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Effect of Exercise Training in Patients With Pulmonary Hypertension

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ClinicalTrials.gov Identifier: NCT02558582
Recruitment Status : Recruiting
First Posted : September 24, 2015
Last Update Posted : November 6, 2020
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Study Description
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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.


Condition or disease Intervention/treatment Phase
Hypertension, Pulmonary Behavioral: respiratory and exercise therapy Behavioral: respiratory and exercise therapy with supplemental oxygen Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. 6 Minute walking test [ Time Frame: Change from Baseline to 15 weeks ]
  2. Constant cardiopulmonary exercise testing change in endurance time [ Time Frame: Change from Baseline to 15 weeks ]

Secondary Outcome Measures :
  1. Quality of Life (questionnaire) [ Time Frame: Baseline, 3 weeks, 15 weeks, 6 and 12 months ]
    Minnesota living with heart failure questionnaire, Camphor, short form 36 item

  2. Sit-to-Stand (physiological parameter) [ Time Frame: Baseline, 3 weeks, 15 weeks, 6 and 12 months ]
    Number of Sit-to-Stand performed in 1 minute

  3. Stair Ascent (physiological parameter) [ Time Frame: Baseline, 3 weeks, 15 weeks, 6 and 12 months ]
    Force, Power and Time needed to climb 5 steps

  4. Cognitive function (questionnaire) [ Time Frame: Baseline, 3 weeks, 15 weeks, 6 and 12 months ]
    Trail Making Test A & B, Stroop 1-3, 5 point test

  5. Hemodynamic (physiological parameter) [ Time Frame: Baseline, 3 weeks, 15 weeks, 6 and 12 months ]
    Pulmonary artery pressure, cardiac output

  6. Functional class (scale) [ Time Frame: Baseline, 3 weeks, 15 weeks, 6 and 12 months ]
  7. Lung function (physiological parameter) [ Time Frame: Baseline, 3 weeks, 15 weeks, 6 and 12 months ]
    Forced vital capacity and liters in 1 second, Total lung capacity, diffusion of carbon dioxide

  8. Daily activity (energy expenditure, steps per day, sleep time and efficiency, lying down time, physical activity level, metabolic equivalent units) [ Time Frame: Baseline, 3 weeks, 15 weeks, 6 and 12 months ]
    Actigraphy


Other Outcome Measures:
  1. Hospitalisation days [ Time Frame: Baseline, 3 weeks, 15 weeks, 6 and 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02558582


Contacts
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Contact: Silvia Ulrich Somaini, PD Dr. 0041442552220 silvia.ulrich@usz.ch
Contact: Stéphanie Saxer, MSc 0041442552220 stephanie.saxer@usz.ch

Locations
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Switzerland
UniversityHospital Zurich, Department of Pulmonology Recruiting
Zurich, Switzerland, 8091
Contact: Silvia Ulrich Somaini, PD Dr.    0041442552220    silvia.ulrich@usz.ch   
Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Silvia Ulrich Somaini, PD Dr. UniversityHospital Zurich
More Information
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02558582    
Other Study ID Numbers: KEK-ZH-Nr. 2015-0231
First Posted: September 24, 2015    Key Record Dates
Last Update Posted: November 6, 2020
Last Verified: November 2020
Keywords provided by University of Zurich:
Pulmonary arterial hypertension
Chronic thromboembolic pulmonary hypertension
Rehabilitation
Oxygen
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Vascular Diseases
 Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases