ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12622000213741

Ethics application status

Approved

Date submitted

18/01/2022

Date registered

7/02/2022

Date last updated

7/02/2022

Date data sharing statement initially provided

7/02/2022

Type of registration

Prospectively registered

Titles & IDs

Public title

Fitness for recovery- Impact of Exercise in People with Substance Use Disorder in Residential Treatment

Scientific title

Fitness For Recovery-Impact of Exercise on Quality of life in People with Substance Use Disorder in Residential Treatment

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Opioid dependence

Condition category

Condition code

Mental Health

Addiction

Physical Medicine / Rehabilitation

Other physical medicine / rehabilitation

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

This study will involve an exercise assessment followed by a twice weekly, 12-week exercise program.
Participants will be instructed how to perform each exercise or assessment correctly each time by the exercise physiologist present. Information will be verbal and given as required.
The exercise intervention will be delivered twice per week for 12 weeks with a minimum of 48 hours between each session. Sessions will run for 40 minutes and involve cardiovascular, resistance and flexibility training. Intensity will be self-selected, with participants being asked to rate intensity at the end of each session.
The exercise session will be designed by an accredited exercise physiologist and delivered by either an accredited exercise physiologist or final year exercise physiology student. All interventions will be delivered face to face at a residential treatment facility (We Help Ourselves, Lilyfield).
Below is an example session plan, however sessions will change week to week throughout the intervention.
5 minutes aerobics and ROM Warm up: Hamstring Curls, High knee marching, heel raises, Arm circles, standing thoracic rotation, Shoulder shrugs
20 minutes Boxing: Including punch technique and boxing combinations
10 minutes strength training superset: Squats, Push ups, TheraBand row and sit up. 3 sets of 10 reps each exercise
5 minutes Stretching: Quadriceps, hamstrings, Glutes, shoulders, back, pecs
Exercise sessions will be modified as required by the study Exercise Physiologist to accommodate any pre-existing injuries or limitations participants have. Adherence to the intervention will be recorded by the study exercise physiologist. If participants are noted to have missed a session, they will be encouraged to participate by study exercise physiologist, however no other strategies will be used to increase fidelity to the study.

Intervention code [1]

Rehabilitation

Comparator / control treatment

A historical control will be used.
This will be a cohort previously admitted to We Help Ourselves rehabilitation between throughout 2021. This was a period where no Exercise Physiology groups or services were avalible.

Control group

Historical

Outcomes

Primary outcome [1]

EUROHIS Quality of Life 8 score

Timepoint [1]

Baseline, week 12 (Post intervention)

Secondary outcome [1]

Three minute step test assessing Cardiorespiratory fitness

Timepoint [1]

Base line, week 12 post-commencement of intervention

Secondary outcome [2]

Kessler 10 depression score

Timepoint [2]

Baseline, Week 12 post-commencement of intervention

Secondary outcome [3]

Brief pain inventory

Timepoint [3]

Weeks 1-12 post-commencement of intervention

Secondary outcome [4]

Pittsburgh sleep quality index assessing sleep quality

Timepoint [4]

Baseline, Week 12 post-commencement of intervention

Secondary outcome [5]

Drug use assessed with the Severity of Dependence Score

Timepoint [5]

Baseline, week 12 post-commencement of intervention

Secondary outcome [6]

Push up to fatigue assessing upper body muscular endurance

Timepoint [6]

Baseline, week 12 post-commencement of intervention

Secondary outcome [7]

3 minute Curl Up test assessing muscular endurance of the trunk

Timepoint [7]

Baseline, week 12 post-commencement of intervention

Secondary outcome [8]

Sit to stand in 30 seconds assessing lower body functional endurance

Timepoint [8]

Baseline, Week 12 post-commencement of intervention

Secondary outcome [9]

Hand Grip Strength assessing whole body strength

Timepoint [9]

Baseline, Week 12 post-commencement of intervention

Secondary outcome [10]

Six Minute Walk test assessing functional aerobic capacity

Timepoint [10]

Baseline, Week 12 post-commencement of intervention

Secondary outcome [11]

Balance Error Scoring System assessing balance

Timepoint [11]

Baseline, Week 12 post-commencement of intervention

Secondary outcome [12]

Epworth sleepiness scale assessing sleep quality

Timepoint [12]

Baseline, Week 12 post-commencement of intervention

Secondary outcome [13]

Positive and Negative Affect Schedule (PANAS) assessing mood

Timepoint [13]

Immediately before exercise assessment, Immediately post exercise assessment

Eligibility

Key inclusion criteria

Resident at one of the Opioid assisted treatment units at We Help Ourselves Lilyfield
Capacity to provide informed consent.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Have mental impairment leading to inability to cooperate.
Unable to communicate sufficiently in English
Does not meet the ACSM pre-exercise screening criteria to participate in moderate intensity exercise without clearance from a medical officer.
Diagnosed with an acute disorder that may affect exercise performance or be aggravated by exercise (ie infection)
have an orthopaedic condition which prevents participation in exercise.

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)

Allocation is not concealed

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

Efficacy

Statistical methods / analysis

We have used several sources on which to explore potential sample size as described below. As described in our objectives we anticipate that there will be drop out through each stage of the study due to either change of mind, or participants leaving the treatment facility. Between phase 1 and 2 of the study we anticipate a modest drop out of 10% due to being unsuitable to exercise or declining to participate in the exercise assessments. However, we anticipate a significant drop out between stage 2 and the completion of stage 3. The average dropout of the opioid assisted treatment program is 50%, with the majority occurring in the first 2 weeks of the treatment program. As we are aiming to recruit participants within the first 2 weeks of their admission it is likely that we will experience a similar drop out from our study due to participants leaving the program, hence no longer being eligible for participation. Based on this we anticipate that 45% of the participants initially recruited will complete the study.

The primary outcome of interest in this study is the change in QOL as measured by the EUROHIS Quality of Life 8 Item scale (EUROHIS QOL8). This is a shortened version of the 25 item World Health Organisation Quality of Life Brief Scale (WHOQOL BREF), assessing the same four domains of QOL- physiological, psychological, social and environmental. To date the EUROHIS QOL8 has not been used in exercise and SUD research therefore the power calculations below are based off a recent study by Muller et al which used the WHOQOL BREF to evaluate changes in QOL in response to a 10-week exercise program in a mixed substance use disorder population. We believe that Physiological and Psychological domains are more applicable measures of an exercise intervention, therefore calculations have been based on these domains. All calculations presented were completed using G power 3.1.9.4

We completed our first analysis using the Physiological QOL outcome. Average at baseline was 11.64 with a standard deviation of 2.66 and increased to 13.29 with a standard deviation of 2.29 following a 10-week intervention for a calculated effect size of 0.66. Utilising an a priori one tail difference between dependent means (matched pairs); Alpha set at 0.05 and power of 0.95 27 participants are required to complete the study. Alternatively, if power is set at 0.8 a sample size of 16 participants is required to complete the study.

We also conducted a second analysis based on the Psychological QOL domain. Average scores at baseline were 11.84 with a standard deviation of 2.28 and increased to 13.78 with a standard deviation of 1.78 following the exercise intervention resulting in a calculated effect of 0.93. Utilising the same parameters as for the physiological QOL outcomes above and power set at 0.95. 14 participants are required to complete the study and for a power at 0.8 9 participants are required to complete the intervention.

Based on the above calculations we propose a minimum recruitment of 36 and a maximum recruitment of 60 to achieve an end sample of 16-27 participants

The primary analysis for survey data and fitness assessments will be descriptive statistics compared to age and sex matched normative data, except for the PANAS for which acute pre-post data will be assessed using separate within-subject ANOVAs including gender as a between-subjects factor. Following completion of the 12-week exercise intervention, PANAS scores will be analysed using mixed-ANOVAs with factors of test (Baseline vs. week 12); Exercise (Pre- vs. post.); and gender (male vs. female).
Following completion of exercise intervention, EUROHIS scores for each psychological and physiological domain will be analysed using mixed-ANOVAs with factors of test (Phase 1 vs. Phase 3); and gender (male vs. female). Changes in fitness scores will be analysed using paired t-tests with Bonferroni correction as appropriate.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

28/02/2022

Actual

Date of last participant enrolment

Anticipated

29/07/2022

Actual

Date of last data collection

Anticipated

28/10/2022

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment postcode(s) [1]

2040 - Lilyfield

Funding & Sponsors

Funding source category [1]

University

Name [1]

The University of Sydney

Address [1]

Susan Wakil Health Building,
Building D17, University of Sydney
Camperdown, 2006, NSW Australia

Country [1]

Australia

Primary sponsor type

University

Name

University of Sydney

Address

Susan Wakil Health Building,
Building D17, University of Sydney
Camperdown, 2006, NSW Australia

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Sydney, Human research ethics committee

Ethics committee address [1]

The University of Sydney
City Rd Level 2 & 3, Sydney New South Wales 2006

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

29/06/2021

Approval date [1]

18/10/2021

Ethics approval number [1]

2021/592

Summary

Brief summary

The primary purpose of this study is to investigate the impact of a 12-week exercise intervention on mood, quality of life (QOL) and exercise capacity of people in a residential opioid assisted treatment rehabilitation. It will also further inform on the physical health and fitness of patients with substance use disorder (SUD), and their preferences regarding exercise interventions. Additionally, we will investigate the effect of performing an acute bout of exercise on psychological outcomes including mood as secondary outcomes in aid of identifying further motivators for participant engagement. 
We hypothesise that the 12-week exercise program will significantly improve QOL and exercise capacity and that a single bout of exercise will lead to an improvement mood state. Regarding exercise participation, we hypothesis that participation at baseline will be lower than the general population, and that there will be a preference towards resistance type exercises over aerobic or flexibility. We also hypothesis that exercise capacity of participants will be below age and sex matched norms.  
With this information we hope to better inform the role of exercise as a treatment modality in the treatment of opioid dependence. We also hope to offer a summary of the exercise capacity and interests of this population to better inform clinical practice and exercise prescription.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Kieron Rooney

Address

Faculty of Medicine and Health, Susan Wakil Health Building,
Building D17, University of Sydney
NSW 2006, Australia.

Country

Australia

Phone

+61 286271877

Fax

Kieron.rooney@sydney.edu.au

Contact person for public queries

Name

Kieron Rooney

Address

Faculty of Medicine and Health, Susan Wakil Health Building,
Building D17, University of Sydney
NSW 2006, Australia.

Country

Australia

Phone

+61 286271877

Fax

Kieron.rooney@sydney.edu.au

Contact person for scientific queries

Name

Kieron Rooney

Address

Faculty of Medicine and Health, Susan Wakil Health Building,
Building D17, University of Sydney
NSW 2006, Australia.

Country

Australia

Phone

+61 286271877

Fax

Kieron.rooney@sydney.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 data collected specifically for the trail including exercise assessments, mood, Quality of life, pain measures, and sleep data will be made avalible.
Data obtained from WHOS as a historic control will not be avalible.

When will data be available (start and end dates)?

At completion of the trial data will be handed over to research data store in June 2023. There is no end date to when this data will be avalible.

Available to whom?

It will be avalible to peer reviewers, journal editors and researchers completing meta analyses on request

Available for what types of analyses?

Data will be made avalible as required for the purpose of checking data integrity and for the use in systematic reviews and meta analyses.

How or where can data be obtained?

Data can be obtained on request by contacting the principle investigator at Kieron.rooney@sydney.edu.au

What supporting documents are/will be available?

Doc. No.	Type	Other Details
14696	Study protocol	Documents will be uploaded onto the University of ... [More Details]
14697	Statistical analysis plan	Documents will be uploaded onto the University of ... [More Details]
14698	Informed consent form	Documents will be uploaded onto the University of ... [More Details]
14699	Clinical study report	Documents will be uploaded onto the University of ... [More Details]
14700	Ethical approval	Documents will be uploaded onto the University of ... [More Details]
14701	Analytic code	Documents will be uploaded onto the University of ... [More Details]

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
Dimensions AI	FITNESS FOR RECOVERY- FEASABILITY AND IMPACT OF AN EXERCISE PROGRAM DURING RESIDENTIAL REHABILITATION	2024	https://doi.org/10.31189/2165-7629-13-s2.429

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

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