NCT06933446

Brief Summary

Objective: To assess the acute effect of a myofascial release protocol applied to the adductor muscles of the thigh on functional, biomechanical, and physiological variables. Methods: This study is a randomized, double-blind, two-arm crossover clinical trial that will analyze male water polo athletes aged 16 to 25 years recruited from a sports training center in the city of Bauru. Data related to the following parameters will be collected for the physical evaluation: functional performance, through the jump test; biomechanical, through maximum isometric torque of hip adductors, electromyography of the hip and gluteus medius muscles; and physiological, through the analysis of serum markers of muscle damage and inflammation, and heart rate variability. After the initial evaluation, the participants will be randomly divided into two groups: intervention group and sham group. Then, all participants will perform a game simulation. After the game, the participants will receive the intervention designated for each group. For the intervention group, a manual therapy protocol will be applied, based on myofascial release in the thigh region that presents trigger points. For the Sham group, a manual technique, called classic massage, will be applied, with superficial pressure, used to reach only subcutaneous tissues, without acting on muscles and fascia. This protocol will be repeated at four different times, always after the games. After a washout week, the participants will change groups and the data collection protocol will be applied again.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
6mo left

Started Feb 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Feb 2024Dec 2026

Study Start

First participant enrolled

February 1, 2024

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 18, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

April 18, 2025

Status Verified

April 1, 2025

Enrollment Period

2.8 years

First QC Date

March 26, 2025

Last Update Submit

April 15, 2025

Conditions

Keywords

fatiguephysical exertionpost-exercise recovery

Outcome Measures

Primary Outcomes (5)

  • Maximum Vertical Jump Test

    From enrollment to the end of treatment at 2 weeks

  • Maximum Voluntary Isometric Torque of the Hip Adductors

    From enrollment to the end of treatment at 2 weeks

  • Electromyography of Adductors, Gluteus Medius and Transversus Abdominis

    From enrollment to the end of treatment at 2 weeks

  • Collection of Serum Markers

    The markers: creatine kinase (CK; Units of Measure= U/L), lactate dehydrogenase (LDH; Units of Measure= UI/L), myoglobin (Myo; Units of Measure= ng/mL), erythrocyte sedimentation rate (ESR; Units of Measure= mm/h), tumor necrosis factor alpha (TNFA; Units of Measure= Å) will be considered for analysis of muscle damage markers and will be determined through specific kits and following the manufacturer's instructions.

    From enrollment to the end of treatment at 2 weeks

  • Heart Rate Variability

    Heart rate variability (HRV) will be collected, at rest, through a non-invasive method used to measure cardiac autonomic control, to assess the autonomic nervous system (ANS), and the RR interval will be recorded by a portable heart rate monitor.

    From enrollment to the end of treatment at 2 weeks

Secondary Outcomes (1)

  • Effort Control Variables: Subjective Perception of Exertion and Lactate Threshold

    From enrollment to the end of treatment at 2 weeks

Study Arms (2)

Myofascial Release

ACTIVE COMPARATOR
Other: Classic Massage

Classic Massage

PLACEBO COMPARATOR
Other: Myofascial Release

Interventions

A myofascial release protocol, applied to the thigh muscles in post-effort recovery in water polo athletes.

Classic Massage

Massagem clássica, com pressão superficial, utilizada para atingir apenas tecidos subcutâneos, sem que haja ação sobre músculos e fáscias

Myofascial Release

Eligibility Criteria

Age16 Years - 25 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale athletes, age 16 to 25 years old, have at least one year of experience in the sport
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Male athletes;
  • Age 16 to 25 years old;
  • Have at least one year of experience in the sport;
  • Perform a training load of at least 10 hours per week in the sport;
  • Participate in at least regional level competitions

You may not qualify if:

  • Have no reports of muscle injury in the thigh in the three months prior to the study,
  • Joint injuries in the hip, such as femoroacetabular impingement or tendinopathies of the tendons of the hip muscles or trochanteric, iliopectineal or ischial bursitis diagnosed by a clinician;
  • Do not present a drop in -performance for more than four weeks that could characterize the occurrence of non-functional overreaching or signs of overtraining syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade do Sagrado Coração

Bauru, São Paulo, 17011-160, Brazil

Location

MeSH Terms

Conditions

Fatigue

Interventions

Myofascial Release Therapy

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Rebeca Gasparoto Carmezin, Acadêmica em Fisioterapia

    Universidade do Sagrado Coração

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

March 26, 2025

First Posted

April 18, 2025

Study Start

February 1, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

April 18, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations