Muscle Fatigue
Conditions
Keywords
Microcurrent therapy, Transcutaneous microcurrent stimulation, Muscle fatigue, Post-exercise recovery, Creatine kinase, Lactate, Military personnel, Rating of perceived exertion
Brief summary
The goal of this clinical trial is to find out whether microcurrent therapy changes blood levels of creatine kinase, a marker of muscle stress, during the first 48 hours after exercise in military personnel. The main question is: Do creatine kinase levels after exercise differ between people who receive active microcurrent therapy and those who receive a sham treatment? Twenty participants will complete a standardized exercise session. Participants will be randomly assigned to one of two groups: 10 will use an active microcurrent device, and 10 will use a sham device for the same period after exercise. The sham device looks and lights up like the active device but delivers no microcurrents. Researchers will measure creatine kinase before exercise and 24 and 48 hours afterward, then compare how levels change in the two groups. Investigators will also measure blood lactate and perceived effort shortly after exercise, before either device is applied. Participants will report any difficulties using the device, discomfort, effects on sleep or rest, and unwanted effects.
Detailed description
Background and study design Demanding physical exercise can cause physiological changes that persist after the activity has ended. Creatine kinase (CK) is an enzyme whose concentration in the blood can increase following muscle stress. This study will investigate whether prolonged transcutaneous microcurrent therapy after exercise changes the pattern of serum CK concentrations during the first 48 hours of recovery. The study will also characterize the immediate response to exercise and assess the practical use and tolerability of the intervention. This is a randomized, controlled, parallel-group clinical trial involving 20 participants. Participants will be randomized in a 1:1 ratio to active microcurrent therapy or sham microcurrent therapy, with 10 participants in each group. All participants will complete the same standardized exercise protocol, and both groups will follow the same device application procedure. Participants will apply the devices to both legs for at least seven hours per day on each leg throughout the post-exercise treatment period. The sham device has been modified so that its indicator light turns on in the same way as the active device, while it delivers no microcurrent output. Participants and outcome assessors will be blinded to group assignment. The personnel responsible for assessing outcomes will not be involved in assigning participants to groups. Study objectives Primary objective: To determine the effect of microcurrent therapy on the post-exercise serum creatine kinase response during the first 48 hours of recovery. Secondary objectives: Objective 1: To assess the feasibility and tolerability of microcurrent therapy, including difficulties with administration, adverse events, negative effects on sleep or rest. Objective 2: To characterize the blood lactate response to the standardized exercise protocol and its short-term recovery during the first 30 minutes following exercise. Objective 3: To characterize the change in perceived exertion immediately after exercise and during the first 30 minutes of recovery. Objective 4: To assess the success of participant and assessor blinding. Exploratory objectives: Exploratory objective 1: To investigate the association between blood lactate concentrations after exercise and CK concentrations at 24 hours and 48 hours Exploratory objective 2: To examine the relationship between post-exercise lactate concentration and subsequent CK concentration according to treatment allocation. Exploratory objective 3: To investigate the association between early lactate recovery and early Rating of Perceived Exertion (RPE) recovery.
Interventions
DEVICEMicrocurrents Therapy
Prolonged post-exercise transcutaneous microcurrent therapy using an active microcurrent patch applied for minium 7 hours following exercise to promote recovery from exercise-induced muscle fatigue.
Prolonged post-exercise sham transcutaneous microcurrent intervention using a modified device engineered to reproduce the appearance and operating indicators of the active device, including illumination of the indicator light, while delivering no microcurrent output. The sham device is applied following the same procedure and for the same duration as the active intervention.
Sponsors
University of Castilla-La Mancha
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Randomized, controlled, parallel-group clinical trial.
Eligibility
Sex/Gender
MALE
Healthy volunteers
Yes
Inclusion criteria
* Age between 18 and 45 years. * Active-duty military personnel. * Healthy volunteers with current medical clearance. * Skin over the quadriceps free of lesions, burns, or irritation. * Availability and willingness to comply with the proposed intervention protocol. * Informed consent form read and signed.
