Reverse Shoulder ArthroplastyNCT07309796
Strengthening Exercises for Humeral Head Depressor Muscles
A study testing Conventional Rehabilitation Group and Depressor Muscle Strengthening Group in people with Reverse Shoulder Arthroplasty and Depressor Muscle Training, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Postoperative rehabilitation after reverse shoulder arthroplasty aims to improve pain control, range of motion, and functional capacity. However, studies examining the effects of strengthening exercises targeting the humeral head depressor muscles are limited. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Reverse Shoulder Arthroplasty, Depressor Muscle Training, Shoulder Rehabilitation
- What is being tested?
- Conventional Rehabilitation Group and Depressor Muscle Strengthening Group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2026to 2 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients scheduled for primary reverse total shoulder arthroplasty Intact teres minor confirmed by physical examination (Hornblower's test) and intraoperative assessment Ability to participate in physiotherapy or a home exercise program
Who cannot join
- Active infection Deltoid muscle insufficiency Inability or unwillingness to comply with randomization Prior shoulder arthroplasty on the same side Unwillingness to participate Inability to read or understand written instructions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kırşehir Ahi Evran University
Kırşehir, 40100
CANER KARARTI, PT, PhD, fzt.caner.92@gmail.com
About this study
Official title: The Effect of Strengthening Exercises for Humeral Head Depressor Muscles on Clinical Outcomes After Reverse Shoulder Arthroplasty
Postoperative rehabilitation after reverse shoulder arthroplasty aims to improve pain control, range of motion, and functional capacity. However, studies examining the effects of strengthening exercises targeting the humeral head depressor muscles are limited. This randomized controlled trial will evaluate the effects of adding a specific strengthening program to standard rehabilitation on pain, range of motion, quality of life, and functional outcomes.
Read the detailed description
Reverse shoulder arthroplasty (RSA) is an effective surgical method, particularly in cases of massive rotator cuff tears that lead to irreversible loss of shoulder function. The primary goals of postoperative rehabilitation are to reduce pain, improve shoulder joint functions, optimize scapulothoracic rhythm, and safely restore functional use. However, studies examining the effects of specific strengthening exercises targeting the humeral head depressor muscle group (latissimus dorsi, teres major, infraspinatus, etc.) on clinical outcomes are quite limited. This study aims to evaluate the effects of a specific strengthening protocol designed for the humeral head depressor muscles following reverse shoulder arthroplasty on pain, range of motion (ROM), quality of life, functional status, and psychological well-being. Planned as a randomized controlled trial, the research will apply an additional humeral head depressor muscle strengthening program to the standard conventional rehabilitation protocol in the experimental group, while the control group will receive only the standard rehabilitation program.
- Being tested
- Conventional Rehabilitation Group, Depressor Muscle Strengthening Group
- Keywords
- Reverse shoulder arthroplasty, Depressor muscle training. Shoulder, Arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Rehabilitation GroupOther
After randomization and baseline assessments, participants will undergo a standard 6-week postoperative shoulder rehabilitation program, consisting of range-of-motion exercises, scapular stabilization training, and progressive strengthening. No additional depressor muscle-specific exercises will be applied.
Depressor Muscle Strengthening GroupOther
After randomization and baseline assessments, participants will receive a 6-week rehabilitation program consisting of conventional postoperative shoulder rehabilitation combined with a specific strengthening protocol targeting the shoulder depressor muscles.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Rehabilitation Group | Active comparator | Participants undergoing reverse shoulder arthroplasty will receive a standard conventional rehabilitation program starting at postoperative 6 th week . The patient will receive treatment 5 days a week for 6 weeks, for a total of 30 sessions. The program consists of passive, active-assisted, and active/resisted exercises.
Exercises Included:
Passive / Assisted
* Scapular mobilization
* Scapular clock
* Passive external rotation with a stick Passive → Active-Assisted
* Active-assisted flexion and abduction with a stick
* Glenohumeral joint mobilization Active / Light Resistance
* Scapular retraction
* Light-resistance strengthening of biceps, triceps, and serratus anterior using a theraband Active / Resistance
* Theraband-based resisted biceps, triceps, and serratus anterior strengthening
* Continuation of glenohumeral mobilization
* Flexion and abduction above 90°
* Posterior capsule stretching Receives: Other: Conventional Rehabilitation Group |
| Depressor Muscle Strengthening Program | Experimental | Participants will receive specific strengthening exercises targeting the shoulder depressor muscles in addition to the conventional rehabilitation program. These exercises will be performed throughout the 6-week intervention period.
