Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000202167
Ethics application status
Approved
Date submitted
4/02/2019
Date registered
12/02/2019
Date last updated
29/01/2020
Date data sharing statement initially provided
12/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of an Intervention Targeting Health through Exergaming as an Alternative to Routine Treatment (FIT HEART)
Scientific title
Feasibility of an Intervention Targeting Health through Exergaming as an Alternative to Routine Treatment (FIT HEART)
Secondary ID [1] 296742 0
None
Universal Trial Number (UTN)
U1111-1224-6524
Trial acronym
FIT HEART
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 310617 0
Obesity 310618 0
Diabetes 310619 0
Mental illness 310620 0
Condition category
Condition code
Cardiovascular 309330 309330 0 0
Coronary heart disease
Cardiovascular 309331 309331 0 0
Other cardiovascular diseases
Metabolic and Endocrine 309332 309332 0 0
Diabetes
Metabolic and Endocrine 309333 309333 0 0
Metabolic disorders
Diet and Nutrition 309334 309334 0 0
Obesity
Mental Health 309335 309335 0 0
Depression
Mental Health 309336 309336 0 0
Schizophrenia
Mental Health 309337 309337 0 0
Anxiety
Mental Health 309830 309830 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The FIT HEART study will be conducted as a quasi-experimental, two-arm pilot study comparing a physical activity intervention (exergaming) with “routine treatment”. The study will employ a non-randomised, pre-test/post-test parallel group design. The study will be conducted in high secure wards at the Long Bay Hospital Mental Health Unit, an inpatient facility that provides specialty mental health services for patients in the NSW correctional system. Wards will be allocated to the intervention or control arm based on available facilities (i.e. space, audiovisual equipment) to implement the intervention.

Potential participants will be screened for eligibility by members of the FIT HEART project team. The team is based at the Justice Health and Forensic Mental Health Network Research Unit and comprises experienced researchers with qualifications in nursing, psychology, forensic mental health, and exercise physiology. Screening will entail the following: i) assessment by the FIT HEART project team of capacity to provide informed consent; ii) assessment by the treating team of security risk and risk factors that could prevent participants being issued an accelerometer; iv) clinical assessment of physical contraindications to exercise by a medical officer.

Eligible participants in both the intervention and comparison units will be administered a face-to-face baseline interview by a member of the project team assessing: demographics; incarceration history; smoking; physical and mental health history; current psychopathology (depression, anxiety, stress, psychosis); and, current activity levels. A baseline assessment of physical health and cardiometabolic risk (e.g. weight, body mass index, waist and hip circumference, blood pressure, HBA1c, fasting glucose, lipid profile, liver function) will also be conducted. VO2 max, a measure of cardiorespiratory fitness, will be determined via a 3-minute step-test protocol using a height-adjustable step, metronome and Polar heart rate monitor.

Following the baseline interview, all participants in the intervention and comparison groups will be issued with an accelerometer (Fitbit® Charge 3) designed to record data on objective measures of daily physical activity (e.g. number of steps, calorie expenditure, heart rate). Participants will be asked to wear the Fitbit for the duration of the intervention period (12 weeks), and up until the post-intervention assessments (Weeks 13-14). All participants will be provided with a weekly summary progress which will include their average steps over the preceding week, average heart rate, activity intensity levels (i.e. low, average, high) and average calorie expenditure.

Eligible participants at the intervention site will receive a physical activity program comprising 3 x 30-minute individual exergaming sessions per week for 12 weeks using activity-based games designed to simulate moderate intensity exercise. The exergaming program will be delivered via Xbox KinectTMvideo gaming consoles, with face-to-face supervision of all sessions provided by the FIT HEART Research Project Officer and Senior Research Nurse, unit-based Corrective Services NSW officers (Long Bay Hospital), and nursing staff. Each 30-minute session will be preceded by a 10-minute warm-up session using one of the exergaming activities and will be followed by a 5-minute cool-down period of stretching. Exergaming activities include soccer, baseball, track and field events (long jump, hurdles, sprinting), skiing, white water rafting, obstacle courses, dancing, and tennis. The subjective intensity of physical activity during each exergaming session will be measured using the OMNI Walk/Run Scale of Perceived Exertion.

Participants from the comparison site will receive “routine care”, defined as the standard model of care provided by the Justice Health and Forensic Mental Health Network.

The intervention will be delivered by members of the FIT HEART project team. All Justice Health and Forensic Mental Health Network staff participating in data collection and intervention delivery will undergo project-specific training and will be provided with a FIT HEART Operations Manual detailing all study procedures.

The feasibility of the intervention will be assessed by examining: participation refusal rates; participant compliance and adherence (i.e. number, length and frequency of intervention sessions attended); rates of retention/attrition; occurrence of adverse events; fidelity of intervention delivery; accelerometer and Xbox durability; “lessons learned”.

Acceptability will be assessed using post-intervention patient and staff evaluation surveys administered by the FIT HEART project team (intervention site only). Participant acceptability questions include questions on self-reported satisfaction with the intervention, ease of use of the exergaming system, and motivation to use exergaming as a form of physical activity in the future. Perceived utility of the intervention will be measured by asking participants about the impact of exergaming on their physical and mental health. Acceptability from the service perspective will be assessed by asking staff about their perceptions of the intervention content and delivery, benefit for patients, and barriers to implementation and uptake.
Intervention code [1] 313056 0
Prevention
Intervention code [2] 313057 0
Behaviour
Intervention code [3] 313466 0
Lifestyle
Comparator / control treatment
Routine treatment: standard model of care provided by the Justice Health and Forensic Mental Health Network, based on the following NSW Ministry of Health guidelines and policy directives:
PD2005_527 Prisoners — Provision of Medical Services
PD2012_050 Forensic Mental Health Services
GL2017_019 Physical Health Care of Mental Health Consumers
PD2017_033 Physical Health Care within Mental Health Services

The standard model of care for patients in Long Bay Hospital does not include structured physical activity programs. Patients have access to an outdoor courtyard to engage in self-directed activity, should they wish to do so.
Control group
Active

Outcomes
Primary outcome [1] 308291 0
Intervention feasibility (composite primary outcome), as assessed by: participation refusal rates; participant compliance and adherence (i.e. number, length and frequency of intervention sessions attended); rates of retention/attrition; occurrence of adverse events (e.g. injury, event related to psychotropic medication, abnormal increase in blood pressure/heart rate during intervention); fidelity of intervention delivery.

Recruitment data will be recorded in the study screening logs, consent forms and study records. Data on intervention compliance, adherence, safety and fidelity of delivery will be recorded on a weekly Participant Assessment Form.


Timepoint [1] 308291 0
Data on participation refusal will be collected at the time of recruitment. Data on intervention compliance, adherence, safety and fidelity of delivery will be collected at each exergaming session throughout the duration of the study.
Primary outcome [2] 308293 0
Acceptability of intervention to participant: self-reported satisfaction with the intervention; ease of use of the exergaming system; motivation to use exergaming as a form of physical activity in the future; impact of exergaming on physical and mental health.

Acceptability assessed via post-intervention evaluation surveys (approx. 5 mins) administered by research staff. Acceptability questions have been adapted from Kimhy et al., (2016) and include questions on self-reported satisfaction with the intervention, ease of use of the exergaming system, and motivation to use exergaming as a form of physical activity in the future. Perceived utility of the intervention will be measured by asking participants about the impact of exergaming on their physical and mental health.
Timepoint [2] 308293 0
1-2 weeks post-intervention (Weeks 13-14) or at the time of discharge from hospital prior to intervention completion (i.e. prior to Week 12).
Primary outcome [3] 318822 0
Acceptability of intervention to staff: self-reported perceptions of the intervention content and delivery; benefit for patients; barriers to implementation and uptake.

Acceptability from the service perspective will be assessed via a post-intervention evaluation survey (approx. 5 mins) using questions based on the theoretical framework of acceptability proposed by Sekhon et al., (2017). Areas assessed include staff perceptions of the intervention content and delivery, benefit for patients, and barriers to implementation and uptake.
Timepoint [3] 318822 0
1-2 weeks post-intervention (Weeks 13-14).
Secondary outcome [1] 354559 0
Primary Outcome: Baseline to post-intervention changes in subjective levels of physical activity assessed by a self-reported measure of physical and sedentary behaviour in preceding week using the Simple Physical Activity Questionnaire (SIMPAQ).
Timepoint [1] 354559 0
Baseline; intervention mid-point (Week 6); post-intervention (Weeks 13-14); time of discharge from hospital prior to Week 12.

Secondary outcome [2] 366576 0
Primary outcome: Baseline to post-intervention changes in objective levels of physical activity assessed by Fitbit data (steps, intensity and duration of activity, calorie expenditure, level and duration of heart rate elevation).






Timepoint [2] 366576 0
Data will be collected for the duration of the study (baseline to Weeks 13-14) while the participant is wearing the Fitbit device. The device collects data at minute, hourly and daily intervals.

Secondary outcome [3] 366577 0
Primary Outcome: Baseline to post-intervention changes in cardiovascular fitness assessed by maximum O2 uptake during exercise (VO2 max). VO2 max will be measured via a 3-minute step-test protocol, using a height-adjustable step, metronome and Polar heart rate monitor.
Timepoint [3] 366577 0
Baseline; post-intervention (Weeks 13-14); time of discharge from hospital prior to Week 12.

Secondary outcome [4] 366580 0
Primary Outcome: Baseline to post-intervention changes in weight (kg). Participants will be weighed using digital scales.
Timepoint [4] 366580 0
Baseline; post-intervention (Weeks 13-14); time of discharge from hospital prior to Week 12.
Secondary outcome [5] 366581 0
Primary Outcome: Baseline to post-intervention changes in waist circumference (cm), measured with a tape measure.

Timepoint [5] 366581 0
Baseline; post-intervention (Weeks 13-14); time of discharge from hospital prior to Week 12.
Secondary outcome [6] 366599 0
Primary Outcome: Baseline to post-intervention changes in hip circumference (cm), measured with a tape measure.
.
Timepoint [6] 366599 0
Baseline; post-intervention (Weeks 13-14); time of discharge from hospital prior to Week 12.
Secondary outcome [7] 366617 0
Primary Outcome: Baseline to post-intervention changes in body mass index (BMI). Participants will have their height measured with a stadiometer in order to calculate BMI using the using the standard formula (weight in kilograms divided by height in metres squared).
Timepoint [7] 366617 0
Baseline; post-intervention (Weeks 13-14); time of discharge from hospital prior to Week 12.
Secondary outcome [8] 366628 0
Primary Outcome: Baseline to post-intervention changes in blood pressure, measured with a sphygmomanometer.
Timepoint [8] 366628 0
Baseline; post-intervention (Weeks 13-14); time of discharge from hospital prior to Week 12.
Secondary outcome [9] 366629 0
Primary Outcome: Baseline to post-intervention changes in HbA1c. Capillary blood samples will be collected via fingerprick and analysed through a point-of-care testing machine. Fingerprick blood sampling will be conducted by project staff trained in point-of-care testing procedures.
Timepoint [9] 366629 0
Baseline; post-intervention (Weeks 13-14); time of discharge from hospital prior to Week 12.
Secondary outcome [10] 366630 0
Primary Outcome: Baseline to post-intervention changes in fasting glucose levels. Capillary blood samples will be collected via fingerprick and analysed through a point-of-care testing machine. Fingerprick blood sampling will be conducted by project staff trained in point-of-care testing procedures.
Timepoint [10] 366630 0
Baseline; post-intervention (Weeks 13-14); time of discharge from hospital prior to Week 12.
Secondary outcome [11] 366631 0
Primary Outcome: Baseline to post-intervention changes in lipid profiles (cholesterol, triglycerides). Capillary blood samples will be collected via fingerprick and analysed through a point-of-care testing machine. Fingerprick blood sampling will be conducted by project staff trained in point-of-care testing procedures.
Timepoint [11] 366631 0
Baseline; post-intervention (Weeks 13-14); time of discharge from hospital prior to Week 12.
Secondary outcome [12] 366632 0
Primary Outcome: Baseline to post-intervention changes in liver function. Liver function tests will be conducted via venous blood collection. All venous blood sampling will be conducted by the Senior Research Nurse (Clinical Nurse Consultant Grade 3).
Timepoint [12] 366632 0
Baseline; post-intervention (Weeks 13-14); time of discharge from hospital prior to Week 12.
Secondary outcome [13] 366633 0
Baseline to post-intervention changes in symptoms of depression, anxiety and stress. Changes will be assessed using the Depression Anxiety Stress Scale (DASS-21).
Timepoint [13] 366633 0
Baseline; intervention mid-point (Week 6); post-intervention (Weeks 13-14); time of discharge prior to Week 12.
Secondary outcome [14] 366634 0
Baseline to post-intervention changes in positive psychiatric symptoms. Changes will be assessed using the Current Community Assessment of Psychic Experiences - Positive Scale (CAPE-P15).
Timepoint [14] 366634 0
Baseline; post-intervention (Weeks 13-14).

Eligibility
Key inclusion criteria
Inclusion criteria: 1. patients currently admitted to the Long Bay Hospital Mental Health Unit; 2. aged 18 years and over.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
1. inability to provide informed consent due to acute mental illness, severe cognitive impairment or severe intellectual disability
2. insufficient English fluency to provide informed consent and/or complete the pre- and post-test interviews
3. suspected or known pregnancy;
4. risk factors that could prevent them being issued a Fitbit (e.g. at risk of self-harm; acute paranoid delusions)
5. unable to participate due to high security risk, as determined by the treating team
6. physical contraindications to exercise which will be assessed via completion of the Adult Pre-exercise Screening System (APSS) Tool in addition to a clinical assessment by a medical officer

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Design: Quasi-experimental, two-arm pilot study comparing a physical activity intervention (exergaming) with “routine treatment”. The study will employ a non-randomised, pre-test/post-test parallel group design.

Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As this is a pilot study, power-based sample size calculations have not been conducted. It is anticipated that findings from this study will inform sample size and power calculations for a subsequent definitive randomised controlled trial (RCT). The proposed sample size of 30 participants per study arm at Long Bay Hospital, a total of 60 participants, is based on recommended sample sizes for pilot studies preceding a main trial powered to detect a small to medium effect size (i.e. 0.1-0.3) and is consistent with the median intended sample size of 30 participants per arm in registered pilot and feasibility trials. Moreover, this sample size is sufficient to estimate recruitment and attrition rates ahead of a larger RCT across multiple sites. While there are no previous studies using a similar 12-week protocol among a wholly inpatient population to guide estimates of attrition, based on the attrition rates of studies among outpatient and non-psychiatric samples (7-19%) we have conservatively allowed for a 20% attrition rate when considering our intended sample size.

A combination of descriptive and inferential statistics methods, including multivariable linear and logistic regression modelling, will be used to analyse quantitative data. All analyses will be performed using IBM SPSS software. Pre- to post-test within-group comparisons will be conducted using paired sample t-tests and chi-square analysis. Pre- and post-test between-group comparisons will be conducted using independent sample t-tests and chi-square analysis. Relationships between predictor and outcome variables will be analysed using general linear model (GLM) multivariate analysis of variance for repeated measures and binary logistic regression. All quantitative analyses will be conducted on an intention-to-treat basis, with the last observation carried forward for missing values. Qualitative data from the patient and staff intervention evaluation surveys will undergo grounded theory analysis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
27/01/2020
Actual
Date of last participant enrolment
Anticipated
30/09/2020
Actual
Date of last data collection
Anticipated
31/12/2020
Actual
Sample size
Target
60
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 12798 0
Long Bay Hospital - Matraville
Recruitment postcode(s) [1] 25258 0
2036 - Matraville

