Clavicle Fracturecrossed1NCT05810129
Crossed Education in Relation to Muscle Mass in Patients Operated of Clavicular Fracture
A study testing concentric-eccentric strength training and standard physical therapy in people with Clavicle Fracture, run by Universidad de La Frontera at 1 site in Chile.
Trial summary
The immobilization process after an operation or injury in the upper extremity causes a loss of muscle mass and strength of 0.2% and 1.3% per day, respectively. Currently, the use of cross-education, which is unilateral training in the uninjured limb, during the immobilization period, is expanding, demonstrating a… Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Clavicle Fracture
- What is being tested?
- concentric-eccentric strength training and standard physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteChile
- Study dates
- 19 Oct 2023to 20 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- male sex, (ii) age 18-40 years (iii), surgically treated mid-clavicular fracture, (iv) body mass index 18.5-30.0 kg/m2, and (v) physically active status.
- The study focused on male participants to minimize variability related to sex-specific neuromuscular and morphological responses
Who cannot join
- previous upper-limb fractures or polytrauma, (ii) surgical delay >12 days, (iii) cardiovascular conditions contraindicating exercise, (iv) uncontrolled comorbidities, (v) neurological injury, (vi) smoking, and (vii) use of nutritional supplements known to affect muscle metabolism (i.e., creatine, leucine, glutamine, casein, whey protein, fatty acids, etc.).
- -
Trial locations and contacts
1 site in 1 country.
Chile1 site
Universidad de La Frontera
Temuco, IX Región de La Araucanía, 4780000
About this study
Official title: Cross-education by Unilateral Resistance Training Preserves Skeletal Muscle Mass and Strength During Immobilization in Patients Undergoing Clavicle Fracture Surgery. A Pilot Randomized Controlled Trial
The immobilization process after an operation or injury in the upper extremity causes a loss of muscle mass and strength of 0.2% and 1.3% per day, respectively. Currently, the use of cross-education, which is unilateral training in the uninjured limb, during the immobilization period, is expanding, demonstrating a magnitude of strength gain in the immobilized limb from 8% to 77% of the mean of strength of the trained limb. Despite the evidenced benefits of cross-education in unilateral injuries such as distal radius fracture, anterior cruciate ligament injury, and knee replacement, very little is known about this effect in shoulder immobilization after clavicle fracture.
Read the detailed description
Objective: : To determine the effects of unilateral resistance exercise training of the uninjured limb on skeletal muscle mass, strength, pain, and disability in the immobilized limb after immobilization (4 weeks) and after standard physiotherapy (8 weeks) in patients undergoing clavicle fracture surgery.
Methodology: Nineteen men (27 ± 5 years) were randomly to a control group (n = 8; immobilization + standard physiotherapy) or experimental group (n = 11; immobilization + unilateral resistance training of the uninjured limb + standard physiotherapy). Outcomes included biceps brachii muscle thickness (ultrasonography), elbow flexion strength (1RM estimate), disability (Quick Dash questionnaire) and pain (visual analog scale), assessed at 4- and 8-week post-clavicle surgery.
Expected results: It is expected to observe a gain in muscle mass and strength in the trained limb and a maintenance/gain of muscle mass and strength in the group that perform cross-training during the immobilization period.
- Conditions
- Clavicle Fracture
- Being tested
- concentric-eccentric strength training, standard physical therapy
- Keywords
- muscle mass, cross education, eccentric training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
concentric-eccentric strength trainingOther
Concentric-eccentric strength cross training in a 8-week immobilization period + 8-week standard kinesic therapy (2 times a week)
standard physical therapyOther
Following the immobilization, participants initiated a standardized physiotherapy program conducted two to three times per week (9 sessions). All sessions were supervised by a physiotherapist experienced in musculoskeletal rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| standard physical therapy | Active comparator | Men with clavicle fracture immobilized for 4 weeks + standard physical therapy for 8 weeks Receives: Other: standard physical therapy |
| Unilateral Strength Training | Experimental | Unilateral resistance training was performed on the elbow flexors of the uninjured arm conducted three times per week for 4 weeks (12 sessions), with intensity ranging from 60 to 80 % of one-repetition maximum. Exercises were performed in a seated position with the elbow and forearm supported on a preacher curl bench at 45º of shoulder flexion. Two types of resistance exercise training modalities were included for exploratory purposes Receives: Other: concentric-eccentric strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in muscle thickness of the biceps brachi muscle by ultrasound.
Biceps brachii muscle thickness was measured using ultrasonography (Sonus SL-5C, Leoni medical, China) by an experienced evaluator blinded to participant allocation. Participants were positioned supine with both arms extended and relaxed. The ultrasound transducer was placed transversely at 60% of the distance between the acromion and the lateral epicondyle of the humerus. Three images were obtained for each measurement using the ImageJ software (v1.54t, Wayne Rasband, USA), in which the average of three different measurements was obtained considering the distance between the superficial muscle fascia and the humerus.
Measured: before surgery, after 4 and 8 weeks postoperatively
Elbow's Flexor Muscles Strength
Participant were with the elbow and forearm supported on a preacher curl bench. Elbow flexion strength was assessed an estimated concentric 1-RM (lifting phase) using adjustable dumbbells. A standardized warm-up was performed consisting of 10 repetitions with 1.5 kg load using the uninjured limb. Subsequently, maximal strength was estimated using a submaximal multiple-repetition test, and 1-RM was calculated using the Brzycki formula. 7 The load was progressively, a maximum of 6 attempts was allowed.
Measured: Before Surgery, 4 and 8 weeks post surgery
Secondary outcomes (3)
Upper and middle arm circumference change in both posterior arms
Upper and middle arm circumference change in both posterior arms
Measured: before surgery, after 6 and 12 weeks postoperatively
Change in functionality using the Quick Dash questionnaire
Change in functionality using the Quick Dash questionnaire
Measured: before surgery, after 6 and 12 weeks postoperatively
Change in relation to pain using the visual analogue scale
Change in relation to pain using the visual analogue scale
Measured: before surgery, after 6 and 12 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start19 Oct 2023
- Primary completion25 Jun 2025
- Study completion20 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clavicle FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de La Frontera
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriel Nasri Marzuca-Nassr, Universidad de La Frontera
- Investigators
- Gabriel Marzuca, MSc, PhD, Principal investigator, Universidad de La Frontera. Temuco, Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05810129
- Sponsor's protocol ID
- 057/23
- Acronym
- crossed1
- Status last verified
- Jun 2026
- First submitted
- 20 Mar 2023
- Last updated
- 4 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-education by Unilateral Resistance Training Preserves Skeletal Muscle Mass and Strength During Immobilization in Patients Undergoing Clavicle Fracture Surgery. A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05810129
- Acronym / sponsor ID
- crossed1 / 057/23
- Conditions
- Clavicle Fracture
- Keywords
- muscle mass, cross education, eccentric training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Universidad de La FronteraUniversity, hospital or other
- Study start
- 19 Oct 2023 (actual)
- Primary completion
- 25 Jun 2025 (actual)
- Study completion
- 20 Dec 2025 (actual)
- First posted
- 12 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The immobilization process after an operation or injury in the upper extremity causes a loss of muscle mass and strength of 0.2% and 1.3% per day, respectively. Currently, the use of cross-education, which is unilateral training in the uninjured limb, during the immobilization period, is expanding, demonstrating a magnitude of strength gain in the immobilized limb from 8% to 77% of the mean of strength of the trained limb. Despite the evidenced benefits of cross-education in unilateral injuries such as distal radius fracture, anterior cruciate ligament injury, and knee replacement, very little is known about this effect in shoulder immobilization after clavicle fracture.
Detailed description
Objective: : To determine the effects of unilateral resistance exercise training of the uninjured limb on skeletal muscle mass, strength, pain, and disability in the immobilized limb after immobilization (4 weeks) and after standard physiotherapy (8 weeks) in patients undergoing clavicle fracture surgery.
Methodology: Nineteen men (27 ± 5 years) were randomly to a control group (n = 8; immobilization + standard physiotherapy) or experimental group (n = 11; immobilization + unilateral resistance training of the uninjured limb + standard physiotherapy). Outcomes included biceps brachii muscle thickness (ultrasonography), elbow flexion strength (1RM estimate), disability (Quick Dash questionnaire) and pain (visual analog scale), assessed at 4- and 8-week post-clavicle surgery.
