Rehabilitation for Patients With Pulmonary Hypertension

NCT03955016 | Unknown

• 1 other identifier: S61141
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Hypertension

Keywords

pulmonary rehabilitation; physical activity

Outcome Measures

Primary Outcomes (1)

• Change in functional exercise capacity

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

  Baseline, 4 weeks, 15 weeks

Secondary Outcomes (12)

• 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

• Change from baseline to 15 weeks between the rehabilitation and the control group in maximal exercise capacity

  Baseline, 15 weeks

Study Arms (2)

Rehabilitation group

EXPERIMENTAL

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

Other: Pulmonary rehabilitation

Control group

NO INTERVENTION

Usual care

Interventions

Pulmonary rehabilitation 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

Rehabilitation group

Eligibility Criteria

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

You may qualify if:

• 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
• Able to understand and willing to sign the Informed Consent Form

You may not qualify if:

• 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

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

University Hospitals Leuven

Leuven, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Hypertension, Pulmonary; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Wim Janssens, Prof

  University hospitals Leuven, KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wim Janssens, Prof

CONTACT

0032 16 34 68 33; wim.janssens@uzleuven.be

Marion Delcroix, Prof

CONTACT

marion.delcroix@uzleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessor will be blinded for the outcome
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: July 16, 2018
• First Posted: May 17, 2019
• Study Start: November 13, 2018
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2020
• Last Updated: October 10, 2019

Record last verified: 2019-10

Locations

BE (1)