Cardiac Implantable Electronic Device (CIED)NCT07496554
Long-term Effects of Early Shoulder Exercise After CIED Implantation
A study testing Structured Stretching and Strengthening Program, Standard Post-operative Care and Pendulum Exercise Protocol in people with Cardiac Implantable Electronic Device (CIED) and Shoulder Dysfunction, run by Erzincan Binali Yildirim Universitesi at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Implantable Electronic Device (CIED), Shoulder Dysfunction
- What is being tested?
- Structured Stretching and Strengthening Program, Standard Post-operative Care and Pendulum Exercise Protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2021to 23 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years or older.
- Patients undergoing first-time transvenous subcutaneous prepectoral CIED (Pacemaker, ICD, or CRT) implantation.
- Patients with no prior history of major shoulder surgery or chronic shoulder pathology on the side of the implantation.
- Patients who are capable of understanding and performing the prescribed exercise protocols.
- Patients who provided written informed consent to participate in a 3-year longitudinal follow-up.
Who cannot join
- Patients undergoing revision or replacement procedures of existing devices or leads.
- Pre-existing frozen shoulder, rotator cuff tear, or severe adhesive capsulitis on the implantation side.
- Neurological or musculoskeletal disorders affecting upper limb function (e.g., prior stroke sequelae or severe cervical disc herniation).
- Cognitive impairment or psychiatric disorders preventing cooperation with the study protocol.
- Lead-related complications (e.g., dislodgement or cardiac perforation) occurring within the first 2 weeks post-implantation, prior to the initiation of the exercise program.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erzincan Binali Yildirim University, Faculty of Medicine
Erzincan, Erzincan, 24100
About this study
Official title: Effects of Early Shoulder Exercise on Functional Recovery After CIED Implantation: A 3-Year Randomized Cohort Follow-Up
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.
Read the detailed description
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:
- Control group (standard care),
- Pendulum Exercise (PE) group,
- Stretching and Strengthening Exercise (SSE) group.
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.
- Being tested
- Structured Stretching and Strengthening Program, Standard Post-operative Care, Pendulum Exercise Protocol
- Keywords
- Shoulder Pain, Muscle Strength, Range of Motion, Quality of Life, Postoperative Complications
- Medical subject headings
- Shoulder Pain, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Stretching and Strengthening ProgramBehavioural
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 Post-operative CareOther
Standard clinical follow-up and verbal instructions regarding temporary activity restrictions (e.g., avoiding heavy lifting) without a structured exercise intervention.
Pendulum Exercise ProtocolBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Standard Post-operative Care |
| 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. Receives: Behavioral: Pendulum Exercise Protocol |
| 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. Receives: Behavioral: Structured Stretching and Strengthening Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (pre-implantation), 2 weeks, 2 months, and 3 years post-implantation.
Secondary outcomes (3)
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.
Measured: 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).
Measured: 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.
Measured: Baseline, 2 weeks, 2 months, and 3 years post-implantation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Feb 2021
- Primary completion1 Mar 2026
- Study completion23 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac Implantable Electronic Device (CIED)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erzincan Binali Yildirim Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muharrem Said Coşgun, Erzincan Binali Yildirim Universitesi
- Investigators
- Muharrem Said Cosgun, MD, Assoc. Prof., Principal investigator, Erzincan Binali Yildirim University, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07496554
- Sponsor's protocol ID
- 2025-22/01
- Other IDs
- 2025-22/01
- Status last verified
- Mar 2026
- First submitted
- 23 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cosgun MS, Cosgun C. Effects of early shoulder exercise on functional recovery after cardiac implantable electronic device implantation: A 3-year randomized cohort follow-up. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2026 Aug 18. doi: 10.5507/bp.2026.024. Online ahead of print.
PubMed 42626767
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Early Shoulder Exercise on Functional Recovery After CIED Implantation: A 3-Year Randomized Cohort Follow-Up
- ClinicalTrials.gov ID
- NCT07496554
- Acronym / sponsor ID
- 2025-22/01
- Keywords
- Shoulder Pain, Muscle Strength, Range of Motion, Quality of Life, Postoperative Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Erzincan Binali Yildirim UniversitesiUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 23 Mar 2026 (actual)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Control group (standard care),
- Pendulum Exercise (PE) group,
- Stretching and Strengthening Exercise (SSE) group.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | Other | Other: Standard Post-operative Careatients 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 | Behavioral: Pendulum Exercise ProtocolPatients 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. |
| Stretching and Strengthening Exercise (SSE) Group | Experimental | Behavioral: Structured Stretching and Strengthening ProgramPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 18 years or older.
- Patients undergoing first-time transvenous subcutaneous prepectoral CIED (Pacemaker, ICD, or CRT) implantation.
- Patients with no prior history of major shoulder surgery or chronic shoulder pathology on the side of the implantation.
- Patients who are capable of understanding and performing the prescribed exercise protocols.
- Patients who provided written informed consent to participate in a 3-year longitudinal follow-up.
Key exclusion criteria (5 listed)
- Patients undergoing revision or replacement procedures of existing devices or leads.
- Pre-existing frozen shoulder, rotator cuff tear, or severe adhesive capsulitis on the implantation side.
- Neurological or musculoskeletal disorders affecting upper limb function (e.g., prior stroke sequelae or severe cervical disc herniation).
- Cognitive impairment or psychiatric disorders preventing cooperation with the study protocol.
- Lead-related complications (e.g., dislodgement or cardiac perforation) occurring within the first 2 weeks post-implantation, prior to the initiation of the exercise program.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Stretching and Strengthening ProgramA 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. | Behavioural | Stretching and Strengthening Exercise (SSE) Group |
| Standard Post-operative CareStandard clinical follow-up and verbal instructions regarding temporary activity restrictions (e.g., avoiding heavy lifting) without a structured exercise intervention. | Other | Control Group |
| Pendulum Exercise ProtocolParticipants 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. | Behavioural | Pendulum Exercise (PE) Group |
Primary outcome
Shoulder Range of Motion (ROM) - Flexion and Abduction
Time frame: Baseline (pre-implantation), 2 weeks, 2 months, and 3 years post-implantation.
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.
3 secondary outcomes
Hand Grip Strength
Time frame: Baseline, 2 weeks, 2 months, and 3 years post-implantation.
QuickDASH (Disabilities of the Arm, Shoulder, and Hand) Score
Time frame: Baseline, 2 weeks, 2 months, and 3 years post-implantation.
hort Form-36 (SF-36) Health Survey
Time frame: Baseline, 2 weeks, 2 months, and 3 years post-implantation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Derived from this study: PubMed 42626767Cosgun MS, Cosgun C. Effects of early shoulder exercise on functional recovery after cardiac implantable electronic device implantation: A 3-year randomized cohort follow-up. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2026 Aug 18. doi: 10.5507/bp.2026.024. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muharrem Said Cosgun, MD, Assoc. Prof. principal investigator
Erzincan Binali Yildirim University, Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Stretching and Strengthening Program, Standard Post-operative Care and Pendulum Exercise Protocol in people with Cardiac Implantable Electronic Device (CIED) and Shoulder Dysfunction, run by Erzincan Binali Yildirim Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder Range of Motion (ROM) - Flexion and Abduction (time frame: Baseline (pre-implantation), 2 weeks, 2 months, and 3 years post-implantation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07496554, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.