Exercises Directed To Dynamic Stiffness Of The Thoracolumbar Region And Performance Of Amateur Runners

April 17, 2024 updated by: Gilmar Moraes Santos, PT, University of the State of Santa Catarina

Exercises Directed To Dynamic Stiffness Of The Thoracolumbar Region And Performance Of Amateur Runners: Randomized Controlled Clinical Trial

Introduction: Worldwide, the number of amateurs runners is growing exponentially, with consequent increase in musculoskeletal injuries. Although prevention and treatment by myofascial release has shown some evidence over the years, many issues remain. However, this evidence is based on studies that are not randomized controlled trials. Thus, issues associated with prevention and treatment strategies and their effects have not yet been fully explored by researchers. Objective: Contribute to the formation of basic knowledge and understanding of the impact of exercises aimed at the fascial system (fascial fitness®) on the dynamic stiffness of the thoracolumbar region and on the performance of amateur runners. Methods: This project tests a randomized, double-blind (evaluator and patient), parallel clinical trial in three groups comparing the effects of fascial fitness®, kinesiotherapy and placebo for a dynamic stiffness of the thoracolumbar thoracolumbar region and for the performance of amateur runners. Participants will be randomly allocated to receive a 6-week fascial fitness® program, either kinesiotherapy or placebo (detuned ultrasound). Outcome measures will be used before interventions, 3 and 6 weeks after randomization. Interventions will be cared out twice a week for six weeks. Primary outcomes will be the dynamic stiffness of the thoracolumbar region and the time to complete the 5 km run. As secondary outcomes form the ability to maintain static posture in three different postures, the pressure pain threshold, the electromyographic activity of the latissimus dorsi muscle, the quality of movement patterns and heart rate variability in the 5 km run. To analyze whether fascial fitness® or kinesiotherapy or placebo will mediate changes in outcome variables, multivariate analysis of variation will be used.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
99

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

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Study Contact Backup

Study Locations

  • Brazil
    • Santa Catarina
      • Florianópolis, Santa Catarina, Brazil, 88080350
        • Recruiting
        • Santa Catarina State University
        • Contact:
          • Mayane Botti

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Eligible runners must meet the following criteria:

  • 5km amateur runners;
  • 18 to 45 years old;
  • the both sexes;
  • be performing running activity for at least 1 year;
  • training rate of at least twice a week.

Exclusion Criteria:

  • Difficulty in understanding the Portuguese language to answer the questionnaires;
  • self-report of carrying neuromusculoskeletal diseases;
  • trauma or surgeries in the last 90 days in the lower limbs;
  • vestibular system in the last 30 days;
  • controlled medicine;
  • previous physiotherapeutic treatment in the last 30 days.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental Group
The fascial fitness® method (12 sessions, twice a week, for six weeks, 15 minutes a day, for 2 sets of 40 seconds each side). Assessments and reassessments will be carried out in the first, fourth and sixth week.
Other: Group Experimental/Fascial Fitness
Participants will receive twelve treatment sessions, twice a week, for six weeks, lasting 30 minutes per session. The interventions will be applied by a physiotherapist with previous experience and training in the proposed protocols.
Active Comparator: Sham Group
Static stretching exercises (12 sessions, twice a week, for six weeks, 15 minutes a day, for 2 sets of 40 seconds each side). Assessments and reassessments will be carried out in the first, fourth and sixth week.
Other: Group Sham/Static stretching exercise
Participants will receive twelve treatment sessions, twice a week, for six weeks, lasting 30 minutes per session. The interventions will be applied by a physiotherapist with previous experience and training in the proposed protocols.
Placebo Comparator: Control Group
The placebo intervention will be performed using ultrasound turned off in the thoracolumbar region for 15 minutes followed by rest for 15 minutes for 6 weeks, twice a week. Ultrasound was chosen because it is easy-to-use equipment and because this form of placebo used, equipment turned off, does not have any treatment effect and has already been established in another study (CHAIBI; BENTH; RUSSELL, 2015). Assessments and reassessments will be carried out in the first, fourth and sixth week.
Other: Control Group/Placebo
The placebo intervention will be performed using ultrasound turned off in the thoracolumbar region for 15 minutes followed by rest for 15 minutes for 6 weeks, twice a week. Participants will be evaluated on the first day, fourth week and sixth week of intervention.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dynamic stiffness
Time Frame: 6 weeks
The primary outcomes will be the dynamic stiffness of the thoracolumbar region and the time to run 5 km. Muscle stiffness will be measured in a relaxed state using a portable device, the MyotonPRO (Myoton AS, Tallinn, Estônia), which applies a short (15 ms) mechanical impulse to cause damped oscillations in the muscle.
6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pressure pain threshold
Time Frame: 6 weeks
For the evaluation of the pressure pain threshold, the participant will be in ventral decubitus with the algebrameter positioned perpendicular to the region of two fingers laterally to the spinous process of L4, in the latissimus muscle of the back of the predominant side. The evaluator will perform pressure perpendicular to the skin up to the maximum pain tolerance supported by the subject and reported by the subject twice, and the mean value between the two measurements will be used.
6 weeks
Functional Moviment Screen
Time Frame: 6 weeks
The quality of the movement patterns will be evaluated by the Functional Moviment Screen. Seven postures will be applied: Deep Squat (deep squat that evaluates bilaterally and symmetrically, the functionality of the hips, knees and ankles), Hurdle Step (one step through an obstacle, examining the mechanics of the stride), In line Lunge (hip and trunk mobility, ankle and knee stability, and hamstring flexibility), Shoulder Mobility (shoulder mobility bilaterally), Active Straight-Leg Raise (actively lift the leg in knee extension, determining tendon activity and flexibility of gastrocnemius-sumour, while maintaining a stable pelvis), Trunk Stability Push-up (trunk stability, while upper-member symmetry is performed) and Rotary Stability (rotation stability test, which assesses trunk stability while upper and lower limbs are in combined motion).
6 weeks
Vertical Jump
Time Frame: 6 weeks
The vertical jump assessment will be performed with the individual with their hands on their hips, from a static position and with their legs straight during the entire jump phase, the landing must be performed with both feet, keeping the ankles dorsiflexed .
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of the State of Santa Catarina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 26, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 8, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Dynamic Stiffness of runners

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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