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

NCT ID: NCT05760664

Last Updated: 2024-04-19

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

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2025-07-30

Brief Summary

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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.

Detailed Description

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Conditions

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Fascia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Group Experimental/Fascial Fitness

Intervention Type OTHER

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.

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.

Group Type ACTIVE_COMPARATOR

Group Sham/Static stretching exercise

Intervention Type OTHER

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.

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.

Group Type PLACEBO_COMPARATOR

Control Group/Placebo

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of the State of Santa Catarina

OTHER

Sponsor Role lead

Responsible Party

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Gilmar Moraes Santos, PT

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Santa Catarina State University

Florianópolis, Santa Catarina, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Mayane Botti

Role: CONTACT

55 (47) 999231325

Gilmar Santos

Role: CONTACT

548999099459

Facility Contacts

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Mayane Botti

Role: primary

Other Identifiers

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Dynamic Stiffness of runners

Identifier Type: -

Identifier Source: org_study_id

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