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Trial registered on ANZCTR


Registration number
ACTRN12618000478213
Ethics application status
Approved
Date submitted
27/03/2018
Date registered
3/04/2018
Date last updated
31/03/2021
Date data sharing statement initially provided
31/03/2021
Date results provided
31/03/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluating the feasibility of an exercise program for people with severe mental illness living within a rehabilitation unit.
Scientific title
Evaluating the feasibility of a pilot exercise intervention implemented within a residential rehabilitation unit for people with severe mental illness ; GO HEART; (Group Health Occupational Exercise And Rehabilitation Treatment)
Secondary ID [1] 294457 0
nil known
Universal Trial Number (UTN)
U1111-1211-4009
Trial acronym
GO HEART; (Group Health Occupational Exercise And Rehabilitation Treatment)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
schizophrenia 307207 0
bipolar disorder 307209 0
Condition category
Condition code
Physical Medicine / Rehabilitation 306319 306319 0 0
Other physical medicine / rehabilitation
Mental Health 306320 306320 0 0
Schizophrenia
Mental Health 306342 306342 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Prospective single arm cohort study involving the delivery of an exercise intervention to people with severe mental illness by 4th year (senior) exercise physiology (EP) students of a University undergraduate degree program. EP students planned and delivered the exercise circuit, under supervision by their University Exercise physiology supervisor.

A risk to exercise screen was undertaken by EP students (Adult pre-exercise screening system, APSS), before informed consent obtained from participants.
A wrist worn accelerometer was worn by participants for 7 days prior to a range of baseline physical and mental health measures being obtained from participants. Collaboration between EP students and mental health staff of the residential rehabilitation unit occurred in order for the program to be delivered.

EP students assessed metabolic outcomes, vascular, autonomic nervous system and functional exercise capacity, physical activity self report and a physical activity acceptability questionnaire. The consultant psychiatrist assessed mental health outcomes.

The exercise intervention involved a group based circuit, that was supervised face to face by EP students, and delivered in the courtyard, on site, at a mental health rehabilitation facility Exercise frequency was three mornings per week, for 10 weeks. Participants who wished to complete a second 10 week block of exercise after the first 10 week block were encouraged to do so. Physical and mental health outcomes were assessed following any further 10 weeks blocks of exercise engaged in by participants.

Exercise equipment utilised included a recumbent exercise bike, a step, boxing pads and gloves for boxing with the EP students, resistance bands, dumbbells, treadmill and skipping rope. .

Each circuit was 45 minutes long, with a 5 minute warm up and 10 minute cool down. The active exercise lasted 30 minutes, and consisted of participants rotating through 10-15 stations that involved a mixture of aerobic and resistance exercises. The Borg Category Ratio 10 scale was used to assess rate of perceived exertion (RPE) and to guide intensity of exercise prescription, by the EP students. The circuit began at intervals of 30 seconds of exercise interspersed with 30 seconds of complete rest and progressed to 60 second interval as the participants’ functional exercise capacity increased.
EP students aimed 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 as per individual participant’s capacity.

Stations were designed such that they can be modified (regressed/progressed) to suit individual participant capacity and preference. If certain elements of the circuit were preferred by participants, EP students documented this in logbooks and increased these elements for participants in the next circuit so as to individualise the circuit, even though it was still in a group format. This was to better engage the participants in the exercise intervention (and reduce non adherence).

Adherence to the program was monitored by logbooks completed by participants and EP students together. Adherence was facilitated by encouragement from EP students and mental health staff of the facility at attend, and by addressing barriers to attendance for participants as they arose. EP students and mental health staff discussed adherence and identification of barriers (and solutions to these barriers), which occurred at team meetings and via email communication.

Participation at each exercise session, preferred elements of the circuit and intensity level achieved was documented in logbooks collaboratively between EP students and participants.

Motivational strategies such as motivational interviewing and goal setting was offered by EP students and the consultant psychiatrist of the unit, to participants, to encourage participation.

EP students were provided with weekly mental health supervision with the consultant psychiatrist to up-skill in mental illness and better engage participants in exercise intervention.
Intervention code [1] 300750 0
Lifestyle
Intervention code [2] 300751 0
Rehabilitation
Intervention code [3] 300755 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305330 0
Feasibility which was was assessed by:
Proportion of participants recruited from available residents in the mental health facility

Timepoint [1] 305330 0
Baseline
Primary outcome [2] 305342 0
Feasibility was assessed by:
Participation rates as by the proportion of total available sessions over the 10 week intervention attended by participants, and after any subsequent blocks of 10 weeks of exercise the participant completes
Timepoint [2] 305342 0
Following 10 weeks of exercise
Primary outcome [3] 305343 0
Feasibility was assessed by:
Completion rates as assessed by the proportion of participants enrolled in the study who completed post measures.
Timepoint [3] 305343 0
Following 10 weeks of exercise, and after any subsequent blocks of 10 weeks of exercise the participant completes
Secondary outcome [1] 344858 0
Six minute walk test - functional exercise capacity (6MWT) - validated test of functional exercise capacity in people with severe mental illness
Timepoint [1] 344858 0
Baseline and following 10 weeks of the exercise intervention, and after any further 10 week blocks of exercise that the participant completes
Secondary outcome [2] 344859 0
Metabolic data:
Body mass index (weight kg/height m*2).
This was assessed using digital scales for body weight (no shoes worn) and a stadiometer for height.
Timepoint [2] 344859 0
Baseline and following 10 weeks of the exercise intervention and after any further 10 week blocks of exercise that the participant completes
Secondary outcome [3] 344860 0
Negative symptoms of schizophrenia - Scale for the assessment of negative symptoms (SANS), a validated scale for the assessment of negative symptoms
Timepoint [3] 344860 0
Baseline and following 10 weeks of the exercise intervention, and after any further 10 week blocks of exercise that the participant completes
Secondary outcome [4] 344861 0
Total psychiatric symptoms as assessed by the BPRS (Brief psychiatric rating scale). validated total psychiatric symptom scale.
Timepoint [4] 344861 0
Baseline and following 10 weeks of the exercise intervention, and after any further 10 week blocks of exercise that the participant completes
Secondary outcome [5] 344862 0
Attitudes to exercise - "BREQ 2" - Behavioural Exercise Regulations Questionnaire (validated attitudinal questionnaire regarding attitudes to exercise).
Timepoint [5] 344862 0
Baseline and following 10 weeks of the exercise intervention, and after any further 10 week blocks of exercise that the participant completes
Secondary outcome [6] 344894 0
Vascular Function as measured by the validated measure:
Flow mediated dilation (FMD),
This test assesses the change in the width of the brachial artery in the right arm using a cuff and a non invasive ultrasound probe.
Timepoint [6] 344894 0
Baseline and following ten week exercise intervention
Secondary outcome [7] 344895 0
Autonomic function as assessed by:

Heart rate variability (HRV)
This test measures the participant’s resting heart rate variability (HRV) as a validated measure of ANS function, and involves 3 electrodes being placed on the participants chest during rest.
Timepoint [7] 344895 0
Baseline and following 10 week exercise intervention
Secondary outcome [8] 344896 0
Participant preference for measurement of physical activity, as assessed by the:

"Acceptability of PA measurement questionnaire".
This questions participants preferences for six minute walk test, accelerometer use or the use of a physical activity self report questionnaire.
Timepoint [8] 344896 0
Baseline, (prior to the exercise intervention starting) only
Secondary outcome [9] 344897 0
Autonomic function as assessed by:
-Heart rate recovery (HRR)

