Mobility LimitationNCT05450666
Effectiveness of Mobility Exercises in Resistance-Trained Males With Shoulder Immobility in Different Age Groups
A study testing mobility exercises in people with Mobility Limitation and Exercises, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
The shoulder is a dynamic and mobile joint between the arm and the trunk. The movement of the joint in three dimensions performs complex movements in almost every activity of daily life. These movements performed during activities of daily living can cause musculoskeletal problems and shoulder pathologies. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Mobility Limitation, Exercises
- What is being tested?
- mobility exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jul 2022to 15 Sep 2022
- 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 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Resistance-trained males over the age of 18 with shoulder immobility.
Who cannot join
- The criteria for exclusion from the study were: having orthopedic or neurological problems, and having undergone upper extremity musculoskeletal surgery.
- Female resistance-trained,
- Athletes under the age of 18 will not be included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
The shoulder is a dynamic and mobile joint between the arm and the trunk. The movement of the joint in three dimensions performs complex movements in almost every activity of daily life.
These movements performed during activities of daily living can cause musculoskeletal problems and shoulder pathologies. For this reason, the shoulder joint should be carefully evaluated, especially in athletes.
Read the detailed description
The shoulder consists of four functional joints. Glenohumeral joint (GH), acromioclavicular joint (AC), sternoclavicular joint (SC), and scapulothoracic joint (ST). The most mobile of these four joints is the glenohumeral joint, located between the scapula and the glenoid. The GH is a synovial joint that has three-dimensional motion, covers the intra-articular capsule, and wraps the biceps long head tendon to the biceps sulcus. The glenohumeral capsule, glenohumeral ligament, and coracohumeral ligament contain a capsuloligamentous complex structure. This complex structure and the rotator cuff tendons form a static and dynamic restrictive structure around the glenohumeral joint. The rotator cuff space forms a triangular tissue between the edge of the anterior supraspinatus tendon and the superior subscapularis, and the apex is located on the lateral ridge of the biceps sulcus at the edge of the humeral ligament.
After providing mobility, movement and balance will return to stability. Increasing muscle strength for joint stabilization is a physical training goal for the shoulder in athletes.
Bone mechanics, intra-articular pressure, glenohumeral labrum and capuloligamentous structures are static components.
Dynamic components are provided by muscle activity coordinated around the joint and modulated by the neuromuscular system.
The basis of static and dynamic interactions is mainly proprioceptive inputs that occur with mechanoreceptors in the muscles, joint capsule ligaments, tendons and skin, which are integrated into each other.
Joint stabilization is provided by the coactivation force of dynamic shoulder stabilizers.
The balance of such forces must be proportional. For this reason, exercises to provide joint stabilization should aim to provide equal force distribution around the joint.
Among the criteria for evaluating the athletes; proprioception and range of motion.
Body Awareness Questionnaire aims to evaluate body awareness. Posture will be evaluated with New York posture analysis.
As a result of the literature review carried out; As far as is known, there is no adequate, up-to-date and evidence-based study in the literature.
- Conditions
- Mobility Limitation, Exercises
- Being tested
- mobility exercises
- Keywords
- exercise, body builders
- Medical subject headings
- Mobility Limitation, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobility exercisesOther
Before starting the exercise program, a video and exercise program including the importance of shoulder mobilization and stabilization and the knowledge of how to contract the right muscle groups will be shared in order to raise awareness of the athletes. Following the evaluations, in addition to the classical training programs, the athletes will perform the Wall Angels and Anterior Shoulder Stretch, Shoulder Circle Rotation, Prone Shoulder Controlled Articular Rotations and Shoulder Side Stretch exercises, Prone I, T, W, Y's 3 days a week for 8 weeks, accompanied by the same physiotherapist.
| Study group | Role | What they receive |
|---|---|---|
| YOUNG GROUP | Experimental | The same exercise program will be applied to both groups. Participants will be included in the exercise program for eight weeks. Athletes between the ages of 18 and 30 will be included in this group. Receives: Other: mobility exercises |
| ADULT GROUP | Experimental | The same exercise program will be applied to both groups. Participants will be included in the exercise program for eight weeks. Athletes between the ages of 30 and 60 will be included in this group. Receives: Other: mobility exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Awareness Questionnairei
Body awareness basically refers to an individual's awareness of body parts. Body awareness measurement provides the definition of body awareness and evaluation of the effectiveness of the exercise programs to be applied. Body Awareness Questionnaire is a questionnaire consisting of four subgroups (changes in body process, sleep-wake cycle, prediction at the onset of the disease, prediction of body responses) and a total of 18 statements, which are conducted to determine the normal or abnormal sensitivity level of body components. Individuals are asked to score between 1 and 7 for each statement. Grading is done on the total score. A high score indicates that the individual's body sensitivity is good.
