Effect of Exercise Training in Patients With Pulmonary Hypertension

University of Zurich (UZH)

Status: Enrolling

Conditions: Hypertension, Pulmonary

Treatments: Behavioral: respiratory and exercise therapy; Behavioral: respiratory and exercise therapy with supplemental oxygen

Study type: Interventional

Funder types: Other

Identifiers

NCT02558582

KEK-ZH-Nr. 2015-0231

Details and patient eligibility

About

Pulmonary Hypertension (PH) is a serious disease with a dismal prognosis when left untreated. Advances in medical therapy have improved survival according to recent registries and systematic reviews, but are associated with high healthcare costs.

Earlier studies in Heidelberg, Germany showed good evidence for the effect of exercise training on improving exercise performance, quality of life and pulmonary hemodynamics in patients with pulmonary hypertension.

The main objectives of the present project are:

1. to investigate the quality of the implementation of a standardized 3 week in-hospital exercise training program on markers of outcome and disease severity in PH-patients in Switzerland immediately after training and after 3 and 12 month.
2. to look whether training with hyperoxia vs. standard care might be more effective.

This is a multicentre, randomized parallel-group trial where the intervention rehabilitation is delayed in one group so that they can serve as standard care controls for the others.

In a nested single-centre randomized-controlled trial patent will additionally be randomized to receive either usual rehabilitation (UR) or rehabilitation with standardized supplemental oxygen therapy (SSOT) during nights and ergometer training.

Patients will receive a PH specific rehabilitation program during 3 weeks followed by an instructed home-based training program for 12 weeks. Patients who are not already under long-term oxygen therapy (LTOT) due to daytime hypoxemia will additionally be randomized to receive standardized supplemental oxygen therapy (SSOT) during training and nights upon written informed consent.

Enrollment: 32 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• WHO functional class II-IV
• PH diagnosed by right heart catheter showing:
• Baseline mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg
• Baseline pulmonary vascular resistance (PVR) > 240 dyn x s x cm-5
• Baseline pulmonary capillary wedge pressure (PCWP) ≤ 15 mm Hg
• Patients receiving maximal PH therapy including intensified treatment with diuretics and who have been stable for 2 months before entering the study
• PH target therapy should not be expected to change during the entire 15-week study period
• Negative pregnancy test (β-HCG) at the start of the trial
• Able to understand and willing to sign the Informed Consent Form

Exclusion criteria

• PH due to significant left heart disease (Wedge ≥ 15mmHg) or lung disease (FEV1 ≤ 60% predicted)
• Pregnancy at study onset
• Walking disability
• Any change in disease-targeted therapy within the last 2 months
• Any subject who is scheduled to receive another investigational drug during the course of this study
• Any other relevant concomitant disease
• Systolic blood pressure < 85 mmHg
• History or suspicion of inability to cooperate adequately

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 4 patient groups

Immediate Rehabilitation

Experimental group

Description:

The PH specific rehabilitation consists of: bicycle ergometer training, respiratory training, dumbbell-training and (mental) gait training.

Treatment:

Behavioral: respiratory and exercise therapy

Immediate Rehabilitation with oxygen

Experimental group

Description:

The PH specific rehabilitation consists of: bicycle ergometer training, respiratory training, dumbbell-training and (mental) gait training. Patients who are not already under long-term oxygen therapy (LTOT) due to daytime hypoxemia will additionally be randomized to receive standardized supplemental oxygen therapy (SSOT) during training and nights.

Treatment:

Behavioral: respiratory and exercise therapy with supplemental oxygen

Delayed Rehabilitation

Experimental group

Description:

Waiting group that participates in the rehabilitation program after 3 months. The PH specific rehabilitation consists of: bicycle ergometer training, respiratory training, dumbbell-training and (mental) gait training.

Treatment:

Behavioral: respiratory and exercise therapy

Delayed Rehabilitation with oxygen

Experimental group

Description:

Waiting group that participates in the rehabilitation program after 3 months. The PH specific rehabilitation consists of: bicycle ergometer training, respiratory training, dumbbell-training and (mental) gait training. Patients who are not already under long-term oxygen therapy (LTOT) due to daytime hypoxemia will additionally be randomized to receive standardized supplemental oxygen therapy (SSOT) during training and nights.

Treatment:

Behavioral: respiratory and exercise therapy with supplemental oxygen