Effect of Exercise Training in Patients With Pulmonary Hypertension

NCT ID: NCT02558582

Last Updated: 2022-11-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-01
• Study Completion Date: 2023-12-31

Brief Summary

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.

Conditions

Hypertension, Pulmonary

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Immediate Rehabilitation

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

Group Type: EXPERIMENTAL

respiratory and exercise therapy

Intervention Type: BEHAVIORAL

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

Immediate Rehabilitation with oxygen

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.

Group Type: EXPERIMENTAL

respiratory and exercise therapy with supplemental oxygen

Intervention Type: BEHAVIORAL

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.

Delayed Rehabilitation

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.

Group Type: EXPERIMENTAL

respiratory and exercise therapy

Intervention Type: BEHAVIORAL

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

Delayed Rehabilitation with oxygen

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.

Group Type: EXPERIMENTAL

respiratory and exercise therapy with supplemental oxygen

Intervention Type: BEHAVIORAL

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.

Interventions

respiratory and exercise therapy

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

Intervention Type: BEHAVIORAL

respiratory and exercise therapy with supplemental oxygen

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Silvia Ulrich Somaini, PD Dr.

Role: PRINCIPAL_INVESTIGATOR

UniversityHospital Zurich

Locations

UniversityHospital Zurich, Department of Pulmonology

Zurich, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Silvia Ulrich Somaini, PD Dr.

Role: CONTACT

silvia.ulrich@usz.ch

0041442552220

Stéphanie Saxer, MSc

Role: CONTACT

stephanie.saxer@usz.ch

0041442552220

Facility Contacts

Silvia Ulrich Somaini, PD Dr.

Role: primary

silvia.ulrich@usz.ch

0041442552220

Other Identifiers

KEK-ZH-Nr. 2015-0231

Identifier Type: -

Identifier Source: org_study_id