Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001148561p
Ethics application status
Submitted, not yet approved
Date submitted
19/08/2024
Date registered
23/09/2024
Date last updated
23/09/2024
Date data sharing statement initially provided
23/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The MOVEMENT study: Exercise and quality of life in people with mental illness
Scientific title
The MOVEMENT study: Exercise and quality of life in people with mental illness
Secondary ID [1] 312040 0
Nil
Universal Trial Number (UTN)
Trial acronym
MOVEMENT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Severe mental illness 332786 0
Condition category
Condition code
Mental Health 329503 329503 0 0
Schizophrenia
Mental Health 329504 329504 0 0
Psychosis and personality disorders
Mental Health 329505 329505 0 0
Depression
Mental Health 330334 330334 0 0
Other mental health disorders
Physical Medicine / Rehabilitation 331452 331452 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is an effectiveness-implementation Hybrid Type 1 design designed to evaluate the clinical-effectiveness of participation in an exercise service delivered by an Accredited Exercise Physiologist (AEP) for improving the quality of life in individuals with severe mental illness (SMI).

This design will be a quasi-experimental trial, in which participant consent to complete the research measures and have the option of accessing an AEP service as part of their participation in the study. Analyses will compare participants who accept vs decline the AEP service.

The study will take place in five mental health service sites in Queensland, specifically in the Brisbane areas. The partner organisations involved are Hospital Health Services (HHSs: Metro North Hospital and Health Service) and non-government organisations (NGOs: Communify QLD; Neami National; Stride; Richmond Fellowship QLD).

The primary aims of the study is to evaluate the effectiveness of the AEP service for improving QoL in people with SMI.

Consenting participants self-allocate into either the control or intervention group. The intervention group will receive an integrated exercise service delivered and supervised by an AEP. The exercise intervention will consist of at least one 60 min session per week. Exercise programs will be individualised to participants and conducted as one-on-one or group sessions in various settings, such as community gyms and outdoor environments. Adherence to the intervention will be monitored using a participant / attendance checklist.

Participants will have access to the AEP service for 6 months. Exercise sessions will be offered weekly over this intervention period, in 8-10-week blocks. Assessments are completed at three time-points (baseline, 3-month and 6-month follow-up). Exercise intensity will be monitored using a Borg rating of perceived exertion (i.e., 1-10) scale. Session intensity will be modified based on participant requirements.

The AEP will engage participants in individual goal setting focused on completing exercises outside supervised sessions. Individual goal setting and exercise prescriptions will be tailored to individual preferences and abilities and include a variety of aerobic (i.e., outdoor walking and running, and machine based activities such as treadmill, rowing, ski, and bike intervals), and resistance exercises (i.e., body weight, free weight, and barbell/machine exercises, including push-ups, squats, dead-lifts, shoulder press, bench press, inverted and bent-over rows, leg curls and leg extensions) and physically active recreation (e.g., sports, active groups), to maximise participant’s ability to participate, safely, in the program.
Intervention code [1] 327922 0
Lifestyle
Intervention code [2] 327923 0
Behaviour
Intervention code [3] 329361 0
Treatment: Other
Comparator / control treatment
Participants elect whether they want to participate in the exercise service or not.

Comparator/Control: The control group elects not to receive the exercise intervention, and therefore are exposed to usual care (i.e., typical psychological, social and medical treatment received by the participant) only. Follow up assessment will be taken at the same time-points as the intervention group.
Control group
Active

Outcomes
Primary outcome [1] 337302 0
Recovering Quality of Life (ReQoL)
Timepoint [1] 337302 0
The primary outcome will be assessed at multiple time-points: baseline measures upon recruitment and follow up measures at 3- (primary endpoint) and 6-months post intervention-commencement.
Secondary outcome [1] 431400 0
NA
Timepoint [1] 431400 0
NA

Eligibility
Key inclusion criteria
Receiving mental health treatment from public services or NGOs
Age: 18 years of age and over
Diagnosis of severe mental illness (ICD-10 codes F20-F33, F60&61)
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Impaired capacity to consent
<18 years of age

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
Parallel
Other design features
Using a quasi-experimental design, consenting participants will self-allocate to either the intervention group (receiving the exercise intervention) or the control group (no exercise / AEP intervention). Primary and secondary data collection methods will be taken at the same time-points for both groups.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Primary outcome (ReQoL): Recovering quality of life will be analysed using linear mixed-effects models for repeated measures, with measurements nested within individuals. First-order auto-regressive covariance structure will account for decreasing correlation over time. Adjustments will be made for potential confounders, including changes to medications, socioeconomic status, psychological distress, and lifestyle behaviors. Dummy variables for the five sites included will be included as fixed effects. Intention-to-treat (ITT) analyses will be conducted and missing data will be handled using multiple imputation techniques.

