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:
* Doe exercise improve how far patients can walk over six minutes * Does exercise improve quality of life scores * Does exercise improve mental health scores * Does extra support after an exercise programme help patients to continue exercising in the long term
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:
* Undergo an exercise programme for 12 weeks, starting around 3 months after their diagnosis * They will undertake the exercise programme at home, remotely supervised by the research team with regular contact * Visit the clinic at the end of the programme for checkups and tests * Keep a diary of their exercise and how they are feeling
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:
* Half of participants will receive extra support to help them continue to exercise * The other half will not receive any additional support * All patients will be reviewed 1 year following the completion of their exercise programme to monitor their ongoing exercise levels.
Aged 18-years-old and above
a baseline mean pulmonary artery pressure >20mmHg
pulmonary vascular resistance >2 Wood Units
pulmonary capillary wedge pressure <15mmHg
Diagnosis with pulmonary hypertension of any other cause
Group II (PH due to left heart disease)
Group III (PH due to hypoxic lung disease)
Operable group IV (PH due to chronic thromboembolic disease amenable to surgical treatment)
Crossover
Home-based, remotely delivered, supervised Exercise programme
Other interventionA home-based remotely delivered supervised exercise programme
Six-minute walk distance
Distance walked as measured during a six-minute walk test. Measured at around 6 months post-diagnosis to compare those from the exercise intervention group who have just completed their exercise programme, with the control group who have not yet had their exercise programme.
EmPHasis-10 questionnaire
EmPHasis-10 quality of life questionnaire. Minimum value 0, Maximum value 50. Higher scores mean a worse outcome.
NT-proBNP blood test
NTproBNP blood test which is a marker of cardiac strain
Patient Health Questionnaire-9
Questionnaire validated for evaluating depression- completed by patients. Minimum value 0, Maximum value 27. Higher values indicated a worse outcome.
Generalised Anxiety Disorder 7-item Scale
Questionnaire validated for evaluating anxiety in patients- completed by patients. Minumum value 0, Maximum value 21. Higher scores indicate a worse outcome.
Exercise adherence rating scale
Questionnaire validated for evaluating adherence to exercise in patients. Completed by patients. Minimum score 0, Maximum score 24. A higher score indicates better adherence.
Heart rate variability
Variation in time between consecutive heart beats, collected by a smartwatch. Measured in milliseconds. Higher heart rate variability means better fitness and recovery.
Exercise Frequency
Average number of recorded exercise sessions per week, measured as an absolute number. Higher number means more regular exercise.
Exercise Intensity
Exercise intensity is recorded by the participant using a smartwatch during recorded exercise sessions. Exercise intensity is measured by the heart rate during exercise expressed as a percentage of the estimated maximum heart rate. The measure will be recorded as time spent in particular heart rate zones, expressed in hours and minutes. Zone 1: 50-60% of maximum heart rate. Zone 2: 60-70% of maximum heart rate. Zone 3: 70-80% of maximum heart rate. Zone 4: 80-90% of maximum heart rate. Zone 5: 90-100% of maximum heart rate. Longer time spent in higher heart rate zones means higher intensity exercise.
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Golden Jubilee National Hospital
Lead sponsor
Chiesi Farmaceutici S.p.A.
Collaborator
University of Glasgow
Collaborator
