Optimized Management After Balloon Pulmonary Angioplasty in Chronic Thromboembolic Pulmonary Hypertension

NCT04777448 | Unknown

• 1 other identifier: EssaiClinique_POPPART
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Thromboembolic Pulmonary Hypertension

Keywords

Chronic Thromboembolic Pulmonary Hypertension; Telerehabilitation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• 6-minutes walking test (6MWT)

  At inclusion and at Month 3

• 3-minutes chair rise test (3-CRT)

  At inclusion and at Month 3

• SF-36

  At inclusion and at Month 3

• Dyspnea (NYHA scale)

  At inclusion, at Month 1, Month 2 and Month 3

• Telerehabilitation

  Through study completion, an average of 3 months

Study Arms (2)

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, ...)

Procedure: telerehabilitation

Interventions

telerehabilitation PROCEDURE

24 sessions (less Thant 1h hour each) of tele rehabilitation. Patients can choose among several activities (gym, dance, cardio training, ...)

telerehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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).

Sponsors & Collaborators

• University Hospital, Grenoble: lead

MeSH Terms

Interventions

Telerehabilitation

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Bruno Degano, MD, PhD

  CHU Grenoble Alpes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bruno Degano, MD, PhD

CONTACT

04 76 76 50 85; BDegano@chu-grenoble.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: March 2, 2021
• Study Start: April 1, 2021
• Primary Completion: April 1, 2023
• Study Completion: July 1, 2023
• Last Updated: March 2, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share