Eccentric or Concentric Contralateral Training in Rehabilitation After Shoulder Surgery With Elbow Immobilization (EXC-IMMO)

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.

Study Overview

• Status: Recruiting
• Conditions: Shoulder Surgery
• Intervention / Treatment: Other: Standard care; Other: Eccentric training of the non-immobilized arm; Other: Concentric training of the non-immobilized arm

Detailed Description

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:

  • Isometric maximal voluntary strength of elbow flexors and extensors using an isokinetic dynamometer.
  • 1-RM (one-repetition maximum) for elbow flexors and extensors.
  • Arm circumference at 5, 10, and 15 cm from the elbow crease.
  • Anatomical cross-sectional area of arm muscles using ultrasound.
  • Forearm circumference at 5 cm from the elbow crease.
  • Handgrip strength (finger flexors).
  • Functional scores: DASH (Disabilities of the Arm, Shoulder, and Hand), Constant-Murley, joint position sense (proprioception), and muscle stiffness.

• Following surgery, patients enter a 4-6 weeks' immobilization period, during which they are randomly assigned to one of three groups:

  • Control Group (CTRL): Receives standard care, including rehabilitation sessions three times per week.
  • Eccentric Training Group (EXC): Performs standard care plus eccentric training of the non-immobilized arm.
  • Concentric Training Group (CON): Performs standard care plus concentric training of the non-immobilized arm.

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:

• V2 (POST): At the end of immobilization, the same measurements as V1 are repeated
• V3 (POST + 6 weeks): Measurements are repeated again.
• V4 (POST + 17 weeks): Measurements are repeated again.

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Magali CESANA; Phone Number: +33 04 83 77 20 60; Email: magali.cesana@ch-toulon.fr

Study Locations

• France
  • Var
    • Toulon, Var, France, 83000
      • Recruiting
      • Hôpital National d'Instruction des Armées Sainte-Anne
      • Contact: Sergio AFONSO, Physiotherapist; Phone Number: +33 04 83 16 20 10; Email: sergio.pimenta-afonso@intradef.gouv.fr
      • Principal Investigator: Sergio AFONSO, Physiotherapist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult patient (≥ 18 years old) undergoing shoulder surgery (i.e., Bankart procedure, rotator cuff repair, arthroplasty)
• With an indication for immobilization, expected to last 4 to 6 weeks
• Free from any neurological pathology
• Having provided their informed consent before any participation in the research

Exclusion Criteria:

• Having a medical contraindication to the practice of physical and sports activities
• Presenting an expected modification of their physical activity of the non-immobilized limb
• Having suffered an injury to the upper limbs in the last 6 months
• Having already undergone surgery on the upper limbs
• Pregnant, parturient, and breastfeeding women
• Presenting a medically established alteration of their cognitive functions
• Subject under guardianship, curatorship, family empowerment, or judicial safeguard
• Not affiliated or beneficiary of health insurance coverage
• Any other reason that, in the investigator's opinion, could interfere with the evaluation of the study objectives

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group (CTRL); Patients receive standard care	Other: Standard care; Standard care including rehabilitation sessions three times per week.
Experimental: Eccentric Training Group (EXC); Patients receive standard care plus eccentric training of the non-immobilized arm.	Other: Standard care; Standard care including rehabilitation sessions three times per week.; Other: Eccentric training of the non-immobilized arm; 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.
Experimental: Concentric Training Group (CON); Patients receive standard care plus concentric training of the non-immobilized arm.	Other: Standard care; Standard care including rehabilitation sessions three times per week.; Other: Concentric training of the non-immobilized arm; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
• Collaborators: Sainte-Anne Military Teaching Hospital
• Investigators: Study Director: Sergio AFONSO, Physiotherapist, Hôpital National d'Instruction des Armées Sainte-Anne

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: March 25, 2025
• First Submitted That Met QC Criteria: March 31, 2025
• First Posted (Actual): April 1, 2025

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Rehabilitation; Immobilization; Contralateral training; Cross-education; Eccentric training; Concentric training
• Additional Relevant MeSH Terms: Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: 2024-CHITS-014; 2024-A02862-45 (Other Identifier: Id-RCB number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No