Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000751471
Ethics application status
Approved
Date submitted
27/05/2016
Date registered
8/06/2016
Date last updated
3/12/2020
Date data sharing statement initially provided
20/08/2019
Date results information initially provided
20/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Brain and body stimulation (CogEx) for older people with mild to moderate dementia: A feasibility study
Scientific title
Brain and body stimulation (CogEx) for older people with mild to moderate dementia: feasibility study
Secondary ID [1] 289323 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
mild to moderate dementia 298919 0
Condition category
Condition code
Neurological 298997 298997 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This pilot compares CogEx (a new intervention integrating Cognitive Stimulation Therapy and the UpRight Exercise Programme into one programme) with CST in older people with mild to moderate dementia living in the community and in residential aged care facility. Two groups of CogEx (one in the community and one in a residential aged care facility) will be compared with two groups of CST (one in the community and one in a residential aged care facility). The usual size of a CST group is 8-10 people and this will be used for all groups. The group sessions will be held for 1.5hours twice a week for 7 weeks in a residential aged care facility and in a community aged care group. Both groups will be facilitated by a health professional (occupational therapist or nurse or physiotherapist) who has completed the CST Master training day. At the Master training day each facilitator will be given an CST manual that outlines the content of activities within each of the group sessions.
The structure of a CST session is:
Introduction (Welcome, group name, theme song, orientation discussion current affairs); Main Activity (Level A – seeking opinion, social interaction; Level B – less complex relaxed exercise. The manual dictates the topic e.g. childhood; food; sound); Finally (thanks for attending and contribution; theme song; Reminders re next session and content; farewells). The resources used within the group sessions vary depending on topic such as music, food or art supplies. The newspaper of the day is used for the orientation discussion.
The CogEx structure is the same as CST but also included are a combination of exercises aimed at challenging the different physiological systems involved in the maintenance of balance (muscle strength, visual integration, vestibular adaptation, balance strategy retraining, and sensory integration). All exercises can be started at a simple, low level and progressed (The exercises can be performed at a low, moderate or hard level through decreasing the amount of support used (2 hands to 1 had to no hands) or increasing the challenge).
Examples of the exercises are:
Normal stance to unsupported to decrease base of support
Normal stance weight shift to moving hips in a figure 8 to marching on the spot
Step forwards/backwards/sideways/diagonally to walk on spot on heels/toes to walking forward/backwards on heels/toes
All the exercises have been piloted and found to be safe and acceptable in a residential care setting. The exercises are progressed according to the abilities of the group. The intensity of the exercise is mild to moderate depending on the abilities of the group. The exercises and progressions are also manualised.
The instructor will complete an attendance log to monitor adherence.
Intervention code [1] 294875 0
Rehabilitation
Intervention code [2] 294895 0
Treatment: Other
Comparator / control treatment
Usual Cognitive Stimulation Therapy: a manualised seven week programme of twice weekly 1.5hour group sessions that combines reality orientation, reminiscence therapy, validation of time and multisensory stimulation activities.
Control group
Active

Outcomes
Primary outcome [1] 298464 0
Brief Balance Evaluation Systems Test (brief-BESTest) (Padgett, Jacobs, & Kasser, 2012)
Timepoint [1] 298464 0
End of intervention (7 weeks)
Primary outcome [2] 298493 0
Short Physical Performance Battery (SPPB) (Guralnik et al., 1994).
Timepoint [2] 298493 0
End of intervention (7 weeks)
Primary outcome [3] 298494 0
Montreal Cognitive Assessment (MoCA) (Nasreddine et al., 2005)
Timepoint [3] 298494 0
End of intervention (7 weeks)
Secondary outcome [1] 324225 0
Alzheimer’s Disease Assessment Scale – Cognitive (ADAS- Cog 11)
Timepoint [1] 324225 0
End of intervention (7 weeks)
Secondary outcome [2] 324365 0
: Quality of Life-Alzheimer’s Disease (QOL-AD) – Version for the person with dementia (Logsdon, Gibbons, McCurry, & Teri, 1999)
Timepoint [2] 324365 0
End of intervention (7 weeks)

