CIED Post-OR Rehabilitation

Fudan University

Status: Not yet enrolling

Conditions: CIED Postoperative Upper Limb Stiffness and Disability

Treatments: Behavioral: a systematic rehabilitation exercise program (rehabilitation exercise routine); Other: regular guidance

Study type: Interventional

Funder types: Other

Identifiers

NCT07494825

CIEDrehabilitation2025

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 2 patient groups

rehabilitation guidance

Experimental group

Description:

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.

Treatment:

Behavioral: a systematic rehabilitation exercise program (rehabilitation exercise routine)

regular postoperative guidance

Active Comparator group

Description:

regular postoperative guidance

Treatment:

Other: regular guidance