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Crossed Education in Relation to Muscle Mass in Patients Operated of Clavicular Fracture (crossed1)

Primary Purpose

Clavicle Fracture

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cross-education training
Cross-education training
Sponsored by
Universidad de La Frontera
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clavicle Fracture focused on measuring muscle mass, cross education, eccentric training

Eligibility Criteria

18 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    Experimental

    Experimental

    Arm Label

    Control group

    Concentric-eccentric group

    Eccentric Group

    Arm Description

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

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

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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
    Upper and middle arm circumference change in both posterior arms
    Upper and middle arm circumference change in both posterior arms
    Change in functionality using the Quick Dash questionnaire
    Change in functionality using the Quick Dash questionnaire
    Change in relation to pain using the visual analogue scale
    Change in relation to pain using the visual analogue scale
    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.

    Full Information

    First Posted
    March 20, 2023
    Last Updated
    April 10, 2023
    Sponsor
    Universidad de La Frontera
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05810129
    Brief Title
    Crossed Education in Relation to Muscle Mass in Patients Operated of Clavicular Fracture
    Acronym
    crossed1
    Official Title
    Effects of Crossed Education in Relation to Muscle Mass, Strength and Functionality in Patients Operated of Clavicular Fracture
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 28, 2023 (Anticipated)
    Primary Completion Date
    January 31, 2024 (Anticipated)
    Study Completion Date
    June 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidad de La Frontera

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Clavicle Fracture
    Keywords
    muscle mass, cross education, eccentric training

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Masking Description
    single-blind study
    Allocation
    Randomized
    Enrollment
    39 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    Men with clavicle fracture immobilized for 6 weeks + standard physical therapy for 12 weeks
    Arm Title
    Concentric-eccentric group
    Arm Type
    Experimental
    Arm Description
    Men with clavicle fracture who perform concentric-eccentric strength training on the uninjured limb during the 6-week immobilization period +Posterior Standard Kinesics Therapy.
    Arm Title
    Eccentric Group
    Arm Type
    Experimental
    Arm Description
    Men with clavicle fracture who perform eccentric strength training on the unaffected limb during the 6-week period of immobilization + Standard Kinesics Therapy.
    Intervention Type
    Other
    Intervention Name(s)
    Cross-education training
    Other Intervention Name(s)
    Concentric-eccentric
    Intervention Description
    Concentric-eccentric cross training in a 6-week immobilization period + 12-week standard kinesic therapy (2 times a week)
    Intervention Type
    Other
    Intervention Name(s)
    Cross-education training
    Other Intervention Name(s)
    Eccentric cross training
    Intervention Description
    Eccentric cross training in immobilization period of 6 weeks + Standard kinesic therapy of 12 weeks (2 times a week)
    Primary Outcome Measure Information:
    Title
    Change in muscle thickness of the biceps brachii, triceps brachii and supraspinatus muscles by ultrasound.
    Description
    Change in muscle thickness of the biceps brachii, triceps brachii and supraspinatus muscles by ultrasound.
    Time Frame
    before surgery, after 6 and 12 weeks postoperatively
    Secondary Outcome Measure Information:
    Title
    Change in grip strength using a dynamometer and change in manual force at 90º elbow flexion, 45º shoulder flexion and 0º shoulder abduction
    Description
    Change in grip strength using a dynamometer and change in manual force at 90º elbow flexion, 45º shoulder flexion and 0º shoulder abduction
    Time Frame
    before surgery, after 6 and 12 weeks postoperatively
    Title
    Upper and middle arm circumference change in both posterior arms
    Description
    Upper and middle arm circumference change in both posterior arms
    Time Frame
    before surgery, after 6 and 12 weeks postoperatively
    Title
    Change in functionality using the Quick Dash questionnaire
    Description
    Change in functionality using the Quick Dash questionnaire
    Time Frame
    before surgery, after 6 and 12 weeks postoperatively
    Title
    Change in relation to pain using the visual analogue scale
    Description
    Change in relation to pain using the visual analogue scale
    Time Frame
    before surgery, after 6 and 12 weeks postoperatively
    Title
    Change in range of motion in elbow flexion, shoulder flexion, shoulder abduction, and rotations.
    Description
    Change in range of motion in elbow flexion, shoulder flexion, shoulder abduction, and rotations.
    Time Frame
    before surgery, after 6 and 12 weeks postoperatively

    10. Eligibility

    Sex
    Male
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Gabriel Marzuca, MSc, PhD
    Phone
    996343630
    Email
    gabriel.marzuca@ufrontera.cl
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gabriel Marzuca, MSc, PhD
    Organizational Affiliation
    Universidad de La Frontera. Temuco, Chile
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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