NCT07366879

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
20mo left

Started Jan 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress15%
Jan 2026Jan 2028

First Submitted

Initial submission to the registry

January 7, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

January 19, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 26, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

January 26, 2026

Status Verified

December 1, 2025

Enrollment Period

1.5 years

First QC Date

January 7, 2026

Last Update Submit

January 16, 2026

Conditions

Pulmonary Arterial Hypertension

Keywords

pulmonary arterial hypertensionPAHpulmonary hypertensionexercise trainingexercise adherence

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    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

    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

    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

    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 Outcomes (6)

  • Exercise adherence rating scale

    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

    This will be recorded during recorded sessions by the participant throughout study completion which is on average 83 weeks.

  • Exercise Frequency

    This will be recorded during recorded sessions by the participant throughout study completion which is on average 83 weeks.

  • +3 more other outcomes

Study Arms (4)

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.

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.

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.

Interventions

Home-based, remotely delivered, supervised Exercise programmeOTHER

A home-based remotely delivered supervised exercise programme

Exercise Intervention Group then Adherence package group during follow-up phaseExercise Intervention Group then control group during follow-up phase

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Golden Jubilee National Hospital

Glasgow, G814DY, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 38264149BACKGROUND

MeSH Terms

Conditions

Pulmonary Arterial HypertensionHypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Central Study Contacts

Jamie Ingram, MBChB

CONTACT

0044 141-951-5440jamie.ingram2@nhs.scot

Colin Church, BSc, MBChB, PhD, FRCP

CONTACT

0044 141-951-5497colinchurch@doctors.org.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 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
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2026

First Posted

January 26, 2026

Study Start

January 19, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

January 1, 2028

Last Updated

January 26, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)