Effects of Personalised Exercise Rehabilitation FOR people with Multimorbidity and cardiac or pulmonary disease: the PERFORM-CPR trial.
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
Monash University
604 participants
Mar 4, 2025
Interventional
Conditions
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.
Eligibility
Plain Language Summary
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Interventions
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.
Locations(8)
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ACTRN12624001191583