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Trial registered on ANZCTR


Registration number
ACTRN12617000634370
Ethics application status
Approved
Date submitted
21/03/2017
Date registered
2/05/2017
Date last updated
2/05/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Combined Cognitive and Exercise Enrichment to Improve Outcomes in Patients with Parkinson's Disease.
Scientific title
Combined Cognitive and Exercise Enrichment to Improve Outcomes in Patients with Parkinson's Disease.
Secondary ID [1] 291477 0
Nil Known
Universal Trial Number (UTN)
U1111-1171-7384
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's Disease 302534 0
Condition category
Condition code
Neurological 302079 302079 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study uses a “randomized controlled trial” design, with people in the treatment condition (active enrichment group) compared to those in the non-treatment condition. (passive enrichment group). The enrichment programme is for a period of 8 months.
Those allocated to the active enrichment programme will complete various physical exercise activities, on a weekly basis, done in small groups, tailored to ability and preference (See #1 below). These will be supervised by a registered physiotherapist. These physical exercise sessions will be 40-50 mins long and will normally take place at the same time each week in the same place. The physiotherapist will assess movement skills and monitor progress. Participants will also complete a set of thinking and memory exercises (see #2 below). These thinking exercises will be given to participants fortnightly by members of the research team from the New Zealand Brain Research Institute. Progress on these exercises will be monitored by the researchers and new cognitive exercises will be provided as the previous ones are completed.. These thinking and memory exercises will be completed with a caregiver/spouse or research staff member in the participants own home. We anticipate the cognitive exercises will take around 40-60 minutes on a weekly basis.. Cognitive tasks will include different types of pencil and paper exercises or tasks that require a verbal response. The level of difficulty of each cognitive task will be tailored to maximise improvements on each of them. A research team member will also talk with participants about common events in the past (e.g. family life and weddings). With permission, they will also record these descriptions of the events (a copy will be available to participants).

#1 Physical Activities:
Participants physical abilities were assessed by a qualified physiotherapist. On that basis they engaged in a suitably tailored circuit of activities consisting of aerobic, balance and strengthening exercises after a warm-up. Examples of each of these exercises include a exercise bike (aerobic), use of hand weights (strength) and walking a beam for balance. The participants are encouraged to work at an intensity that is “Somewhat hard” using the Borg “Rating of Perceived Exertion” Emoticon Chart.”

#2 Cognitive Activities:
Examples included elaborating vivid memories of personal events using personal prompts and reminders; envisioning a future event; visual-spatial puzzles; selective attention, mental rotation.

Adherence to the programme was assessed by records of attendance at the physiotherapy sessions (physiotherapists) and by return of completed cognitive activities folders. (Psychology PhD students and Research Coordinator).
Intervention code [1] 297542 0
Lifestyle
Intervention code [2] 297889 0
Treatment: Other
Comparator / control treatment
Standard care group, described as a passive enrichment group because they will be asked to continue with usual activities and usual medical care for 8 months, but in addition they will receive contact from the research team, maintain weekly diaries and receive various disease-relevant questionnaires. Purpose of the contact was to approximate the contact made for those in the intervention group. Phone contact occurred at 4-6 week intervals with additional contact when needed (Email or postal) and at least 3 face-face contacts during the intervention period.
Control group
Active

Outcomes
Primary outcome [1] 301514 0
A risk score for cognitive decline in PD developed at the New Zealand Brain Research Institute which calculates the percentage risk of cognitive decline in 4 yrs. The risk score is based on three cognitive screening measures and the participant's age.
Timepoint [1] 301514 0
At Baseline, 8 months and 20 months post commencement of the intervention.
Secondary outcome [1] 332886 0
Motor function assessed using the mini-Balance Evaluation Systems Test (mini-BEST).
Timepoint [1] 332886 0
At Baseline, 8 months and 20 months post commencement of the intervention.

Eligibility
Key inclusion criteria
Patients with a diagnosis of Parkinson’s disease (PD) whose cognition is relatively intact. Specifically, PD participants are eligible if their cognition remains better than that required for a status of PD with mild cognitive impairment (PD-MCI).
Minimum age
60 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of major medical or psychiatric illness in past 12 months,
Current or history of other neurological or psychiatric conditions,
Non-Parkinson medications impacting cognition.
History of alcohol or substance abuse,
History of learning disability,
Poor comprehension of English language.