.Participants will be asked to wear an external heart rate monitor strap around their chest, inferior to the sternum, for the length of time that is required for their heart rate to return to baseline following the 6MWT (Six minute walk test).
Timepoint [9] 344897 0
Baseline and following 10 week exercise intervention
Secondary outcome [10] 344898 0
Vascular Function as measured by the validated measure:
Pulse wave velocity (PWV).
This test is a validated assessment of the stiffness of the participant’s blood vessels. The participant will be asked to remain on the bed in a relaxed state. A blood pressure cuff will be attached to their thigh. The clinician will then identify the location of the pulse in their neck and place a small mark (with a soft pen marker). The test will then begin when the thigh cuff inflates and the clinician will place a small blunt pen-like device on the participant’s neck at the marked spot. This pen will be held on their neck for the duration of the test and removed upon completion. Each trial will last approximately 30-60 seconds and three trials will be performed
Timepoint [10] 344898 0
Baseline and following the 10 week exercise intervention
Secondary outcome [11] 344899 0
Vascular Function as measured by the validated measure:
-pulse wave analysis (PWA).
This test will assess the function of the participant’s blood vessels. The participant will be asked to remain on the bed in a relaxed state. A blood pressure cuff will be attached to their right arm. During the test, the cuff will inflate and deflate twice. Each trial will last approximately 30-50 seconds and three trials will be performed
Timepoint [11] 344899 0
Baseline and following the 10 week exercise intervention
Secondary outcome [12] 344914 0
Oxidative stress markers - this test assesses the change in oxidative stress markers, as a validated marker of cardiovascular function.
These markers are:
Vascular endothelial growth factor - 1 (VEGF)
intercellular adhesion molecule-1 (ICAM-1)
vascular cell adhesion molecule-1 (VCAM-1)

This involves analysis of a venous blood sample.
Timepoint [12] 344914 0
Baseline and following the 10 week intervention
Secondary outcome [13] 344915 0
Sleep - as assessed by the validated questionnaire, the Pittsburgh sleep quality index (PSQI).

The PSQI is a 19-item self-rated questionnaire composed of 15 multiple-choice items and 4 write-in items that cover the domains: subjective sleep quality, sleep onset latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medications, and daytime dysfunction. The PSQI has demonstrated good psychometric properties in psychiatric populations and healthy controls
Timepoint [13] 344915 0
Baseline, prior to the 10 week exercise intervention
Secondary outcome [14] 344916 0
Physical Activity - will be objectively measured using GENEActiv ‘Original’ wrist-worn accelerometers.

These monitors measure bodily acceleration, which can be converted into an estimate of physical activity (time spent above a validated threshold of activity) and sleep quality (by measuring ‘tossing and turning’ and night time awakenings). They are also waterproof (can be worn in shower and while swimming). There will be no restrictions on participants during the monitoring period, and participants will be asked to go about their usual activities. Recent research indicates that accelerometry is an acceptable measure of data collection for adults with mental illness.
GENEActivs will be worn for 7 consecutive days and nights prior to the baseline assessments before the fitness program starts. They will be asked to note times to bed, out of bed, and non-wear times, in a log book (GENEActive Logbook). Baseline log book information will be used in the analyse
Timepoint [14] 344916 0
GENEActivs will be worn for 7 consecutive days and nights prior to the baseline assessments before the exercise intervention starts.
Secondary outcome [15] 344917 0
Self reported physical activity - as assessed by "The Simple Physical Activity Questionnaire" (SIMPAQ), which is a simple 5-item clinical tool designed to assess physical activity amoung populations at high risk of sedentary behavior. A multinational validation study of SIMPAQ has been completed in 2016.
Timepoint [15] 344917 0
baseline and following the 10 week intervention, and after any further 10 week blocks of exercise that the participant completes.
Secondary outcome [16] 344918 0
Tolerability as assessed by:

