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The goal of this clinical trial is to learn if an exercise programme started shortly after diagnosis improves the fitness and mental wellbeing of patients with pulmonary hypertenion over and above medication alone. It will also learn about whether extra support can help patients keep up with exercise in the long term. The main questions it aims to answer are:
Researchers will compare the exercise programme to a control group (a group of similar patients who do not receive the exercise programme) to see the effect that exercise has.
Participants in the exercise programme group will:
Participants in the control group will:
-Still undergo the exercise programme, but this will happen at a delayed time, starting around 6 months after diagnosis, to allow for a comparison between the two groups.
Following completion of the exerise programme:
Full description
This study is designed to deliver a remotely supervised, home-based exercise programme to patients newly diagnosed with pulmonary arterial hypertension with a view to early optimisation of their condition. The design is a waitlist randomised controlled trial whereby participants will be randomised to an exercise intervention or control group, with the control group then going on to have access to the exercise programme after a 12-week delay. There will be further randomisation after completion of the exercise programme to determine if participants have access to support package aimed at improving adherence to exercise.
The study objectives are to evaluate:
Methodology Patients will be recruited from the Scottish Pulmonary Vascular Unit and consented for the study at the time of diagnosis with pulmonary arterial hypertension.
Participants will be commenced on pulmonary vasodilator therapy as per standard of care decided by the clinical team, then will be reviewed 3 months later at outpatient clinic.
Half of participants will then be randomly assigned to an intervention group and the remaining half to a control group. The intervention group will start a 12-week home-based remotely supervised exercise programme while the control group continue on medical therapy alone to allow for comparison. After this 12 weeks, participants in both groups will be seen back in clinic for further review and data collection. The control group will then commence the exercise programme.
After each participant completes the exercise programme they will then be randomly assigned to either receive a support package from the research team, designed to improve adherence to exercise, or to act as a control group and continue with self-directed exercise. All participants will be reviewed one year after completing the exercise programme to review their adherence to exercise.
Data collection:
Data will be collected at standard of care outpatient clinic appointments (six-minute walk test results, EmPHasis-10 questionnaires, NT-proBNP test. Study questionnaires will also be checked at these visits (PHQ-9 and GAD-7 questionnaires at all visits, exercise adherence rating scale questionnaire at the final visits).
Smartwatches will also be worn by study participants and data will be collected on step count, exercise frequency and intensity, heart rate variability, sleep.
Qualitative data will be gathered from the participants by interview at the end of the exercise programme and following their follow-up phase to evaluate factors that helped or hindered exercise.
Exercise programme:
The exercise programme is carried out fully remotely and has been adopted from the PHAHB study by McCormack et al 2019 and includes induction training sessions (discussing the introduction to exercise equipment, the provided materials, exercise safety and demonstrations) and health coaching sessions (discussing various topics including benefits of exercise, goal setting, action planning, self-monitoring, identification and management of barriers to exercise, problem solving and feedback on behaviour).
There are three types of training activities in the programme which are aerobic training (either walking, cycling or a combination), resistance training (using body weight exercises, but may progress to using resistance bands or light weights) and respiratory training. These activities are built up gradually throughout the programme on an individualised basis over a 12-week period.
Exercise support package:
The exercise adherence package will consist of access to online exercise resources, monthly phone calls from the research team and a forum to allow participant discussion and encouragement.
Sample size: Recruitment target is 40 patients with a 1:1 randomisation to the intervention and control groups.
Enrollment
Sex
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Volunteers
Inclusion criteria
Aged 18-years-old and above
Diagnosed with pulmonary hypertension (group I and non-operable group IV) by right heart catheterisation showing:
Able to provide written informed consent
Exclusion criteria
Diagnosis with pulmonary hypertension of any other cause
Planned treatment with a research trial medication during the study timeframe
Consenting clinician and/or patient concern regarding the patient's safety in performing a home-based exercise programme
Patients with syncopal episodes felt to be related to pulmonary hypertension at time of exercise intervention initiation.
Severe concurrent medical condition that would prevent participation in study procedures
Life expectancy <3 months
Primary purpose
Allocation
Interventional model
Masking
40 participants in 4 patient groups
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Central trial contact
Colin Church, BSc, MBChB, PhD, FRCP; Jamie Ingram, MBChB
Data sourced from clinicaltrials.gov
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