Pulmonary HypertensionNCT03955016
Rehabilitation for Patients With Pulmonary Hypertension
A study testing Pulmonary rehabilitation in people with Pulmonary Hypertension, run by KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- Pulmonary rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 13 Nov 2018to 1 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Marion Delcroix, Prof contact
Belgium1 site, 1 recruiting
- Recruiting
University Hospitals Leuven
Leuven, 3000
Wim Janssens, Prof
About this study
Official title: A Randomized Controlled Trial to Evaluate the Effect of a Rehabilitation Program on the Exercise Capacity of Patients With Pulmonary Hypertension
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.
Read the 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
- Being tested
- Pulmonary rehabilitation
- Keywords
- pulmonary rehabilitation, physical activity
- Medical subject headings
- Hypertension, Pulmonary, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary rehabilitationOther
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:
- Interval training on a cyclo-ergometer
- Strength training of the upper and lower extremities
- Guided walks
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation group | Experimental | 15 weeks pulmonary rehabilitation program consisting of 2 weeks inpatient, 2 weeks outpatient and 11 weeks home-based rehabilitation. Receives: Other: Pulmonary rehabilitation |
| Control group | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, 4 weeks, 15 weeks
Secondary outcomes (12)
Difference in change over time between the rehabilitation and the control group in SF-36
Health related quality of life (HRQoL) will be measured by the extensively validated generic HRQoL questionnaire, the 36-Item Short Form Survey Instrument (SF-36). This questionnaire includes two main scores with a physical component and an emotional component scale and eight subscales. The score ranges between 0 and 100, higher scores indicate a better quality of life. The questionnaire is self-administered and will be completed on paper
Measured: Baseline, 4 weeks, 15 weeks
Difference in change over time between the rehabilitation and the control group in EmPHasis-10.
Health related quality of life (HRQoL) will be measured the EmPHasis-10 questionnaire, measuring the impact of PH on health related quality of life. The score ranges between 0 and 50, higher scores indicate worse quality of life.
Measured: Baseline, 4 weeks, 15 weeks
Change from baseline to 15 weeks between the rehabilitation and the control group in WHO functional class
The WHO functional classification ranges from class I (patients with PH but without resting limitation of physical activity) to class IV (patients with PH with inability to carry out any physical activity without symptoms). The WHO functional class is a powerful predictor of survival in patients with PH.
Measured: Baseline, 15 weeks
Difference in change over time between the rehabilitation and the control group in Borgscale at the end of the 6MWD test
Borg (0-10) scale reporting on dyspnea and fatigue will be administered at the end of the six-minutes walk test. The score ranges between 0 and 10, a higher score means more symptoms of dyspnea / fatigue.
Measured: Baseline, 4 weeks, 15 weeks
Change from baseline to 15 weeks between the rehabilitation and the control group in maximal exercise capacity
Maximal exercise capacity will be assessed by a maximal incremental cycling test. After a 2-min resting period and 3 minutes of unloaded cycling, the patients will start at 20 W and cycle until symptom limitation at an incremental workload of 10 W/min. Oxygen consumption, carbon dioxide output and ventilation will be measured breath by breath (Vmax series, SensorMedics, Anaheim, CA). Heart rate and oxygen saturation will be registered continuously. Peak workload, oxygen consumption (VO2 max), heart rate, blood pressure, oxygen saturation, ventilation and VE/VCO2 slope will be retrieved.
Measured: Baseline, 15 weeks
Difference in change over time between the rehabilitation and the control group in Objectively measured physical activity
At every time point, physical activity will be measured for 1 week, using a physical activity monitor validated to be used in patients with respiratory disease. Patients will be asked to wear the monitor during waking hours. The mean number of steps per day and time spent in activities of at least moderate intensity will be retrieved as outcomes.
Measured: Baseline, 4 weeks, 15 weeks
Difference in change over time between the rehabilitation and the control group in symptoms of anxiety and depression (HADs questionnaire)
Symptoms of anxiety and depression will be assessed by the Depression, Anxiety, and Stress Scale. This questionnaires is self-administered and will be completed on paper. Higher scores indicate more symptoms of anxiety / depression.
Measured: Baseline, 4 weeks, 15 weeks
Difference in change over time between the rehabilitation and the control group in Isometric quadriceps force
An isometric maximal volitional contraction of the right quadriceps muscle be performed using the Biodex dynamometer with the patient seated with a 90° hip and 60° knee flexion. The best of 3 reproducible measurements will be retrieved as a measure of quadriceps force.
