Clinical trial NCT06855316: Evaluating Combined Electromagnetic Stimulation for Enhanced Physical and Psychological Recovery in Athletes with DOMS
Official title: Evaluating Combined Electromagnetic Stimulation for Enhanced Physical and Psychological Recovery in Athletes with DOMS: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Recovery, Psychological
Transcranial Magnetic Stimulation
Keywords: transcraneal magnetic stimulation
delay onset muscle soreness
psychological profile
Lead sponsor: Sierra Varona SL
Sponsor class: OTHER
Collaborators: name: Universidad Europea de Madrid
First posted: 2025-03-03
Enrollment: 48
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controlled trial explores the impact of a combined transcranial and peripheral electromagnetic stimulation over the potential correlation between psychological well-being and recovery outcomes of young athletes experiencing Delayed Onset Muscle Soreness.

Detailed description: This randomized controlled trial explores the impact of a combined transcranial and peripheral electromagnetic stimulation (TMS and PES) over the potential correlation between psychological well-being and recovery outcomes of young athletes experiencing Delayed Onset Muscle Soreness. Grounded in the emerging theory of DOMS as an axonopathy affecting muscle spindles, this study examines whether paired-associative stimulation can show link over physical and psychological recovery processes. Forty-eight male athletes, aged 18 to 35 years, regularly engaged in exercise, will be randomly assigned to one of four groups: Control (placebo), PES, TMS, and Combined Stimulation (TMS + PES). All participants will perform a muscle-damaging exercise protocol to induce DOMS, followed by the assigned electromagnetic intervention. Assessments will include dynamometry, Counter Movement Jump (CMJ), Visual Analog Scale for Fatigue (VAS-F), Pain Pressure Threshold (PPT), sprint performance, and various psychological measures, such as the State-Trait Anxiety Inventory (STAI), Acceptance and Action Questionnaire-II (AAQ-II), and the Spanish versions of the Big Five Personality Traits, Perceived Stress Scale (PSS), and the Zung Self-Rating Depression Scale. These assessments will be conducted at baseline and at multiple intervals post-exercise (1 hour, 24 hours, 48 hours, and 72 hours).

Eligibility criteria: Inclusion Criteria:

1. be male,
2. aged between 18 and 35 years
3. engage in regular exercise at least three times per week for a minimum of one year
4. have no hypersensitivity to the areas designated for peripheral stimulation
5. be free from chronic conditions incompatible with exercise performance
6. have no recent musculoskeletal injuries to the lower limbs within the past six months,
7. be non-smokers
8. possess the cognitive capacity to understand the study's objectives and procedures.

Exclusion Criteria:

-

Primary outcomes:
measure: Big Five Personality Trait Short Questionnaire (Spanish version)
timeFrame: Participants will complete questionnaires at 2 time points: just before treatment and after de last treatment (3 days after the first time frame).
measure: State-Trait Anxiety Inventory (STAI, Spanish version)
timeFrame: Participants will complete questionnaires at 2 time points: just before treatment and after de last treatment (3 days after the first time frame)
measure: Acceptance and Action Questionnaire-II (AAQ-II, Spanish version)
timeFrame: Participants will complete questionnaires at 2 time points: just before treatment and after de last treatment (3 days after the first time frame)
measure: UCLA Loneliness Scale (Spanish version):
timeFrame: Participants will complete questionnaires at 2 time points: just before treatment and after de last treatment (3 days after the first time frame)
measure: Zung Self-Rating Depression Scale (Spanish version):
timeFrame: Participants will complete questionnaires at 2 time points: just before treatment and after de last treatment (3 days after the first time frame)
Secondary outcomes:
Other outcomes:
Locations:
city: Toledo
country: Spain
facility: Alberto Sanchez Sierra
Study officials:
References: