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

Fascia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05760664
• Other study ID #: Dynamic Stiffness of runners
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: July 30, 2025

Study information

• Verified date: April 2024
• Source: University of the State of Santa Catarina
• Contact: Mayane Botti
• Phone: 55 (47) 999231325
• Email: mayane_amorim[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 99
• Est. completion date: July 30, 2025
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fascia

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Brazil	Santa Catarina State University	Florianópolis	Santa Catarina

Sponsors (1)

Lead Sponsor	Collaborator
University of the State of Santa Catarina

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pressure pain threshold	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
Secondary	Functional Moviment Screen	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
Secondary	Vertical Jump	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