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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]

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

bipolar disorder

Condition category

Condition code

Physical Medicine / Rehabilitation

Other physical medicine / rehabilitation

Mental Health

Schizophrenia

Mental Health

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]

Lifestyle

Intervention code [2]

Rehabilitation

Intervention code [3]

Treatment: Other

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Feasibility which was was assessed by:
Proportion of participants recruited from available residents in the mental health facility

Timepoint [1]

Baseline

Primary outcome [2]

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]

Following 10 weeks of exercise

Primary outcome [3]

Feasibility was assessed by:
Completion rates as assessed by the proportion of participants enrolled in the study who completed post measures.

Timepoint [3]

Following 10 weeks of exercise, and after any subsequent blocks of 10 weeks of exercise the participant completes

Secondary outcome [1]

Six minute walk test - functional exercise capacity (6MWT) - validated test of functional exercise capacity in people with severe mental illness

Timepoint [1]

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]

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]

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]

Negative symptoms of schizophrenia - Scale for the assessment of negative symptoms (SANS), a validated scale for the assessment of negative symptoms

Timepoint [3]

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]

Total psychiatric symptoms as assessed by the BPRS (Brief psychiatric rating scale). validated total psychiatric symptom scale.

Timepoint [4]

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]

Attitudes to exercise - "BREQ 2" - Behavioural Exercise Regulations Questionnaire (validated attitudinal questionnaire regarding attitudes to exercise).

Timepoint [5]

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]

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]

Baseline and following ten week exercise intervention

Secondary outcome [7]

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]

Baseline and following 10 week exercise intervention

Secondary outcome [8]

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]

Baseline, (prior to the exercise intervention starting) only

Secondary outcome [9]

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]

Baseline and following 10 week exercise intervention

Secondary outcome [10]

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]

Baseline and following the 10 week exercise intervention

Secondary outcome [11]

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]

Baseline and following the 10 week exercise intervention

Secondary outcome [12]

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]

Baseline and following the 10 week intervention

Secondary outcome [13]

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]

Baseline, prior to the 10 week exercise intervention

Secondary outcome [14]

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]

GENEActivs will be worn for 7 consecutive days and nights prior to the baseline assessments before the exercise intervention starts.

Secondary outcome [15]

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]

baseline and following the 10 week intervention, and after any further 10 week blocks of exercise that the participant completes.

Secondary outcome [16]

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]

Documented throughout the 10 week exercise intervention and any subsequent blocks of 10 weeks of exercise

Secondary outcome [17]

Metabolic data:
Fasting total cholesterol (mmol/l), by venous blood sample

Timepoint [17]

baseline and following 10 weeks of the exercise intervention and any further 10 week blocks of exercise engaged in.

Secondary outcome [18]

Metabolic data:
fasting blood glucose in mol/L

Timepoint [18]

Baseline and following 10 weeks of exercise intervention and any following any subsequent blocks of exercise a participant engages in.

Secondary outcome [19]

Metabolic data:
abdominal circumference in cm

Timepoint [19]

baseline and following 10 weeks of exercise and any subsequent blocks of exercise the participant engages in.

Secondary outcome [20]

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]

baseline and following 10 weeks of exercise intervention and following any subsequent blocks of exercise engaged in

Secondary outcome [21]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Logan Hospital - Meadowbrook

Recruitment hospital [2]

Redland Hospital - Cleveland

Recruitment hospital [3]

Ipswich Hospital - Ipswich

Recruitment hospital [4]

Princess Alexandra Hospital - Woolloongabba

Recruitment postcode(s) [1]

4131 - Meadowbrook

Recruitment postcode(s) [2]

4163 - Cleveland

Recruitment postcode(s) [3]

4305 - Ipswich

Recruitment postcode(s) [4]

4102 - Woolloongabba

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Princess Alexandra Hospital

Address [1]

199 Ipswich Road, Woolloongabba Qld 4102

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

University

Name [1]

Queensland University of Technology (QUT)

Address [1]

kelvin Grove Campus
149 Victoria Park Road
kelvin Grove

Country [1]

Australia

Other collaborator category [2]

University

Name [2]

Universtiy of Queensland

Address [2]

