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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

Tracking Information
First Submitted Date  ICMJE September 14, 2015
First Posted Date  ICMJE September 24, 2015
Last Update Posted Date November 6, 2020
Study Start Date  ICMJE September 2015
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2015)
  • 6 Minute walking test [ Time Frame: Change from Baseline to 15 weeks ]
  • Constant cardiopulmonary exercise testing change in endurance time [ Time Frame: Change from Baseline to 15 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2016)
  • 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
  • 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
  • Stair Ascent (physiological parameter) [ Time Frame: Baseline, 3 weeks, 15 weeks, 6 and 12 months ]
    Force, Power and Time needed to climb 5 steps
  • 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
  • Hemodynamic (physiological parameter) [ Time Frame: Baseline, 3 weeks, 15 weeks, 6 and 12 months ]
    Pulmonary artery pressure, cardiac output
  • Functional class (scale) [ Time Frame: Baseline, 3 weeks, 15 weeks, 6 and 12 months ]
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2015)
  • 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
  • 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
  • Stair Ascent (physiological parameter) [ Time Frame: Baseline, 3 weeks, 15 weeks, 6 and 12 months ]
    Force, Power and Time needed to climb 5 steps
  • 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
  • Hemodynamic (physiological parameter) [ Time Frame: Baseline, 3 weeks, 15 weeks, 6 and 12 months ]
    Pulmonary artery pressure, cardiac output
  • WHO functional class (scale) [ Time Frame: Baseline, 3 weeks, 15 weeks, 6 and 12 months ]
  • 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
  • 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
Current Other Pre-specified Outcome Measures
 (submitted: September 21, 2015)
Hospitalisation days [ Time Frame: Baseline, 3 weeks, 15 weeks, 6 and 12 months ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effect of Exercise Training in Patients With Pulmonary Hypertension
Official Title  ICMJE Effect of Exercise Training in Arterial and Chronic Thromboembolic Pulmonary Hypertension in Switzerland and Standardization With European Countries
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hypertension, Pulmonary
Intervention  ICMJE
  • Behavioral: respiratory and exercise therapy
    The PH specific rehabilitation consists of: bicycle ergometer training, respiratory training, dumbbell-training and (mental) gait training.
  • 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.

Study Arms  ICMJE
  • Experimental: Immediate Rehabilitation
    The PH specific rehabilitation consists of: bicycle ergometer training, respiratory training, dumbbell-training and (mental) gait training.
    Intervention: Behavioral: respiratory and exercise therapy
  • 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.

    Intervention: Behavioral: respiratory and exercise therapy with supplemental oxygen
  • 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.
    Intervention: Behavioral: respiratory and exercise therapy
  • 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.

    Intervention: Behavioral: respiratory and exercise therapy with supplemental oxygen
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 21, 2015)
32
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Silvia Ulrich Somaini, PD Dr. 0041442552220 silvia.ulrich@usz.ch
Contact: Stéphanie Saxer, MSc 0041442552220 stephanie.saxer@usz.ch
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02558582
Other Study ID Numbers  ICMJE KEK-ZH-Nr. 2015-0231
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Zurich
Study Sponsor  ICMJE University of Zurich
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Silvia Ulrich Somaini, PD Dr. UniversityHospital Zurich
PRS Account University of Zurich
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP