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

NCT05810129 | Recruiting

• 1 other identifier: 057/23
• Study Type: interventional
• Target: 39
• 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 (1)

• Change in muscle thickness of the biceps brachii, triceps brachii and supraspinatus muscles by ultrasound.

  Change in muscle thickness of the biceps brachii, triceps brachii and supraspinatus muscles by ultrasound.

  before surgery, after 6 and 12 weeks postoperatively

Secondary Outcomes (5)

• Change in grip strength using a dynamometer and change in manual force at 90º elbow flexion, 45º shoulder flexion and 0º shoulder abduction

  before surgery, after 6 and 12 weeks postoperatively

• 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

• Change in range of motion in elbow flexion, shoulder flexion, shoulder abduction, and rotations.

  before surgery, after 6 and 12 weeks postoperatively

Study Arms (3)

standard physical therapy

ACTIVE COMPARATOR

Men with clavicle fracture immobilized for 6 weeks + standard physical therapy for 12 weeks

Other: standard physical therapy

concentric-eccentric strength training

EXPERIMENTAL

Men with clavicle fracture who perform concentric-eccentric strength training on the uninjured limb during the 6-week immobilization period + Posterior Standard PhysicalTherapy.

Other: concentric-eccentric strength training

eccentric strength training

EXPERIMENTAL

Men with clavicle fracture who perform eccentric strength training on the unaffected limb during the 6-week period of immobilization + Posterior Standard Physical Therapy.

Other: eccentric strength training

Interventions

concentric-eccentric strength training OTHER

Concentric-eccentric cross training in a 6-week immobilization period + 12-week standard kinesic therapy (2 times a week)

concentric-eccentric strength training

eccentric strength training OTHER

Eccentric cross training in immobilization period of 6 weeks + Standard kinesic therapy of 12 weeks (2 times a week)

eccentric strength training

standard physical therapy OTHER

Men with clavicle fracture immobilized for 6 weeks + standard physical therapy for 12 weeks

standard physical therapy

Eligibility Criteria

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

You may qualify if:

• Men from 18 to 40 years old, diagnosed with radiographically verified clavicle fracture and awaiting surgical procedure. They have a body mass index of not less than 18.5 and not more than 29.9 kg/m2 and sign an informed consent.

You may not qualify if:

• Patients with previous injuries, pathological fracture or polytrauma
• Patients who report pain, a history of rotator cuff tear or surgery in the non-injured upper extremity.
• Patients with uncontrolled cardiovascular diseases.
• Any history of neurological problems in the upper extremities.
• Use of nutritional supplementation (leucine, glutamine, casein, whey-protein, fatty acids and creatine) and/or Hormonal Replacement Therapy.

Sponsors & Collaborators

• Universidad de La Frontera: lead

Study Sites (1)

Universidad de La Frontera

Temuco, IX Región de La Araucanía, 4780000, Chile

RECRUITING

Study Officials

• Gabriel Marzuca, MSc, PhD

  Universidad de La Frontera. Temuco, Chile

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Castillo

CONTACT

982692727; l.castillo06@ufromail.cl

Gabriel Marzuca, MSc, PhD

CONTACT

996343630; gabriel.marzuca@ufrontera.cl

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: May 2, 2023
• Primary Completion: July 31, 2025
• Study Completion: October 30, 2025
• Last Updated: January 22, 2025

Record last verified: 2025-01

Locations

CL (1)