258432 0
10/12/2009
Ethics approval number [2] 258432 0
09/16 (provisional approval)

Summary
Brief summary
This research project intends to assess the effects of mental and physical stimulation on participants with Huntington's disease, an inherited, degenerative brain disorder. The effect of the intervention will be assessed by measuring brain function and volume, and other indicators of the disease such as balance capability, body composition and biochemical markers to determine the ability of environmental enrichment to delay the progression of the disease, thereby impacting the quality of life for patients with Huntington's disease. Carers will also be recruited where possible to assist with patient participation and compliance, and to complete quality of life questionnaires regarding the participants. Carers may also undertake the exercise regimen and may act as a control group for select exercise-related tests (voluntary).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30736 0
Address 30736 0
Country 30736 0
Phone 30736 0
Fax 30736 0
Email 30736 0
Contact person for public queries
Name 13983 0
Dr Jennifer Thompson
Address 13983 0
Edith Cowan University,
School of Exercise, Biomedical and Health Sciences,
270 Joondalup Drive,
Joondalup WA 6027
Country 13983 0
Australia
Phone 13983 0
+61 8 6304 3401
Fax 13983 0
+61 8 6304 2626
Email 13983 0
[email protected]
Contact person for scientific queries
Name 4911 0
Dr Jennifer Thompson
Address 4911 0
Edith Cowan University,
School of Exercise, Biomedical and Health Sciences,
270 Joondalup Drive,
Joondalup WA 6027
Country 4911 0
Australia
Phone 4911 0
+61 8 6304 3401
Fax 4911 0
+61 8 6304 2626
Email 4911 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffects of multidisciplinary therapy on physical function in Huntington's disease.2018https://dx.doi.org/10.1111/ane.13002
N.B. These documents automatically identified may not have been verified by the study sponsor.