Effect of Exercise Training in Patients With Pulmonary Hypertension

Hypertension, Pulmonary Clinical Trial

Official title:

Effect of Exercise Training in Arterial and Chronic Thromboembolic Pulmonary Hypertension in Switzerland and Standardization With European Countries

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02558582
• Other study ID #: KEK-ZH-Nr. 2015-0231
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2015
• Est. completion date: December 2023

Study information

• Verified date: November 2022
• Source: University of Zurich
• Contact: Silvia Ulrich Somaini, PD Dr.
• Phone: 0041442552220
• Email: silvia.ulrich[@]usz.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 (ß-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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary

Intervention

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

Locations

Country	Name	City	State
Switzerland	UniversityHospital Zurich, Department of Pulmonology	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hospitalisation days		Baseline, 3 weeks, 15 weeks, 6 and 12 months
Primary	6 Minute walking test		Change from Baseline to 15 weeks
Primary	Constant cardiopulmonary exercise testing change in endurance time		Change from Baseline to 15 weeks
Secondary	Quality of Life (questionnaire)	Minnesota living with heart failure questionnaire, Camphor, short form 36 item	Baseline, 3 weeks, 15 weeks, 6 and 12 months
Secondary	Sit-to-Stand (physiological parameter)	Number of Sit-to-Stand performed in 1 minute	Baseline, 3 weeks, 15 weeks, 6 and 12 months
Secondary	Stair Ascent (physiological parameter)	Force, Power and Time needed to climb 5 steps	Baseline, 3 weeks, 15 weeks, 6 and 12 months
Secondary	Cognitive function (questionnaire)	Trail Making Test A & B, Stroop 1-3, 5 point test	Baseline, 3 weeks, 15 weeks, 6 and 12 months
Secondary	Hemodynamic (physiological parameter)	Pulmonary artery pressure, cardiac output	Baseline, 3 weeks, 15 weeks, 6 and 12 months
Secondary	Functional class (scale)		Baseline, 3 weeks, 15 weeks, 6 and 12 months
Secondary	Lung function (physiological parameter)	Forced vital capacity and liters in 1 second, Total lung capacity, diffusion of carbon dioxide	Baseline, 3 weeks, 15 weeks, 6 and 12 months
Secondary	Daily activity (energy expenditure, steps per day, sleep time and efficiency, lying down time, physical activity level, metabolic equivalent units)	Actigraphy	Baseline, 3 weeks, 15 weeks, 6 and 12 months