CIED Post-OR Rehabilitation

Официальное название

Construction of a Postoperative Upper Limb Rehabilitation Exercise System With Transvenous Leads for CIED Implantation and Its Safety and Effectiveness Verification

Обзор

The purpose of this study is to develop a systematic rehabilitation exercise program (rehabilitation exercise routine), focusing on the rehabilitation training of the upper limb on the implantation side after transvenous cardiac implantable electronic devices (CIEDs) implantation, and to explore its impact on the joint function of the implanted upper limb and the overall quality of life of patients. This study will conduct long-term follow-up by comprehensively using imaging examinations and relevant professional assessment scales, focusing on evaluating the clinical safety of this rehabilitation exercise routine, and simultaneously clarifying its improvement effect on discomfort symptoms (such as pain, stiffness, etc.) and functional abnormalities of the implanted limb, so as to provide scientific basis and practical guidance for the standardized rehabilitation of patients after transvenous CIEDs implantation.

Вмешательства

• Поведенческое a systematic rehabilitation exercise program (rehabilitation exercise routine)
  a systematic rehabilitation exercise program (rehabilitation exercise routine)
• Другое regular guidance
  regular guidance

Первичные конечные точки

• Change in shoulder joint range of motion of the implanted upper limb after rehabilitation exercise intervention [Срок оценки: 3-month follow-up (compared with baseline preoperative data)]
• Major safety endpoint - Composite of severe rehabilitation-related complications [Срок оценки: Through 12-month follow-up (from postoperative day 1 to 12-month follow-up)]

Вторичные конечные точки (4)

• Change in upper limb functional ability of the implanted upper limb [Срок оценки: 1-month, 3-month, 6-month, 9-month, and 12-month follow-up (each compared with baseline preoperative data)]
• Change in pain level of the implanted upper limb [Срок оценки: Immediate postoperative (within 24 hours), 1-month, 3-month, 6-month, 9-month, and 12-month follow-up (each compared with baseline preoperative data)]
• Change in quality of life [Срок оценки: 1-month, 3-month, 6-month, 9-month, and 12-month follow-up (each compared with baseline preoperative data)]
• Minor safety endpoint - Incidence of rehabilitation-related adverse events [Срок оценки: Through 12-month follow-up (from postoperative day 1 to 12-month follow-up)]

Критерии участия

Критерии включения

• Patients who meet the indications for transvenous CIEDs implantation in accordance with ACC/AHA/HRS or ESC guidelines, including single-chamber, dual-chamber, and triple-chamber pacemakers;
• Patients who have previously implanted a transvenous pacemaker and plan to upgrade the pacemaker requiring the addition of electrode leads;
• Patients aged > 18 years at the time of enrollment;
• The subject (or the patient's legal authorized representative) is willing and able to sign their name and date on the patient informed consent form.

Критерии исключения

• Subjects aged ≤ 18 years old, pregnant women or lactating patients;
• Patients with disease conditions that the researcher deems inappropriate for participation in this study;
• Patients who have previously implanted a transvenous pacemaker and only need to replace the pulse generator;
• Patients who are simultaneously participating in other clinical studies related to cardiac electronic implantable devices.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 1. Mond HG, Proclemer A. The 11th world survey of cardiac pacing and implantable cardioverter-defibrillators: calendar year 2009--a World Society of Arrhythmia's project. Pacing Clin Electrophysiol. 2011;34(8):1013-27. 2. Burri H, Starck C, Auricchio A, Biffi M, Burri M, D'Avila A, et al. EHRA expert consensus statement and practical guide on optimal implantation technique for conventional pacemak

Идентификаторы

NCT: NCT07494825 · CIEDrehabilitation2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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