Clinical Trial: Effect of Exercise Training in Patients With Pulmonary Hypertension

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 (SS

Detailed Summary:
Sponsor: University of Zurich

Current Primary Outcome:

  • 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: Same as current

Current Secondary Outcome:

  • 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:

  • 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


Information By: University of Zurich

Dates:
Date Received: September 14, 2015
Date Started: September 2015
Date Completion: December 2021
Last Updated: May 4, 2017
Last Verified: May 2017