Number and type of adverse events which may have arisen during the exercise intervention, and as a direct result of participating in the exercise intervention. This may include injuries (such as a torn muscle or injured joint).
A study-specific logbook was completed for every exercise session completed, and any injuries or adverse events were to be logged in the logbook. At study completion the logbooks were analysed by the exercise physiology students and the consultant psychiatrist together to assess type and severity of injury.
Timepoint [16] 344918 0
Documented throughout the 10 week exercise intervention and any subsequent blocks of 10 weeks of exercise
Secondary outcome [17] 344919 0
Metabolic data:
Fasting total cholesterol (mmol/l), by venous blood sample
Timepoint [17] 344919 0
baseline and following 10 weeks of the exercise intervention and any further 10 week blocks of exercise engaged in.
Secondary outcome [18] 344920 0
Metabolic data:
fasting blood glucose in mol/L
Timepoint [18] 344920 0
Baseline and following 10 weeks of exercise intervention and any following any subsequent blocks of exercise a participant engages in.
Secondary outcome [19] 344921 0
Metabolic data:
abdominal circumference in cm
Timepoint [19] 344921 0
baseline and following 10 weeks of exercise and any subsequent blocks of exercise the participant engages in.
Secondary outcome [20] 344923 0
Blood pressure systolic mmHg/diastolic mmHg
This was assessed using a digital blood pressure monitor, with cuff placed on the upper arm, and reading systolic and diastolic blood pressure as a digital read-out.
Timepoint [20] 344923 0
baseline and following 10 weeks of exercise intervention and following any subsequent blocks of exercise engaged in
Secondary outcome [21] 344936 0
Observations of participation in the exercise intervention.
A study-specific log book was completed collaboratively by the participant and exercise physiology students after each session to document rate of perceived exertion, preferred elements of the circuit (if any), adverse events or injuries sustained, and reasons for nonattendance at circuit sessions.
Timepoint [21] 344936 0
After every exercise session for the duration of the study, which was a total of 30 sessions (3 times per week, for 10 weeks), for each participant.
if the participant did not attend, the exercise physiology student would attempt to determine reasons for nonattendance and document this.

Eligibility
Key inclusion criteria
All residents of the mental health residential rehabilitation facility were eligible. (i) current resident at the Coorparoo CCU, (ii) aged 18-65 years, and (iii) able to provide informed consent.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) presented with absolute medical contraindication to exercise as determined by a general practitioner, (ii) were considered high risk for aggression or suicide, (iii) were considered to have an acutely unstable mental state by the treating psychiatrist (iv) were pregnant, or (v) were currently engaging in an regular exercise or physical activity program outside of the CCU at the time of recruitment.

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
Statistical methods / analysis
Statistical analyses are conducted using SPSS 24 (SPSS 2016). Feasibility measures are summarized with percentages. Normality probability plots and the Shapiro-Wilk statistic are used to check for normality and appropriate nonparametric statistics were applied to outcomes that were not parametric. Normally distributed pre and post outcome measures are tested using a paired t test with significance level of a= 0.05. Mean differences and associated 95% confident intervals (CI) are calculated and Cohen’s d statistic was calculated. Non-parametric data was analyzed using medians, interquartile range and Wilcoxon signed rank tests.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
18/04/2016
Date of last participant enrolment
Anticipated
Actual
1/04/2019
Date of last data collection
Anticipated
Actual
1/04/2019
Sample size
Target
65
Accrual to date
Final
61
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 10488 0
Logan Hospital - Meadowbrook
Recruitment hospital [2] 10490 0
Redland Hospital - Cleveland
Recruitment hospital [3] 10491 0
Ipswich Hospital - Ipswich
Recruitment hospital [4] 10513 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 22203 0
4131 - Meadowbrook
Recruitment postcode(s) [2] 22205 0
4163 - Cleveland
Recruitment postcode(s) [3] 22206 0
4305 - Ipswich
Recruitment postcode(s) [4] 22227 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 299081 0
Hospital
Name [1] 299081 0
Princess Alexandra Hospital
Country [1] 299081 0
Australia
Primary sponsor type
Individual
Name
Dr Nicole Korman
Address
Coorparoo Community Care Unit
6 Baragoola St
Coorparoo qld 4151
Country
Australia
Secondary sponsor category [1] 298324 0
None
Name [1] 298324 0
Address [1] 298324 0
Country [1] 298324 0
Other collaborator category [1] 280044 0
University
Name [1] 280044 0
Queensland University of Technology (QUT)
Address [1] 280044 0
kelvin Grove Campus
149 Victoria Park Road
kelvin Grove
Country [1] 280044 0
Australia
Other collaborator category [2] 280045 0
University
Name [2] 280045 0
Universtiy of Queensland
Address [2] 280045 0
Sir Fred Schonell Drive,
St Lucia
Qld 4072
Country [2] 280045 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300017 0
Metro South HHS HREC
Ethics committee address [1] 300017 0
Ethics committee country [1] 300017 0
Australia
Date submitted for ethics approval [1] 300017 0
13/01/2016
Approval date [1] 300017 0
01/03/2016
Ethics approval number [1] 300017 0
HREC 16/QPAH/042
Ethics committee name [2] 300018 0
West Moreton HHS HREC
Ethics committee address [2] 300018 0
Ethics committee country [2] 300018 0
Australia
Date submitted for ethics approval [2] 300018 0
12/12/2017
Approval date [2] 300018 0
25/01/2018
Ethics approval number [2] 300018 0
HREC 16/QPAH/042

