Clinical trial NCT06036953: Electrical Muscle Stimulation on Muscle Mass, Strength, and Body Composition
Official title: Effect of 8-week Frequency-specific Electrical Muscle Stimulation Combined With Resistance Exercise Training on Muscle Mass, Strength, and Body Composition in Men and Women: A Feasibility and Safety Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Electrical Muscle Stimulation
Exercise
Resistance Training
Lead sponsor: National Taiwan Sport University
Sponsor class: OTHER
First posted: 2023-09-14
Enrollment: 28
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: In recent years, electrical muscle stimulation (EMS) devices have been developed as a complementary training technique that is novel, attractive, and time-saving for physical fitness and rehabilitation. While it is known that EMS training can improve muscle mass and strength, most studies have focused on the elderly or specific patient populations. The aim of this study was to investigate the effects of frequency-specific EMS combined with resistance exercise training for 8 weeks on muscle mass, strength, power, body composition, and parameters related to exercise fatigue. Additionally, we aimed to evaluate the feasibility and safety of EMS as an exercise aid to improve body composition. We recruited 14 male and 14 female subjects who were randomly assigned to two groups with gender parity (7 male and 7 female/group): (1) no EMS group and (2) daily EMS group. Blood biochemical routine analysis was performed every 4 weeks from pre-intervention to post-intervention, and body composition, muscle strength, and explosive power were evaluated 8 weeks before and after the intervention. We also performed an exercise challenge analysis of fatigue biochemical indicators after 8 weeks of intervention.


Eligibility criteria: Inclusion Criteria:

* healthy

Exclusion Criteria:

* smoking or drinking habits
* cardiovascular disease
* neuromuscular disease
* metabolic disease
* asthma
* pregnancy
* body mass index (BMI) over 27

Primary outcomes:
measure: VO2max
timeFrame: After 8 weeks of EMS
measure: Body composition_body fat
timeFrame: up to 8 weeks
measure: Body composition_muscle mass
timeFrame: up to 8 weeks
measure: Grip strength
timeFrame: up to 8 weeks
measure: The Countermovement Jump (CMJ) Test
timeFrame: up to 8 weeks
measure: Clinical Biochemistry of lactate level
timeFrame: After 8 weeks of EMS
measure: Clinical Biochemistry of ammonia level
timeFrame: After 8 weeks of EMS
measure: Clinical Biochemistry of glucose level
timeFrame: After 8 weeks of EMS
Secondary outcomes:
measure: Safety assessment - AST
timeFrame: baseline, 4 week and 8 week
measure: Safety assessment - ALT
timeFrame: baseline, 4 week and 8 week
measure: Safety assessment - BUN
timeFrame: baseline, 4 week and 8 week
measure: Safety assessment - Creatinine
timeFrame: baseline, 4 week and 8 week
measure: Safety assessment - Uric Acid
timeFrame: baseline, 4 week and 8 week
measure: Safety assessment - total protein
timeFrame: baseline, 4 week and 8 week
measure: Safety assessment - free fatty acid
timeFrame: baseline, 4 week and 8 week
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Graduate Institute of Sports Science, National Taiwan Sport University
Study officials:
References: