Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Simple physical activity advices will be given to the 27 patients of the control arm | |
| telerehabilitation | Experimental | Patients in the tele rehabilitation arm will perform 24 1h-telerehabilition sessions (dance, gym, cardio training, yoga, ...) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| telerehabilitation | Procedure | 24 sessions (less Thant 1h hour each) of tele rehabilitation. Patients can choose among several activities (gym, dance, cardio training, ...) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | At inclusion and after 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 6-minutes walking test (6MWT) | Distance walked in 6-min (in meters) | At inclusion and at Month 3 |
| 3-minutes chair rise test (3-CRT) | Number of rises during 3-CRT (n) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bruno Degano, MD, PhD | Contact | 04 76 76 50 85 | +33 | BDegano@chu-grenoble.fr |
| Name | Affiliation | Role |
|---|---|---|
| Bruno Degano, MD, PhD | CHU Grenoble Alpes | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000069350 | Telerehabilitation |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| At inclusion and at Month 3 |
| SF-36 | Physical dimensions of the SF-36 questionnaire | At inclusion and at Month 3 |
| Dyspnea (NYHA scale) | Either I, II, III or IV | At inclusion, at Month 1, Month 2 and Month 3 |
| Telerehabilitation | Total number of sessions achieved | Through study completion, an average of 3 months |
| St George Respiratory Questionnaire (SGRQ) | Total SGRQ score | At inclusion and at Month 3 |
| Dyspnea (mMRC score) | Either 0, 1, 2, 3 or 4 | At inclusion, at Month 1, Month 2 and Month 3 |
| D013812 |
| Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D017216 | Telemedicine |
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |