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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.
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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
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Secondary ID [1]
312823
0
None
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Universal Trial Number (UTN)
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Trial acronym
PERFORM-CPR
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Post myocardial infarction
334924
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Post cardiac revascularization
334925
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Stable angina
334926
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Heart failure
334927
0
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Chronic Obstructive Pulmonary Disease (COPD)
334928
0
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Bronchiectasis
334929
0
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Asthma
334930
0
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Cancer
334931
0
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Interstitial lung disease
335232
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Condition category
Condition code
Metabolic and Endocrine
331460
331460
0
0
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Diabetes
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Mental Health
331461
331461
0
0
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Depression
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Cancer
331462
331462
0
0
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Any cancer
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Cardiovascular
331463
331463
0
0
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Hypertension
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Inflammatory and Immune System
331464
331464
0
0
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Connective tissue diseases
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Musculoskeletal
331465
331465
0
0
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Osteoarthritis
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Neurological
331467
331467
0
0
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Multiple sclerosis
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Neurological
331468
331468
0
0
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Parkinson's disease
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Neurological
331469
331469
0
0
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Other neurological disorders
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Metabolic and Endocrine
331470
331470
0
0
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Metabolic disorders
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
329371
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Rehabilitation
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Intervention code [2]
329567
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Behaviour
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
339209
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Health-related quality of life
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Assessment method [1]
339209
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EQ-5D-5L.
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Timepoint [1]
339209
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Baseline and end intervention (3 months)
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Secondary outcome [1]
439142
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Exercise capacity
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Assessment method [1]
439142
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Six-minute walk distance (6MWD)
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Timepoint [1]
439142
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Baseline, end intervention (3 months) and 12 months
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Secondary outcome [2]
439143
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Mental health (depression)
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Assessment method [2]
439143
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Patient Health Questionnaire-9 (PHQ-9)
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Timepoint [2]
439143
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Baseline, end intervention (3 months), and 12-month follow-up
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Secondary outcome [3]
439145
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Self-reported physical activity
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Assessment method [3]
439145
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International Physical Activity Questionnaire (IPAQ – short form)
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Timepoint [3]
439145
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Baseline, end intervention (3 months), and 12-month follow-up
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Secondary outcome [4]
439146
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Treatment Burden
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Assessment method [4]
439146
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Multimorbidity Treatment Burden Questionnaire
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Timepoint [4]
439146
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Baseline, end intervention (3 months), and 12-month follow-up
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Secondary outcome [5]
439148
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Fatigue
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Assessment method [5]
439148
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Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F)
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Timepoint [5]
439148
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Baseline, end intervention (3 months), and 12-month follow-up
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Secondary outcome [6]
439149
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Musculoskeletal pain
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Assessment method [6]
439149
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Brief Pain Inventory (BPI)
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Timepoint [6]
439149
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Baseline, end intervention (3 months), and 12-month follow-up
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Secondary outcome [7]
439150
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Breathlessness
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Assessment method [7]
439150
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Dyspnoea-12 questionnaire
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Timepoint [7]
439150
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Baseline, end intervention (3 months), and 12-month follow-up
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Secondary outcome [8]
439151
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Physical frailty
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Assessment method [8]
439151
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Self-reported exhaustion will be assessed using two questions from the Center for Epidemiologic Studies Depression (CES-D) scale. Participants will indicate whether they feel that everything they do is an effort and how often they felt this way in the past week (question 1). They will also respond regarding their feeling of not getting going and the frequency of this feeling over the last week (question 2).
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Timepoint [8]
439151
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Baseline, end intervention (3 months), and 12-month follow-up
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Secondary outcome [9]
439153
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Exercise adherence
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Assessment method [9]
439153
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Exercise Adherence Rating Scale (EARS)
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Timepoint [9]
439153
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End intervention (3 months), and 12-month follow-up
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Secondary outcome [10]
439154
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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.
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Assessment method [10]
439154
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AE log.