Exclusion criteria
* Implanted electronic devices: pacemakers, defibrillators, neurostimulators, etc. * Neuromuscular disease or peripheral neuropathy. * Treatment for HIV or chronic viral infections. * Uncontrolled seizure disorders (active epilepsy). * Uncontrolled, clinically significant heart disease. * Depression. * Uncontrolled hypertension. * Thrombosis. * Diabetes with neuropathy or impaired wound healing. * Active neoplasms or suspected cancer. * Recent musculoskeletal injuries (within the past three months) or chronic muscle pain in a lower limb. * Recent major surgery. * A dermatological condition in the quadriceps region. * Prescription of medications that may confound pain assessment during the seven days before or during the intervention, including nonsteroidal anti-inflammatory drugs (NSAIDs), muscle relaxants, and systemic corticosteroids. * Long-term treatment for hypercholesterolemia. * Prescription of antipsychotic or neuroleptic medications. * Long-term treatment for hypertriglyceridemia. * Alcohol or other substance abuse. * Inability to follow the intervention instructions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum creatine kinase (CK) concentration. | Baseline, 24 hours, and 48 hours after exercise. | Unit: U/L. Definition: Serum CK concentration will be measured at baseline and during the post- exercise recovery period at 24 and 48 hours. Baseline CK will be calculated as the mean of two measurements obtained one day before and on the day of the exercise protocol. The primary analysis will evaluate whether the CK concentrations over time differs between the active microcurrent and sham groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant-perceived feasibility of microcurrent treatment administration | Immediately after the microcurrent treatment period. | Participants will report whether the intervention was easy to administer using a dichotomous response (Yes/No). The outcome will be summarized as the number and percentage of participants answering "Yes". |
| Blood lactate concentration | Pre-exercise, immediately post-exercise, and 30 minutes post-exercise. | Unit: mmol/L. Definition: blood lactate concentration will be measured at baseline and inmediately post- exercise and at 30 min post-exercise. The analysis will focus on changes over time during the first 30 minutes of recovery. The primary comparisons will concern the effect of time rather than the effect of treatment group, because all lactate measurements are obtained before microcurrent treatment. These measurements will be considered indicators of biochemical response to the exercise bout rather than measures of the effect of microcurrent therapy. |
| Change in perceived exertion after exercise | Immediately post-exercise and 30 minutes post-exercise. | Unit of Measure: Scale points from 0 to 10 Points Description: Rating of perceived exertion will be assessed using the Borg Category-Ratio 10 Scale immediately after the standardized exercise protocol and 30 minutes later. The recorded score ranges from a minimum of 0 ("nothing at all") to a maximum of 10 ("extremely strong-maximal exertion"). Higher scores indicate greater perceived exertion, representing a less favorable outcome in terms of perceived exertion. The change in perceived exertion will be calculated as the score at 30 minutes post-exercise minus the score immediately post-exercise. Possible change scores range from -10 to +10. Negative values indicate a reduction in perceived exertion, representing more favorable perceptual recovery; positive values indicate an increase, representing less favorable perceptual recovery. |
| Participant and assessor blinding success | Immediately after completion of the study intervention. | Unit: Categorical responses Blinding success will be assessed by asking participants and outcome assessors to identify treatment allocation using five predefined response options: (1) strongly believe the treatment was active; (2) somewhat believe the treatment was active; (3) strongly believe the treatment was sham; (4) somewhat believe the treatment was sham; and (5) do not know |
| Occurrence of adverse events | Immediately after the microcurrent treatment period. | The occurrence of adverse events will be recorded as a yes/no response for each participant. The outcome will be reported as the number of participants experiencing at least one adverse event. The nature and characteristics of reported adverse events will also be documented descriptively. |
| Negative effects on sleep or rest | During and Immediately after the microcurrent treatment period. | Negative effects on sleep or rest during the microcurrent intervention will be assessed using participant-reported yes/no responses. The outcome will be reported as the number of participants reporting at least one negative effect on sleep or rest. The nature of reported effects will also be documented descriptively. |
| Perceived unpleasantness of the microcurrent intervention | Immediately after the microcurrent treatment period. | Unit of Measure: Numerical Rating Scale (NRS) score (1-10). Description: Perceived unpleasantness of the microcurrent intervention will be assessed using a 11-point Numerical Rating Scale (NRS), ranging from 0 ("not unpleasant at all") to 10 ("extremely unpleasant"). Higher scores indicate greater perceived unpleasantness |
Countries
Spain
Contacts
CONTACTJuan Avendaño-Coy, PhD
PRINCIPAL_INVESTIGATORJuan Avendaño-Coy, PhD
University of Castilla-La Mancha
Outcome results
None listed