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
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington 6011
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
Dementia is a neurodegenerative disorder associated with high levels of disability, dependency and carer burden. Non-pharmacological interventions for dementia can provide an improvement in cognitive impairment and psychosocial aspects without little if any side effects. Cognitive Stimulation Therapy (CST) is a structured and manualised group treatment specifically developed for people with mild to moderate dementia. It involves 14 sessions (twice a week over 7 weeks) of themed activities. Sessions aim to actively stimulate and engage people with dementia, whilst providing an optimal learning environment and the social benefits of a group of 6 to 8 participants with 2 facilitators. Prince et al. reviewed the evidence on cognitive stimulation in dementia and reported its effect size (for cognitive outcomes ADAS-Cog and MMSE) are comparable to those seen for acetylcholinesterase inhibitor medication.

Mind-body interventions such as yoga, tai chi and mindfulness meditation have promising effects on cognitive issues related to aging. Yoga consists of the practice of specific posture (asana), regulated breathing (Pranayama) and meditation. It integrates the physical, mental, and spiritual components of an individual in order to improve health and well-being. Lacking the opportunity to exercise on a regular basis, persons with mild to moderate dementia can benefit as exercise is reported to improve cognition, specifically executive function, and general well-being. Older adults engaging in yoga with and without cognitive impairment experience positive outcomes.

Cognitively and physically challenging activities provide the most efficient stimuli to induce neuroplastic changes. It has been suggested that future studies should consider combined intervention approaches because they may use complementary physiological and mutually enhancing routes to maximize the therapeutic effect. This single-blinded pilot study will test a novel intervention combining cognitive stimulation and physical activities using yoga in the treatment of mild to moderate dementia.

The primary aim of this study is to compare CST+Chair Yoga with CST alone and Chair Yoga alone on cognition and neurobehavioural symptoms in people with mild to moderate dementia.
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
g.cheung@auckland.ac.nz
Contact person for public queries
Name 81355 0
Dr 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
g.cheung@auckland.ac.nz
Contact person for scientific queries
Name 81356 0
Dr 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
g.cheung@auckland.ac.nz

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.