Optimized Management After Balloon Pulmonary Angioplasty in Chronic Thromboembolic Pulmonary Hypertension (POpPART)
Primary Purpose
Chronic Thromboembolic Pulmonary Hypertension
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
telerehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Thromboembolic Pulmonary Hypertension focused on measuring Chronic Thromboembolic Pulmonary Hypertension, Telerehabilitation
Eligibility Criteria
Inclusion Criteria:
- Age > 18 years old
- Patients who have undergone pulmonary angioplasty for CTEPH (group 4 of the international classification)
- Patients with a mean pulmonary artery pressure <= 30 mmHg and cardiac output > 2.5 L/min/m2 at the last angioplasty session
- Patients who had completed an incremental cardiopulmonary exercise test
- Patients affiliated to the French social security system
- Patients with signed informed consent
Exclusion Criteria:
- Patients unable to complete an incremental cardiopulmonary exercise test
- Patients unable to complete a 6-minutes walking test, 3-minutes chair raising test and a rehabilitation
- Patient unable, for technical or any other reason, to connect via the Internet for remote monitoring and/or telerehabilitation
- Patient for whom a refusal to participate in a rehabilitation programme is anticipated
- Patient who has participated in a rehabilitation programme in the 6 months prior to the date of inclusion
- Patients referred to in Articles L1121-5 to L1121-8 of the CSP (pregnant women, parturients, nursing mothers, persons deprived of their liberty by a judicial or administrative decision, persons under psychiatric care and adults subject to a legal protection measure or unable to express their consent).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
telerehabilitation
Arm Description
Simple physical activity advices will be given to the 27 patients of the control arm
Patients in the tele rehabilitation arm will perform 24 1h-telerehabilition sessions (dance, gym, cardio training, yoga, ...)
Outcomes
Primary Outcome Measures
Difference of endurance time on cycloergometer
Expressed in seconds and calculated as follow: endurance time after 3 months - endurance time at inclusion The two tests are performed at 80% of the maximum power reached during a maximum incremental effort test (performed before inclusion)
Secondary Outcome Measures
6-minutes walking test (6MWT)
Distance walked in 6-min (in meters)
3-minutes chair rise test (3-CRT)
Number of rises during 3-CRT (n)
SF-36
Physical dimensions of the SF-36 questionnaire
Dyspnea (NYHA scale)
Either I, II, III or IV
Telerehabilitation
Total number of sessions achieved
St George Respiratory Questionnaire (SGRQ)
Total SGRQ score
Dyspnea (mMRC score)
Either 0, 1, 2, 3 or 4
Full Information
NCT ID
NCT04777448
First Posted
February 2, 2021
Last Updated
March 1, 2021
Sponsor
University Hospital, Grenoble
1. Study Identification
Unique Protocol Identification Number
NCT04777448
Brief Title
Optimized Management After Balloon Pulmonary Angioplasty in Chronic Thromboembolic Pulmonary Hypertension
Acronym
POpPART
Official Title
Optimised Management After Balloon Pulmonary Angioplasty in Patients With Chronic Thromboembolic Pulmonary Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 2021 (Anticipated)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Balloon pulmonary angioplasty (BPA) is a new method of treatment for inoperable chronic thromboembolic pulmonary hypertension (CTEPH) or persistent CTEPH after surgery. BPA improves or even normalises hemodynamic parameters measured during a right heart catheterization. Nevertheless, the vast majority of patients retain dyspnea and impaired exercise capacity despite considerable hemodynamic improvements.
Pulmonary rehabilitation (RHB) can improve symptoms, quality of life and exercise capacity in patients with CTEPH. Unfortunately, access to RHB remains a concern in many countries. Tele-rehabilitation (tRHB) has been shown feasible and effective some cardiac or pulmonary diseases.
This randomized controlled study aims at comparing the effects of tRHB with the effects of simple advices regarding exercising in CTEPH patients with normalized or near-normalized pulmonary hemodynamics after BPA treatment.
Detailed Description
Chronic thromboembolic pulmonary hypertension (CTEPH) is a complication of pulmonary embolism leading to dyspnea, effort limitation and sometimes right heart failure and death. Balloon pulmonary angioplasty (BPA) is a new method of treatment for inoperable CTEPH or persistent CTEPH after surgery. BPA restores blood flow in the treated areas and improves or even normalises hemodynamic parameters measured during a right heart catheterization. Nevertheless, the vast majority of patients retain dyspnea and impaired exercise capacity after angioplasty procedures.
Exercise training has been demonstrated to alleviate exercise dyspnea and to improve exercise capacity in many chronic cardiopulmonary conditions. Pulmonary rehabilitation (RHB) can improve symptoms, quality of life and exercise capacity in patients with pulmonary vascular disease of different etiologies including CTEPH. Furthermore, RHB does not present any particular risk for CTEPH patients with normalized or near-normalized pulmonary hemodynamics. Unfortunately, access to RHB remains a concern in many countries. Tele-rehabilitation (tRHB) has been shown feasible and effective some cardiac or pulmonary diseases. Our hypothesis is that tRHB may also be effective in CTEPH patients with normalized or near-normalized pulmonary hemodynamics after BPA treatment.
This randomized controlled study aims at comparing the effects of tRHB with the effects of simple advices regarding exercising in CTEPH patients with normalized or near-normalized pulmonary hemodynamics after BPA treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Thromboembolic Pulmonary Hypertension
Keywords
Chronic Thromboembolic Pulmonary Hypertension, Telerehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Simple physical activity advices will be given to the 27 patients of the control arm
Arm Title
telerehabilitation
Arm Type
Experimental
Arm Description
Patients in the tele rehabilitation arm will perform 24 1h-telerehabilition sessions (dance, gym, cardio training, yoga, ...)
Intervention Type
Procedure
Intervention Name(s)
telerehabilitation
Intervention Description
24 sessions (less Thant 1h hour each) of tele rehabilitation. Patients can choose among several activities (gym, dance, cardio training, ...)
Primary Outcome Measure Information:
Title
Difference of endurance time on cycloergometer
Description
Expressed in seconds and calculated as follow: endurance time after 3 months - endurance time at inclusion The two tests are performed at 80% of the maximum power reached during a maximum incremental effort test (performed before inclusion)
Time Frame
At inclusion and after 3 months
Secondary Outcome Measure Information:
Title
6-minutes walking test (6MWT)
Description
Distance walked in 6-min (in meters)
Time Frame
At inclusion and at Month 3
Title
3-minutes chair rise test (3-CRT)
Description
Number of rises during 3-CRT (n)
Time Frame
At inclusion and at Month 3
Title
SF-36
Description
Physical dimensions of the SF-36 questionnaire
Time Frame
At inclusion and at Month 3
Title
Dyspnea (NYHA scale)
Description
Either I, II, III or IV
Time Frame
At inclusion, at Month 1, Month 2 and Month 3
Title
Telerehabilitation
Description
Total number of sessions achieved
Time Frame
Through study completion, an average of 3 months
Title
St George Respiratory Questionnaire (SGRQ)
Description
Total SGRQ score
Time Frame
At inclusion and at Month 3
Title
Dyspnea (mMRC score)
Description
Either 0, 1, 2, 3 or 4
Time Frame
At inclusion, at Month 1, Month 2 and Month 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age > 18 years old
Patients who have undergone pulmonary angioplasty for CTEPH (group 4 of the international classification)
Patients with a mean pulmonary artery pressure <= 30 mmHg and cardiac output > 2.5 L/min/m2 at the last angioplasty session
Patients who had completed an incremental cardiopulmonary exercise test
Patients affiliated to the French social security system
Patients with signed informed consent
Exclusion Criteria:
Patients unable to complete an incremental cardiopulmonary exercise test
Patients unable to complete a 6-minutes walking test, 3-minutes chair raising test and a rehabilitation
Patient unable, for technical or any other reason, to connect via the Internet for remote monitoring and/or telerehabilitation
Patient for whom a refusal to participate in a rehabilitation programme is anticipated
Patient who has participated in a rehabilitation programme in the 6 months prior to the date of inclusion
Patients referred to in Articles L1121-5 to L1121-8 of the CSP (pregnant women, parturients, nursing mothers, persons deprived of their liberty by a judicial or administrative decision, persons under psychiatric care and adults subject to a legal protection measure or unable to express their consent).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bruno Degano, MD, PhD
Phone
04 76 76 50 85
Ext
+33
Email
BDegano@chu-grenoble.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno Degano, MD, PhD
Organizational Affiliation
CHU Grenoble Alpes
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Optimized Management After Balloon Pulmonary Angioplasty in Chronic Thromboembolic Pulmonary Hypertension
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