CIED Post-OR Rehabilitation

N/ANot Yet RecruitingNCT07494825

Shanghai Zhongshan Hospital600 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

600

Conditions

CIED Postoperative Upper Limb Stiffness and Disability

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria * 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. Exclusion Criteria * 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.

Outcomes

Primary Outcomes

Change in shoulder joint range of motion of the implanted upper limb after rehabilitation exercise intervention

Outcome Measure: Change in shoulder joint range of motion of the implanted upper limb after rehabilitation exercise intervention Unit of Measure: Degrees (°) (difference between follow-up and baseline) Time Frame: 3-month follow-up (compared with baseline preoperative data)

Time frame: 3-month follow-up (compared with baseline preoperative data)

Major safety endpoint - Composite of severe rehabilitation-related complications

Description: Severe complications related to rehabilitation exercise, including lead dislodgement caused by improper exercise, severe muscle strain, and joint dislocation of the implanted upper limb Unit of Measure: Percentage (%) Time Frame: Through 12-month follow-up (from postoperative day 1 to 12-month follow-up)

Time frame: Through 12-month follow-up (from postoperative day 1 to 12-month follow-up)

Secondary Outcomes

Change in upper limb functional ability of the implanted upper limb

Assessment Tool: Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH) Scale Details: Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH); minimum score = 0, maximum score = 100; higher scores indicate worse upper limb function Unit of Measure: Score (0-100) (difference between follow-up and baseline) Time Frame:1-month, 3-month, 6-month, 9-month, and 12-month follow-up (each compared with baseline preoperative data)

Time frame: 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

Assessment Tool: Visual Analog Scale (VAS) Scale Details: Visual Analog Scale (VAS); minimum score = 0 (no pain), maximum score = 10 (severe pain); higher scores indicate more severe pain Unit of Measure: Score (0-10) (difference between follow-up and baseline) Time Frame: Immediate postoperative (within 24 hours), 1-month, 3-month, 6-month, 9-month, and 12-month follow-up (each compared with baseline preoperative data)

Time frame: 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

Assessment Tool: 36-Item Short Form Health Survey (SF-36) Scale Details: 36-Item Short Form Health Survey (SF-36); each domain score ranges from 0 to 100, total score ranges from 0 to 100; higher scores indicate better quality of life Unit of Measure: Score (0-100) (difference between follow-up and baseline) Time Frame: 1-month, 3-month, 6-month, 9-month, and 12-month follow-up (each compared with baseline preoperative data)