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

NCT05760664 | Recruiting

• 1 other identifier: Dynamic Stiffness of runners
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fascia

Keywords

Sports Performance; Fascia; Running

Outcome Measures

Primary Outcomes (1)

• Dynamic stiffness

  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 Outcomes (3)

• Pressure pain threshold

  6 weeks

• Functional Moviment Screen

  6 weeks

• Vertical Jump

  6 weeks

Study Arms (3)

Experimental Group

EXPERIMENTAL

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

Sham Group

ACTIVE COMPARATOR

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

Control Group

PLACEBO COMPARATOR

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

Interventions

Group Experimental/Fascial Fitness 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.

Experimental Group

Group Sham/Static stretching exercise 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

Control Group/Placebo 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.

Control Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Eligible runners must meet the following criteria:
• km amateur runners;
• to 45 years old;
• the both sexes;
• be performing running activity for at least 1 year;
• training rate of at least twice a week.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of the State of Santa Catarina: lead

Study Sites (1)

Santa Catarina State University

Florianópolis, Santa Catarina, 88080350, Brazil

RECRUITING

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Mayane Botti

CONTACT

55 (47) 999231325; mayane_amorim@hotmail.com

Gilmar Santos

CONTACT

548999099459; gilmar.santos@udesc.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 26, 2023
• First Posted: March 8, 2023
• Study Start: February 1, 2022
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2025
• Last Updated: April 19, 2024

Record last verified: 2024-04

Locations

BR (1)