| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| 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 |
|---|---|
|
Experimental: Rehabilitation group
15 weeks pulmonary rehabilitation program consisting of 2 weeks inpatient, 2 weeks outpatient and 11 weeks home-based rehabilitation.
|
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:
|
|
No Intervention: Control group
Usual care
|
| 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 | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| 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).
|
||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
|
||||||||
| 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
|
||||||||
| 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:
|
||||||||
| Study Arms ICMJE |
|
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| 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:
|
||||||||
| Sex/Gender ICMJE |
|
||||||||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
|
||||||||
| 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 |
|
||||||||
| IPD Sharing Statement ICMJE |
|
||||||||
| Responsible Party | Wim Janssens, KU Leuven | ||||||||
| Study Sponsor ICMJE | KU Leuven | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
|
||||||||
| 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 |
|||||||||