Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001309976
Ethics application status
Approved
Date submitted
6/10/2020
Date registered
4/12/2020
Date last updated
4/12/2020
Date data sharing statement initially provided
4/12/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating resistance training in people with chronic psychotic disorders.
Scientific title
Investigating the Feasibility and Acceptability of Resistance training in People with Psychotic Disorders: a Randomised Controlled Trial
Secondary ID [1] 302480 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychotic disorders 319315 0
schizophrenia 319779 0
Condition category
Condition code
Mental Health 317285 317285 0 0
Psychosis and personality disorders
Mental Health 317286 317286 0 0
Schizophrenia
Physical Medicine / Rehabilitation 317711 317711 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants randomised to the intervention will be engaged in supervised resistance training (repetitive strength activities using hand weights suitable to a small clinic gym) three times per week for 8 weeks, 45 minutes per session. This will include a 10 minute warm up and 5 minute cool down.
Participants will be supervised by an accredited exercise physiologist (AEP). They will participate in one to one sessions, in the small clinic gym of the mental health residential rehabilitation facility, the community care unit (CCU) in which they reside.
The intensity of the intervention will be moderate in intensity, and will be calculated by conducting a 12 repetition maximum test (12-RM) for relevant large muscle groups - ie squat, bench press, bicep curl, and then via an established conversion calculator, Brzycki 1-RM Formula, 1-RM = Weight x (36 / (37 – Repetitions). The aim will be to increase muscle strength progressively over the 8 weeks. Training will be appropriate for beginners and be aimed at moderate intensity (40-70%) of estimated maximum strength, (1-RM). Week 1 will start with 40% of 1-RM, and progressed with 5% increments each week as per capacity of the individual, with 3 sets of 8-10 repetitions, of approximate 40 seconds duration per set, and a 90 seconds duration between sets.
Six exercises across main muscle groups used in activities of daily living will be prescribed per resistance training session. As strength increases, sessions will be progressed using heavier weights, however each participant will be monitored for their response to training, and progression individualised. A typical session will include 6 exercises that target main muscle groups such as lower legs, back, arms/shoulders, and core, using a variety of standard resistance training equipment, for example; hand weights, kettle bells, resistance bands and a chest press bar and floor mat.
An intervention session will involve whole body exercises that can be conducted using hand weights in a small clinic gym and hence easily replicated.
Intervention sessions will be separated by a day to allow recovery in-between (ie Monday, Wednesday, Friday).
A typical session is as follows:
Sumo Squat
Calf raises
Bicep curl
Crunches
Row – theraband or hand weights
Chest press

All exercises are appropriate for resistance training in untrained participants and will be supervised by the AEP employed at each site. The content and weights of each session will be recorded using standard AEP protocol.

Attendance will be recorded in a spreadsheet.
Adverse events will be recorded, and addressed as per standard injury management protocol for the exercise program at the facility.



Intervention code [1] 318771 0
Lifestyle
Intervention code [2] 318772 0
Rehabilitation
Comparator / control treatment
Participants randomised to control will be engaged in supervised moderate intensity interval training (MIIT) three times per week for 8 weeks. The control condition will be supervised one to one by an accredited exercise physiologist (AEP).
Participants randomised to the aerobic interval intervention will engage in a 10 minute warm up and 5 minute cool down and a 30 minute aerobic interval training intervention in a circuit style, with total duration of exercise 45 minutes.
Equipment used for the circuit will include a stationary bike, a treadmill, boxing pads and gloves, step and mat. The circuit stations will vary each week to reduce boredom. Stations are designed such that they could be modified (regressed/progressed) to suit individual participant capacity and preference.
Participants will engage in a circuit style training supervised by the AEP at each site, three times per week. The aerobic intervention will begin slowly, aimed at beginners, but adapted for experience level and baseline fitness of participants.
Intensity of the aerobic intervention will be monitored using the Borg Category Ratio 10 scale of Perceived Exertion scale (RPE), a 10 point scale to assess subjective perception of effort that has been calibrated against exercise intensity and will guide intensity of exercise prescription. Initial prescription will be aimed at an intensity achievable for participants with low initial CRF but progressed to reach moderate intensity by week 3. The AEP will aim for the participant to maintain an RPE at 2–3 for the first 2 weeks, then increased to a minimum RPE of 4/10 by week 3 and further increased by 5% each week as per individual participant's capacity. Following warm-up, participants will rotate through interval stations, beginning with four minutes of exercise interspersed with 60s of complete rest until a total of 30 minutes of MIIT is completed. Participants will progress to five minute active intervals as the participants' functional capacity increases.
Attendance will be monitored by completing a spreadsheet of attendance, The content of a session will be recorded using standard AEP procedure (ie the equipment chosen, the RPE of the individual before, during and after the control condition).
Adverse events will be recorded, and addressed as per standard injury management protocol for the exercise program at the facility.
Control group
Active

