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| Name | Class |
|---|---|
| Chiesi Farmaceutici S.p.A. | INDUSTRY |
| University of Glasgow | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise Intervention Group then Adherence package group during follow-up phase | Experimental | Initially randomised to the exercise intervention group. Following completion of the exercise intervention, then randomised to receive the adherence support package. |
|
| Exercise Intervention Group then control group during follow-up phase | Experimental | Initially randomised to the exercise intervention group. Following completion of the exercise intervention, then randomised to the control group during the follow-up phase, so not given the adherence support package. |
|
| Control group, then the Adherence package group during the follow-up phase | No Intervention | Initially randomised to the control group. Then randomised to receive the adherence support package in the follow-up phase | |
| Control group, then also randomised to the control group in the follow-up phase | No Intervention | Initially randomised to the control group. Following completion of the exercise intervention, then randomised to be in the control group in follow-up phase, so not given the adherence support package. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home-based, remotely delivered, supervised Exercise programme | Other | A home-based remotely delivered supervised exercise programme |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Around 6 months post diagnosis. (After completion of the exercise programme for those in the intervention group, and on medical therapy alone for those in the control group). |
| Measure | Description | Time Frame |
|---|---|---|
| EmPHasis-10 questionnaire | EmPHasis-10 quality of life questionnaire. Minimum value 0, Maximum value 50. Higher scores mean a worse outcome. | Around 6 months post diagnosis. (After completion of the exercise programme for those in the intervention group, and on medical therapy alone for those in the control group). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | This will be collected after patients complete the exercise programme and again at the end of their follow-up phase. For patients randomised to Study Group 1, this is at week 37 and week 89 from enrolment. For Study group 2, this is week 25 and week 77. |
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jamie Ingram, MBChB | Contact | 0044 141-951-5440 | jamie.ingram2@nhs.scot | |
| Colin Church, BSc, MBChB, PhD, FRCP | Contact | 0044 141-951-5497 | colinchurch@doctors.org.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Golden Jubilee National Hospital | Recruiting | Glasgow | G814DY | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38264149 | Background | McCormack C, Kehoe B, Cullivan S, McCaffrey N, Gaine S, McCullagh B, McCarren A, Hardcastle SJ, Moyna NM. Safety, feasibility and effectiveness of the remotely delivered Pulmonary Hypertension and Home-Based (PHAHB) physical activity intervention. ERJ Open Res. 2024 Jan 8;10(1):00608-2023. doi: 10.1183/23120541.00608-2023. eCollection 2024 Jan. |
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More fitting to a Waitlist Randomised Control Trial as participants are assigned to an intervention or control group initially, but the control group will go on to receive the intervention at a later time, whereas the intervention group will be allowed to continue exercising. Therefore not strictly a crossover trial
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| NT-proBNP blood test |
NTproBNP blood test which is a marker of cardiac strain |
| Around 6 months post diagnosis. (After completion of the exercise programme for those in the intervention group, and on medical therapy alone for those in the control group). |
| Patient Health Questionnaire-9 | Questionnaire validated for evaluating depression- completed by patients. Minimum value 0, Maximum value 27. Higher values indicated a worse outcome. | Around 6 months post diagnosis. (After completion of the exercise programme for those in the intervention group, and on medical therapy alone for those in the control group). |
| 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. | Around 6 months post diagnosis. (After completion of the exercise programme for those in the intervention group, and on medical therapy alone for those in the control group). |
| 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. | This will be recorded during recorded sessions by the participant throughout study completion which is on average 83 weeks. |
| Exercise Frequency | Average number of recorded exercise sessions per week, measured as an absolute number. Higher number means more regular exercise. | This will be recorded during recorded sessions by the participant throughout study completion which is on average 83 weeks. |
| 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. | This will be recorded during recorded sessions by the participant throughout study completion which is on average 83 weeks. |
| Sleep score | Sleep score is measured by the smartwatch during sleep and expressed as an absolute value between 0-100. This is calculated based on sleep duration, stages (light, deep or rapid eye movement sleep), movement, and heart rate variability. Higher score means better rest. | This will be recorded throughout study completion which is on average 83 weeks. |
| Step Count | Number of steps walked by the participant each day, recorded by the smartwatch. Measured as an absolute value. Higher step count indicates higher activity levels. | This will be recorded throughout study completion which is on average 83 weeks. |
| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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