Pulmonary Arterial HypertensionNCT07366879
Exercise Intervention as an Adjunct to Medical Therapy in Newly Diagnosed Patients With Pulmonary Arterial Hypertension
A study testing Home-based, remotely delivered, supervised Exercise programme in people with Pulmonary Arterial Hypertension, run by Golden Jubilee National Hospital at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Home-based, remotely delivered, supervised Exercise programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Apr 2026to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-years-old and above
- Diagnosed with pulmonary hypertension (group I and non-operable group IV) by right heart catheterisation showing:
- a baseline mean pulmonary artery pressure >20mmHg
- pulmonary vascular resistance >2 Wood Units
- pulmonary capillary wedge pressure <15mmHg
- Able to provide written informed consent
Who cannot join
- 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)
- Group V (unclear and/or multifactorial elements).
- Planned treatment with a research trial medication during the study timeframe
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Golden Jubilee National Hospital
Glasgow, G814DY
Jamie Ingram, MBChB, 00441419515497, jamie.ingram2@nhs.scot
jamie.ingram2@nhs.scot
About this study
Official title: Randomised Controlled Trial of Exercise Intervention as an Adjunct to Medical Therapy in Newly Diagnosed Patients With Pulmonary Arterial Hypertension
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
Read more
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.
Read the detailed 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:
- The incremental effect of an exercise programme on exercise capacity, quality of life and mental health
- The impact of an additional support package following completion of the exercise programme on adherence to exercise in the long term.
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.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Home-based, remotely delivered, supervised Exercise programme
- Keywords
- pulmonary arterial hypertension, PAH, pulmonary hypertension, exercise training, exercise adherence
- Medical subject headings
- Pulmonary Arterial Hypertension, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based, remotely delivered, supervised Exercise programmeOther
A home-based remotely delivered supervised exercise programme
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Home-based, remotely delivered, supervised Exercise programme |
| 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. Receives: Other: Home-based, remotely delivered, supervised Exercise programme |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Secondary outcomes (4)
EmPHasis-10 questionnaire
EmPHasis-10 quality of life questionnaire. Minimum value 0, Maximum value 50. Higher scores mean a worse outcome.
Measured: 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).
NT-proBNP blood test
NTproBNP blood test which is a marker of cardiac strain
Measured: 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.
Measured: 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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start2 Apr 2026
- Primary completionAug 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Golden Jubilee National Hospital
- Sponsor type
- Other government
- Collaborators
- Chiesi Farmaceutici S.p.A., University of Glasgow
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07366879
- Sponsor's protocol ID
- 25/CARD/29
- Status last verified
- May 2026
- First submitted
- 7 Jan 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38264149
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial of Exercise Intervention as an Adjunct to Medical Therapy in Newly Diagnosed Patients With Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT07366879
- Acronym / sponsor ID
- 25/CARD/29
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- pulmonary arterial hypertension, PAH, pulmonary hypertension, exercise training, exercise adherence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Golden Jubilee National HospitalOther government
- Collaborators
- Chiesi Farmaceutici S.p.A., University of Glasgow
- Study start
- 2 Apr 2026 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- The incremental effect of an exercise programme on exercise capacity, quality of life and mental health
- The impact of an additional support package following completion of the exercise programme on adherence to exercise in the long term.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Exercise Intervention Group then Adherence package group during follow-up phase | Experimental | Other: Home-based, remotely delivered, supervised Exercise programmeInitially 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 | Other: Home-based, remotely delivered, supervised Exercise programmeInitially 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based, remotely delivered, supervised Exercise programmeA home-based remotely delivered supervised exercise programme | Other | Exercise Intervention Group then Adherence package group during follow-up phase, Exercise Intervention Group then control group during follow-up phase |
Primary outcome
Six-minute walk distance
Time frame: 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).
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.
4 secondary outcomes
EmPHasis-10 questionnaire
Time frame: 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).
NT-proBNP blood test
Time frame: 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
Time frame: 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
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Background: PubMed 38264149McCormack 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based, remotely delivered, supervised Exercise programme in people with Pulmonary Arterial Hypertension, run by Golden Jubilee National Hospital at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jamie Ingram, MBChB (0044 141-951-5440, jamie.ingram2@nhs.scot), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six-minute walk distance (time frame: 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07366879, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.