Outcomes
Primary outcome [1] 325338 0
This is a composite primary outcome.
1. Feasibility - as determined by procedural statistics for recruitment (percentage of those who consent as a proportion of those who are eligible), retention in the trial (percentage of those who complete post measures as a percentage of those who started the trial), and participation in exercise sessions (proportion of sessions attended as a proportion of those available).
2. Safety will be measured - this will be participant-reported. Participants will be asked about health conditions prior to every session by the AEP. Any new injuries or exacerbations of existing injuries will be reported, as a subset of feasibility. The PI will be notified, and causality established.
(An adverse events protocol exists within the overall protocol, with monitoring of every intervention and control session.)
Timepoint [1] 325338 0
At 8 weeks post intervention
Primary outcome [2] 325339 0
This is a composite outcome.
Acceptability - as measured by an acceptability questionnaire for both the intervention (RT) and control condition (MIIT). This questionnaire is not validated but based on previous published exercise research in people with Severe Mental Illness (Chapman et al 2017, The feasibility and acceptability of high-intensity interval training for adults with mental illness: A pilot study). This questionnaire has been adapted specifically for this study which is exploring resistance training (RT). (There are no validated questionnaires on resistance training in this population yet.)
Answers to questionnaire items will be in a 5 point likert scale from "totally disagree, to totally agree".

Following the 8 week intervention participants from the intervention condition (RT) will be invited to contribute to a small focus group (5 participants) at which time semi-structured interviews will be conducted, and responses coded and analysed using thematic analysis.
Timepoint [2] 325339 0
At 8 weeks post intervention
Secondary outcome [1] 387575 0
Global Functioning - the WHODAS 2.0 will be utilised - an interviewer administered questionnaire investigating global, social and occupational functioning.
Timepoint [1] 387575 0
baseline and at 8 weeks post intervention
Secondary outcome [2] 387576 0
Mental health outcomes - BPRS - Brief Psychiatric Rating scale - an interviewer administered questionnaire for people with psychotic symptoms measuring a range of psychiatric symptoms,
Timepoint [2] 387576 0
baseline and at 8 weeks post intervention,.
Secondary outcome [3] 387577 0
Physical capacity tests:
6MWT - six minute walk test -measuring functional exercise capacity, walking distance in metres across a 15 metre course, over 6 minutes using standardised techniques.


Timepoint [3] 387577 0
baseline and at 8 weeks post intervention
Secondary outcome [4] 387578 0
Physical health:
BMI - there are 2 components contributing to this outcome., The first is height; as measured using a stadiometer in cms, and the second is weight, measured in kilograms on an electronic scale.
BMI is then calculated by diving weight (in kilograms) by height (in cms) squared.
Timepoint [4] 387578 0
baseline and at 8 weeks post intervention
Secondary outcome [5] 387579 0
Physical activity levels via self-report
1. Self report physical activity questionnaire - SIMPAQ, validated questionnaire.
Timepoint [5] 387579 0
Baseline and at 8 weeks post intervention
Secondary outcome [6] 387581 0
Subjective Exercise Enjoyment Scale (SEES)- this validated questionnaire will be administered before and after a single session of exercise.
Timepoint [6] 387581 0
The SEES will be administered pre and post a single session of the intervention in week 3 of the intervention and at 8 weeks post intervention
Secondary outcome [7] 389007 0
Scale assessment of negative symptoms - SANS - interview administered objective assessment measuring negative symptoms of schizophrenia.
Timepoint [7] 389007 0
Baseline and at 8 weeks, following the intervention
Secondary outcome [8] 389008 0
Abdominal circumference - using a tape measure to the nearest cm.
Timepoint [8] 389008 0
At baseline and at 8 weeks following the intervention
Secondary outcome [9] 389012 0
Sit to stand test - a standardised functional strength test of lower limbs, number of sit up and stands from a chair in one minute
Timepoint [9] 389012 0
Baseline and at 8 weeks post intervention
Secondary outcome [10] 389013 0
AMRAP push up test - an established functional strength test of upper and core strength - number of floor or wall push ups in one minute, either on toes or knees - repeated at whichever was chosen by the participant at baseline, at 8 weeks.
Timepoint [10] 389013 0
At baseline and at 8 weeks post intervention
Secondary outcome [11] 389014 0
Grip strength - hand grip strength (proxy measure of upper arm strength) using a dynamometer (hand held).
Timepoint [11] 389014 0
baseline and at 8 weeks post intervention

Eligibility
Key inclusion criteria
Patients will be invited to participate in the study if they meet all of the following criteria:
1. Aged between 18-64 years (inclusive)
2. Fulfil the DSM 5 criteria for schizophrenia and related psychotic disorders (any psychotic spectrum disorder such as schizophrenia, schizoaffective disorder, bipolar disorder with psychotic features, major depressive disorders with psychosis) as confirmed by the treating psychiatrist of the unit.
3. Have a treatment plan such that they are likely to reside within the CCU for the duration of the 8-week study
4. Agree to participate, has capacity to consent and able to follow the study instructions and procedures.
5. Has been cleared to participate in an exercise program by the accredited exercise physiologist (AEP) within the service, following standard assessment of suitability and risk as per AEP exercise guidelines within the CCU’s.
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Potential participants will be excluded if:
1. They are pregnant
2. They have a comorbid eating disorder in which exercise is considered to be contraindicated by the treating psychiatrist of the unit (ie anorexia nervosa where BMI <18; presence of medical complications of an eating disorder; or anorexia or bulimia nervosa is comorbid with exercise addiction)
3. Substance abuse is considered to be interfering with rehabilitation engagement, and their ongoing suitability for rehabilitation is under review by the treating team.
4. Inability to follow the study instructions and procedures

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)
Concealed allocation involves a statistician off site not involved in the study, who performs randomisation, which occurs after baseline investigations have been performed on consenting participants. Participants will be informed of their group by someone not involved with the study,
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be assigned a unique code that will be sent to an independent biostatistician for randomisation using a computer -generated sequence of numbers. Randomisation to either RT or MIIT condition, will occur in a 1:1 ratio, using block randomisation.
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
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
This study will be conducted as an exploratory RCT with feasibility as the primary outcome. Based on recruiting an adequate sample to assess the feasibility of the study with the resources available we aim to recruit 40 participants assuming approximately 20 participants will be assigned to each intervention arm, based on previous exercise research within this setting – we anticipate 20% drop outs per exercise condition.
Procedural statistics will be used to describe recruitment, withdrawal and participation for each condition. Acceptability questionnaire responses for each condition will be collapsed into three categories: disagree/strongly disagree, neutral, and agree/strongly agree and reported per item as a percentage of those completing questionnaires.
Data analyses will be conducted using SPSS Statistics 24, (SPSS Inc, Chicago, Illinois). Variables will be tested for normality using the Shapiro-wilks test and inspecting visual probability plots.
Baseline demographic and clinical variables will be compared between the 2 exercise groups using independent t tests (or Mann Whitney U tests if data non parametric) for continuous data and Chi2 square analysis for categorical data to detect any baseline differences between the 2 exercise groups. Baseline characteristics of those who complete >50% of the program will be compared to those who withdraw to identify characteristics of those who drop out.
To analyse the impact of the proposed exercise intervention on secondary outcomes, analyses will be performed on an intention-to-treat basis, comparing baseline data with post intervention outcomes between randomisation groups, using ANCOVA to detect group/time effects, taking into account covariates such as age, gender, education, symptom severity and medication. Where group/time differences are detected, posthoc analyses will be carried out separately for the intervention and control group, with adjustment for multiple comparisons.
Associations will be explored between baseline preference for exercise type and adherence to the intervention, using Pearsons correlation. The three feeling state domains from the SEES would be assessed using a group (RT, MIIT), time (pre/post) ANOVA with repeated measures. The effect size of the differences between values will be interpreted using Cohen’s d statistic (Cohen, 1988). An effect size of less than 0.2 reflects a negligible difference; greater than or equal to 0.2 to less than 0.4 is a small difference; from greater than or equal to 0.4 to less than 0.8, a moderate difference; and greater than or equal to 0.8, a large difference.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/12/2020
Actual
Date of last participant enrolment
Anticipated
1/03/2021
Actual
Date of last data collection
Anticipated
30/03/2021
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 17751 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 17752 0
Logan Hospital - Meadowbrook
Recruitment hospital [3] 17753 0
Redland Health Service Centre - Cleveland
Recruitment postcode(s) [1] 31614 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 31615 0
4131 - Meadowbrook
Recruitment postcode(s) [3] 31616 0
4163 - Cleveland

