Clinical trial NCT03955016: Rehabilitation for Patients With Pulmonary Hypertension
Official title: A Randomized Controlled Trial to Evaluate the Effect of a Rehabilitation Program on the Exercise Capacity of Patients With Pulmonary Hypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Hypertension
Keywords: pulmonary rehabilitation
physical activity
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2019-05-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in functional exercise capacity
timeFrame: Baseline, 4 weeks, 15 weeks
Secondary outcomes:
measure: Difference in change over time between the rehabilitation and the control group in SF-36
timeFrame: Baseline, 4 weeks, 15 weeks
measure: Difference in change over time between the rehabilitation and the control group in EmPHasis-10.
timeFrame: Baseline, 4 weeks, 15 weeks
measure: Change from baseline to 15 weeks between the rehabilitation and the control group in WHO functional class
timeFrame: Baseline, 15 weeks
measure: Difference in change over time between the rehabilitation and the control group in Borgscale at the end of the 6MWD test
timeFrame: Baseline, 4 weeks, 15 weeks
measure: Change from baseline to 15 weeks between the rehabilitation and the control group in maximal exercise capacity
timeFrame: Baseline, 15 weeks
measure: Difference in change over time between the rehabilitation and the control group in Objectively measured physical activity
timeFrame: Baseline, 4 weeks, 15 weeks
measure: Difference in change over time between the rehabilitation and the control group in symptoms of anxiety and depression (HADs questionnaire)
timeFrame: Baseline, 4 weeks, 15 weeks
measure: Difference in change over time between the rehabilitation and the control group in Isometric quadriceps force
timeFrame: Baseline, 4 wekes, 15 weeks
measure: Change from baseline to 15 weeks between the rehabilitation and the control group in hemodynamics measured by echocardiography
timeFrame: Baseline, 15 weeks
measure: Change from baseline to 15 weeks between the rehabilitation and the control group in proportion of patients who exceeded the MID in 6MWD
timeFrame: Baseline, 15 weeks
measure: Change from baseline to 15 weeks between the rehabilitation and the control group in heart function as measured by MRI (optional)
timeFrame: Baseline, 15 weeks
measure: adverse events
timeFrame: 15 weeks
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
Study officials:
affiliation: University hospitals Leuven, KU Leuven
name: Wim Janssens, Prof
role: PRINCIPAL_INVESTIGATOR
References: