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The effect of an outpatient exercise training rehabilitation programme on haemodynamics and cardiac magnetic resonance parameters of right ventricular function in patients with pulmonary arterial hypertension: the ExPAH trial.

The effect of an outpatient exercise training rehabilitation programme on haemodynamics and cardiac magnetic resonance parameters of right ventricular function in patients with pulmonary arterial hypertension: the ExPAH trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615001041549
Acronym
ExPAH
Enrollment
16
Registered
2015-10-07
Start date
2017-02-06
Completion date
2022-12-05
Last updated
2021-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study looks at the effect of an outpatient exercise program on how the heart functions, using the latest technology (cardiac magnetic resonance imaging) and more established indicators of prognosis measured by right heart catheterisation. It also examines the effect of exercise on patient endurance and quality of life. The results of this study will have important widespread implications for the outpatient treatment of PAH, providing guidance regarding the optimal format of exercise in patients with PAH.

Interventions

Outpatient rehabilitation exercise training program. a) This involves participants attending a physiotherapy department for an exercise training programme. b) Sessions are twice weekly for 12 weeks (i.e. total of 24 sessions). c) Each session runs for one hour. d) Sessions are run by physiotherapist. e) Exercises involve: aerobic training (treadmill or cycle), respiratory muscle training and light weight training f) intensity of Borg RPE of 12-13. g) Format is small group (maximum of 5 particip

Outpatient rehabilitation exercise training program. a) This involves participants attending a physiotherapy department for an exercise training programme. b) Sessions are twice weekly for 12 weeks (i.e. total of 24 sessions). c) Each session runs for one hour. d) Sessions are run by physiotherapist. e) Exercises involve: aerobic training (treadmill or cycle), respiratory muscle training and light weight training f) intensity of Borg RPE of 12-13. g) Format is small group (maximum of 5 participants to one phyisotherapist). h) Monitoring of adherence will be via record of attendance and exercises performed. Participants randomised to the training group will also have 3 structured telephone education sessions with the study psychologist (of 20 minutes duration each). These sessions will include education on managing hyperventilation, anxiety during dyspnea, and skills training (progressive muscle relaxation). These will be done at approximately week3, 6 and 9. In addition, Sydney based participants will have the option of undergoing an exercise right heart catheterisation (RHC). These participants will have exactly the same outcome measures and undergo the same randomisation process. They will have haemodynamics, measured by RHC at rest and during exercise. The only difference is that after the initial standard haemodynamic measurements, the participant is asked to pedal at a certain work rate (for example, 60 rpm). The workload is then increased by 10W every 3 minutes, as tolerated by the participant, to a maximum of 40W, as described by Provencher, S., et al., Changes in exercise haemodynamics during treatment in pulmonary arterial hypertension. Eur Respir J, 2008. 32(2): p. 393-8. Participants for this sub-study will be voluntary (all participants to the study based in Sydney will be asked if they wish to participate in the sub-study).

Sponsors

St Vincent's Hospital Sydney.
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Pulmonary arterial hypertension, functional class I-III.

Exclusion criteria

Change in PAH specific medication in preceding 3 months. Enrolment in formal exercise program in preceding 3 months. Pregnancy. Unable to follow instructions. Patients with significant unstable cardiac disease (e.g. unstable angina). Patients who are unable to have MRI (impaired renal function, permanent pacemaker etc).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 27, 2026