Eccentric or Concentric Contralateral Training in Rehabilitation After Shoulder Surgery With Elbow Immobilization

NCT06905093 | Recruiting

• 2 other identifiers: 2024-CHITS-0142024-A02862-45
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Shoulder Surgery

Keywords

Cross-education; Contralateral training; Eccentric training; Concentric training; Immobilization; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Isometric maximal voluntary strength of the immobilized arm

  6 weeks and 17 weeks after immobilization

• Isometric maximal voluntary strength of the non-immobilized arm

  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

  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

  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

  Preoperatively, at the end of the 4-6 weeks immobilization period, and then 6 weeks and 17 weeks after immobilization

Study Arms (3)

Control Group (CTRL)

ACTIVE COMPARATOR

Patients receive standard care

Other: Standard care

Eccentric Training Group (EXC)

EXPERIMENTAL

Patients receive standard care plus eccentric training of the non-immobilized arm.

Other: Standard care; Other: Eccentric training of the non-immobilized arm

Concentric Training Group (CON)

EXPERIMENTAL

Patients receive standard care plus concentric training of the non-immobilized arm.

Other: Standard care; Other: Concentric training of the non-immobilized arm

Interventions

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.

Concentric Training Group (CON)

Standard care OTHER

Standard care including rehabilitation sessions three times per week.

Concentric Training Group (CON); Control Group (CTRL); Eccentric Training Group (EXC)

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.

Eccentric Training Group (EXC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer: lead
• Sainte-Anne Military Teaching Hospital: collaborator

Study Sites (1)

Hôpital National d'Instruction des Armées Sainte-Anne

Toulon, Var, 83000, France

RECRUITING

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Sergio AFONSO, Physiotherapist

  Hôpital National d'Instruction des Armées Sainte-Anne

  STUDY DIRECTOR

Central Study Contacts

Magali Cesana

CONTACT

04 83 77 20 60; magali.cesana@ch-toulon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 1, 2025
• Study Start: December 2, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: July 7, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)