Eligibility
Key inclusion criteria
1. Aged 65 years or older living in the community or in a residential aged care facility with a diagnosis of mild to moderate dementia, scoring >10 or above on the Montreal Cognitive assessment
2. Able to have a “meaningful” conversation
3. Able to hear well enough to participate in a small group discussion
4. Able to see well enough to see most pictures
5. Likely to remain in a group for 1.5 hoursassessment
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Have had a recent significant medical illness such as stroke or heart attack (within 6 weeks)
2. Are wheelchair/bed bound or unable to walk
3. Have severe visual or hearing impairment
4. Are receiving terminal/palliative care

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Descriptive statistics were used to describe the number of residents recruited (percentage), the group demographics at baseline pre and post intervention clinical measures (means, standard deviations), change in outcome measures (difference, 95% Confidence Intervals), class attendance (percentage). Length of class was recorded (minutes).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/09/2017
Actual
7/02/2018
Date of last participant enrolment
Anticipated
13/10/2017
Actual
13/07/2018
Date of last data collection
Anticipated
Actual
30/08/2018
Sample size
Target
32
Accrual to date
Final
23
Recruitment outside Australia
Country [1] 7919 0
New Zealand
State/province [1] 7919 0
Auckland

Funding & Sponsors
Funding source category [1] 293695 0
University
Name [1] 293695 0
Brain Research NZ Core of Research Excellence, Auckland University
Country [1] 293695 0
New Zealand
Primary sponsor type
Individual
Name
Prof Ngaire Kerse
Address
School of Population Health
Faculty of Medical and Health Sciences
The University of Auckland
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 292529 0
None
Name [1] 292529 0
Address [1] 292529 0
Country [1] 292529 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295135 0
Health & Disabilities Ethics Committees
Ethics committee address [1] 295135 0
Ministry of Health
Ethics Department
Freyberg Building
Reception – Ground Floor
20 Aitken Street
Wellington 6011
Ethics committee country [1] 295135 0
New Zealand
Date submitted for ethics approval [1] 295135 0
17/06/2016
Approval date [1] 295135 0
23/08/2016
Ethics approval number [1] 295135 0
16/NTB/121

Summary
Brief summary
This project aims to pilot test CogEx (a new programme integrating Cognitive Stimulation Therapy (Cog) and the UpRight exercise programme (Ex) into one programme) in 2 groups (one in a residential aged care facility and one in a community aged care group) comparing them to 2 groups undertaking usual CST in similar settings (the usual size of one group is 8-10 people).
Objectives: To establish the feasibility of all aspects of a RCT: recruitment rate; delivery of the programme; acceptability of the programme to participants, their families and facilitators; estimate the distribution of the outcomes for analysis, planning and sample size computation.
Design: Pilot study comparing CogEx with usual CST. Pre and post intervention outcome measures of cognition and physical function will be used as well as video recorded observations and group discussions to ascertain the acceptability of the programme to the participants and facilitators.
Settings: Residential aged care facilities and community-based aged care groups.
Participants: Adults aged 65 years or older with a diagnosis of mild to moderate dementia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66250 0
Prof Ngaire Kerse
Address 66250 0
School of Population Health
Faculty of Medical and Health Sciences
The University of Auckland
Private Bag 92019
Auckland 1142
Country 66250 0
New Zealand
Phone 66250 0
+64099234467
Fax 66250 0
Email 66250 0
[email protected]
Contact person for public queries
Name 66251 0
Prof Ngaire Kerse
Address 66251 0
School of Population Health
Faculty of Medical and Health Sciences
The University of Auckland
Private Bag 92019
Auckland 1142
Country 66251 0
New Zealand
Phone 66251 0
+64099234467
Fax 66251 0
Email 66251 0
[email protected]
Contact person for scientific queries
Name 66252 0
Prof Ngaire Kerse
Address 66252 0
School of Population Health
Faculty of Medical and Health Sciences
The University of Auckland
Private Bag 92019
Auckland 1142
Country 66252 0
New Zealand
Phone 66252 0
+64099234467
Fax 66252 0
Email 66252 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
This was not included in the original informed consent that participants signed


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1880Ethical approval    370798-(Uploaded-15-04-2019-08-36-00)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo The difference in group baseline and reassessments... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseCombining cognitive stimulation therapy and fall prevention exercise (CogEx) in older adults with mild to moderate dementia: A feasibility randomised controlled trial.2020https://dx.doi.org/10.1186/s40814-020-00646-6
N.B. These documents automatically identified may not have been verified by the study sponsor.