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

NCT05810129 | Completed

• 1 other identifier: 057/23
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Clavicle Fracture

Keywords

muscle mass; cross education; eccentric training

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Before Surgery, 4 and 8 weeks post surgery

Secondary Outcomes (3)

• Upper and middle arm circumference change in both posterior arms

  before surgery, after 6 and 12 weeks postoperatively

• Change in functionality using the Quick Dash questionnaire

  before surgery, after 6 and 12 weeks postoperatively

• Change in relation to pain using the visual analogue scale

  before surgery, after 6 and 12 weeks postoperatively

Study Arms (2)

standard physical therapy

ACTIVE COMPARATOR

Men with clavicle fracture immobilized for 4 weeks + standard physical therapy for 8 weeks

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

Other: concentric-eccentric strength training

Interventions

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)

Unilateral Strength Training

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.

standard physical therapy

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• (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

You may not qualify if:

• (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.).

Sponsors & Collaborators

• Universidad de La Frontera: lead

Study Sites (1)

Universidad de La Frontera

Temuco, IX Región de La Araucanía, 4780000, Chile

Location

Study Officials

• Gabriel Marzuca, MSc, PhD

  Universidad de La Frontera. Temuco, Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: single-blind study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: April 12, 2023
• Study Start: October 19, 2023
• Primary Completion: June 25, 2025
• Study Completion: December 20, 2025
• Last Updated: June 4, 2026

Record last verified: 2026-06

Locations

CL (1)