FasciaNCT05760664
Exercises Directed To Dynamic Stiffness Of The Thoracolumbar Region And Performance Of Amateur Runners
A study testing Group Experimental/Fascial Fitness in people with Fascia, run by University of the State of Santa Catarina at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Fascia
- What is being tested?
- Group Experimental/Fascial Fitness
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Feb 2022to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Santa Catarina State University
Florianópolis, Santa Catarina, 88080350
Mayane Botti
About this study
Official title: 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.
- Conditions
- Fascia
- Being tested
- Group Experimental/Fascial Fitness, Group Sham/Static stretching exercise, Control Group/Placebo
- Keywords
- Sports Performance, Fascia, Running
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Experimental/Fascial FitnessOther
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 exerciseOther
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/PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Control Group/Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (3)
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.
Measured: 6 weeks
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).
Measured: 6 weeks
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 .
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start1 Feb 2022
- Primary completion30 Jul 2024 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FasciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of the State of Santa Catarina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gilmar Moraes Santos, PT, University of the State of Santa Catarina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05760664
- Sponsor's protocol ID
- Dynamic Stiffness of runners
- Status last verified
- Apr 2024
- First submitted
- 26 Feb 2023
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercises Directed To Dynamic Stiffness Of The Thoracolumbar Region And Performance Of Amateur Runners: Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05760664
- Acronym / sponsor ID
- Dynamic Stiffness of runners
- Conditions
- Fascia
- Keywords
- Sports Performance, Fascia, Running
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- University of the State of Santa CatarinaUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 8 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Group Experimental/Fascial FitnessThe 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. |
| Sham Group | Active comparator | Other: Group Sham/Static stretching exerciseStatic 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. |
| Control Group | Placebo comparator | Other: Control Group/PlaceboThe 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group Experimental/Fascial FitnessParticipants 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. | Other | Experimental Group |
| Group Sham/Static stretching exerciseParticipants 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. | Other | Sham Group |
| Control Group/PlaceboThe 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. | Other | Control Group |
Primary outcome
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.
3 secondary outcomes
Pressure pain threshold
Time frame: 6 weeks
Functional Moviment Screen
Time frame: 6 weeks
Vertical Jump
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Experimental/Fascial Fitness in people with Fascia, run by University of the State of Santa Catarina at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mayane Botti (55 (47) 999231325, mayane_amorim@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic stiffness (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.