Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001198516
Ethics application status
Approved
Date submitted
4/09/2024
Date registered
1/10/2024
Date last updated
1/10/2024
Date data sharing statement initially provided
1/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Personalised Exercise Rehabilitation FOR people with Multimorbidity - The PERFORM-Aus trial
Scientific title
Effects of a Personalised Exercise Rehabilitation FOR people with Multimorbidity on hospitalisation compared to usual care: The PERFORM-Aus trial
Secondary ID [1] 312690 0
None
Universal Trial Number (UTN)
U1111-1311-5563
Trial acronym
PERFORM-Aus
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arthritis 334697 0
Cancer 334701 0
Chronic kidney disease 334702 0
Musculoskeletal pain 334704 0
Mild dementia 334706 0
Depression 334707 0
Diabetes mellitus 334708 0
Long-COVID 334711 0
Neuromuscular diseases 334712 0
Osteoporosis 334713 0
Peripheral vascular disease 334714 0
Polycystic ovarian syndrome 334715 0
Psychoactive substance misuse 334716 0
Anxiety 335012 0
Anorexia nervosa or bulimia 335013 0
Chronic liver disease 335014 0
Chronic sinusitis 335015 0
Diverticular disease 335016 0
Endometriosis 335017 0
Epilepsy 335018 0
Condition category
Condition code
Mental Health 331268 331268 0 0
Depression
Neurological 331269 331269 0 0
Dementias
Neurological 331270 331270 0 0
Multiple sclerosis
Neurological 331271 331271 0 0
Parkinson's disease
Neurological 331272 331272 0 0
Other neurological disorders
Cancer 331273 331273 0 0
Any cancer
Metabolic and Endocrine 331274 331274 0 0
Diabetes
Eye 331528 331528 0 0
Diseases / disorders of the eye
Metabolic and Endocrine 331529 331529 0 0
Thyroid disease
Inflammatory and Immune System 331530 331530 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants randomised to the PERFORM intervention will undergo an 8-week in-person supervised program at a rehabilitation centre, with sessions held twice weekly. Each session will last 2 hours and consist of one hour of exercise training (Move and Improve) and another hour focusing on patient self-care support and education (Health and Wellbeing sessions).
Staff will receive at least 4 hours of training in delivery of the PERFORM intervention, delivered in hybrid format (F2F and online), prior to enrolling the first participant.

Move and Improve: The exercise program will be based on the American College of Sports Medicine's guideline (Exercise management for persons with chronic diseases and disabilities). It will be supervised by seasoned physiotherapists/exercise physiologists.
The exercise program will feature personalized and progressive aerobic and resistance training. Aerobic training will consist of walking (treadmill or corridor) and cycle training for up to 30 minutes in a moderate intensity (Borg RPE scale rates exertion between 12 to 14 or Borg breathlessness scale, range 3-4). The resistance training will consist of lower limb and upper limb dumbbell exercises prescribed as tolerated to achieve 2–3 sets of 10 – 15 repetitions of each exercise.
Participants will receive a comprehensive exercise booklet and a standardized progress-tracking diary to encourage their involvement in a home exercise routine. In the progress-tracking diary, participants will document exercise frequency, duration, and post-exercise symptom evaluations for aerobic and resistance training.

The fidelity of Move and Improve component will involve three steps:
- Staff Training: The Move and Improvement program staff will undergo training to ensure that everyone will adhere to the intervention protocol. Regular supervision and refresher training will help maintain consistency.
- Audit of Exercise Prescription and Progression: Periodic audits of exercise prescription records and progression will be carried out to ensure that the exercise plan is being implemented as intended. This includes confirming that the exercises, intensity, duration and frequency align with the study protocol.
- Assessment of Participant Engagement: This will involve tracking attendance, adherence to prescribed exercises, and completion of the exercise booklet for the home exercise program.

Health and Wellbeing sessions: The health and wellbeing (H&WB) sessions will be delivered in a group of participants by a healthcare professional trained by experienced behaviour change personnel. The H&WB will be grounded in behaviour change to support positive lifestyle modifications and symptom management. In total, 16 topics will be delivered throughout the eight weeks (one topic per session). The chosen topics are broad to embrace multiple health aspects which are potentially shared by people with multimorbidity covering healthy diet (two sessions), physical activity, exercise, sleep, stress, relaxation, energy, pain management, respiratory symptom management, mood management, how to cope multiple health conditions, medicines adherence, principle and strategies for changing behaviour, and habit formation.
Additionally, written leaflets and materials will be provided to support participants to share information with their families and caregivers.

The resources (exercise booklet and leaflets) were developed by the University of Leicester and adapted for the Australian context.

For the fidelity assessment for the Health & Wellbeing component, all sessions will be recorded over a one-month period at two specific times: 6 months and 18 months at all sites. From these recorded sessions, a random selection will be made for the fidelity assessment.
Intervention code [1] 329218 0
Rehabilitation
Intervention code [2] 329566 0
Behaviour
Comparator / control treatment
Usual care. It refers to the treatment provided by the participant's regular health care team, including prescribed medications and scheduled follow-up visits.
Control group
Active

Outcomes
Primary outcome [1] 339031 0
All cause non-elective hospital admission
Timepoint [1] 339031 0
12-month follow-up
Secondary outcome [1] 438312 0
Exercise capacity
Timepoint [1] 438312 0
Baseline, end intervention (3 months) and 12-month follow-up
Secondary outcome [2] 438505 0
Mental health - Depression
Timepoint [2] 438505 0
Baseline, end intervention (3 months), and 12-month follow-up
Secondary outcome [3] 438506 0
Self-reported physical activity
Timepoint [3] 438506 0
Baseline, end intervention (3 months), and 12-month follow-up.
Secondary outcome [4] 438507 0
Treatment Burden
Timepoint [4] 438507 0
Baseline, end intervention (3 months), and 12-month follow-up.
Secondary outcome [5] 438508 0
Fatigue
Timepoint [5] 438508 0
Baseline, end intervention (3 months), and 12-month follow-up.
Secondary outcome [6] 438509 0
Pain
Timepoint [6] 438509 0
Baseline, end intervention (3 months), and 12-month follow-up
Secondary outcome [7] 438510 0
Breathlessness
Timepoint [7] 438510 0
Baseline, end intervention (3 months), and 12-month follow-up
Secondary outcome [8] 438511 0
Physical frailty
Timepoint [8] 438511 0
Baseline, end intervention (3 months), and 12-month follow-up
Secondary outcome [9] 438513 0
Adverse events (AE), including musculoskeletal injuries or other injuries causally attributable to the intervention,
Timepoint [9] 438513 0
End intervention (3 months) and 12-month follow-up
Secondary outcome [10] 439310 0
Functional capacity
Timepoint [10] 439310 0
Baseline, end intervention (3 months), 12-month follow-up
Secondary outcome [11] 439338 0
Mental health - Anxiety
Timepoint [11] 439338 0
Baseline, end intervention (3 months), and 12-month follow-up
Secondary outcome [12] 439378 0
Health-related quality of life
Timepoint [12] 439378 0
Baseline, end intervention (3 months), and 12-month follow-up

Eligibility
Key inclusion criteria
Adults aged 18 years
Able and willing to provide informed consent
Able to ambulate independently (including the use of walking aids).
Scores in the modified Medical Research Council dyspnoea scale => 2 OR New York Heart Association classification => II
Diagnosis of two or more long-term health conditions, at least one of which has evidence of benefit from an exercise-based intervention:
- arthritis
- cancer
- chronic kidney disease
- connective tissue disease (pain)
- mild dementia (less than or equal to four errors in the Short Portable Mental Status Questionnaire)
- depression
- diabetes mellitus
- long-COVID
- multiple sclerosis
- osteoporosis
- painful condition due to chronic musculoskeletal conditions: osteoarthritis (hand, hip, and knee), chronic back and neck pain, shoulder impingement, and rotator cuff degeneration
- Parkinson’s disease
- peripheral vascular disease
- polycystic ovarian syndrome
- psychoactive substance misuse
- stroke or transient ischaemic attack.

