Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000380796
Ethics application status
Approved
Date submitted
10/12/2021
Date registered
4/03/2022
Date last updated
4/03/2022
Date data sharing statement initially provided
4/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Move Your Mind: Preliminary efficacy of a small group exercise intervention for older adults with dementia.
Scientific title
Move Your Mind: Preliminary efficacy of a small group exercise intervention for older adults with dementia.
Secondary ID [1] 305619 0
Nil
Universal Trial Number (UTN)
U1111-1270-6968
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 324050 0
Condition category
Condition code
Neurological 321564 321564 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The exercise sessions will be 45 minutes in duration and delivered twice per week for 12 weeks, at Movement HQ, Brellah, Frenchs Forest. They will be run by an exercise physiologist with experience in clinical settings, including working with people with mild cognitive impairment and falls prevention.
The mode of delivery will be face-to-face in small groups of 4 or less. Each session will consist of Warm-up (5 minutes), Exercise Circuit (10 minutes), Education (10 minutes), Exercise Circuit (10 minutes), Cool Down (5 minutes). Examples of exercises prescribed as part of the intervention include Sit-to-stand, Step-ups, High Knee Marching, Weights (Bicep Curls, Shoulder Press) and Box Squats. The education component will cover different topics related to dementia and movement. Example topics include the importance of balance for people with dementia, or how to safely stand from the ground after a fall. Participants will be asked to aim for moderate intensity exercise, determined as 6-7 RPE. Session attendance will be used as a measure of adherence to the intervention.
Intervention code [1] 322022 0
Lifestyle
Intervention code [2] 322628 0
Rehabilitation
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329326 0
Change in memory function - as measured using an objective neuropsychological test assessing word list learning.
Timepoint [1] 329326 0
Baseline (within one week prior to intervention commencement) and 12 weeks post-intervention commencement.
Primary outcome [2] 330147 0
Change in information processing speed as measured using an objective neuropsychological test.
Timepoint [2] 330147 0
Baseline (within one week prior to the intervention commencing) and 12 weeks post-commencement of the intervention
Primary outcome [3] 330148 0
Change in divided attention as measured using an objective neuropsychological test.
Timepoint [3] 330148 0
Baseline (within one week prior to the intervention commencing) and 12 weeks post-intervention commencement.
Secondary outcome [1] 402148 0
Change in patient rated subjective memory function - as measured using the Everyday Memory Questionnaire.
Timepoint [1] 402148 0
Baseline (within one week prior to intervention commencement) and 12 weeks post-intervention commencement.
Secondary outcome [2] 402149 0
Depression symptoms, measured using the Geriatric Depression Scale.
Timepoint [2] 402149 0
Baseline (within one week prior to intervention commencement) and 12 weeks post-intervention commencement.
Secondary outcome [3] 402150 0
Caregiver mood (measured using the Depression Anxiety and Stress Scale-21).
Timepoint [3] 402150 0
Baseline (within one week prior to intervention commencement) and 12 weeks post-intervention commencement.
Secondary outcome [4] 405062 0
Change in verbal fluency as measured using an objective neuropsychological test.
Timepoint [4] 405062 0
Baseline (within one week prior to intervention commencing) and 12 weeks post0-intervention commencement.
Secondary outcome [5] 405063 0
Caregiver burden (measured using the Zarit Caregiver Burden Questionnaire)
Timepoint [5] 405063 0
Baseline (within one week prior to the intervention commencing) and 12 weeks post-intervention commencement.
Secondary outcome [6] 405630 0
Any change in cognition (carer-rated) as measured using the Everyday Memory Questionnaire
Timepoint [6] 405630 0
Baseline (within one week prior to the intervention commencing) and 12 weeks post-intervention commencement.
Secondary outcome [7] 405631 0
Physical function assessed by an exercise physiologist - STS-30s Test
Timepoint [7] 405631 0

Baseline (within one week prior to the intervention commencing) and 12 weeks post-intervention commencement.
Secondary outcome [8] 405633 0
Physical function assessed by an exercise physiologist - Lower limb strength and function - assessed using the 30-second Sit-to-Stand test
Timepoint [8] 405633 0
Baseline (within one week prior to the intervention commencing) and 12 weeks post-intervention commencement.
Secondary outcome [9] 405634 0
Physical function assessed by an exercise physiologist -Timed up-and-go
Timepoint [9] 405634 0
Baseline (within one week prior to the intervention commencing) and 12 weeks post-intervention commencement.
Secondary outcome [10] 405635 0
Physical function assessed by an exercise physiologist - BERG Balance scale
Timepoint [10] 405635 0
Baseline (within one week prior to the intervention commencing) and 12 weeks post-intervention commencement.

Eligibility
Key inclusion criteria
Diagnosis of mild-moderate dementia based on Geriatrician assessment at baseline. Independently ambulant based on physical function tests by Exercise Physiolologist (EP) or Physiotherapist (PT) at baseline.
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Score <12 on the mini-ACE of the Addenbrooke's Cognitive Evaluation-III.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To investigate which outcome measures show change over time, repeated measures analysis of variance (ANOVA) will be carried out for each outcome over the two time points.
To determine clinical significance of change in participants over time, change scores (baseline to 12 weeks) will analysed using the Reliable Change Index - the difference between pre- and post-scores, accounting for outcome measure test-retest reliability.
Clinical significance will be defined as an absolute RCI value greater than 1.96 (the absolute z-score level of significance). For participants who are retained at 6 months, we additionally aim to determine if this change persists by examining change from pre-intervention to 6-months post-intervention.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/03/2022
Actual
Date of last participant enrolment
Anticipated
29/09/2023
Actual
Date of last data collection
Anticipated
22/12/2023
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 309982 0
Other
Name [1] 309982 0
Brellah Medical Centre
Country [1] 309982 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Balaclava Rd, Macquarie Park, NSW 2109
Country
Australia
Secondary sponsor category [1] 311032 0
None
Name [1] 311032 0
Address [1] 311032 0
Country [1] 311032 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309691 0
Macquarie University Human Research Ethics Committee
Ethics committee address [1] 309691 0
Ethics committee country [1] 309691 0
Australia
Date submitted for ethics approval [1] 309691 0
Approval date [1] 309691 0
16/08/2021
Ethics approval number [1] 309691 0
52021994531735

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

Contacts
Principal investigator
Name 115054 0
Dr Heather Francis
Address 115054 0
Room 510, 4 First Walk, Macquarie University, Macquarie Park NSW 2109
Country 115054 0
Australia
Phone 115054 0
+61 2 9850 1808
Fax 115054 0
Email 115054 0
heather.francis@mq.edu.au
Contact person for public queries
Name 115055 0
Belinda Ramirez
Address 115055 0
Brellah
Bld. 8, 49 Frenchs Forest Rd E
Frenchs Forest, NSW 2086
Country 115055 0
Australia
Phone 115055 0
+61 02 9122 0888
Fax 115055 0
Email 115055 0
belinda.ramirez@brellah.com.au
Contact person for scientific queries
Name 115056 0
Heather Francis
Address 115056 0
Room 510, 4 First Walk, Macquarie University, Macquarie Park NSW 2109
Country 115056 0
Australia
Phone 115056 0
+61 2 9850 1808
Fax 115056 0
Email 115056 0
heather.francis@mq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Percentile rank scores on cognitive tests, summed scores for responses on questionnaires. No identifying information will be provided.
When will data be available (start and end dates)?
22/12/2023 - indefinitely
Available to whom?
Searchable to any researcher
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Macquarie Research Data Repository accessible via website (https://figshare.mq.edu.au).


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.