Additional Exercises:
Latissimus dorsi: Seated rowing exercise - 3 sets × 10 repetitions Pectoralis major: Supine fly exercise - 3 sets × 10 repetitions Teres major: Prone shoulder adduction, extension, and internal rotation exercise Receives: Other: Conventional Rehabilitation Group; Other: Depressor Muscle Strengthening Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity (Visual Analog Scale - VAS)
Pain intensity will be assessed using the Visual Analog Scale, a 10-cm line ranging from "no pain" to "worst imaginable pain." The distance from the "no pain" anchor to the participant's mark will be measured in millimeters (0-100 mm), with higher scores indicating higher pain intensity.
Measured: 6 weeks
Upper Extremity Disability (Disabilities of the Arm, Shoulder and Hand Questionnaire - DASH)
The DASH is a 30-item self-administered questionnaire assessing upper-extremity functional limitations. Items are scored 1-5 and converted to a 0-100 scale, where higher scores indicate greater disability.
Measured: 6 weeks
Shoulder Range of Motion (ROM)
Active shoulder flexion, abduction, external rotation, and internal rotation will be measured using a standard goniometer. Results will be recorded in degrees (°).
Measured: 6 weeks
Secondary outcomes (6)
Shoulder Function (American Shoulder and Elbow Surgeons Score - ASES)
The ASES score includes pain and functional assessments, yielding a total score between 0 and 100. Higher scores represent better shoulder function.
Measured: 6 weeks
Thoracic Kyphosis Angle (Spinal Mouse Assessment)
Thoracic spine curvature will be evaluated using the Spinal Mouse device during flexion and extension. The system provides non-invasive, objective measurements of thoracic kyphosis.
Measured: 6 weeks
Pain Catastrophizing (Pain Catastrophizing Scale - PCS)
The PCS consists of 13 items assessing rumination, magnification, and helplessness. Total scores range from 0 to 52, with higher scores indicating greater catastrophizing.
Measured: 6 weeks
Anxiety and Depression (Hospital Anxiety and Depression Scale - HADS)
HADS includes 14 items (7 anxiety, 7 depression), each scored 0-3. Higher scores indicate higher levels of anxiety or depression.
Measured: 6 weeks
Kinesiophobia (Tampa Scale of Kinesiophobia - TSK)
The TSK is a 17-item tool measuring fear of movement and reinjury. Scores range between 17 and 68, with higher scores indicating greater kinesiophobia.
Measured: 6 weeks
Quality of Life (12-Item Short-Form Health Survey - SF-12)
The SF-12 generates Physical Component Summary (PCS) and Mental Component Summary (MCS) scores ranging from 0 to 100. Higher scores reflect better health-related quality of life.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start2 Jan 2026
- Primary completion2 Sep 2026 (estimated)
- Study completion2 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reverse Shoulder ArthroplastyStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caner Karartı, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07309796
- Sponsor's protocol ID
- 20251224
- Status last verified
- Mar 2026
- First submitted
- 15 Dec 2025
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Strengthening Exercises for Humeral Head Depressor Muscles on Clinical Outcomes After Reverse Shoulder Arthroplasty
- ClinicalTrials.gov ID
- NCT07309796
- Acronym / sponsor ID
- 20251224
- Keywords
- Reverse shoulder arthroplasty, Depressor muscle training. Shoulder, Arthroplasty
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 2 Jan 2026 (actual)
- Primary completion
- 2 Sep 2026 (estimated)
- Study completion
- 2 Dec 2026 (estimated)
- First posted
- 30 Dec 2025 (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.
Postoperative rehabilitation after reverse shoulder arthroplasty aims to improve pain control, range of motion, and functional capacity. However, studies examining the effects of strengthening exercises targeting the humeral head depressor muscles are limited. This randomized controlled trial will evaluate the effects of adding a specific strengthening program to standard rehabilitation on pain, range of motion, quality of life, and functional outcomes.
Detailed description
Reverse shoulder arthroplasty (RSA) is an effective surgical method, particularly in cases of massive rotator cuff tears that lead to irreversible loss of shoulder function. The primary goals of postoperative rehabilitation are to reduce pain, improve shoulder joint functions, optimize scapulothoracic rhythm, and safely restore functional use. However, studies examining the effects of specific strengthening exercises targeting the humeral head depressor muscle group (latissimus dorsi, teres major, infraspinatus, etc.) on clinical outcomes are quite limited. This study aims to evaluate the effects of a specific strengthening protocol designed for the humeral head depressor muscles following reverse shoulder arthroplasty on pain, range of motion (ROM), quality of life, functional status, and psychological well-being. Planned as a randomized controlled trial, the research will apply an additional humeral head depressor muscle strengthening program to the standard conventional rehabilitation protocol in the experimental group, while the control group will receive only the standard rehabilitation program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized
| Arm | Type | Receives |
|---|---|---|
| Conventional Rehabilitation Group | Active comparator | Other: Conventional Rehabilitation GroupParticipants undergoing reverse shoulder arthroplasty will receive a standard conventional rehabilitation program starting at postoperative 6 th week . The patient will receive treatment 5 days a week for 6 weeks, for a total of 30 sessions. The program consists of passive, active-assisted, and active/resisted exercises. Exercises Included: Passive / Assisted * Scapular mobilization * Scapular clock * Passive external rotation with a stick Passive → Active-Assisted * Active-assisted flexion and abduction with a stick * Glenohumeral joint mobilization Active / Light Resistance * Scapular retraction * Light-resistance strengthening of biceps, triceps, and serratus anterior using a theraband Active / Resistance * Theraband-based resisted biceps, triceps, and serratus anterior strengthening * Continuation of glenohumeral mobilization * Flexion and abduction above 90° * Posterior capsule stretching |
| Depressor Muscle Strengthening Program | Experimental | Other: Conventional Rehabilitation Group, Other: Depressor Muscle Strengthening GroupParticipants will receive specific strengthening exercises targeting the shoulder depressor muscles in addition to the conventional rehabilitation program. These exercises will be performed throughout the 6-week intervention period. Additional Exercises: Latissimus dorsi: Seated rowing exercise - 3 sets × 10 repetitions Pectoralis major: Supine fly exercise - 3 sets × 10 repetitions Teres major: Prone shoulder adduction, extension, and internal rotation exercise |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for primary reverse total shoulder arthroplasty Intact teres minor confirmed by physical examination (Hornblower's test) and intraoperative assessment Ability to participate in physiotherapy or a home exercise program
Key exclusion criteria (1 listed)
- Active infection Deltoid muscle insufficiency Inability or unwillingness to comply with randomization Prior shoulder arthroplasty on the same side Unwillingness to participate Inability to read or understand written instructions
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 |
|---|---|---|
| Conventional Rehabilitation GroupAfter randomization and baseline assessments, participants will undergo a standard 6-week postoperative shoulder rehabilitation program, consisting of range-of-motion exercises, scapular stabilization training, and progressive strengthening. No additional depressor muscle-specific exercises will be applied. | Other | Conventional Rehabilitation Group, Depressor Muscle Strengthening Program |
| Depressor Muscle Strengthening GroupAfter randomization and baseline assessments, participants will receive a 6-week rehabilitation program consisting of conventional postoperative shoulder rehabilitation combined with a specific strengthening protocol targeting the shoulder depressor muscles. | Other | Depressor Muscle Strengthening Program |
Primary outcome
Pain Intensity (Visual Analog Scale - VAS)
Time frame: 6 weeks
Pain intensity will be assessed using the Visual Analog Scale, a 10-cm line ranging from "no pain" to "worst imaginable pain." The distance from the "no pain" anchor to the participant's mark will be measured in millimeters (0-100 mm), with higher scores indicating higher pain intensity.
Upper Extremity Disability (Disabilities of the Arm, Shoulder and Hand Questionnaire - DASH)
Time frame: 6 weeks
The DASH is a 30-item self-administered questionnaire assessing upper-extremity functional limitations. Items are scored 1-5 and converted to a 0-100 scale, where higher scores indicate greater disability.
Shoulder Range of Motion (ROM)
Time frame: 6 weeks
Active shoulder flexion, abduction, external rotation, and internal rotation will be measured using a standard goniometer. Results will be recorded in degrees (°).
6 secondary outcomes
Shoulder Function (American Shoulder and Elbow Surgeons Score - ASES)
Time frame: 6 weeks
Thoracic Kyphosis Angle (Spinal Mouse Assessment)
Time frame: 6 weeks
Pain Catastrophizing (Pain Catastrophizing Scale - PCS)
Time frame: 6 weeks
Anxiety and Depression (Hospital Anxiety and Depression Scale - HADS)
Time frame: 6 weeks
Kinesiophobia (Tampa Scale of Kinesiophobia - TSK)
Time frame: 6 weeks
Quality of Life (12-Item Short-Form Health Survey - SF-12)
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Rehabilitation Group and Depressor Muscle Strengthening Group in people with Reverse Shoulder Arthroplasty and Depressor Muscle Training, run by Hacettepe University 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 3 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caner KARARTI, Assoc. Prof. (903862805362, fzt.caner.92@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (Visual Analog Scale - VAS) (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Mar 2026.