Funding & Sponsors
Funding source category [1] 306903 0
Hospital
Name [1] 306903 0
Princess Alexandra Hospital, Metro South Addiction and Mental Health Services
Country [1] 306903 0
Australia
Funding source category [2] 306906 0
Charities/Societies/Foundations
Name [2] 306906 0
Royal Australian and New Zealand College of Psychiatry
Country [2] 306906 0
Australia
Primary sponsor type
Individual
Name
Dr Nicole Korman
Address
Coorparoo Community Care Unit, 6 Baragoola St, Coorparoo QLD 4151 Australia
Country
Australia
Secondary sponsor category [1] 307465 0
None
Name [1] 307465 0
Address [1] 307465 0
Country [1] 307465 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307057 0
Metro South HREC
Ethics committee address [1] 307057 0
Ethics committee country [1] 307057 0
Australia
Date submitted for ethics approval [1] 307057 0
13/08/2020
Approval date [1] 307057 0
30/09/2020
Ethics approval number [1] 307057 0
HREC/2020/QMS/67647

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

Contacts
Principal investigator
Name 105878 0
Dr Nicole Korman
Address 105878 0
Coorparoo Community Care Unit, Metro South Addiction and Mental Health Unit
6 Baragoola St Coorparoo Qld 4151
Country 105878 0
Australia
Phone 105878 0
+61 7 37277200
Fax 105878 0
+ 61 7 37277250
Email 105878 0
[email protected]
Contact person for public queries
Name 105879 0
Nicole Korman
Address 105879 0
Coorparoo Community Care Unit, Metro South Addiction and Mental Health Unit
6 Baragoola St Coorparoo Qld 4151
Country 105879 0
Australia
Phone 105879 0
+61 7 37277200
Fax 105879 0
+ 61 7 37277250
Email 105879 0
[email protected]
Contact person for scientific queries
Name 105880 0
Nicole Korman
Address 105880 0
Coorparoo Community Care Unit, Metro South Addiction and Mental Health Unit
6 Baragoola St Coorparoo Qld 4151
Country 105880 0
Australia
Phone 105880 0
+61 7 37277200
Fax 105880 0
+ 61 7 37277250
Email 105880 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?
All of the individual participant data collected during the trial, after de-identification will be shared.
When will data be available (start and end dates)?
From April 2021 - 2025
Available to whom?
Researchers who may be interested in obtaining this de-identified data for further analysis such as meta-analysis
Available for what types of analyses?
For meta-analyses
How or where can data be obtained?
Contact PI
[email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9374Study protocol    380705-(Uploaded-06-10-2020-14-13-51)-Study-related document.doc
9375Informed consent form    380705-(Uploaded-06-10-2020-14-14-01)-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.