Condition or disease | Intervention/treatment | Phase |
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Pulmonary Hypertension | Other: Pulmonary rehabilitation | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Randomized controlled trial |
Masking: | Single (Outcomes Assessor) |
Masking Description: | Outcome assessor will be blinded for the outcome |
Primary Purpose: | Treatment |
Official Title: | A Randomized Controlled Trial to Evaluate the Effect of a Rehabilitation Program on the Exercise Capacity of Patients With Pulmonary Hypertension |
Actual Study Start Date : | November 13, 2018 |
Estimated Primary Completion Date : | November 1, 2020 |
Estimated Study Completion Date : | November 1, 2020 |
Arm | Intervention/treatment |
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Experimental: Rehabilitation group
15 weeks pulmonary rehabilitation program consisting of 2 weeks inpatient, 2 weeks outpatient and 11 weeks home-based rehabilitation.
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Other: 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:
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No Intervention: Control group
Usual care
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
PH diagnosed by right heart catheter showing:
Exclusion Criteria:
Contact: Wim Janssens, Prof | 0032 16 34 68 33 | wim.janssens@uzleuven.be | |
Contact: Marion Delcroix, Prof | marion.delcroix@uzleuven.be |
Belgium | |
University Hospitals Leuven | Recruiting |
Leuven, Belgium, 3000 | |
Contact: Wim Janssens, Prof |
Principal Investigator: | Wim Janssens, Prof | University hospitals Leuven, KU Leuven |
Tracking Information | |||||||||
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First Submitted Date ICMJE | July 16, 2018 | ||||||||
First Posted Date ICMJE | May 17, 2019 | ||||||||
Last Update Posted Date | October 10, 2019 | ||||||||
Actual Study Start Date ICMJE | November 13, 2018 | ||||||||
Estimated Primary Completion Date | November 1, 2020 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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).
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Rehabilitation for Patients With Pulmonary Hypertension | ||||||||
Official Title ICMJE | A Randomized Controlled Trial to Evaluate the Effect of a Rehabilitation Program on the Exercise Capacity of Patients With Pulmonary Hypertension | ||||||||
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. | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Randomized controlled trial Masking: Single (Outcomes Assessor)Masking Description: Outcome assessor will be blinded for the outcome Primary Purpose: Treatment
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Condition ICMJE | Pulmonary Hypertension | ||||||||
Intervention ICMJE | Other: 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:
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
20 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | November 1, 2020 | ||||||||
Estimated Primary Completion Date | November 1, 2020 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Belgium | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03955016 | ||||||||
Other Study ID Numbers ICMJE | S61141 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Wim Janssens, KU Leuven | ||||||||
Study Sponsor ICMJE | KU Leuven | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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PRS Account | KU Leuven | ||||||||
Verification Date | October 2019 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |