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Completed

NCT Number: NCT05810129

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

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.

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Key information

Conditions

Clavicle Fracture

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Universidad de La Frontera

Temuco, IX Región de La Araucanía, 4780000, Chile

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.).

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Treatment and study plan

concentric-eccentric strength training

Other

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

Standard physical therapy

Other

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Upper and middle arm circumference change in both posterior arms

    Time frame: before surgery, after 6 and 12 weeks postoperatively

    Upper and middle arm circumference change in both posterior arms

  2. Change in functionality using the Quick Dash questionnaire

    Time frame: before surgery, after 6 and 12 weeks postoperatively

    Change in functionality using the Quick Dash questionnaire

  3. Change in relation to pain using the visual analogue scale

    Time frame: before surgery, after 6 and 12 weeks postoperatively

    Change in relation to pain using the visual analogue scale

Sponsors and collaborators

Lead sponsor

Universidad de La Frontera

Other

Registry information

Official study 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

Acronym: crossed1

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 12, 2023
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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