NCT06906146

Brief Summary

This study aims to evaluate the effectiveness of Capacitive Resistive Electric Transfer (CRET) therapy combined with post-competition massage in the recovery and muscle function of professional athletes. It is designed as a randomized, double-blind, crossover clinical trial. The primary objective is to analyze the efficacy of this combined protocol in muscle recovery after performing the Wingate anaerobic power and capacity test. Secondary objectives include assessing changes in muscle fatigue, muscle function of the rectus femoris and vastus lateralis, physiological changes in blood lactate concentration and oxygen saturation, and intramuscular structural changes through ultrasound before and after the intervention. The study will recruit professional athletes from disciplines that require anaerobic muscle metabolism, such as cycling, athletics, triathlon, CrossFit, and duathlon. Participants must be federated athletes who train at least four times per week and actively compete at regional, national, or international levels. Exclusion criteria include recent sports injuries preventing test performance, prior exposure to CRET therapy, allergies to conductive gel, language barriers, participation in other research studies, or ongoing pharmacological treatment that could interfere with measurements. Participants will attend four study sessions, divided into two sets of two consecutive days. On the first day, they will perform the Wingate test followed by the assigned post-competition massage with either CRET therapy or a placebo intervention. On the second day, they will repeat the Wingate test. After a three-week washout period, participants will switch to the opposite group. The intervention group will receive a 60-minute CRET therapy session with both resistive and capacitive modes applied at different power intensities, combined with a standardized recovery massage. The placebo group will receive the same massage while undergoing a simulated CRET therapy, with the machine turned on but without power application to prevent participant awareness of the placebo condition. The study will analyze various dependent variables, including Wingate test performance, blood lactate levels, subjective fatigue perception using the modified Borg scale, muscle stiffness and tone through myotonometry, muscle oxygen saturation via near-infrared spectroscopy (NIRS), cross-sectional muscle area and grayscale values from ultrasound imaging, body composition using a Tanita analyzer, maximum isometric quadriceps strength via handheld dynamometry, and muscle activity measured by surface electromyography (sEMG). Each of these variables will be assessed at specific time points before, during, and after the intervention. The estimated sample size is approximately 50 subjects, with 25 participants per group, determined through a preliminary pilot study. Statistical analyses will be conducted using IBM SPSS Statistics 26.0. Descriptive statistics will be calculated for quantitative and qualitative variables. A linear mixed model will be applied to compare changes between and within groups over five measurement periods using a one-way mixed ANOVA. If the sphericity assumption is violated, the Greenhouse-Geisser correction will be applied. Statistically significant effects will undergo post-hoc analysis with Bonferroni correction for multiple comparisons. All originally enrolled participants will be included in the final analysis following an intention-to-treat approach, and effect sizes will be calculated using eta squared. The significance level will be set at p \< 0.05.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2025

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 2, 2025

Completed
8 days until next milestone

Study Start

First participant enrolled

April 10, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2025

Completed
Last Updated

April 2, 2025

Status Verified

March 1, 2025

Enrollment Period

1 month

First QC Date

March 6, 2025

Last Update Submit

March 28, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Lactate

    Capacitive resistive electrical transfer therapy (CRET) is a treatment modality that applies high-frequency electrical currents to stimulate tissue regeneration, improve blood circulation and reduce muscle pain. It works through two modes: the capacitive mode, which targets superficial tissues such as skin and muscle, and the resistive mode, which penetrates deeper structures such as tendons, ligaments and joints. This technique is widely used in rehabilitation, sports physiotherapy and pain management to accelerate muscle recovery and optimize neuromuscular function.

    1 hour after the test

Secondary Outcomes (5)

  • Wingate Test

    During the test

  • Muscle oxygen saturation percentage

    During the test

  • Muscle thickness

    1 hour after the test

  • Maximal voluntary knee extension force

    Before the test

  • muscle activity

    Before the test

Study Arms (2)

CRET therapy

EXPERIMENTAL
Device: CRET therapy

Sham

SHAM COMPARATOR
Device: Sham CRET Therapy

Interventions

Capacitive Resistive Electric Transfer (CRET) therapy is a treatment modality that applies high-frequency electrical currents to stimulate tissue regeneration, enhance blood circulation, and reduce muscle pain. It operates through two modes: the capacitive mode, which targets superficial tissues such as skin and muscle, and the resistive mode, which penetrates deeper structures like tendons, ligaments, and joints. This technique is widely used in rehabilitation, sports physiotherapy, and pain management to accelerate muscle recovery and optimize neuromuscular function.

CRET therapy

Same as CRET therapy but in a aham form.

Sham

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Athletes who practice a type of sport that requires the use of anaerobic muscle metabolism (cycling, athletics, triathlon, crossfit, spinning and duathlon)
  • Athletes must be federated and train a minimum of 4 days/week
  • Active participation in regional, national or international competitions.

You may not qualify if:

  • Volunteers who have suffered a sports injury that makes it impossible for them to perform the test
  • Having received the CRET therapy technique.
  • Subjects who report allergies to the conductive cream.
  • Subjects undergoing pharmacological medical treatment that may interfere with the measurements.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2025

First Posted

April 2, 2025

Study Start

April 10, 2025

Primary Completion

May 10, 2025

Study Completion

June 10, 2025

Last Updated

April 2, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share