Effect of Exercise Training in Patients With Pulmonary Hypertension

Sponsor

University of Zurich (Other)

Overall Status

Recruiting

CT.gov ID

NCT02558582

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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:

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.
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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension, Pulmonary	Behavioral: respiratory and exercise therapy Behavioral: respiratory and exercise therapy with supplemental oxygen	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2020

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Immediate Rehabilitation The PH specific rehabilitation consists of: bicycle ergometer training, respiratory training, dumbbell-training and (mental) gait training.	Behavioral: respiratory and exercise therapy The PH specific rehabilitation consists of: bicycle ergometer training, respiratory training, dumbbell-training and (mental) gait training.
Experimental: 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.	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.
Experimental: 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.	Behavioral: respiratory and exercise therapy The PH specific rehabilitation consists of: bicycle ergometer training, respiratory training, dumbbell-training and (mental) gait training.
Experimental: 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.	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.

Outcome Measures

Primary Outcome Measures

6 Minute walking test [Change from Baseline to 15 weeks]
Constant cardiopulmonary exercise testing change in endurance time [Change from Baseline to 15 weeks]

Secondary Outcome Measures

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

Other Outcome Measures

Hospitalisation days [Baseline, 3 weeks, 15 weeks, 6 and 12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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