An interventional study of Structured Stretching and Strengthening Program and Standard Post-operative Care in Cardiac Implantable Electronic Device (CIED) and Shoulder Dysfunction, sponsored by Erzincan Binali Yildirim Universitesi. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by Erzincan Binali Yildirim Universitesi · Not applicable, Interventional, and Supportive care
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.
707 studies on the registry are indexed under Shoulder Pain; 152 are open to participants now.
This study's enrollment of 89 is above the median of 60 across 561 interventional studies indexed under Shoulder Pain.
Browse Shoulder Pain studies →Erzincan Binali Yildirim Universitesi is the lead sponsor of 21 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
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.
Other: Standard Post-operative Care
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.
Behavioral: Pendulum Exercise Protocol
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.
Behavioral: Structured Stretching and Strengthening Program
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.
Standard clinical follow-up and verbal instructions regarding temporary activity restrictions (e.g., avoiding heavy lifting) without a structured exercise intervention.
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.
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.
Time frame: Baseline (pre-implantation), 2 weeks, 2 months, and 3 years post-implantation.
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.
Time frame: Baseline, 2 weeks, 2 months, and 3 years post-implantation.
QuickDASH (Disabilities of the Arm, Shoulder, and Hand) Score
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).
Time frame: 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.
Time frame: Baseline, 2 weeks, 2 months, and 3 years post-implantation.
Lead-related complications
Time frame: Up to 3 years
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Erzincan Binali Yildirim Universitesi