Hôpital National d'Instruction des Armées Sainte-Anne
Toulon, Var, 83000, France
Location status: Recruiting
Location contact
Sergio AFONSO, Physiotherapist
CONTACT
04 83 16 20 10 ext. +33
Sergio AFONSO, Physiotherapist
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06905093
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Toulon, Var, 83000, France
Location status: Recruiting
Sergio AFONSO, Physiotherapist
CONTACT
04 83 16 20 10 ext. +33
Sergio AFONSO, Physiotherapist
PRINCIPAL_INVESTIGATOR
The study is structured into four visits:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Standard care including rehabilitation sessions three times per week.
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.
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.
Time frame: Preoperatively and at the end of the 4-6 weeks immobilization period
Isometric maximal voluntary strength will be assessed using an isokinetic dynamometer.
Time frame: 6 weeks and 17 weeks after immobilization
Isometric maximal voluntary strength will be assessed using an isokinetic dynamometer.
Time frame: Preoperatively, at the end of the 4-6 weeks immobilization period, and then 6 weeks and 17 weeks after immobilization
Isometric maximal voluntary strength will be assessed using an isokinetic dynamometer.
Time frame: Preoperatively, at the end of the 4-6 weeks immobilization period, and then 6 weeks and 17 weeks after immobilization
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
Time frame: 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 arms muscles will be measured by ultrasound.
Time frame: Preoperatively, at the end of the 4-6 weeks immobilization period, and then 6 weeks and 17 weeks after immobilization
Maximum load lifted once (1-RM, in kilograms) for elbow flexors and extensors of the immobilized arm and the non-immobilized arm.
Time frame: Preoperatively, at the end of the 4-6 weeks immobilization period, and then 6 weeks and 17 weeks after immobilization
Handgrip strength in kilograms will be assessed for the immobilized arm and the non-immobilized arm.
Time frame: Preoperatively, at the end of the 4-6 weeks immobilization period, and then 6 weeks and 17 weeks after immobilization
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.
Time frame: Preoperatively, at the end of the 4-6 weeks immobilization period, and then 6 weeks and 17 weeks after immobilization
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.
Time frame: Preoperatively, at the end of the 4-6 weeks immobilization period, and then 6 weeks and 17 weeks after immobilization
Joint position sense measurement of the immobilized arm and the non-immobilized arm.
Time frame: Preoperatively, at the end of the 4-6 weeks immobilization period, and then 6 weeks and 17 weeks after immobilization
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.
Time frame: 17 weeks after immobilization
The S-STARTS test consists of 5 validated tests that assess neuromuscular control after shoulder surgery. Higher scores indicate better shoulder function.
Time frame: Before and after each exercise during the 4-6 weeks immobilization period
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.
Time frame: After each exercise during the 4-6 weeks immobilization period
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).
Contact information is provided by the study sponsor or research team.
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Other
Acronym: EXC-IMMO
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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