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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
United Kingdom
Golden Jubilee National Hospital
RECRUITING
Glasgow
Contact Information
Primary
Jamie Ingram, MBChB
jamie.ingram2@nhs.scot
0044 141-951-5440
Backup
Colin Church, BSc, MBChB, PhD, FRCP
colinchurch@doctors.org.uk
0044 141-951-5497
Time Frame
Start Date: 2026-04-02
Estimated Completion Date: 2028-01
Participants
Target number of participants: 40
Treatments
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.
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.
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.
Related Therapeutic Areas
Sponsors
Collaborators: Chiesi Farmaceutici S.p.A., University of Glasgow
Leads: Golden Jubilee National Hospital

This content was sourced from clinicaltrials.gov

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