Measured: Baseline, 4 wekes, 15 weeks
Change from baseline to 15 weeks between the rehabilitation and the control group in hemodynamics measured by echocardiography
Hemodynamics measured by echocardiography at rest and during a symptom limiting exercise test. The following outcomes will be investigated: Change in tricuspid annular plane systolic excursion, Change in tissue Doppler imaging, Change in left ventricular pump function, Change in right ventricular pump function , Change in thickness of interventricular septum, Change insize of inferior vena cava, Change in systolic pulmonary arterial pressure, Change in left ventricular eccentricity index, Change in Tei index , Change in right ventricular area, Change in right atrial area
Measured: 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
MID will be defined as an increase of at least 30m
Measured: Baseline, 15 weeks
Change from baseline to 15 weeks between the rehabilitation and the control group in heart function as measured by MRI (optional)
MRI scan at rest and during exercise combined with right heart catherization and blood sampling before and after the exercise protocol.
Measured: Baseline, 15 weeks
adverse events
Patients will be asked about visits to general practitioner and hospitalizations due to any medical reasons in order to control the occurrence of adverse events. In a semi-structured way,, occurrence of exercise related and non-exercise related adverse events will be collected.
Measured: 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2019
- Study start13 Nov 2018
- Primary completion1 Nov 2020 (estimated)
- Study completion1 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wim Janssens, KU Leuven
- Investigators
- Wim Janssens, Prof, Principal investigator, University hospitals Leuven, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03955016
- Sponsor's protocol ID
- S61141
- Status last verified
- Oct 2019
- First submitted
- 16 Jul 2018
- Last updated
- 10 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Evaluate the Effect of a Rehabilitation Program on the Exercise Capacity of Patients With Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT03955016
- Acronym / sponsor ID
- S61141
- Conditions
- Pulmonary Hypertension
- Keywords
- pulmonary rehabilitation, physical activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 13 Nov 2018 (actual)
- Primary completion
- 1 Nov 2020 (estimated)
- Study completion
- 1 Nov 2020 (estimated)
- First posted
- 17 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation group | Experimental | Other: Pulmonary rehabilitation15 weeks pulmonary rehabilitation program consisting of 2 weeks inpatient, 2 weeks outpatient and 11 weeks home-based rehabilitation. |
| Control group | No intervention | –Usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- Patients receiving optimized conventional PH therapy including intensified treatment with diuretics and who have been stable for 2 months before entering the study.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary rehabilitationRehabilitation 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 | Other | Rehabilitation group |
Primary outcome
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).
12 secondary outcomes
Difference in change over time between the rehabilitation and the control group in SF-36
Time frame: Baseline, 4 weeks, 15 weeks
Difference in change over time between the rehabilitation and the control group in EmPHasis-10.
Time frame: Baseline, 4 weeks, 15 weeks
Change from baseline to 15 weeks between the rehabilitation and the control group in WHO functional class
Time frame: Baseline, 15 weeks
Difference in change over time between the rehabilitation and the control group in Borgscale at the end of the 6MWD test
Time frame: Baseline, 4 weeks, 15 weeks
Change from baseline to 15 weeks between the rehabilitation and the control group in maximal exercise capacity
Time frame: Baseline, 15 weeks
Difference in change over time between the rehabilitation and the control group in Objectively measured physical activity
Time frame: Baseline, 4 weeks, 15 weeks
Difference in change over time between the rehabilitation and the control group in symptoms of anxiety and depression (HADs questionnaire)
Time frame: Baseline, 4 weeks, 15 weeks
Difference in change over time between the rehabilitation and the control group in Isometric quadriceps force
Time frame: Baseline, 4 wekes, 15 weeks
Change from baseline to 15 weeks between the rehabilitation and the control group in hemodynamics measured by echocardiography
Time frame: 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
Time frame: Baseline, 15 weeks
Change from baseline to 15 weeks between the rehabilitation and the control group in heart function as measured by MRI (optional)
Time frame: Baseline, 15 weeks
adverse events
Time frame: 15 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marion Delcroix, Prof contact
Wim Janssens, Prof principal investigator
University hospitals Leuven, KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary rehabilitation in people with Pulmonary Hypertension, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wim Janssens, Prof (0032 16 34 68 33, wim.janssens@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in functional exercise capacity (time frame: Baseline, 4 weeks, 15 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2019.