Measured: 8 weeks
The range of motion
The range of motion of the shoulder flexion, abduction, internal and external rotator muscles will be measured with a goniometer. Measurements will be made by the dominant side of the athlete in evaluations other than bilateral functional tests. Joint range of motion assessment was measured with a goniometer
Measured: 8 weeks
Secondary outcomes (1)
New York Posture Scale
Posture is the state of being in the most suitable position of every part of the body in relation to the adjacent segment and the whole body.
Posture analysis is done while standing upright. The postures of the subjects participating in the study were evaluated with the New York Posture Scale. In this evaluation system, posture that can occur in 13 different parts of the body is evaluated. For scoring, a score of five was given if the person's posture was correct, three if it was moderately impaired, and one if it was severely impaired. The total score obtained with the test evaluation is a maximum of 65 and a minimum of 13. The standard evaluation criteria developed for this test were defined as "very good" if the total score is >=45, "good" if 40-44, "moderate" if 30-39, "poor" if 20-29, and "poor" if <=19. detected.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start3 Jul 2022
- Primary completion3 Sep 2022
- Study completion15 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mobility LimitationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Evaluation was made before the exercise application, after the eight-week application.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hazal genc, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05450666
- Sponsor's protocol ID
- hazal genç 3
- Status last verified
- Sep 2022
- First submitted
- 4 Jul 2022
- Last updated
- 16 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Salles JI, Costa F, Cunha-Cruz V, Cagy M, Piedade R, Ribeiro P. Electrophysiological analysis of the perception of passive movement. Neurosci Lett. 2011 Aug 26;501(2):61-6. doi: 10.1016/j.neulet.2011.05.005. Epub 2011 May 7.
PubMed 21596095Moro T, Tinsley G, Bianco A, Marcolin G, Pacelli QF, Battaglia G, Palma A, Gentil P, Neri M, Paoli A. Effects of eight weeks of time-restricted feeding (16/8) on basal metabolism, maximal strength, body composition, inflammation, and cardiovascular risk factors in resistance-trained males. J Transl Med. 2016 Oct 13;14(1):290. doi: 10.1186/s12967-016-1044-0.
PubMed 27737674
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Mobility Exercises in Resistance-Trained Males With Shoulder Immobility in Different Age Groups
- ClinicalTrials.gov ID
- NCT05450666
- Acronym / sponsor ID
- hazal genç 3
- Conditions
- Mobility Limitation, Exercises
- Keywords
- exercise, body builders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 3 Jul 2022 (actual)
- Primary completion
- 3 Sep 2022 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 11 Jul 2022 (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.
The shoulder is a dynamic and mobile joint between the arm and the trunk. The movement of the joint in three dimensions performs complex movements in almost every activity of daily life.
These movements performed during activities of daily living can cause musculoskeletal problems and shoulder pathologies. For this reason, the shoulder joint should be carefully evaluated, especially in athletes.
Detailed description
The shoulder consists of four functional joints. Glenohumeral joint (GH), acromioclavicular joint (AC), sternoclavicular joint (SC), and scapulothoracic joint (ST). The most mobile of these four joints is the glenohumeral joint, located between the scapula and the glenoid. The GH is a synovial joint that has three-dimensional motion, covers the intra-articular capsule, and wraps the biceps long head tendon to the biceps sulcus. The glenohumeral capsule, glenohumeral ligament, and coracohumeral ligament contain a capsuloligamentous complex structure. This complex structure and the rotator cuff tendons form a static and dynamic restrictive structure around the glenohumeral joint. The rotator cuff space forms a triangular tissue between the edge of the anterior supraspinatus tendon and the superior subscapularis, and the apex is located on the lateral ridge of the biceps sulcus at the edge of the humeral ligament.
After providing mobility, movement and balance will return to stability. Increasing muscle strength for joint stabilization is a physical training goal for the shoulder in athletes.
Bone mechanics, intra-articular pressure, glenohumeral labrum and capuloligamentous structures are static components.
Dynamic components are provided by muscle activity coordinated around the joint and modulated by the neuromuscular system.
The basis of static and dynamic interactions is mainly proprioceptive inputs that occur with mechanoreceptors in the muscles, joint capsule ligaments, tendons and skin, which are integrated into each other.
Joint stabilization is provided by the coactivation force of dynamic shoulder stabilizers.
The balance of such forces must be proportional. For this reason, exercises to provide joint stabilization should aim to provide equal force distribution around the joint.
Among the criteria for evaluating the athletes; proprioception and range of motion.
Body Awareness Questionnaire aims to evaluate body awareness. Posture will be evaluated with New York posture analysis.
As a result of the literature review carried out; As far as is known, there is no adequate, up-to-date and evidence-based study in the literature.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Evaluation was made before the exercise application, after the eight-week application.
| Arm | Type | Receives |
|---|---|---|
| YOUNG GROUP | Experimental | Other: mobility exercisesThe same exercise program will be applied to both groups. Participants will be included in the exercise program for eight weeks. Athletes between the ages of 18 and 30 will be included in this group. |
| ADULT GROUP | Experimental | Other: mobility exercisesThe same exercise program will be applied to both groups. Participants will be included in the exercise program for eight weeks. Athletes between the ages of 30 and 60 will be included in this group. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Resistance-trained males over the age of 18 with shoulder immobility.
Key exclusion criteria (3 listed)
- The criteria for exclusion from the study were: having orthopedic or neurological problems, and having undergone upper extremity musculoskeletal surgery.
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 |
|---|---|---|
| mobility exercisesBefore starting the exercise program, a video and exercise program including the importance of shoulder mobilization and stabilization and the knowledge of how to contract the right muscle groups will be shared in order to raise awareness of the athletes. Following the evaluations, in addition to the classical training programs, the athletes will perform the Wall Angels and Anterior Shoulder Stretch, Shoulder Circle Rotation, Prone Shoulder Controlled Articular Rotations and Shoulder Side Stretch exercises, Prone I, T, W, Y's 3 days a week for 8 weeks, accompanied by the same physiotherapist. | Other | ADULT GROUP, YOUNG GROUP |
Primary outcome
Body Awareness Questionnairei
Time frame: 8 weeks
Body awareness basically refers to an individual's awareness of body parts. Body awareness measurement provides the definition of body awareness and evaluation of the effectiveness of the exercise programs to be applied. Body Awareness Questionnaire is a questionnaire consisting of four subgroups (changes in body process, sleep-wake cycle, prediction at the onset of the disease, prediction of body responses) and a total of 18 statements, which are conducted to determine the normal or abnormal sensitivity level of body components. Individuals are asked to score between 1 and 7 for each statement. Grading is done on the total score. A high score indicates that the individual's body sensitivity is good.
The range of motion
Time frame: 8 weeks
The range of motion of the shoulder flexion, abduction, internal and external rotator muscles will be measured with a goniometer. Measurements will be made by the dominant side of the athlete in evaluations other than bilateral functional tests. Joint range of motion assessment was measured with a goniometer
1 secondary outcome
New York Posture Scale
Time frame: 8 weeks
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 16 Sep 2022.
- Background: PubMed 21596095Salles JI, Costa F, Cunha-Cruz V, Cagy M, Piedade R, Ribeiro P. Electrophysiological analysis of the perception of passive movement. Neurosci Lett. 2011 Aug 26;501(2):61-6. doi: 10.1016/j.neulet.2011.05.005. Epub 2011 May 7.
- Background: PubMed 27737674Moro T, Tinsley G, Bianco A, Marcolin G, Pacelli QF, Battaglia G, Palma A, Gentil P, Neri M, Paoli A. Effects of eight weeks of time-restricted feeding (16/8) on basal metabolism, maximal strength, body composition, inflammation, and cardiovascular risk factors in resistance-trained males. J Transl Med. 2016 Oct 13;14(1):290. doi: 10.1186/s12967-016-1044-0.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mobility exercises in people with Mobility Limitation and Exercises, run by Istanbul Medipol University Hospital 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 3 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 16 Sep 2022. 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?
Body Awareness Questionnairei (time frame: 8 weeks). The study lists 2 primary outcomes in all. 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 NCT05450666, which also lists 2 linked publications.
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 16 Sep 2022.