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

Clavicle Fracture Clinical Trial

— crossed1  

Official title:

Effects of Crossed Education in Relation to Muscle Mass, Strength and Functionality in Patients Operated of Clavicular Fracture

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05810129
• Other study ID #: 057/23
• Status: Recruiting
• Phase: N/A
• Start date: May 2, 2023
• Est. completion date: October 30, 2024

Study information

• Verified date: February 2024
• Source: Universidad de La Frontera
• Contact: Laura Castillo
• Phone: 982692727
• Email: l.castillo06[@]ufromail.cl
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Description:

Objective: To determine the effectiveness of cross-education training through eccentric strength exercises compared to concentric-eccentric after the 6-week immobilization period and after 12 postoperative weeks in relation to muscle mass, strength, and functionality in patients operated of clavicular fracture.

Hypothesis: Cross-education training through eccentric strength exercises produces greater effects compared to concentric-eccentric training during the immobilization period and after 12 postoperative weeks, in relation to muscle mass, strength and functionality in patients operated for clavicle fracture.

Methodology: An experimental, randomized, single-blind study will be carried out, in which 39 men from 18 to 40 years of age will be recruited, who are awaiting surgery for clavicle fracture. They will be divided into three groups: control group (Standard Kinesic Therapy 12 weeks after immobilization of 6 weeks, n=13), concentric-eccentric group (concentric-eccentric strength training in the uninjured limb during the 6-week immobilization period + Standard Kinesics Therapy, n=13) and group eccentric (eccentric strength training on the uninjured limb during the 6-week immobilization period + Standard Kinesics Therapy, n=13).

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 groups that perform cross-training during the immobilization period, presenting the greatest benefit in the group that performs training eccentric force.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 39
• Est. completion date: October 30, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Clavicle Fracture
• Fractures, Bone

Intervention

Other:
• concentric-eccentric strength training
Concentric-eccentric cross training in a 6-week immobilization period + 12-week standard kinesic therapy (2 times a week)
• eccentric strength training
Eccentric cross training in immobilization period of 6 weeks + Standard kinesic therapy of 12 weeks (2 times a week)
• standard physical therapy
Men with clavicle fracture immobilized for 6 weeks + standard physical therapy for 12 weeks

Locations

Country	Name	City	State
Chile	Universidad de La Frontera	Temuco	IX Región De La Araucanía

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de La Frontera

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in grip strength using a dynamometer and change in manual force at 90º elbow flexion, 45º shoulder flexion and 0º shoulder abduction	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
Secondary	Upper and middle arm circumference change in both posterior arms	Upper and middle arm circumference change in both posterior arms	before surgery, after 6 and 12 weeks postoperatively
Secondary	Change in functionality using the Quick Dash questionnaire	Change in functionality using the Quick Dash questionnaire	before surgery, after 6 and 12 weeks postoperatively
Secondary	Change in relation to pain using the visual analogue scale	Change in relation to pain using the visual analogue scale	before surgery, after 6 and 12 weeks postoperatively
Secondary	Change in range of motion in elbow flexion, shoulder flexion, shoulder abduction, and rotations.	Change in range of motion in elbow flexion, shoulder flexion, shoulder abduction, and rotations.	before surgery, after 6 and 12 weeks postoperatively