Sample size calculation: Previous research has estimated mean baseline ReQoL scores of 21.99 (SD=10.26) for a sample of people with mental health difficulties, and that a change of five points or more on the ReQoL is reliable for detecting clinical changes. Using Power Analysis and Sample Size software (PASS) 2020 for a repeated measures design with a first-order autoregressive covariance structure, we estimate that 75 participants would be required in each condition to provide at least 90% power to detect a clinically significant increase of five points on the ReQoL questionnaire, assuming a correlation between three time points of 0.6 and a statistical significance level set at 5%. Acounting for dropout, we will aim to recruit a total of 200 participants over two-years.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2025
Actual
Date of last participant enrolment
Anticipated
1/01/2026
Actual
Date of last data collection
Anticipated
31/12/2027
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 26948 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 26949 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [3] 26950 0
Logan Central Community Health Centre - Logan Central
Recruitment hospital [4] 26951 0
The Prince Charles Hospital - Chermside
Recruitment hospital [5] 26952 0
Caboolture Hospital - Caboolture
Recruitment postcode(s) [1] 43020 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 43021 0
4029 - Herston
Recruitment postcode(s) [3] 43022 0
4114 - Logan Central
Recruitment postcode(s) [4] 43023 0
4032 - Chermside
Recruitment postcode(s) [5] 43024 0
4510 - Caboolture

Funding & Sponsors
Funding source category [1] 315756 0
Government body
Name [1] 315756 0
Medical Research Futures Fund, Department of Health
Country [1] 315756 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Country
Australia
Secondary sponsor category [1] 319462 0
None
Name [1] 319462 0
Address [1] 319462 0
Country [1] 319462 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314615 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 314615 0
Ethics committee country [1] 314615 0
Australia
Date submitted for ethics approval [1] 314615 0
15/08/2024
Approval date [1] 314615 0
Ethics approval number [1] 314615 0

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

Contacts
Principal investigator
Name 132182 0
Dr Justin Chapman
Address 132182 0
Building N70; Griffith University, Nathan Campus, 170 Kessels Rd, QLD 4111
Country 132182 0
Australia
Phone 132182 0
+61 7 373 52004
Fax 132182 0
Email 132182 0
[email protected]
Contact person for public queries
Name 132183 0
Justin Chapman
Address 132183 0
Building N70 Room 1.10, Griffith University, Nathan Campus, 170 Kessels Rd, QLD 4111
Country 132183 0
Australia
Phone 132183 0
+61 7 373 52004
Fax 132183 0
Email 132183 0
[email protected]
Contact person for scientific queries
Name 132184 0
Justin Chapman
Address 132184 0
Building N70 Room 1.10, Griffith University, Nathan Campus, 170 Kessels Rd, QLD 4111
Country 132184 0
Australia
Phone 132184 0
+61 7 373 52004
Fax 132184 0
Email 132184 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data and meta-data of all participant results will be shared. This will include the primary outcomes and published data.
When will data be available (start and end dates)?
Data will be available from trial completion, 1st March 2028. Data will be available for 15 years (2043), as per guidelines for clinical trials. After this date, data will be destroyed.
Available to whom?
Researchers with a methodologically sound and ethically approved proposal, by application.
Available for what types of analyses?
Secondary analyses for scientific, noncommercial reasons.
How or where can data be obtained?
Data will be shared on an open access repository (yet to be determined). Trial registration details will be updated when the repository is determined. However, Dr Justin Chapman can be contacted at [email protected] in the interim.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24194Informed consent form    387281-(Uploaded-16-09-2024-11-15-27)-PICF_MOVEMENT-v1.1-MASTER_2024-09-13_Clean.docx
24195Study protocol    387281-(Uploaded-16-09-2024-11-15-43)-MOVEMENT protocol_v1.1-2024_09-13_Clean.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.