Trial Review

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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] 306204 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Opioid dependence 324913 0
Condition category
Condition code
Mental Health 322347 322347 0 0
Addiction
Physical Medicine / Rehabilitation 322507 322507 0 0
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] 322607 0
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] 330112 0
EUROHIS Quality of Life 8 score
Timepoint [1] 330112 0
Baseline, week 12 (Post intervention)
Secondary outcome [1] 404911 0
Three minute step test assessing Cardiorespiratory fitness
Timepoint [1] 404911 0
Base line, week 12 post-commencement of intervention
Secondary outcome [2] 404912 0
Kessler 10 depression score
Timepoint [2] 404912 0
Baseline, Week 12 post-commencement of intervention
Secondary outcome [3] 404913 0
Brief pain inventory
Timepoint [3] 404913 0
Weeks 1-12 post-commencement of intervention
Secondary outcome [4] 404914 0
Pittsburgh sleep quality index assessing sleep quality
Timepoint [4] 404914 0
Baseline, Week 12 post-commencement of intervention
Secondary outcome [5] 404915 0
Drug use assessed with the Severity of Dependence Score
Timepoint [5] 404915 0
Baseline, week 12 post-commencement of intervention
Secondary outcome [6] 405661 0
Push up to fatigue assessing upper body muscular endurance
Timepoint [6] 405661 0
Baseline, week 12 post-commencement of intervention
Secondary outcome [7] 405662 0
3 minute Curl Up test assessing muscular endurance of the trunk
Timepoint [7] 405662 0
Baseline, week 12 post-commencement of intervention
Secondary outcome [8] 405663 0
Sit to stand in 30 seconds assessing lower body functional endurance
Timepoint [8] 405663 0
Baseline, Week 12 post-commencement of intervention
Secondary outcome [9] 405664 0
Hand Grip Strength assessing whole body strength
Timepoint [9] 405664 0
Baseline, Week 12 post-commencement of intervention
Secondary outcome [10] 405665 0
Six Minute Walk test assessing functional aerobic capacity
Timepoint [10] 405665 0
Baseline, Week 12 post-commencement of intervention
Secondary outcome [11] 405666 0
Balance Error Scoring System assessing balance
Timepoint [11] 405666 0
Baseline, Week 12 post-commencement of intervention
Secondary outcome [12] 405667 0
Epworth sleepiness scale assessing sleep quality
Timepoint [12] 405667 0
Baseline, Week 12 post-commencement of intervention
Secondary outcome [13] 405668 0
Positive and Negative Affect Schedule (PANAS) assessing mood
Timepoint [13] 405668 0
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?
No
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
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 36372 0
2040 - Lilyfield

Funding & Sponsors
Funding source category [1] 310552 0
University
Name [1] 310552 0
The University of Sydney
Country [1] 310552 0
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] 311722 0
None
Name [1] 311722 0
Address [1] 311722 0
Country [1] 311722 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310162 0
University of Sydney, Human research ethics committee
Ethics committee address [1] 310162 0
Ethics committee country [1] 310162 0
Australia
Date submitted for ethics approval [1] 310162 0
29/06/2021
Approval date [1] 310162 0
18/10/2021
Ethics approval number [1] 310162 0
2021/592

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

Contacts
Principal investigator
Name 116706 0
A/Prof Kieron Rooney
Address 116706 0
Faculty of Medicine and Health, Susan Wakil Health Building,
Building D17, University of Sydney
NSW 2006, Australia.
Country 116706 0
Australia
Phone 116706 0
+61 286271877
Fax 116706 0
Email 116706 0
[email protected]
Contact person for public queries
Name 116707 0
Kieron Rooney
Address 116707 0
Faculty of Medicine and Health, Susan Wakil Health Building,
Building D17, University of Sydney
NSW 2006, Australia.
Country 116707 0
Australia
Phone 116707 0
+61 286271877
Fax 116707 0
Email 116707 0
[email protected]
Contact person for scientific queries
Name 116708 0
Kieron Rooney
Address 116708 0
Faculty of Medicine and Health, Susan Wakil Health Building,
Building D17, University of Sydney
NSW 2006, Australia.
Country 116708 0
Australia
Phone 116708 0
+61 286271877
Fax 116708 0
Email 116708 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 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 [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14696Study protocol    Documents will be uploaded onto the University of ... [More Details]
14697Statistical analysis plan    Documents will be uploaded onto the University of ... [More Details]
14698Informed consent form    Documents will be uploaded onto the University of ... [More Details]
14699Clinical study report    Documents will be uploaded onto the University of ... [More Details]
14700Ethical approval    Documents will be uploaded onto the University of ... [More Details]
14701Analytic 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
SourceTitleYear of PublicationDOI
Dimensions AIFITNESS FOR RECOVERY- FEASABILITY AND IMPACT OF AN EXERCISE PROGRAM DURING RESIDENTIAL REHABILITATION2024https://doi.org/10.31189/2165-7629-13-s2.429
N.B. These documents automatically identified may not have been verified by the study sponsor.