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

U

University of the State of Santa Catarina

Status

Enrolling

Conditions

Fascia

Treatments

Other: Group Sham/Static stretching exercise
Other: Control Group/Placebo
Other: Group Experimental/Fascial Fitness

Study type

Interventional

Funder types

Other

Identifiers

NCT05760664
Dynamic Stiffness of runners

Details and patient eligibility

About

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.

Enrollment

99 estimated patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

99 participants in 3 patient groups, including a placebo group

Experimental Group
Experimental group
Description:
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.
Treatment:
Other: Group Experimental/Fascial Fitness
Sham Group
Active Comparator group
Description:
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.
Treatment:
Other: Group Sham/Static stretching exercise
Control Group
Placebo Comparator group
Description:
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.
Treatment:
Other: Control Group/Placebo

Trial contacts and locations

1

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Central trial contact

Gilmar Santos; Mayane Botti

Data sourced from clinicaltrials.gov

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