Effect of Exercise Training in Patients With Pulmonary Hypertension

Not Applicable

Recruiting

• Conditions: Hypertension, Pulmonary
• Interventions: Behavioral: respiratory and exercise therapy; Behavioral: respiratory and exercise therapy with supplemental oxygen

• Registration Number: NCT02558582
• Lead Sponsor: University of Zurich

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-01
• Study First Submitted: 2015-09-14
• Study First Submitted QC: 2015-09-21
• Study First Posted: 2015-09-24
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-01
• Last Update Posted: 2022-11-02
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 32

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Delayed Rehabilitation	respiratory and exercise therapy	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.
Immediate Rehabilitation	respiratory and exercise therapy	The PH specific rehabilitation consists of: bicycle ergometer training, respiratory training, dumbbell-training and (mental) gait training.
Immediate Rehabilitation with oxygen	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.
Delayed Rehabilitation with oxygen	respiratory and exercise therapy with supplemental 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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Quality of Life (questionnaire)	Baseline, 3 weeks, 15 weeks, 6 and 12 months	Minnesota living with heart failure questionnaire, Camphor, short form 36 item
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
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
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

Trial Locations

Locations (1)

UniversityHospital Zurich, Department of Pulmonology; 🇨🇭 Zurich, Switzerland