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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-02

Study Completion Date

2025-10-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Clavicle Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

single-blind study

Study Groups

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standard physical therapy

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

Group Type ACTIVE_COMPARATOR

standard physical therapy

Intervention Type OTHER

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

concentric-eccentric strength training

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

Group Type EXPERIMENTAL

concentric-eccentric strength training

Intervention Type OTHER

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

eccentric strength training

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

Group Type EXPERIMENTAL

eccentric strength training

Intervention Type OTHER

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

Interventions

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concentric-eccentric strength training

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

Intervention Type OTHER

eccentric strength training

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

Intervention Type OTHER

standard physical therapy

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes