Effect of Exercise Training in Patients With Pulmonary Hypertension

NCT02558582 | Unknown

• 1 other identifier: KEK-ZH-Nr. 2015-0231
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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. 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. 2.to look whether training with hyperoxia vs. standard care might be more effective.

Conditions

Hypertension, Pulmonary

Keywords

Pulmonary arterial hypertension; Chronic thromboembolic pulmonary hypertension; Rehabilitation; Oxygen

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Quality of Life (questionnaire)

  Baseline, 3 weeks, 15 weeks, 6 and 12 months

• Sit-to-Stand (physiological parameter)

  Baseline, 3 weeks, 15 weeks, 6 and 12 months

• Stair Ascent (physiological parameter)

  Baseline, 3 weeks, 15 weeks, 6 and 12 months

• Cognitive function (questionnaire)

  Baseline, 3 weeks, 15 weeks, 6 and 12 months

• Hemodynamic (physiological parameter)

  Baseline, 3 weeks, 15 weeks, 6 and 12 months

Other Outcomes (1)

• Hospitalisation days

  Baseline, 3 weeks, 15 weeks, 6 and 12 months

Study Arms (4)

Immediate Rehabilitation

EXPERIMENTAL

The PH specific rehabilitation consists of: bicycle ergometer training, respiratory training, dumbbell-training and (mental) gait training.

Behavioral: respiratory and exercise therapy

Immediate Rehabilitation with oxygen

EXPERIMENTAL

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

Delayed Rehabilitation

EXPERIMENTAL

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

Delayed Rehabilitation with oxygen

EXPERIMENTAL

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

Interventions

respiratory and exercise therapy BEHAVIORAL

The PH specific rehabilitation consists of: bicycle ergometer training, respiratory training, dumbbell-training and (mental) gait training.

Delayed Rehabilitation; Immediate Rehabilitation

respiratory and exercise therapy with supplemental oxygen BEHAVIORAL

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; Immediate Rehabilitation with oxygen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

UniversityHospital Zurich, Department of Pulmonology

Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Hypertension, Pulmonary; Pulmonary Arterial Hypertension

Interventions

Respiratory Rate; Exercise Therapy

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Silvia Ulrich Somaini, PD Dr.

  UniversityHospital Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Silvia Ulrich Somaini, PD Dr.

CONTACT

0041442552220; silvia.ulrich@usz.ch

Stéphanie Saxer, MSc

CONTACT

0041442552220; stephanie.saxer@usz.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2015
• First Posted: September 24, 2015
• Study Start: September 1, 2015
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: November 2, 2022

Record last verified: 2022-11

Locations

CH (1)