Patients can also have one of the following conditions from the list below:
- anorexia nervosa or bulimia
- anxiety
- chronic fatigue syndrome
- chronic liver disease
- chronic sinusitis
- diverticular disease
- endometriosis, epilepsy
- glaucoma
- inflammatory bowel disease
- irritable bowel syndrome
- Meniere’s disease
- migraines
- pernicious anaemia
- prostate disorders
- psoriasis or eczema
- schizophrenia or bipolar affective disorder
- thyroid disease
- treated constipation
- treated dyspepsia
- viral hepatitis
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to communicate in English
Known contraindications to exercise (as defined by the American College of Sports Medicine, Ed. 2021): unstable cardiac disease, current fever, and significant aortic aneurysm (more than 5.5 cm).
Unable to attend in-person training sessions
Participation in a exercised rehabilitation programme in the last 6 months
Unstable psychiatric disorder that limits or disrupts group based interventions
Active malignancy (on chemotherapy/radiotherapy/planned urgent surgery) with a prognosis of less than 12 months survival
Pregnancy
Living in a residential aged care facility
Unsafe to exercise in a group without 1:1 supervision (e.g. significant risk of falls)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation (Griffith Randomisation Service, Griffith University)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratification by site and minimisation on age (<75 and =>75 years), number of LTCs (=<3 or >3), and sex (male/female)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
(1) Sample size
A total of 1044 participants (522 per arm) will provide 90% power to detect, at the 2-sided 5% Type I error control level, a 7% difference between groups in the proportion of patients admitted to the hospital over 12 months (16% vs 9%), based on a meta-analysis of data from 14 RCTs of exercise-rehabilitation in 1674 participants with multiple long-term health condition (Bricca et al. Ageing Res Rev 2020). This is a conservative estimate, as some included RCTs provided a lower (and likely suboptimal) exercise ‘dose’ than that delivered in rehabilitation for other long-term health conditions where reduced hospitalisation is an established outcome (Puhan MA et al. Cochrane Database Syst Rev 2016 and Cox N et al. J Physiother 2017). This assumes a loss to follow-up of 10% for this outcome collected using administrative data. PERFORM-Aus trial will recruit 440 participants from Australia. Alongside 604 participants from the UK, this will provide the required sample size for a conclusive assessment of the impact of PERFORM on hospital admissions.

(2) Data analysis for the primary outcome
Hospitalisation: We will pool individual participant data from PERFORM-Aus Trial and PERFORM-UK to evaluate the primary outcome. We will use mixed-effect logistic regression modeling with the presence of hospitalisation as the dependent variable, treatment group as independent variable, minimisation variables (age, sex, number of LTC) and country (UK vs. Australia) as covariates, and individual centres as random effect to account for potential clustering.

(3) Data analysis for the secondary and safety outcomes
All other analyses of secondary and safety outcomes will use linear mixed-effect models for continuous outcomes and generalised linear mixed-effect models for dichotomous and count outcomes, adjusting for relevant baseline values where appropriate and minimisation variables (age, sex, number of LTC) and country (UK vs. Australia, PERFORM-Aus Trial), with individual centres as a random effect. All analyses will be conducted using an intention-to-treat (ITT) approach. Subject to the satisfiability of missingness-at-random assumptions, missing outcome data will be handled through multiple imputation with subsequent tipping point sensitivity analyses.


