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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A02862-45 | Other Identifier | Id-RCB number |
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| Name | Class |
|---|---|
| Sainte-Anne Military Teaching Hospital | UNKNOWN |
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This clinical study investigates whether contralateral training (exercising the non-immobilized arm) can help preserve muscle strength and mass in patients recovering from shoulder surgery with elbow immobilization. Immobilization is often necessary to prevent further injury, but it can lead to significant muscle loss and reduced strength, delaying recovery and increasing healthcare costs. Recent studies suggest that training the non-immobilized arm may help maintain muscle function in the immobilized arm, particularly when using eccentric exercises (where muscles lengthen under tension). This study aims to compare the effects of eccentric and concentric (shortening) contralateral training versus standard care (no training) in patients undergoing shoulder surgery.
The study involves 4 visits: pre-surgery assessments, a 4-6 weeks' immobilization period with or without training, and follow-ups at the end of immobilization, 6 weeks' post-immobilization, and 17 weeks' post-immobilization. Participants will be randomly assigned to one of three groups: a control group receiving standard care, a group performing eccentric training, or a group performing concentric training. Muscle strength, mass, and function will be measured using tests such as isometric strength, ultrasound imaging, and functional scores.
The hypothesis is that eccentric contralateral training will better preserve neuromuscular function and muscle mass in the immobilized arm compared to both standard care and concentric training. This could lead to faster recovery and improved outcomes for patients. The study will provide valuable insights into optimizing rehabilitation strategies for patients recovering from shoulder surgery.
The study is structured into four visits:
Inclusion Visit (V0): During the pre-surgical consultation, patients are informed about the study and provided with an information sheet and consent form.
Pre-Surgery Visit (V1, PRE): Conducted within 7 days before surgery, this visit includes baseline measurements on both arms (immobilized and non-immobilized). Assessments include:
Following surgery, patients enter a 4-6 weeks' immobilization period, during which they are randomly assigned to one of three groups:
The training protocol involves 3 sessions per week, separated by 24-48 hours. Each session includes 4-6 sets of 10 repetitions of elbow flexion/extension exercises on the non-immobilized arm at 60-90% of 1-RM, depending on the week. Eccentric or concentric actions are performed based on group assignment, with controlled contraction duration (4 seconds) using a metronome. Rest periods of 2 seconds between repetitions and 2 minutes between sets are provided.
• Follow-Up Visits:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group (CTRL) | Active Comparator | Patients receive standard care |
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| Eccentric Training Group (EXC) | Experimental | Patients receive standard care plus eccentric training of the non-immobilized arm. |
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| Concentric Training Group (CON) | Experimental | Patients receive standard care plus concentric training of the non-immobilized arm. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard care | Other | Standard care including rehabilitation sessions three times per week. |
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| Measure | Description | Time Frame |
|---|---|---|
| Isometric maximal voluntary strength of the immobilized arm | Isometric maximal voluntary strength will be assessed using an isokinetic dynamometer. | Preoperatively and at the end of the 4-6 weeks immobilization period |
| Measure | Description | Time Frame |
|---|---|---|
| Isometric maximal voluntary strength of the immobilized arm | Isometric maximal voluntary strength will be assessed using an isokinetic dynamometer. | 6 weeks and 17 weeks after immobilization |
| Isometric maximal voluntary strength of the non-immobilized arm |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Magali Cesana | Contact | 04 83 77 20 60 | +33 | magali.cesana@ch-toulon.fr |
| Name | Affiliation | Role |
|---|---|---|
| Sergio AFONSO, Physiotherapist | Hôpital National d'Instruction des Armées Sainte-Anne | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital National d'Instruction des Armées Sainte-Anne | Recruiting | Toulon | Var | 83000 | France |
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| Eccentric training of the non-immobilized arm | Other | The training protocol involves 3 sessions per week, separated by 24-48 hours. Each session includes 4-6 sets of 10 repetitions of elbow flexion/extension exercises on the non-immobilized arm at 60-90% of 1-RM, depending on the week. Eccentric actions are performed with controlled contraction duration (4 seconds) using a metronome. Rest periods of 2 seconds between repetitions and 2 minutes between sets are provided. |
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| Concentric training of the non-immobilized arm | Other | The training protocol involves 3 sessions per week, separated by 24-48 hours. Each session includes 4-6 sets of 10 repetitions of elbow flexion/extension exercises on the non-immobilized arm at 60-90% of 1-RM, depending on the week. Concentric actions are performed with controlled contraction duration (4 seconds) using a metronome. Rest periods of 2 seconds between repetitions and 2 minutes between sets are provided. |
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Isometric maximal voluntary strength will be assessed using an isokinetic dynamometer. |
| Preoperatively, at the end of the 4-6 weeks immobilization period, and then 6 weeks and 17 weeks after immobilization |
| Circumference of the immobilized arm and the non-immobilized arm | Arm circumference will be assessed in cm at 5, 10, and 15 cm from the elbow crease and forearm circumference at 5 cm from the elbow crease | Preoperatively, at the end of the 4-6 weeks immobilization period, and then 6 weeks and 17 weeks after immobilization |
| Anatomical cross-sectional area of the immobilized arm and the non-immobilized arm | Anatomical cross-sectional area of arms muscles will be measured by ultrasound. | Preoperatively, at the end of the 4-6 weeks immobilization period, and then 6 weeks and 17 weeks after immobilization |
| Maximum load, one repetition maximum (1-RM) for elbow flexors and extensors | Maximum load lifted once (1-RM, in kilograms) for elbow flexors and extensors of the immobilized arm and the non-immobilized arm. | Preoperatively, at the end of the 4-6 weeks immobilization period, and then 6 weeks and 17 weeks after immobilization |
| Handgrip strength (finger flexors) | Handgrip strength in kilograms will be assessed for the immobilized arm and the non-immobilized arm. | Preoperatively, at the end of the 4-6 weeks immobilization period, and then 6 weeks and 17 weeks after immobilization |
| Disabilities of the Arm, Shoulder and Hand (DASH) score | The DASH is a self-report 30-item questionnaire. Patients can rate difficulty and interference with daily life on a 5 point Likert scale. The scoring ranges from 0 for best to 100 for worst outcomes. | Preoperatively, at the end of the 4-6 weeks immobilization period, and then 6 weeks and 17 weeks after immobilization |
| Constant-Murley score | Pain and activities of daily living are answered by the patient ; range of motion and strength are answered by the clinician. The possible maximum total score ranges from 0 to 100. Higher scores indicate better shoulder function. | Preoperatively, at the end of the 4-6 weeks immobilization period, and then 6 weeks and 17 weeks after immobilization |
| Joint position sense (proprioception) | Joint position sense measurement of the immobilized arm and the non-immobilized arm. | Preoperatively, at the end of the 4-6 weeks immobilization period, and then 6 weeks and 17 weeks after immobilization |
| Muscle stiffness | Muscle stiffness of the immobilized arm and the non-immobilized arm will be assessed by a device named MyotonPro. A smaller muscle stiffness indicates a better outcome. | Preoperatively, at the end of the 4-6 weeks immobilization period, and then 6 weeks and 17 weeks after immobilization |
| Shoulder-SanTy Athletic Return To Sport (S-STARTS) score | The S-STARTS test consists of 5 validated tests that assess neuromuscular control after shoulder surgery. Higher scores indicate better shoulder function. | 17 weeks after immobilization |
| Pain intensity of the non-immobilized arm according to a numerical rating scale (NRS) | Pain intensity will be assessed using a Numeric Rating Scale (NRS). The minimum value of the scale, corresponding to no pain at all, is 0 and the maximum value is 10. | Before and after each exercise during the 4-6 weeks immobilization period |
| Borg rating of perceived exertion (RPE) scale | The CR-10 Borg Scale will be presented to the participants after cessation of each exercise to measure the rate of perceived exertion (RPE). Possible scores range from 0 (no effort, resting) to 10 (maximal effort). | After each exercise during the 4-6 weeks immobilization period |
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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