Effect of Exercise Training in Patients With Pulmonary Hypertension

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

Tracking Information

• First Submitted Date: September 14, 2015
• First Posted Date: September 24, 2015
• Last Update Posted Date: November 6, 2020
• Study Start Date: September 2015
• Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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 (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: Effect of Exercise Training in Patients With Pulmonary Hypertension
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: 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.
• 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

• 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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 21, 2015): 32
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2021
• Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Silvia Ulrich Somaini, PD Dr.; 0041442552220; silvia.ulrich@usz.ch

Contact: Stéphanie Saxer, MSc; 0041442552220; stephanie.saxer@usz.ch

• Listed Location Countries: Switzerland

Administrative Information

• NCT Number: NCT02558582
• Other Study ID Numbers: KEK-ZH-Nr. 2015-0231
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: University of Zurich
• Study Sponsor: University of Zurich
• Collaborators: Not Provided

Investigators

• Principal Investigator: Silvia Ulrich Somaini, PD Dr.; UniversityHospital Zurich

• PRS Account: University of Zurich
• Verification Date: November 2020