Sir Fred Schonell Drive,
St Lucia
Qld 4072

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Metro South HHS HREC

Ethics committee address [1]

199 Ipswich Road, Woolloongabba, Qld 4102

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

13/01/2016

Approval date [1]

01/03/2016

Ethics approval number [1]

HREC 16/QPAH/042

Ethics committee name [2]

West Moreton HHS HREC

Ethics committee address [2]

The Park, centre for Mental Health,
Level 2 Dawson house
locked bag 500
Archerfield QLD 4108

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

12/12/2017

Approval date [2]

25/01/2018

Ethics approval number [2]

HREC 16/QPAH/042

Summary

Brief summary

People with severe mental illness are sedentary, have high cardio-metabolic risks and reduced life expectancy. Despite evidence regarding positive physical and mental health outcomes following exercise interventions, evaluation of real-world programs is lacking. The aim was to evaluate the feasibility of an exercise intervention implemented by exercise physiology students within a residential rehabilitation unit for people with severe mental illness.
Exercise physiology students implemented a supervised group exercise program for people with severe mental illness.  It occurred three times per week,  for 10 weeks, on site, at a mental health residential rehabilitation unit,  Outcomes were measured pre and post the intervention.
Participants in the study were residents of the rehabilitation unit, with a primary diagnosis of schizophrenia. Primary outcomes were the feasibility of the exercise program (recruitment, completion, participation and adverse events). Secondary outcomes included a range of other physical and mental health outcomes assessed pre and post the 10 week exercise intervention.

Trial website

Trial related presentations / publications

Presentations to date:

1.Korman, N (December 2016). "Translating Physical Activity Research Evidence into practice: Just do it". Oral presentation within a symposium 38th Annual Society for Mental Health Research (SMHR) Conference, Sydney
2. Korman, N (May 2017). "Biopsychosocial and More: Treating Difficult to Treat Psychotic Disorder".  Oral presentation within a symposium, Royal Australian New Zealand College of Psychiatry (RANZCP) College Congress, Adelaide
3. Korman, N, Suetani, S (July 2017) "Evaluating effects of a physical activity intervention implemented at a residential mental health rehabilitation unit".  Translational Research Institute (TRI) poster presentation, Brisbane 
4. Korman, N (December 2017) "Evaluating effects of a physical activity intervention implemented at a residential mental health rehabilitation unit".  Poster presentation at the 39th Annual Society for Mental Health Research (SMHR), Canberra 

5. Elements of the model are briefly described (no data analysis) in the publication;  “Embedding exercise interventions as routine mental health care: implementation strategies in residential, inpatient and community settings” (Lederman et al., 2017)

Public notes

Attachments [1]

/AnzctrAttachments/374804-CCU physical activity study3.docx (Protocol)

Attachments [2]

/AnzctrAttachments/374804-consent form version 2.doc (Participant information/consent)

Attachments [3]

/AnzctrAttachments/374804-PICF version 2.0 GO HEART 2016.doc (Participant information/consent)

Attachments [4]

/AnzctrAttachments/374804-HREC clearance letter.pdf (Ethics approval)

Contacts

Principal investigator

Name

Dr Nicole Korman

Address

Coorparoo CCU'
6 Baragoola St
Coorparoo qld 4151

Country

Australia

Phone

+61 07 37277200

Fax

+61 07 3727 7250

[email protected]

Contact person for public queries

Name

Nicole Korman

Address

Coorparoo CCU'
6 Baragoola St
Coorparoo qld 4151

Country

Australia

Phone

+61 07 37277200

Fax

+61 07 3727 7250

[email protected]

Contact person for scientific queries

Name

Nicole Korman

Address

Coorparoo CCU'
6 Baragoola St
Coorparoo qld 4151

Country

Australia

Phone

+61 07 37277200

Fax

+61 07 3727 7250

[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 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 [email protected]

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
11247	Ethical 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

Source	Title	Year of Publication	DOI
Embase	Evaluating 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).	2018	https://dx.doi.org/10.3389/fpsyt.2018.00343
Embase	Feasibility 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).	2020	https://dx.doi.org/10.3389/fpsyt.2020.00319

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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