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)
Central randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Central computerized stratified randomisation.
Blocked by; initial cognition score, followed by duration of PD, age and sex.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be collected from ~200 PD patients (from a pool of ~400 patients in Chch and ~350 in Otago/Southland) over 16 months using the screen, followed by in-depth data from a minimum of 40 PD participants. This feasibility trial will provide measures of variability to power larger phase II/phase III studies. We will recruit 20 pre-MCI patients per arm assigned by random stratification on key variables into each arm to balance variables of initial cognitive screening score, age, years of education and PD duration. The inital screen is expected to enrol 40 Pre-MCI PD patients. Achieving 80% power would require an extra 30/arm if our trial indicated a clinically relevant standardised RCT difference on the primary outcome of 0.4 (ANCOVA, with adjustment of R-sq of 0.5 for baseline x retest cognition). Additional analyses will test the association, across all patients, between cognitive change in the trial and (a) pre-existing factors (premorbid IQ; education; engagement in cognitive activities), (b) cognitive and physical activity during the trial, irrespective of group allocation; and (c) a composite measure, excluding cognition, of non-dopaminergic PD features. An a priori minimum protocol compliance of 4 months (or equivalent) will be used for the intention-to-treat analysis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
4/11/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 8748 0
New Zealand
State/province [1] 8748 0
Christhcurch

Funding & Sponsors
Funding source category [1] 295948 0
Government body
Name [1] 295948 0
Brain Research New Zealand - Rangahau Roro Aotearoa
Country [1] 295948 0
New Zealand
Funding source category [2] 295956 0
Charities/Societies/Foundations
Name [2] 295956 0
Canterbury Medical Research Foundation
Country [2] 295956 0
New Zealand
Primary sponsor type
Individual
Name
John Dalrymple-Alford
Address
C/o The New Zealand Brain Research Institute
66 Stewart Street
Christchurch 8011.
New Zealand
Country
New Zealand
Secondary sponsor category [1] 294839 0
Individual
Name [1] 294839 0
Prof Leigh Hale
Address [1] 294839 0
Dean
School of Physiotherapy
University of Otago
New Zealand
Country [1] 294839 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297224 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 297224 0
Postal address:
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140

Street address:
133 Molesworth Street
Thorndon
Wellington 6011
Ethics committee country [1] 297224 0
New Zealand
Date submitted for ethics approval [1] 297224 0
07/09/2015
Approval date [1] 297224 0
17/09/2015
Ethics approval number [1] 297224 0
15/NTB/161

Summary
Brief summary
The aim of this study is to examine whether a lifestyle programme is beneficial in people who have been diagnosed with Parkinson’s disease (PD). The lifestyle programme will use a combination of (1) physical exercises and (2) thinking-based exercises over an 8 month period. If you agree to take part, you will be randomly assigned to either the lifestyle programme or the standard care group. Please note that you will have a fifty-fifty chance of getting into either group. You will not be able to choose which group you want to be in.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73386 0
Prof John Dalrymple-Alford
Address 73386 0
New Zealand Brain Research Institute
66 Stewart Street
Christchurch 8011
New Zealand
Country 73386 0
New Zealand
Phone 73386 0
+64 3 378 6347
Fax 73386 0
Email 73386 0
[email protected]
Contact person for public queries
Name 73387 0
Marie Goulden
Address 73387 0
New Zealand Brain Research Institute
66 Stewart Street
Christchurch 8011
New Zealand
Country 73387 0
New Zealand
Phone 73387 0
+64 3 378 6348
Fax 73387 0
Email 73387 0
[email protected]
Contact person for scientific queries
Name 73388 0
John Dalrymple-Alford
Address 73388 0
New Zealand Brain Research Institute
66 Stewart Street
Christchurch 8011
New Zealand
Country 73388 0
New Zealand
Phone 73388 0
+64 3 378 6347
Fax 73388 0
Email 73388 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
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