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

Sponsor
Golden Jubilee National Hospital
Study ID
NCT07366879
Status
Recruiting
Apply to this trial

Conditions

  • Pulmonary Arterial Hypertension

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Home-based, remotely delivered, supervised Exercise programme — OTHER
    A home-based remotely delivered supervised exercise programme

Study Details

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.

Key Dates

First listed
Jan 26, 2026
Start date
Apr 2, 2026
Status verified
May 2026
Primary completion
Aug 31, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

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). ]

Central Contacts

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