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2543 2543 0 0
/AnzctrAttachments/374804-CCU physical activity study3.docx (Protocol)
Attachments [2] 2544 2544 0 0
/AnzctrAttachments/374804-consent form version 2.doc (Participant information/consent)
Attachments [3] 2545 2545 0 0
/AnzctrAttachments/374804-PICF version 2.0 GO HEART 2016.doc (Participant information/consent)
Attachments [4] 2546 2546 0 0
/AnzctrAttachments/374804-HREC clearance letter.pdf (Ethics approval)

Contacts
Principal investigator
Name 82274 0
Dr Nicole Korman
Address 82274 0
Coorparoo CCU'
6 Baragoola St
Coorparoo qld 4151
Country 82274 0
Australia
Phone 82274 0
+61 07 37277200
Fax 82274 0
+61 07 3727 7250
Email 82274 0
n.korman@uq.edu.au
Contact person for public queries
Name 82275 0
Nicole Korman
Address 82275 0
Coorparoo CCU'
6 Baragoola St
Coorparoo qld 4151
Country 82275 0
Australia
Phone 82275 0
+61 07 37277200
Fax 82275 0
+61 07 3727 7250
Email 82275 0
n.korman@uq.edu.au
Contact person for scientific queries
Name 82276 0
Nicole Korman
Address 82276 0
Coorparoo CCU'
6 Baragoola St
Coorparoo qld 4151
Country 82276 0
Australia
Phone 82276 0
+61 07 37277200
Fax 82276 0
+61 07 3727 7250
Email 82276 0
n.korman@uq.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?
All outcomes collected
When will data be available (start and end dates)?
March 2019-2025
Available to whom?
Other researchers who may require it
Available for what types of analyses?
any analyses required by other researchers,
How or where can data be obtained?
Excel spreadsheet or SPSS file shared via drop box or cloud.
Dr Nicole Korman may be contacted via email n.korman@uq.edu.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11247Ethical approval    374804-(Uploaded-06-10-2020-12-42-22)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEvaluating the feasibility of a pilot exercise intervention implemented within a residential rehabilitation unit for people with severe mental illness: GO HEART: (group occupational health exercise and rehabilitation treatment).2018https://dx.doi.org/10.3389/fpsyt.2018.00343
EmbaseFeasibility and Acceptability of a Student-Led Lifestyle (Diet and Exercise) Intervention Within a Residential Rehabilitation Setting for People With Severe Mental Illness, GO HEART (Group Occupation, Health, Exercise And Rehabilitation Treatment).2020https://dx.doi.org/10.3389/fpsyt.2020.00319
N.B. These documents automatically identified may not have been verified by the study sponsor.