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Crossed Education in Relation to Muscle Mass in Patients Operated of Clavicular Fracture

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05810129
Acronym
crossed1
Enrollment
19
Registered
2023-04-12
Start date
2023-10-19
Completion date
2025-12-20
Last updated
2026-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clavicle Fracture

Keywords

muscle mass, cross education, eccentric training

Brief 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 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.

Interventions

OTHERconcentric-eccentric strength training

Concentric-eccentric strength cross training in a 8-week immobilization period + 8-week standard kinesic therapy (2 times a week)

OTHERstandard physical therapy

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.

Sponsors

Universidad de La Frontera
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

single-blind study

Eligibility

Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

(i) 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

Exclusion criteria

(i) 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.). \-

Design outcomes

Primary

MeasureTime frameDescription
Change in muscle thickness of the biceps brachi muscle by ultrasound.before surgery, after 4 and 8 weeks postoperativelyBiceps 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 StrengthBefore Surgery, 4 and 8 weeks post surgeryParticipant 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.

Secondary

MeasureTime frameDescription
Upper and middle arm circumference change in both posterior armsbefore surgery, after 6 and 12 weeks postoperativelyUpper and middle arm circumference change in both posterior arms
Change in functionality using the Quick Dash questionnairebefore surgery, after 6 and 12 weeks postoperativelyChange in functionality using the Quick Dash questionnaire
Change in relation to pain using the visual analogue scalebefore surgery, after 6 and 12 weeks postoperativelyChange in relation to pain using the visual analogue scale

Countries

Chile

Contacts

PRINCIPAL_INVESTIGATORGabriel Marzuca, MSc, PhD

Universidad de La Frontera. Temuco, Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 5, 2026