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Shoulder SurgeryEXC-IMMONCT06905093

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

A study testing Eccentric training of the non-immobilized arm and Concentric training of the non-immobilized arm in people with Shoulder Surgery, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Shoulder Surgery
What is being tested?
Eccentric training of the non-immobilized arm and Concentric training of the non-immobilized arm
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteFrance
Study dates
2 Dec 2025to Oct 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

France1 site, 1 recruiting
  • Hôpital National d'Instruction des Armées Sainte-Anne

    Toulon, Var, 83000

    Sergio AFONSO, Physiotherapist, 04 83 16 20 10 ext. +33, sergio.pimenta-afonso@intradef.gouv.fr

    Sergio AFONSO, Physiotherapist

    Recruiting

Other trials in France

About this study

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.

Read the 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.
Being tested
Standard care, Eccentric training of the non-immobilized arm, Concentric training of the non-immobilized arm
Keywords
Cross-education, Contralateral training, Eccentric training, Concentric training, Immobilization, Rehabilitation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard careOther

    Standard care including rehabilitation sessions three times per week.

  • Eccentric training of the non-immobilized armOther

    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.

  • Concentric training of the non-immobilized armOther

    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.

Study groups in NCT06905093
Study groupRoleWhat they receive
Control Group (CTRL)Active comparatorPatients receive standard care
Receives: Other: Standard care
Eccentric Training Group (EXC)ExperimentalPatients receive standard care plus eccentric training of the non-immobilized arm.
Receives: Other: Standard care; Other: Eccentric training of the non-immobilized arm
Concentric Training Group (CON)ExperimentalPatients receive standard care plus concentric training of the non-immobilized arm.
Receives: Other: Standard care; Other: Concentric training of the non-immobilized arm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Isometric maximal voluntary strength of the immobilized arm

    Isometric maximal voluntary strength will be assessed using an isokinetic dynamometer.

    Measured: Preoperatively and at the end of the 4-6 weeks immobilization period

Secondary outcomes (13)
  1. Isometric maximal voluntary strength of the immobilized arm

    Isometric maximal voluntary strength will be assessed using an isokinetic dynamometer.

    Measured: 6 weeks and 17 weeks after immobilization

  2. Isometric maximal voluntary strength of the non-immobilized arm

    Isometric maximal voluntary strength will be assessed using an isokinetic dynamometer.

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

  3. 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

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

  4. 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.

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

  5. 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.

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

  6. Handgrip strength (finger flexors)

    Handgrip strength in kilograms will be assessed for the immobilized arm and the non-immobilized arm.

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

  7. 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.

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

  8. 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.

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

  9. Joint position sense (proprioception)

    Joint position sense measurement of the immobilized arm and the non-immobilized arm.

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

  10. 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.

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

  11. 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.

    Measured: 17 weeks after immobilization

  12. 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.

    Measured: Before and after each exercise during the 4-6 weeks immobilization period

  13. 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).

    Measured: After each exercise during the 4-6 weeks immobilization period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2025
  2. Study start2 Dec 2025
  3. Primary completionJun 2027 (estimated)
  4. Study completionOct 2027 (estimated)

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06905093
Sponsor's protocol ID
2024-CHITS-014
Other IDs
2024-A02862-45
Acronym
EXC-IMMO
Status last verified
Jul 2026
First submitted
25 Mar 2025
Last updated
7 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Eccentric training of the non-immobilized arm and Concentric training of the non-immobilized arm in people with Shoulder Surgery, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 1 site in France.

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 4 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 7 Jul 2026. 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 France. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Magali Cesana (04 83 77 20 60 ext. +33, magali.cesana@ch-toulon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Isometric maximal voluntary strength of the immobilized arm (time frame: Preoperatively and at the end of the 4-6 weeks immobilization period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 7 Jul 2026.

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