Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000336280
Ethics application status
Approved
Date submitted
22/02/2018
Date registered
6/03/2018
Date last updated
22/01/2020
Date data sharing statement initially provided
8/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Cognitive Stimulation Therapy and Chair Yoga in Dementia
Scientific title
Cognitive Stimulation Therapy and Chair Yoga for People with Mild to Moderate Dementia:
A Pilot Study on Cognition and Neurobehavioural Symptoms
Secondary ID [1] 294131 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 306752 0
Condition category
Condition code
Neurological 305840 305840 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cognitive Stimulation Therapy (CST) + Chair Yoga: 2 Selwyn Foundation staff will deliver CST, followed by a yoga instructor delivering Chair Yoga in a 90-minute session (45-minute CST; 45 minute Chair Yoga), ..

- CST (45 minutes): CST is a structured and manualised group treatment specifically developed for people with mild to moderate dementia. It involves 14 or more sessions of themed activities. They were designed to run twice a week over a seven-week period. Sessions are aimed to actively stimulate and engage people with dementia, while providing an optimal learning environment and the social benefits of a group. The following themes are covered in the 14 sessions: physical games, sound, childhood, food, current affairs, faces /scenes, word association, being creative, categorising objects, orientation, using money, number games, word games, team quiz.
- Chair Yoga (45 minutes): The Chair Yoga protocol will include: breath work; sit, breathe, notice breath; alternate nostril breathing/bee’s breath to calm-move within; exercises for joints and lymph system-seated; lion’s breath; face, forehead, sinus, ear massage; neck rolls (only side to side gently); shoulder shrugs; keep spine long, relax chin to chest in chai; side bends; knee lifts; Sa, Ta, Na, Ma with finger mudra (bringing together thumb and middle finger in a circle); and sit and notice.

- 2 Selwyn Foundation staff who attended a 1-day CST training workshop will deliver the CST; a qualified yoga instructor delivering Chair Yoga

- The mode of administration of CST and Chair Yoga involves face-to-face groups of 8 participants;
- A total of 20 CST and Chair Yoga sessions (90 minutes per session, 2 sessions per week for 10 weeks.
- the location where the intervention occurs: a Selwyn Foundation residential care facility

Intervention code [1] 300412 0
Other interventions
Comparator / control treatment
2 comparators

(i) Cognitive Stimulation Therapy (CST): Each CST group has 8 participants and is facilitated by 2 Selwyn Foundation staff trained by the research team. According to the CST manual, the group meets for 50 minutes twice a week for 7 weeks. However, for this study CST will be delivered twice a week for 10 weeks in order to match the duration required for Chair Yoga (see below). This is acceptable given CST also has a maintenance programme beyond the first 7 weeks.

(ii) Chair Yoga: Each Chair Yoga group has 8 participants. A yoga instructor from Wellpark College of Complementary Therapies will deliver Chair Yoga for 50 minutes twice a week for 10 weeks.

The Chair Yoga protocol will include: breath work; sit, breathe, notice breath; alternate nostril breathing/bee’s breath to calm-move within; exercises for joints and lymph system-seated; lion’s breath; face, forehead, sinus, ear massage; neck rolls (only side to side gently); shoulder shrugs; keep spine long, relax chin to chest in chai; side bends; knee lifts; Sa, Ta, Na, Ma with finger mudra (bringing together thumb and middle finger in a circle); and sit and notice.
Control group
Active

Outcomes
Primary outcome [1] 304892 0
Alzheimer’s Disease Assessment Scale – cognitive subscale (ADAS-Cog)
Timepoint [1] 304892 0
immediately post 10-week intervention
Secondary outcome [1] 343538 0
Neuropsychiatric Inventory
Timepoint [1] 343538 0
immediately post 10-week intervention

Eligibility
Key inclusion criteria
1. People aged 50 years and over with a diagnosis of mild to moderate dementia (Montreal Cognitive Assessment score of 10 or more).
2. The person can have a ‘meaningful’ conversation.
3. The person can hear well enough to participate in a 1 to 1 discussion.
4. The person’s vision is good enough to see most pictures.
5. The person is likely to remain in a session for 50-90 minutes.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Those within the past 6 weeks who have had a recent acute medical illness such as stroke or heart attack.
2. Those who is currently participating in a cognitive stimulation treatment

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
not applicable
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
2 comparator arms
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Repeated measures ANOVA will be used for comparing the pre- and post-outcome measures in the 3 intervention groups, with a statistical significance level set at 0.05. Since the effects of CST are already established in previous studies, the comparisons will be CST+ Chair Yoga vs CST alone, and Chair Yoga vs CST alone.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2018
Actual
11/09/2018
Date of last participant enrolment
Anticipated
29/02/2020
Actual
Date of last data collection
Anticipated
31/07/2020
Actual
Sample size
Target
72
Accrual to date
42
Final
Recruitment outside Australia
Country [1] 9614 0
New Zealand
State/province [1] 9614 0
Auckland

Funding & Sponsors
Funding source category [1] 298767 0
University
Name [1] 298767 0
Brain Research New Zealand
Country [1] 298767 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
University of Auckland
85 Park Road, Grafton
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 297951 0
None
Name [1] 297951 0
Address [1] 297951 0
Country [1] 297951 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299707 0
Health and Disability Ethics Committee
Ethics committee address [1] 299707 0
Ethics committee country [1] 299707 0
New Zealand
Date submitted for ethics approval [1] 299707 0
30/04/2018
Approval date [1] 299707 0
20/06/2018
Ethics approval number [1] 299707 0
18/NTB/62

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

Contacts
Principal investigator
Name 81354 0
Dr Gary Cheung
Address 81354 0
Room 12.003, Level 12, Auckland Hospital Support Building, Grafton, Auckland 1142
Private Bag 92019, Auckland Mail Centre, Auckland 1142
Country 81354 0
New Zealand
Phone 81354 0
+6421332823
Fax 81354 0
Email 81354 0
[email protected]
Contact person for public queries
Name 81355 0
Gary Cheung
Address 81355 0
Room 12.003, Level 12, Auckland Hospital Support Building, Grafton, Auckland 1142
Private Bag 92019, Auckland Mail Centre, Auckland 1142
Country 81355 0
New Zealand
Phone 81355 0
+6421332823
Fax 81355 0
Email 81355 0
[email protected]
Contact person for scientific queries
Name 81356 0
Gary Cheung
Address 81356 0
Room 12.003, Level 12, Auckland Hospital Support Building, Grafton, Auckland 1142
Private Bag 92019, Auckland Mail Centre, Auckland 1142
Country 81356 0
New Zealand
Phone 81356 0
+6421332823
Fax 81356 0
Email 81356 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We have not completed the trial


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1315Ethical approval    374574-(Uploaded-07-02-2019-05-26-38)-Study-related document.pdf
1316Informed consent form    374574-(Uploaded-07-02-2019-05-25-58)-Study-related document.pdf
1317Study protocol    374574-(Uploaded-07-02-2019-05-27-22)-Study-related document.docx



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.