Exercise Intervention as an Adjunct to Medical Therapy in Newly Diagnosed Patients With Pulmonary Arterial Hypertension

May 12, 2026 updated by: Golden Jubilee National Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • Glasgow, United Kingdom, G814DY
        • Recruiting
        • Golden Jubilee National Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Jamie Ingram, MBChB
        • Principal Investigator:
          • Colin Church, BSc, MBChB, FRCP, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise Intervention Group then Adherence package group during follow-up phase
Initially randomised to the exercise intervention group. Following completion of the exercise intervention, then randomised to receive the adherence support package.
Other: Home-based, remotely delivered, supervised Exercise programme
A home-based remotely delivered supervised exercise programme
Experimental: Exercise Intervention Group then control group during follow-up phase
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.
Other: Home-based, remotely delivered, supervised Exercise programme
A home-based remotely delivered supervised exercise programme
No Intervention: Control group, then the Adherence package group during the follow-up phase
Initially randomised to the control group. Then randomised to receive the adherence support package in the follow-up phase
No Intervention: Control group, then also randomised to the control group in the follow-up phase
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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).
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).
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
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).
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
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).
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).

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exercise adherence rating scale
Time Frame: 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.
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.
Heart rate variability
Time Frame: This will be recorded during recorded sessions by the participant throughout study completion which is on average 83 weeks.
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
Time Frame: This will be recorded during recorded sessions by the participant throughout study completion which is on average 83 weeks.
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
Time Frame: This will be recorded during recorded sessions by the participant throughout study completion which is on average 83 weeks.
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
Time Frame: This will be recorded throughout study completion which is on average 83 weeks.
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
Time Frame: This will be recorded throughout study completion which is on average 83 weeks.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Golden Jubilee National Hospital

Collaborators

Chiesi Farmaceutici S.p.A.
University of Glasgow

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

January 7, 2026

First Submitted That Met QC Criteria

January 16, 2026

First Posted (Actual)

January 26, 2026

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25/CARD/29

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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