Funding & Sponsors
Funding source category [1] 301322 0
Government body
Name [1] 301322 0
Translational Research Grants Scheme- NSW Ministry of Health
Country [1] 301322 0
Australia
Primary sponsor type
Government body
Name
Justice Health and Forensic Mental Health Network
Address
1300 Anzac Parade
MALABAR NSW 2036

Postal address:
PO Box 150
MATRAVILLE NSW 2036
Australia
Country
Australia
Secondary sponsor category [1] 300989 0
None
Name [1] 300989 0
N/A
Address [1] 300989 0
N/A
Country [1] 300989 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302064 0
Justice Health and Forensic Mental Health Network Human research Ethics Committee
Ethics committee address [1] 302064 0
Ethics committee country [1] 302064 0
Australia
Date submitted for ethics approval [1] 302064 0
18/10/2018
Approval date [1] 302064 0
01/11/2018
Ethics approval number [1] 302064 0
2018/ETH00361
Ethics committee name [2] 302069 0
Corrective Services Ethics Committee
Ethics committee address [2] 302069 0
Ethics committee country [2] 302069 0
Australia
Date submitted for ethics approval [2] 302069 0
01/11/2018
Approval date [2] 302069 0
Ethics approval number [2] 302069 0
Ethics committee name [3] 305228 0
Aboriginal Health & Medical Research Council of NSW
Ethics committee address [3] 305228 0
Ethics committee country [3] 305228 0
Australia
Date submitted for ethics approval [3] 305228 0
23/11/2018
Approval date [3] 305228 0
14/10/2019
Ethics approval number [3] 305228 0
1465/18

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

Contacts
Principal investigator
Name 89002 0
Dr Sharlene Kaye
Address 89002 0
Research Unit
Justice Health and Forensic Mental Health Network
Long Bay Complex, Roundhouse,
1300 Anzac Parade
Malabar, NSW, 2036
Country 89002 0
Australia
Phone 89002 0
+61 2 9700 3836
Fax 89002 0
+61 2 9700 3603
Email 89002 0
sharlene.goodhew@justicehealth.nsw.gov.au
Contact person for public queries
Name 89003 0
Sharlene Kaye
Address 89003 0
Research Unit
Justice Health and Forensic Mental Health Network
Long Bay Complex, Roundhouse,
1300 Anzac Parade
Malabar, NSW, 2036
Country 89003 0
Australia
Phone 89003 0
+61 2 9700 3836
Fax 89003 0
+61 2 9700 3603
Email 89003 0
sharlene.goodhew@justicehealth.nsw.gov.au
Contact person for scientific queries
Name 89004 0
Sharlene Kaye
Address 89004 0
Research Unit
Justice Health and Forensic Mental Health Network
Long Bay Complex, Roundhouse,
1300 Anzac Parade
Malabar, NSW, 2036
Country 89004 0
Australia
Phone 89004 0
+61 2 9700 3836
Fax 89004 0
+61 2 9700 3603
Email 89004 0
sharlene.goodhew@justicehealth.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
As the patients that will be participating in the study are in custody for criminal offences, data they provide may be potentially identifiable. To ensure anonymity and privacy, individual data will not be available or disseminated. Only group data will be reported.


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
SourceTitleYear of PublicationDOI
EmbaseFeasibility of an Intervention Targeting Health through Exergaming as an Alternative to Routine Treatment (FIT HEART): protocol for a non-randomised two-armed pilot study.2022https://dx.doi.org/10.1186/s40814-022-01068-2
N.B. These documents automatically identified may not have been verified by the study sponsor.