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Timepoint [10]
439154
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From randomisation, end intervention (3 months) and 12-month follow-up
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Secondary outcome [11]
439345
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Functional capacity
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Assessment method [11]
439345
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Short Physical Performance Battery (SPPB)
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Timepoint [11]
439345
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Baseline, end intervention (3 months), and 12 months
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Secondary outcome [12]
439346
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Anxiety
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Assessment method [12]
439346
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Generalised Anxiety Disorder Assessment-7 (GAD-7) tool
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Timepoint [12]
439346
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Baseline, end intervention (3 months), and 12 months
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Secondary outcome [13]
439347
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Health-related quality of life
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Assessment method [13]
439347
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EQ-5D-5L
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Timepoint [13]
439347
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12 months after randomisation
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation (Griffith Randomisation Service, Griffith University)
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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)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/10/2024
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Actual
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Date of last participant enrolment
Anticipated
1/10/2026
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Actual
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Date of last data collection
Anticipated
1/10/2027
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Actual
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Sample size
Target
604
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Recruitment hospital [1]
27036
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The Alfred - Melbourne
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Recruitment hospital [2]
27037
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Austin Health - Austin Hospital - Heidelberg
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Recruitment hospital [3]
27038
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Frankston Hospital - Frankston
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Recruitment hospital [4]
27039
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Kingston Centre - Cheltenham
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Recruitment hospital [5]
27040
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Prince of Wales Private Hospital - Randwick
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Recruitment hospital [6]
27041
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Royal Brisbane & Womens Hospital - Herston
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Recruitment hospital [7]
27042
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The Royal Adelaide Hospital - Adelaide
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Recruitment hospital [8]
27079
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The Queen Elizabeth Hospital - Woodville
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Recruitment postcode(s) [1]
43105
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3004 - Melbourne
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Recruitment postcode(s) [2]
43106
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3084 - Heidelberg
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Recruitment postcode(s) [3]
43107
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3199 - Frankston
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Recruitment postcode(s) [4]
43108
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3192 - Cheltenham
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Recruitment postcode(s) [5]
43109
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2031 - Randwick
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Recruitment postcode(s) [6]
43110
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4029 - Herston
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Recruitment postcode(s) [7]
43111
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5000 - Adelaide
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Recruitment postcode(s) [8]
43146
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5011 - Woodville
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Funding & Sponsors
Funding source category [1]
317261
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Government body
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Name [1]
317261
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Department of Health and Aged Care: Medical Research Future Fund - Clinical Trials Activity Initiative - International Clinical Trial Collaborations
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Address [1]
317261
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Country [1]
317261
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Australia
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Primary sponsor type
University
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Name
Monash University
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Address
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Country
Australia
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Secondary sponsor category [1]
319560
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None
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Name [1]
319560
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Address [1]
319560
0
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Country [1]
319560
0
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Other collaborator category [1]
283173
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University
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Name [1]
283173
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University of Leicester
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Address [1]
283173
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Country [1]
283173
0
United Kingdom
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315999
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Alfred Hospital Ethics Committee
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Ethics committee address [1]
315999
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https://www.alfredhealth.org.au/research/ethics-research-governance
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Ethics committee country [1]
315999
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Australia
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Date submitted for ethics approval [1]
315999
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27/03/2024
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Approval date [1]
315999
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22/05/2024
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Ethics approval number [1]
315999
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Project Number: 105208 (Local Reference: Project 142/24)
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Summary
Brief summary
This study aims to compare the impact of Personalised Exercise Rehabilitation for people with Multimorbidity (PERFORM) with traditional cardiac/pulmonary rehabilitation (CPR) on the quality of life of individuals who have both cardiac or pulmonary disease and other additional health conditions. Who is it for? You may be eligible for this study if you are a male or female age 18 or older independently ambulant, with multimorbidity and cardiac or pulmonary disease. Study details Participants will be randomised to receive either PREFORM intervention or pulmonary/cardiac rehabilitation as per guidelines (Alison JA et al. Respirology 2017 and Woodruffe S et al. Heart Lung Circ 2015). The PREFORM intervention involves 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). After completion of the intervention, participants will be tested for quality of life, exercise capacity, mental health, physical activity, treatment burden, fatigue, pain, breathlessness, adverse events and adherence. It is hoped that findings from this study will help managing these patients effectively with a multidisciplinary approach to address complex disease interactions.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Anne E Holland
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Address
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Monash University Level 6, The Alfred Centre 99 Commercial Road Melbourne Vic 3004
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Country
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Australia
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Phone
136458
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+613 99030214
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Fax
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Email
136458
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[email protected]
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Contact person for public queries
Name
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Simone Dal Corso
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Address
136459
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Monash University Level 6, The Alfred Centre 99 Commercial Road Melbourne Vic 3004
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Country
136459
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Australia
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Phone
136459
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+613 99038934
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Fax
136459
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Email
136459
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[email protected]
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Contact person for scientific queries
Name
136460
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Anne E Holland
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Address
136460
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Monash University Level 6, The Alfred Centre 99 Commercial Road Melbourne Vic 3004
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Country
136460
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Australia
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Phone
136460
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+613 99030214
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Fax
136460
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Email
136460
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Individual participant data will be shared only after obtaining approval from the appropriate Human Research Ethics Committee.
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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.
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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.
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Available for what types of analyses?
Data will be made available for analyses that have received approval from the relevant Human Research Ethics Committees.
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How or where can data be obtained?
Access to the data requires approval from the Coordinating Principal Investigator. Please send email requests to
[email protected]
. 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.
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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.
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