a systematic rehabilitation exercise program (rehabilitation exercise routine)
Behaviorala systematic rehabilitation exercise program (rehabilitation exercise routine)
Not Yet Recruiting
NCT Number: NCT07494825
CIED Post-OR Rehabilitation
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.
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
regular guidance
Otherregular guidance
Primary outcomes
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Change in shoulder joint range of motion of the implanted upper limb after rehabilitation exercise intervention
Time frame: 3-month follow-up (compared with baseline preoperative data)
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)
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Major safety endpoint - Composite of severe rehabilitation-related complications
Time frame: Through 12-month follow-up (from postoperative day 1 to 12-month follow-up)
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)
Secondary outcomes
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Change in upper limb functional ability of the implanted upper limb
Time frame: 1-month, 3-month, 6-month, 9-month, and 12-month follow-up (each compared with baseline preoperative data)
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)
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Change in pain level of the implanted upper limb
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)
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)
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Change in quality of life
Time frame: 1-month, 3-month, 6-month, 9-month, and 12-month follow-up (each compared with baseline preoperative data)
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)
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Minor safety endpoint - Incidence of rehabilitation-related adverse events
Time frame: Through 12-month follow-up (from postoperative day 1 to 12-month follow-up)
Minor adverse events related to rehabilitation exercise, including mild muscle soreness, local discomfort at the implantation site during exercise, and transient fatigue Unit of Measure: Percentage (%)
Time Frame: Through 12-month follow-up (from postoperative day 1 to 12-month follow-up)
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Shanghai Zhongshan Hospital
Other
Registry information
Official study title
Construction of a Postoperative Upper Limb Rehabilitation Exercise System With Transvenous Leads for CIED Implantation and Its Safety and Effectiveness Verification
Important dates
- Study start
- 2026
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Mar 27, 2026
- Registry last updated
- Mar 27, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.