Clinical trial NCT02558582: Effect of Exercise Training in Patients With Pulmonary Hypertension
Official title: Effect of Exercise Training in Arterial and Chronic Thromboembolic Pulmonary Hypertension in Switzerland and Standardization With European Countries
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension, Pulmonary
Keywords: Pulmonary arterial hypertension
Chronic thromboembolic pulmonary hypertension
Rehabilitation
Oxygen
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2015-09-24
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 6 Minute walking test
timeFrame: Change from Baseline to 15 weeks
measure: Constant cardiopulmonary exercise testing change in endurance time
timeFrame: Change from Baseline to 15 weeks
Secondary outcomes:
measure: Quality of Life (questionnaire)
timeFrame: Baseline, 3 weeks, 15 weeks, 6 and 12 months
measure: Sit-to-Stand (physiological parameter)
timeFrame: Baseline, 3 weeks, 15 weeks, 6 and 12 months
measure: Stair Ascent (physiological parameter)
timeFrame: Baseline, 3 weeks, 15 weeks, 6 and 12 months
measure: Cognitive function (questionnaire)
timeFrame: Baseline, 3 weeks, 15 weeks, 6 and 12 months
measure: Hemodynamic (physiological parameter)
timeFrame: Baseline, 3 weeks, 15 weeks, 6 and 12 months
measure: Functional class (scale)
timeFrame: Baseline, 3 weeks, 15 weeks, 6 and 12 months
measure: Lung function (physiological parameter)
timeFrame: Baseline, 3 weeks, 15 weeks, 6 and 12 months
measure: Daily activity (energy expenditure, steps per day, sleep time and efficiency, lying down time, physical activity level, metabolic equivalent units)
timeFrame: Baseline, 3 weeks, 15 weeks, 6 and 12 months
Other outcomes:
measure: Hospitalisation days
timeFrame: Baseline, 3 weeks, 15 weeks, 6 and 12 months
Locations:
city: Zurich
country: Switzerland
facility: UniversityHospital Zurich, Department of Pulmonology
Study officials:
affiliation: UniversityHospital Zurich
name: Silvia Ulrich Somaini, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References: