Optimized Management After Balloon Pulmonary Angioplasty in Chronic Thromboembolic Pulmonary Hypertension (POpPART)
Optimised Management After Balloon Pulmonary Angioplasty in Patients With Chronic Thromboembolic Pulmonary Hypertension
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Bruno Degano, MD, PhD
- 電話番号：+33 04 76 76 50 85
- メール：BDegano@chu-grenoble.fr
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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).
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
介入なし：Control
Simple physical activity advices will be given to the 27 patients of the control arm
|
|
|
実験的：telerehabilitation
Patients in the tele rehabilitation arm will perform 24 1h-telerehabilition sessions (dance, gym, cardio training, yoga, ...)
|
24 sessions (less Thant 1h hour each) of tele rehabilitation.
Patients can choose among several activities (gym, dance, cardio training, ...)
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Difference of endurance time on cycloergometer
時間枠：At inclusion and after 3 months
|
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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
6-minutes walking test (6MWT)
時間枠：At inclusion and at Month 3
|
Distance walked in 6-min (in meters)
|
At inclusion and at Month 3
|
|
3-minutes chair rise test (3-CRT)
時間枠：At inclusion and at Month 3
|
Number of rises during 3-CRT (n)
|
At inclusion and at Month 3
|
|
SF-36
時間枠：At inclusion and at Month 3
|
Physical dimensions of the SF-36 questionnaire
|
At inclusion and at Month 3
|
|
Dyspnea (NYHA scale)
時間枠：At inclusion, at Month 1, Month 2 and Month 3
|
Either I, II, III or IV
|
At inclusion, at Month 1, Month 2 and Month 3
|
|
Telerehabilitation
時間枠：Through study completion, an average of 3 months
|
Total number of sessions achieved
|
Through study completion, an average of 3 months
|
|
St George Respiratory Questionnaire (SGRQ)
時間枠：At inclusion and at Month 3
|
Total SGRQ score
|
At inclusion and at Month 3
|
|
Dyspnea (mMRC score)
時間枠：At inclusion, at Month 1, Month 2 and Month 3
|
Either 0, 1, 2, 3 or 4
|
At inclusion, at Month 1, Month 2 and Month 3
|
協力者と研究者
捜査官
- 主任研究者：Bruno Degano, MD, PhD、Chu Grenoble Alpes
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- EssaiClinique_POPPART
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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