Rehabilitation for Patients With Pulmonary Hypertension

NCT ID: NCT03955016

Last Updated: 2019-10-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-13
• Study Completion Date: 2020-11-01

Brief Summary

The purpose of this study is to test the impact of a personalized, partly supervised rehabilitation program on the exercise capacity in patients with pulmonary hypertension. The rehabilitation program consists of 2 weeks inpatient, 2 weeks ambulatory and 11 weeks home based rehabilitation.

Detailed Description

The present study is a 15 weeks, randomized (1:1) controlled trial. Patients in both groups will not change their usual medical treatment. After 2 clinical visits (screening and randomization visit), patients in the intervention group will follow a 15 week rehabilitation program consisting of 2 weeks inpatient, 2 weeks outpatient and 11 weeks home based rehabilitation. At the end of the outpatient rehabilitation phase (week 4) and the home-based program (week 15), clinical outcomes will be reassessed.

Conditions

Pulmonary Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Rehabilitation group

15 weeks pulmonary rehabilitation program consisting of 2 weeks inpatient, 2 weeks outpatient and 11 weeks home-based rehabilitation.

Group Type: EXPERIMENTAL

Pulmonary rehabilitation

Intervention Type: OTHER

Rehabilitation program consisting of 2 weeks inpatient (supervised training 5 times per week), 2 weeks outpatient (supervised sessions 3 times per week) and 11 weeks home-based exercise training (weekly phone call).

During the inpatient phase, patients will receive on top of the supervised training sessions a consultation of the dietitian, PH psychologist, social worker and specialized nurse. During the ambulatory rehabilitation phase patients will have 2 session with the occupational therapist.

Every supervised training session contains:

1. Interval training on a cyclo-ergometer

2. Strength training of the upper and lower extremities

3. Guided walks

Control group

Usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Pulmonary rehabilitation

Rehabilitation program consisting of 2 weeks inpatient (supervised training 5 times per week), 2 weeks outpatient (supervised sessions 3 times per week) and 11 weeks home-based exercise training (weekly phone call).

During the inpatient phase, patients will receive on top of the supervised training sessions a consultation of the dietitian, PH psychologist, social worker and specialized nurse. During the ambulatory rehabilitation phase patients will have 2 session with the occupational therapist.

Every supervised training session contains:

1. Interval training on a cyclo-ergometer

2. Strength training of the upper and lower extremities

3. Guided walks

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Female and male patients ≥ 18 years
• Pulmonary arterial hypertension (PAH, Group 1 of Nice classification) and chronic thromboembolic pulmonary hypertension (CTEPH, group 4)
• WHO functional class II-III
• PH diagnosed by right heart catheter showing:

1. Baseline mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg

2. Baseline pulmonary vascular resistance (PVR) ≥ 240dyn x s x cm-5

3. Baseline pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHgg

• Patients receiving optimized conventional PH therapy including intensified treatment with diuretics and who have been stable for 2 months before entering the study.
• Except for diuretics, medical treatment should not be expected to change during the entire 15-week study period.
• Negative pregnancy test (β-HCG) at the start of the trial and appropriate contraception throughout the study for women with child- bearing potential
• Able to understand and willing to sign the Informed Consent Form

Exclusion Criteria

• PH of any cause other than permitted in the entry criteria, e.g. concomitantly to portal hypertension, complex congenital heart disease, reversed shunt, HIV infection, suspected pulmonary veno-occlusive disease based on pulmonary edema during a previous vasoreactivity test or on abnormal findings compatible with this diagnosis (septal lines or pulmonary edema at high resolution computer tomography), congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension or unclear diagnosis
• Patients with signs of right heart decompensation
• Walking disability
• Acute infection, pyrexia
• Any change in disease-targeted therapy within the last 2 months
• Any subject who is scheduled to receive an investigational drug during the course of this study
• Severe lung disease: FEV1/FVC <0.5 and total lung capacity <70% of the normal value
• Active myocarditis, instable angina pectoris, exercise induced ventricular arrhythmias, decompensated heart failure, active liver disease, porphyria or elevations of serum transaminases >3 x ULN (upper limit of normal) or bilirubin >1.5 x ULN
• Hemoglobin concentration of less than 75% of the lower limit of normal
• Systolic blood pressure <85 mmHg
• History or suspicion of inability to cooperate adequately

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Wim Janssens

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wim Janssens, Prof

Role: PRINCIPAL_INVESTIGATOR

University hospitals Leuven, KU Leuven

Locations

University Hospitals Leuven

Leuven, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Wim Janssens, Prof

Role: CONTACT

wim.janssens@uzleuven.be

0032 16 34 68 33

Marion Delcroix, Prof

Role: CONTACT

marion.delcroix@uzleuven.be

Facility Contacts

Wim Janssens, Prof

Role: primary

Other Identifiers

S61141

Identifier Type: -

Identifier Source: org_study_id