Expected results: It is expected to observe a gain in muscle mass and strength in the trained limb and a maintenance/gain of muscle mass and strength in the group that perform cross-training during the immobilization period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard physical therapy | Active comparator | Other: standard physical therapyMen with clavicle fracture immobilized for 4 weeks + standard physical therapy for 8 weeks |
| Unilateral Strength Training | Experimental | Other: concentric-eccentric strength trainingUnilateral resistance training was performed on the elbow flexors of the uninjured arm conducted three times per week for 4 weeks (12 sessions), with intensity ranging from 60 to 80 % of one-repetition maximum. Exercises were performed in a seated position with the elbow and forearm supported on a preacher curl bench at 45º of shoulder flexion. Two types of resistance exercise training modalities were included for exploratory purposes |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- male sex, (ii) age 18-40 years (iii), surgically treated mid-clavicular fracture, (iv) body mass index 18.5-30.0 kg/m2, and (v) physically active status.
- The study focused on male participants to minimize variability related to sex-specific neuromuscular and morphological responses
Key exclusion criteria (2 listed)
- previous upper-limb fractures or polytrauma, (ii) surgical delay >12 days, (iii) cardiovascular conditions contraindicating exercise, (iv) uncontrolled comorbidities, (v) neurological injury, (vi) smoking, and (vii) use of nutritional supplements known to affect muscle metabolism (i.e., creatine, leucine, glutamine, casein, whey protein, fatty acids, etc.).
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| concentric-eccentric strength trainingConcentric-eccentric strength cross training in a 8-week immobilization period + 8-week standard kinesic therapy (2 times a week) | Other | Unilateral Strength Training |
| standard physical therapyFollowing the immobilization, participants initiated a standardized physiotherapy program conducted two to three times per week (9 sessions). All sessions were supervised by a physiotherapist experienced in musculoskeletal rehabilitation. | Other | standard physical therapy |
Primary outcome
Change in muscle thickness of the biceps brachi muscle by ultrasound.
Time frame: before surgery, after 4 and 8 weeks postoperatively
Biceps brachii muscle thickness was measured using ultrasonography (Sonus SL-5C, Leoni medical, China) by an experienced evaluator blinded to participant allocation. Participants were positioned supine with both arms extended and relaxed. The ultrasound transducer was placed transversely at 60% of the distance between the acromion and the lateral epicondyle of the humerus. Three images were obtained for each measurement using the ImageJ software (v1.54t, Wayne Rasband, USA), in which the average of three different measurements was obtained considering the distance between the superficial muscle fascia and the humerus.
Elbow's Flexor Muscles Strength
Time frame: Before Surgery, 4 and 8 weeks post surgery
Participant were with the elbow and forearm supported on a preacher curl bench. Elbow flexion strength was assessed an estimated concentric 1-RM (lifting phase) using adjustable dumbbells. A standardized warm-up was performed consisting of 10 repetitions with 1.5 kg load using the uninjured limb. Subsequently, maximal strength was estimated using a submaximal multiple-repetition test, and 1-RM was calculated using the Brzycki formula. 7 The load was progressively, a maximum of 6 attempts was allowed.
3 secondary outcomes
Upper and middle arm circumference change in both posterior arms
Time frame: before surgery, after 6 and 12 weeks postoperatively
Change in functionality using the Quick Dash questionnaire
Time frame: before surgery, after 6 and 12 weeks postoperatively
Change in relation to pain using the visual analogue scale
Time frame: before surgery, after 6 and 12 weeks postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
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KT Tape for Pediatric Clavicle Fractures
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Descriptive Single-center Retrospective Study of a Series of Cases of Clavicle Pseudarthrosis: Epidemiology, Surgical Management, and Functional Outcomes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriel Marzuca, MSc, PhD principal investigator
Universidad de La Frontera. Temuco, Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing concentric-eccentric strength training and standard physical therapy in people with Clavicle Fracture, run by Universidad de La Frontera at 1 site in Chile.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 4 Jun 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 Chile. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in muscle thickness of the biceps brachi muscle by ultrasound. (time frame: before surgery, after 4 and 8 weeks postoperatively). The study lists 2 primary outcomes in all. 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 4 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.