Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001191583
Ethics application status
Approved
Date submitted
4/09/2024
Date registered
30/09/2024
Date last updated
30/09/2024
Date data sharing statement initially provided
30/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of Personalised Exercise Rehabilitation FOR people with Multimorbidity and cardiac or pulmonary disease: the PERFORM-CPR trial.
Scientific title
Impact of Personalised Exercise Rehabilitation FOR people with Multimorbidity and cardiac or pulmonary disease on quality of life compared to standard cardiac and pulmonary rehabilitation: The PERFORM-CPR trial
Secondary ID [1] 312823 0
None
Universal Trial Number (UTN)
Trial acronym
PERFORM-CPR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post myocardial infarction 334924 0
Post cardiac revascularization 334925 0
Stable angina 334926 0
Heart failure 334927 0
Chronic Obstructive Pulmonary Disease (COPD) 334928 0
Bronchiectasis 334929 0
Asthma 334930 0
Cancer 334931 0
Interstitial lung disease 335232 0
Condition category
Condition code
Metabolic and Endocrine 331460 331460 0 0
Diabetes
Mental Health 331461 331461 0 0
Depression
Cancer 331462 331462 0 0
Any cancer
Cardiovascular 331463 331463 0 0
Hypertension
Inflammatory and Immune System 331464 331464 0 0
Connective tissue diseases
Musculoskeletal 331465 331465 0 0
Osteoarthritis
Neurological 331467 331467 0 0
Multiple sclerosis
Neurological 331468 331468 0 0
Parkinson's disease
Neurological 331469 331469 0 0
Other neurological disorders
Metabolic and Endocrine 331470 331470 0 0
Metabolic disorders

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 with at least five years of experience.
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 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] 329371 0
Rehabilitation
Intervention code [2] 329567 0
Behaviour
Comparator / control treatment
Pulmonary or cardiac rehabilitation as per guidelines (Alison JA et al. Respirology 2017 and Woodruffe S et al. Heart Lung Circ 2015). In Australia, programs are generally delivered in an outpatient setting, with twice weekly supervised sessions for 8-12 weeks, focusing on exercise training, and disease-specific education, and self-management training. Cardiac and pulmonary rehabilitation will be delivered as per usual practice at participating sites.
Control group
Active

Outcomes
Primary outcome [1] 339209 0
Health-related quality of life
Timepoint [1] 339209 0
Baseline and end intervention (3 months)
Secondary outcome [1] 439142 0
Exercise capacity
Timepoint [1] 439142 0
Baseline, end intervention (3 months) and 12 months
Secondary outcome [2] 439143 0
Mental health (depression)
Timepoint [2] 439143 0
Baseline, end intervention (3 months), and 12-month follow-up
Secondary outcome [3] 439145 0
Self-reported physical activity
Timepoint [3] 439145 0
Baseline, end intervention (3 months), and 12-month follow-up
Secondary outcome [4] 439146 0
Treatment Burden
Timepoint [4] 439146 0
Baseline, end intervention (3 months), and 12-month follow-up
Secondary outcome [5] 439148 0
Fatigue
Timepoint [5] 439148 0
Baseline, end intervention (3 months), and 12-month follow-up
Secondary outcome [6] 439149 0
Musculoskeletal pain
Timepoint [6] 439149 0
Baseline, end intervention (3 months), and 12-month follow-up
Secondary outcome [7] 439150 0
Breathlessness
Timepoint [7] 439150 0
Baseline, end intervention (3 months), and 12-month follow-up
Secondary outcome [8] 439151 0
Physical frailty
Timepoint [8] 439151 0
Baseline, end intervention (3 months), and 12-month follow-up
Secondary outcome [9] 439153 0
Exercise adherence
Timepoint [9] 439153 0
End intervention (3 months), and 12-month follow-up
Secondary outcome [10] 439154 0
Adverse events.
Possible adverse events are related to exercise training and include musculoskeletal injuries or other injuries attributable to study intervention, chest pain, syncope symptoms or fall fall during exercise session, hypertensive/hypotensive response, dizziness, lightheadedness, and cardiac arrhythmias.




Timepoint [10] 439154 0
From randomisation, end intervention (3 months) and 12-month follow-up
Secondary outcome [11] 439345 0
Functional capacity
Timepoint [11] 439345 0
Baseline, end intervention (3 months), and 12 months
Secondary outcome [12] 439346 0
Anxiety
Timepoint [12] 439346 0
Baseline, end intervention (3 months), and 12 months
Secondary outcome [13] 439347 0
Health-related quality of life
Timepoint [13] 439347 0
12 months after randomisation

Eligibility
Key inclusion criteria
Adults aged 18 years
Able and willing to provide informed consent
Independently ambulant (including the use of walking aids)
Scores in the modified Medical Research Council dyspnoea scale => 2 OR New York Heart Association classification => II
Cardiac or pulmonary chronic conditions such as post myocardial infarction, post cardiac revascularization, stable angina, heart failure, COPD, bronchiectasis, and asthma
In addition, one of the following long-term health conditions:
- arthritis
- atrial fibrillation
- 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
- hypertension,
- 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
- atrial fibrillation
- 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 604 participants (302 per arm) will provide 90% power to detect, at the 2-sided 5% Type I error control level, a minimum clinically important difference (MCID) between groups in the primary outcome (EQ-5D-5L) of 0.05 (McClure NS et al. Value Health 2017 and McClure NS et al. J Clin Epi 2022). This assumes a standard deviation (SD) of 0.24 in people with multiple LTC (Salisbury C et al. Lancet 2018), a within patient correlation coefficient of 0.7 for the follow-up and baseline measurements, and loss to follow-up of 20%, a conservative estimate based on our previous trials (Holland AE et al. Thorax 2017 and Cox NS et al. Thorax 2022).

(2) Primary outcome analysis: We will apply linear mixed-effect modelling adjusting for baseline value of EQ-5D-5L and minimisation variables (age, sex, number of LTC), and centre as a random effect.

(3) Secondary and Safety Outcome
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), 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
604
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 27036 0
The Alfred - Melbourne
Recruitment hospital [2] 27037 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [3] 27038 0
Frankston Hospital - Frankston
Recruitment hospital [4] 27039 0
Kingston Centre - Cheltenham
Recruitment hospital [5] 27040 0
Prince of Wales Private Hospital - Randwick
Recruitment hospital [6] 27041 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [7] 27042 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [8] 27079 0
The Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 43109 0
2031 - Randwick
Recruitment postcode(s) [2] 43105 0
3004 - Melbourne
Recruitment postcode(s) [3] 43106 0
3084 - Heidelberg
Recruitment postcode(s) [4] 43108 0
3192 - Cheltenham
Recruitment postcode(s) [5] 43107 0
3199 - Frankston
Recruitment postcode(s) [6] 43110 0
4029 - Herston
Recruitment postcode(s) [7] 43111 0
5000 - Adelaide
Recruitment postcode(s) [8] 43146 0
5011 - Woodville

Funding & Sponsors
Funding source category [1] 317261 0
Government body
Name [1] 317261 0
Department of Health and Aged Care: Medical Research Future Fund - Clinical Trials Activity Initiative - International Clinical Trial Collaborations
Country [1] 317261 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 319560 0
None
Name [1] 319560 0
Address [1] 319560 0
Country [1] 319560 0
Other collaborator category [1] 283173 0
University
Name [1] 283173 0
University of Leicester
Address [1] 283173 0
Country [1] 283173 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315999 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 315999 0
Ethics committee country [1] 315999 0
Australia
Date submitted for ethics approval [1] 315999 0
27/03/2024
Approval date [1] 315999 0
22/05/2024
Ethics approval number [1] 315999 0
Project Number: 105208 (Local Reference: Project 142/24)

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

Contacts
Principal investigator
Name 136458 0
Prof Anne E Holland
Address 136458 0
Monash University Level 6, The Alfred Centre 99 Commercial Road Melbourne Vic 3004
Country 136458 0
Australia
Phone 136458 0
+613 99030214
Fax 136458 0
Email 136458 0
a.holland@alfred.org.au
Contact person for public queries
Name 136459 0
Simone Dal Corso
Address 136459 0
Monash University Level 6, The Alfred Centre 99 Commercial Road Melbourne Vic 3004
Country 136459 0
Australia
Phone 136459 0
+613 99038934
Fax 136459 0
Email 136459 0
simone.dalcorso@monash.edu
Contact person for scientific queries
Name 136460 0
Anne E Holland
Address 136460 0
Monash University Level 6, The Alfred Centre 99 Commercial Road Melbourne Vic 3004
Country 136460 0
Australia
Phone 136460 0
+613 99030214
Fax 136460 0
Email 136460 0
a.holland@alfred.org.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?
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 the data requires approval from the Coordinating Principal Investigator. Please send email requests to a.holland@alfred.org.au. Requesters must also apply to the Alfred Health Human Research Ethics Committee, providing details of how they intend to use the data. Data will only be shared 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.