CIED Postoperative Upper Limb Stiffness and Disability
Conditions
Brief summary
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.
Interventions
BEHAVIORALa systematic rehabilitation exercise program (rehabilitation exercise routine)
a systematic rehabilitation exercise program (rehabilitation exercise routine)
OTHERregular guidance
regular guidance
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in shoulder joint range of motion of the implanted upper limb after rehabilitation exercise intervention | 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) |
| Major safety endpoint - Composite of severe rehabilitation-related complications | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in upper limb functional ability of the implanted upper limb | 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) |
| Change in pain level of the implanted upper limb | 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) |
| Change in quality of life | 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) |
| Minor safety endpoint - Incidence of rehabilitation-related adverse events | 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) |
Contacts
CONTACTZiqing Yu, PhD
Outcome results
None listed