Home-based exercise plus medication for people newly diagnosed with pulmonary arterial hypertension
Randomised Controlled Trial of Exercise Intervention as an Adjunct to Medical Therapy in Newly Diagnosed Patients With Pulmonary Arterial Hypertension
This trial will try a 12-week home-based, remotely supervised exercise program added to usual medication for adults newly diagnosed with pulmonary arterial hypertension to see if it improves fitness, quality of life, and mental wellbeing.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Golden Jubilee National Hospital Government |
| Locations | 1 site (Glasgow) |
| Trial ID | NCT07366879 on ClinicalTrials.gov |
What this trial studies
This randomized, waitlist-controlled trial enrolls adults newly diagnosed with pulmonary arterial hypertension from the Scottish Pulmonary Vascular Unit. After starting standard pulmonary vasodilator therapy and a three-month clinic review, participants are randomized to a 12-week home-based, remotely supervised exercise program or to a control (delayed access) group. After completing the exercise program, participants are further randomized to receive an additional support package or not to test long-term adherence. Primary outcomes include change in six-minute walk distance, quality of life and mental health scores, and adherence to exercise.
Who should consider this trial
Good fit: Adults (18+) newly diagnosed with group I pulmonary arterial hypertension or non-operable group IV confirmed by right heart catheterisation, able to consent and judged safe to perform home exercise are ideal candidates.
Not a fit: Patients with pulmonary hypertension due to left heart disease, hypoxic lung disease, operable chronic thromboembolic disease, multifactorial causes, those with exercise-related syncope, or those unable to safely exercise or already starting investigational medications are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the program could increase walking distance, improve quality of life and mental health, and help people keep exercising long-term.
How similar studies have performed: Previous supervised exercise programs in PAH have shown improved six-minute walk distance and quality of life, but early, remotely supervised home programs and adherence-support packages are less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Glasgow
- Golden Jubilee National Hospital — Glasgow, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Jamie Ingram, MBChB
- Email: jamie.ingram2@nhs.scot
- Phone: 0044 141-951-5440
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.