Clinical trial NCT05810129: Crossed Education in Relation to Muscle Mass in Patients Operated of Clavicular Fracture
Official title: Effects of Crossed Education in Relation to Muscle Mass, Strength and Functionality in Patients Operated of Clavicular Fracture
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Clavicle Fracture
Keywords: muscle mass
cross education
eccentric training
Lead sponsor: Universidad de La Frontera
Sponsor class: OTHER
First posted: 2023-04-12
Enrollment: 39
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in muscle thickness of the biceps brachii, triceps brachii and supraspinatus muscles by ultrasound.
timeFrame: before surgery, after 6 and 12 weeks postoperatively
Secondary outcomes:
measure: Change in grip strength using a dynamometer and change in manual force at 90º elbow flexion, 45º shoulder flexion and 0º shoulder abduction
timeFrame: before surgery, after 6 and 12 weeks postoperatively
measure: Upper and middle arm circumference change in both posterior arms
timeFrame: before surgery, after 6 and 12 weeks postoperatively
measure: Change in functionality using the Quick Dash questionnaire
timeFrame: before surgery, after 6 and 12 weeks postoperatively
measure: Change in relation to pain using the visual analogue scale
timeFrame: before surgery, after 6 and 12 weeks postoperatively
measure: Change in range of motion in elbow flexion, shoulder flexion, shoulder abduction, and rotations.
timeFrame: before surgery, after 6 and 12 weeks postoperatively
Other outcomes:
Locations:
city: Temuco
country: Chile
facility: Universidad de La Frontera
state: IX Región De La Araucanía
Study officials:
affiliation: Universidad de La Frontera. Temuco, Chile
name: Gabriel Marzuca, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References: