A Randomized Controlled Trial to Evaluate the Effect of a Rehabilitation Program on the Exercise Capacity of Patients With Pulmonary Hypertension

KU Leuven1 site in 1 country20 target enrollmentNovember 13, 2018

ConditionsPulmonary Hypertension

Overview

Phase: N/A
Intervention: Not specified
Conditions: Pulmonary Hypertension
Sponsor: KU Leuven
Enrollment: 20
Locations: 1
Primary Endpoint: Change in functional exercise capacity
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 13, 2018

End Date

November 1, 2020

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

KU Leuven

Responsible Party

Principal Investigator

Wim Janssens

Prof. Dr.

KU Leuven

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:
•Baseline mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg
•Baseline pulmonary vascular resistance (PVR) ≥ 240dyn x s x cm-5
•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

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

Outcomes

Primary Outcomes

Change in functional exercise capacity

Time Frame: Baseline, 4 weeks, 15 weeks

Change in six minutes-walk distance measured at baseline, after 4 weeks and at the end of the study (15 weeks after randomization).

Secondary Outcomes

Change from baseline to 15 weeks between the rehabilitation and the control group in maximal exercise capacity(Baseline, 15 weeks)
Difference in change over time between the rehabilitation and the control group in symptoms of anxiety and depression (HADs questionnaire)(Baseline, 4 weeks, 15 weeks)
Difference in change over time between the rehabilitation and the control group in Isometric quadriceps force(Baseline, 4 wekes, 15 weeks)
Difference in change over time between the rehabilitation and the control group in SF-36(Baseline, 4 weeks, 15 weeks)
Difference in change over time between the rehabilitation and the control group in EmPHasis-10.(Baseline, 4 weeks, 15 weeks)
Change from baseline to 15 weeks between the rehabilitation and the control group in WHO functional class(Baseline, 15 weeks)
Difference in change over time between the rehabilitation and the control group in Borgscale at the end of the 6MWD test(Baseline, 4 weeks, 15 weeks)
Difference in change over time between the rehabilitation and the control group in Objectively measured physical activity(Baseline, 4 weeks, 15 weeks)
Change from baseline to 15 weeks between the rehabilitation and the control group in hemodynamics measured by echocardiography(Baseline, 15 weeks)
Change from baseline to 15 weeks between the rehabilitation and the control group in proportion of patients who exceeded the MID in 6MWD(Baseline, 15 weeks)
Change from baseline to 15 weeks between the rehabilitation and the control group in heart function as measured by MRI (optional)(Baseline, 15 weeks)
adverse events(15 weeks)