Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07366879

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

Led by Golden Jubilee National Hospital · Updated on 2026-05-13

40

Participants Needed

1

Research Sites

91 weeks

Total Duration

On this page

Sponsors

G

Golden Jubilee National Hospital

Lead Sponsor

C

Chiesi Farmaceutici S.p.A.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18-years-old and above
  • Diagnosed with pulmonary hypertension (group I and non-operable group IV) confirmed 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
Not Eligible

You will not qualify if you...

  • Diagnosis with pulmonary hypertension of any other cause including group II (due to left heart disease), group III (due to hypoxic lung disease), operable group IV (amenable to surgery), or group V (unclear or multifactorial causes)
  • Planned treatment with a research trial medication during the study
  • Concerns about safety performing a home-based exercise programme by patient or clinician
  • Syncopal episodes related to pulmonary hypertension at exercise start
  • Severe concurrent medical condition preventing study participation
  • Life expectancy less than 3 months

AI-Screening

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Trial Site Locations

Total: 1 location

1

Golden Jubilee National Hospital

Glasgow, United Kingdom, G814DY

Actively Recruiting

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Research Team

J

Jamie Ingram, MBChB

CONTACT

C

Colin Church, BSc, MBChB, PhD, FRCP

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

4

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