Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000760572
Ethics application status
Approved
Date submitted
1/07/2015
Date registered
22/07/2015
Date last updated
8/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Dance activities to maintain and improve health in older persons.
Scientific title
The effectiveness of dance activity programs on cognitive function and physical abilities in older persons with mild cognitive impairment: protocol for a feasibility randomized controlled trial.
Secondary ID [1] 286984 0
None
Universal Trial Number (UTN)
Nil
Trial acronym
Music, Movement and Memory Study
3Ms
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Some memory problems 295441 0
Cognitive difficulties 295534 0
Dementia 295621 0
Condition category
Condition code
Neurological 295692 295692 0 0
Dementias
Mental Health 295813 295813 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1) Method Dance Activity [Ronnie Gardiner Method (RGM)], incorporates: music, rhythm, colour, language training, symbol recognition, coordination, endurance, attention, memory, and social interaction. The session involves symbols and words that represent up to 18 body movements, E.g., clapping hands with or without stamping feet, which are displayed on a screen. Participants will move in various sequences performed to music. Group sessions will be led by a RGM trained therapist and will take place for an hour weekly over 12 continuous weeks. Adherence will be monitored using a register of attendance at each session.

Arm 2) Movement dance activity focuses on moving to music, creative problem solving, improvisation, and play. Sessions will involve learning short dance sequences, making and performing short dance sequences and having fun. The emphasis is on process not product. Group sessions will be led by a trained dance instructor and will take place for an hour weekly over 12 continuous weeks. Adherence will be monitored using a register of attendance at each session.
Intervention code [1] 292188 0
Prevention
Intervention code [2] 292283 0
Lifestyle
Comparator / control treatment
Music appreciation activity is a weekly social interaction group who will listen to the same music as the interventions and discuss it without movement. Group sessions will be led by a trained music and dance instructor and will take place for an hour weekly over 12 continuous weeks. Adherence will be monitored using a register of attendance at each session.
Control group
Active

Outcomes
Primary outcome [1] 295402 0
Cognitive function measured by CNS –Vital Sign.
Timepoint [1] 295402 0
Baseline and at end of intervention (12 weeks).
Secondary outcome [1] 315522 0
Physical performance measured by Short Performance Battery.
Timepoint [1] 315522 0
Baseline and at end of intervention (12 weeks).
Secondary outcome [2] 315523 0
Depressive symptoms measured by Geriatric Depression Scale.
Timepoint [2] 315523 0
Baseline and at end of intervention (12 weeks).
Secondary outcome [3] 315724 0
Assess the suitability and acceptability of the activities by interviewing participants.
Timepoint [3] 315724 0
At end of intervention (12 weeks).
Secondary outcome [4] 321774 0
Health-rated quality of life measured by the Short Form (36) Health Survey
Timepoint [4] 321774 0
Baseline and at end of the intervention (12 week)
Secondary outcome [5] 322158 0
Activity enjoyment measured by Physical Activity Enjoyment Scale
Timepoint [5] 322158 0
At end of intervention (12 weeks)
Secondary outcome [6] 324480 0
Hearing measured using pure-tone air-conduction audiometry
Timepoint [6] 324480 0
At end of intervention (12 weeks)

Eligibility
Key inclusion criteria
65 years of age or older, living in the community in Auckland, New Zealand, subjective memory complaint or concern expressed by others, objective evidence of impaired memory [assessed by Rey Auditory Verbal Learning Test (RAVLT)], or, presence of mild cognitive difficulties [assessed by the Montreal Cognitive Assessment (MoCA)], or both, no evidence of functional impairment in daily life [assessed by Functional Abilities Questionnaire (FAQ)], can communicate in English
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Dementia present, Significant psychiatric history (e.g., Schizophrenia, Bipolar affective disorder), Moderate to severe traumatic brain injury, Intellectual disability, known significant cerebral infarct (Stroke), Significant neurological condition (e.g., Parkinson’s disease, epilepsy, intracerebral tumor), blind or deaf, Heart attack in last 3 months, Significant alcohol / substance abuse / dependence

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be invited to participate in the trial through advertisements in retirement village newsletters, posters in the community, and through referral from general practitioners.

Interested participants will be asked to complete a reply card and return via reply-paid envelope. Once a reply is received that indicates problems with memory and the potential participant requests more information about the study, a researcher will then contact them to fully discuss the trial, ascertain eligibility. Qualified potential participants will receive the participant information sheet by post. They will be invited to a 30-minute meeting to fully discuss the trial and establish written informed consent.
During the meeting consenting participants will be asked to nominate an informant who can be anyone who knows them well and the appointment time and date for the thinking and memory screening assessment will be booked.


Consenting and eligible participants will be invited to participate in the study activities and proceed with baseline questionnaire.

The researchers will liaise with an off site colleague from the University of Auckland who is not involved in this trial, who will use a computer generated randomisation schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated randomisation schedule will be used to allocate participants to one of three groups using stratified randomization to uphold balance of: sex, age, cognitive screen scores, and primary and secondary outcomes between groups.

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/02/2016
Actual
3/03/2016
Date of last participant enrolment
Anticipated
24/03/2016
Actual
22/04/2016
Date of last data collection
Anticipated
Actual
12/08/2016
Sample size
Target
30
Accrual to date
Final
30
Recruitment outside Australia
Country [1] 7000 0
New Zealand
State/province [1] 7000 0
Auckland

Funding & Sponsors
Funding source category [1] 291539 0
University
Name [1] 291539 0
The University of Auckland
Country [1] 291539 0
New Zealand
Funding source category [2] 291540 0
University
Name [2] 291540 0
Brain Research New Zealand - Rangahau Roro Aotearoa
University of Auckland
Country [2] 291540 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Centre for Brain Research
University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country
New Zealand
Secondary sponsor category [1] 290218 0
None
Name [1] 290218 0
Address [1] 290218 0
Country [1] 290218 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293081 0
Health and Disability Ethics Committee
Ethics committee address [1] 293081 0
Ethics committee country [1] 293081 0
New Zealand
Date submitted for ethics approval [1] 293081 0
22/07/2015
Approval date [1] 293081 0
17/08/2015
Ethics approval number [1] 293081 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58382 0
Prof Ngaire Kerse
Address 58382 0
Department of General Practice & Primary Health Care
School of Population Health
Faculty of Medical and Health Sciences
The University of Auckland
Private Bag 92019
Auckland, 1142
Country 58382 0
New Zealand
Phone 58382 0
+64 (09) 923 5567
Fax 58382 0
Email 58382 0
n.kerse@auckland.ac.nz
Contact person for public queries
Name 58383 0
Ngaire Kerse
Address 58383 0
Department of General Practice & Primary Health Care
School of Population Health
Faculty of Medical and Health Sciences
The University of Auckland
Private Bag 92019
Auckland, 1142
Country 58383 0
New Zealand
Phone 58383 0
+64 (09) 923 5567
Fax 58383 0
Email 58383 0
n.kerse@auckland.ac.nz
Contact person for scientific queries
Name 58384 0
Ngaire Kerse
Address 58384 0
Department of General Practice & Primary Health Care
School of Population Health
Faculty of Medical and Health Sciences
The University of Auckland
Private Bag 92019
Auckland, 1142
Country 58384 0
New Zealand
Phone 58384 0
+64 (09) 923 5567
Fax 58384 0
Email 58384 0
n.kerse@auckland.ac.nz

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
No additional documents have been identified.