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2024
Actual
Date of last participant enrolment
Anticipated
1/10/2026
Actual
Date of last data collection
Anticipated
1/10/2027
Actual
Sample size
Target
440
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 26939 0
The Alfred - Melbourne
Recruitment hospital [2] 26940 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [3] 26942 0
Prince of Wales Hospital - Randwick
Recruitment hospital [4] 26943 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [5] 26944 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [6] 26945 0
Mt Wilga Private Hospital - Hornsby
Recruitment hospital [7] 26946 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [8] 26947 0
Kingston Centre - Cheltenham
Recruitment hospital [9] 26957 0
Frankston Hospital - Frankston
Recruitment postcode(s) [1] 43011 0
3004 - Melbourne
Recruitment postcode(s) [2] 43012 0
3084 - Heidelberg
Recruitment postcode(s) [3] 43014 0
2031 - Randwick
Recruitment postcode(s) [4] 43015 0
4029 - Herston
Recruitment postcode(s) [5] 43016 0
5000 - Adelaide
Recruitment postcode(s) [6] 43017 0
2077 - Hornsby
Recruitment postcode(s) [7] 43018 0
5011 - Woodville
Recruitment postcode(s) [8] 43019 0
3192 - Cheltenham
Recruitment postcode(s) [9] 43029 0
3199 - Frankston
Recruitment outside Australia
Country [1] 26511 0
United Kingdom
State/province [1] 26511 0

Funding & Sponsors
Funding source category [1] 317123 0
Government body
Name [1] 317123 0
Department of Health and Aged Care: Medical Research Future Fund (MRFF) - Clinical Trials Activity Initiative - International Clinical Trial Collaborations
Country [1] 317123 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 319454 0
None
Name [1] 319454 0
Address [1] 319454 0
Country [1] 319454 0
Other collaborator category [1] 283171 0
University
Name [1] 283171 0
University of Leicester
Address [1] 283171 0
Country [1] 283171 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315876 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 315876 0
Ethics committee country [1] 315876 0
Australia
Date submitted for ethics approval [1] 315876 0
27/03/2024
Approval date [1] 315876 0
22/05/2024
Ethics approval number [1] 315876 0
Project Number: 105208 (Local Reference: Project 142/24)

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

Contacts
Principal investigator
Name 136062 0
Prof Anne E Holland
Address 136062 0
Monash Universtiy Level 6, The Alfred Centre 99 Commercial Road Melbourne Vic 3004
Country 136062 0
Australia
Phone 136062 0
+613 99030214
Fax 136062 0
Email 136062 0
[email protected]
Contact person for public queries
Name 136063 0
Simone Dal Corso
Address 136063 0
Monash Universtiy Level 6, The Alfred Centre 99 Commercial Road Melbourne Vic 3004
Country 136063 0
Australia
Phone 136063 0
+613 99038934
Fax 136063 0
Email 136063 0
[email protected]
Contact person for scientific queries
Name 136064 0
Anne E Holland
Address 136064 0
Monash Universtiy Level 6, The Alfred Centre 99 Commercial Road Melbourne Vic 3004
Country 136064 0
Australia
Phone 136064 0
+613 99030214
Fax 136064 0
Email 136064 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?
Individual participant data will be shared only after obtaining approval from the appropriate Human Research Ethics Committee.
When will data be available (start and end dates)?
Data will not be accessible until the main trial results are published, with no fixed end date for availability.
Available to whom?
Data access will be available on a case-by-case basis, subject to the Coordinating Principal Investigator's discretion and approval by the relevant Human Research Ethics Committees.
Available for what types of analyses?
Data will be made available for analyses that have received approval from the relevant Human Research Ethics Committees.
How or where can data be obtained?
Access to data requires approval from the Coordinating Principal Investigator (email requests to [email protected]) and the Alfred Health Human Research Ethics Committee. Requesters must also apply to the Alfred Health HREC, detailing their intended use of the data. Data will be shared only after securing all necessary approvals.


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
No additional documents have been identified.