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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-22/01 | Other Identifier | Erzincan Binali Yıldırım Üniversitesi Non-Interventional Clinical Research Ethics Committee |
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Shoulder dysfunction frequently occurs after cardiac implantable electronic device (CIED) implantation, adversely affecting quality of life. While early postoperative exercise is known to be effective in the short term, data on long-term durability is limited. This 3-year longitudinal follow-up study evaluates the sustained benefits of pendulum exercises (PE) and stretching & strengthening exercises (SSE) compared to standard care. We assessed shoulder range of motion, grip strength, and quality of life to determine if early mobilization provides lasting functional recovery without compromising lead safety.
This study is a 3-year follow-up of a randomized controlled trial involving patients who underwent transvenous subcutaneous prepectoral CIED implantation. Participants were originally randomized into three groups:
The exercise protocols were initiated 2 weeks post-implantation and continued for 6 weeks. In this longitudinal phase, patients were re-evaluated at a 3-year follow-up mark. Functional outcomes were measured using grip strength (kilogram-force), shoulder range of motion (flexion and abduction degrees), Visual Analog Scale (VAS) for pain, QuickDASH for functional disability, and the SF-36 survey for quality of life. Long-term safety was also monitored by assessing lead-related complications (dislodgement or fracture) over the 3-year period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Other | atients received standard post-operative instructions with temporary activity restrictions (avoiding heavy lifting and excessive overhead reaching) for the first few weeks, but no structured exercise program. |
|
| Pendulum Exercise (PE) Group | Experimental | Patients performed Codman's pendulum exercises starting 2 weeks post-implantation. The protocol included passive circular movements of the affected arm, performed twice daily for 6 weeks. |
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| Stretching and Strengthening Exercise (SSE) Group | Experimental | Patients followed a structured program involving active stretching and progressive resistance exercises for the shoulder girdle, starting 2 weeks post-implantation. Exercises were performed every other day for 6 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Structured Stretching and Strengthening Program | Behavioral | A structured exercise program initiated 2 weeks post-implantation, focusing on active stretching and progressive resistance exercises for the shoulder girdle muscles. The protocol was performed every other day for a total of 6 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Shoulder Range of Motion (ROM) - Flexion and Abduction | Measured in degrees using a universal goniometer. Active shoulder flexion and abduction were recorded to assess functional recovery of the shoulder joint on the side of the CIED implantation. | Baseline (pre-implantation), 2 weeks, 2 months, and 3 years post-implantation. |
| Measure | Description | Time Frame |
|---|---|---|
| Hand Grip Strength | Measured in kilogram-force (kgf) using a Jamar hydraulic hand dynamometer. Three measurements were taken for the affected side, and the average value was recorded. | Baseline, 2 weeks, 2 months, and 3 years post-implantation. |
| QuickDASH (Disabilities of the Arm, Shoulder, and Hand) Score |
| Measure | Description | Time Frame |
|---|---|---|
| Lead-related complications | Up to 3 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Muharrem Said Cosgun, MD, Assoc. Prof. | Erzincan Binali Yildirim University, Faculty of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erzincan Binali Yildirim University, Faculty of Medicine | Erzincan | Erzincan | 24100 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D020069 | Shoulder Pain |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D018771 | Arthralgia |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
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| Standard Post-operative Care | Other | Standard clinical follow-up and verbal instructions regarding temporary activity restrictions (e.g., avoiding heavy lifting) without a structured exercise intervention. |
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| Pendulum Exercise Protocol | Behavioral | Participants performed Codman's pendulum exercises starting 2 weeks after CIED implantation. The protocol involved passive, gravity-assisted circular and linear movements of the affected arm. Exercises were performed twice daily for a duration of 6 weeks. |
|
A shortened version of the DASH questionnaire used to measure physical function and symptoms in patients with musculoskeletal disorders of the upper limb. Scores range from 0 (no disability) to 100 (most severe disability). |
| Baseline, 2 weeks, 2 months, and 3 years post-implantation. |
| hort Form-36 (SF-36) Health Survey | A self-reported questionnaire measuring eight dimensions of health, including physical functioning and mental health. Scores for each domain range from 0 to 100, where higher scores represent better health status. | Baseline, 2 weeks, 2 months, and 3 years post-implantation. |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |