xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06036953</url>
    </required_header>
    <id_info>
      <org_study_id>21-034-A2</org_study_id>
      <nct_id>NCT06036953</nct_id>
    </id_info>
    <brief_title>Electrical Muscle Stimulation on Muscle Mass, Strength, and Body Composition</brief_title>
    <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</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National Taiwan Sport University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>National Taiwan Sport University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        In recent years, electrical muscle stimulation (EMS) devices have been developed as a&#xD;
        complementary training technique that is novel, attractive, and time-saving for physical&#xD;
        fitness and rehabilitation. While it is known that EMS training can improve muscle mass and&#xD;
        strength, most studies have focused on the elderly or specific patient populations. The aim&#xD;
        of this study was to investigate the effects of frequency-specific EMS combined with&#xD;
        resistance exercise training for 8 weeks on muscle mass, strength, power, body composition,&#xD;
        and parameters related to exercise fatigue. Additionally, we aimed to evaluate the&#xD;
        feasibility and safety of EMS as an exercise aid to improve body composition. We recruited 14&#xD;
        male and 14 female subjects who were randomly assigned to two groups with gender parity (7&#xD;
        male and 7 female/group): (1) no EMS group and (2) daily EMS group. Blood biochemical routine&#xD;
        analysis was performed every 4 weeks from pre-intervention to post-intervention, and body&#xD;
        composition, muscle strength, and explosive power were evaluated 8 weeks before and after the&#xD;
        intervention. We also performed an exercise challenge analysis of fatigue biochemical&#xD;
        indicators after 8 weeks of intervention.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">November 15, 2021</start_date>
    <completion_date type="Actual">November 23, 2022</completion_date>
    <primary_completion_date type="Actual">January 14, 2022</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>VO2max</measure>
      <time_frame>After 8 weeks of EMS</time_frame>
      <description>To evaluate the maximum oxygen consumption and exercise performance, we used a treadmill (Pulsar, h/p/cosmos, Nussdorf-Traunstein, Germany) and an automatic breathing analyzer (Vmax 29c, Sensor Medics, Yorba Linda, CA, USA). In addition, a polar heart rate device was used to monitor the heart rate (HR). The speed range of the treadmill was set to 7.2 km/h and increased by 1.8 km/h every 2 min until fatigue, according to Bruce's protocol. When the breathing exchange rate (the volume ratio of carbon dioxide produced to oxygen consumed, VCO2/VO2) was higher than 1.10 and reached the maximum heart rate (maximum heart rate = 220 - age), oxygen consumption was considered to be maximum. The three highest VO2max peak were averaged to obtain the VO2max values of the individual volunteers.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Body composition_body fat</measure>
      <time_frame>up to 8 weeks</time_frame>
      <description>The multi-frequency principle was applied to measure body composition by using a bioelectrical impedance analyzer (BIA) on an InBody 570 device (In-body, Seoul, South Korea). To perform the measurements, after the subjects' palms and soles were removed from the sensors, the subjects stood on the footing electrodes and held the sensing handles with two hands. During the measurements, the subjects kept their arms open and left their bodies at an angle of 30° without speaking or moving. The subjects also fasted for at least 8 h before the test. The body fat were meansure</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Body composition_muscle mass</measure>
      <time_frame>up to 8 weeks</time_frame>
      <description>The multi-frequency principle was applied to measure body composition by using a bioelectrical impedance analyzer (BIA) on an InBody 570 device (In-body, Seoul, South Korea). To perform the measurements, after the subjects' palms and soles were removed from the sensors, the subjects stood on the footing electrodes and held the sensing handles with two hands. During the measurements, the subjects kept their arms open and left their bodies at an angle of 30° without speaking or moving. The subjects also fasted for at least 8 h before the test. The muscle mass were meansure</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Grip strength</measure>
      <time_frame>up to 8 weeks</time_frame>
      <description>Use the armed grip machine (T.K.K.5401, Takei Scientific Instruments Co.,Ltd, Niigata, Japan) to measure, hold each of the left and right hands three times until they are weak, and record the maximum value</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The Countermovement Jump (CMJ) Test</measure>
      <time_frame>up to 8 weeks</time_frame>
      <description>The CMJ test is a practical, effective, reliable, and simple method of measuring lower limb strength, which is related to the maximum speed, strength and explosive force of the lower limbs. For this test, participants stood on the Kistler force measurement platform (9260AA, Kistler Co., Ltd., Switzerland) on both feet and performed to inspection. During the test, they were asked to put their hands on their hips and remain on the platform. After that, they were asked to squat down until the knees bent 90 degrees and then to immediately jump as high as possible. The average power (MF), were recorded during the jump. Each participant repeated the test 3 times, and CMJ data were obtained at the designated points. The instrument was calibrated for each individual's weight.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinical Biochemistry of lactate level</measure>
      <time_frame>After 8 weeks of EMS</time_frame>
      <description>For assessment of fatigue-related indices, volunteers fasted for at least 8 h before the 60% VO2max fixed intensity exercise challenge. Blood samples were collected with an arm venous catheter at indicated time points during exercise and recovery periods, including baseline (0), 30 (E30) min during the exercise phase, and 60 (R60) min in the recovery phase. Serum lactate (mmol/L), were assessed for monitoring physiological adaptation. All biochemical indices were assessed using an autoanalyzer (Hitachi 7060, Tokyo, Japan).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinical Biochemistry of ammonia level</measure>
      <time_frame>After 8 weeks of EMS</time_frame>
      <description>For assessment of fatigue-related indices, volunteers fasted for at least 8 h before the 60% VO2max fixed intensity exercise challenge. Blood samples were collected with an arm venous catheter at indicated time points during exercise and recovery periods, including baseline (0), 30 (E30) min during the exercise phase, and 60 (R60) min in the recovery phase. Serum ammonia (umol/L), were assessed for monitoring physiological adaptation. All biochemical indices were assessed using an autoanalyzer (Hitachi 7060, Tokyo, Japan).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinical Biochemistry of glucose level</measure>
      <time_frame>After 8 weeks of EMS</time_frame>
      <description>For assessment of fatigue-related indices, volunteers fasted for at least 8 h before the 60% VO2max fixed intensity exercise challenge. Blood samples were collected with an arm venous catheter at indicated time points during exercise and recovery periods, including baseline (0), 30 (E30) min during the exercise phase, and 60 (R60) min in the recovery phase. Serum glucose (mg/dL), were assessed for monitoring physiological adaptation. All biochemical indices were assessed using an autoanalyzer (Hitachi 7060, Tokyo, Japan).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Safety assessment - AST</measure>
      <time_frame>baseline, 4 week and 8 week</time_frame>
      <description>Safety is assessed function of liver such as AST (8-38 IU/L).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Safety assessment - ALT</measure>
      <time_frame>baseline, 4 week and 8 week</time_frame>
      <description>Safety is assessed function of liver such as ALT (4-44 IU/L).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Safety assessment - BUN</measure>
      <time_frame>baseline, 4 week and 8 week</time_frame>
      <description>Safety is assessed function of kidney such as Bun (6-20 mg/dl)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Safety assessment - Creatinine</measure>
      <time_frame>baseline, 4 week and 8 week</time_frame>
      <description>Safety is assessed function of kidney such as Creatinine (0.6-1.3 mg/dl)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Safety assessment - Uric Acid</measure>
      <time_frame>baseline, 4 week and 8 week</time_frame>
      <description>Safety is assessed function of kidney such as Uric Acid (3.4-7.6 mg/dl)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Safety assessment - total protein</measure>
      <time_frame>baseline, 4 week and 8 week</time_frame>
      <description>Safety is assessed function of kidney such as total protein (6.4-8.9 g/dl)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Safety assessment - free fatty acid</measure>
      <time_frame>baseline, 4 week and 8 week</time_frame>
      <description>Safety is assessed function of lipid metabolism such as free fatty acid (0.1-0.9 mmol/L)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">28</enrollment>
    <condition>Electrical Muscle Stimulation</condition>
    <condition>Exercise</condition>
    <condition>Resistance Training</condition>
    <arm_group>
      <arm_group_label>No EMS</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>EMS</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>electrical muscle stimulation</intervention_name>
      <description>The electric muscle stimulator (EMS) used in this study was from Funcare (Funcare Co., Ltd, Taichung, Taiwan). EMS electrodes were attached to the biceps of both hands, the abdomen, and the quadriceps of both legs sequentially. Each part was stimulated once a day for 30 minutes.</description>
      <arm_group_label>EMS</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  healthy&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  smoking or drinking habits&#xD;
  &#xD;
            -  cardiovascular disease&#xD;
  &#xD;
            -  neuromuscular disease&#xD;
  &#xD;
            -  metabolic disease&#xD;
  &#xD;
            -  asthma&#xD;
  &#xD;
            -  pregnancy&#xD;
  &#xD;
            -  body mass index (BMI) over 27&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Graduate Institute of Sports Science, National Taiwan Sport University</name>
        <address>
          <city>Taoyuan</city>
          <zip>33301</zip>
          <country>Taiwan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 7, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>National Taiwan Sport University</investigator_affiliation>
      <investigator_full_name>Chi-Chang Huang</investigator_full_name>
      <investigator_title>Distinguished Professor</investigator_title>
    </responsible_party>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06036953
  org study id: 21-034-A2
  nct id: NCT06036953
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: VO2max
  time frame: After 8 weeks of EMS
  description: To evaluate the maximum oxygen consumption and exercise performance, we used a treadmill (Pulsar, h/p/cosmos, Nussdorf-Traunstein, Germany) and an automatic breathing analyzer (Vmax 29c, Sensor Medics, Yorba Linda, CA, USA). In addition, a polar heart rate device was used to monitor the heart rate (HR). The speed range of the treadmill was set to 7.2 km/h and increased by 1.8 km/h every 2 min until fatigue, according to Bruce's protocol. When the breathing exchange rate (the volume ratio of carbon dioxide produced to oxygen consumed, VCO2/VO2) was higher than 1.10 and reached the maximum heart rate (maximum heart rate = 220 - age), oxygen consumption was considered to be maximum. The three highest VO2max peak were averaged to obtain the VO2max values of the individual volunteers.
  measure: Body composition_body fat
  time frame: up to 8 weeks
  description: The multi-frequency principle was applied to measure body composition by using a bioelectrical impedance analyzer (BIA) on an InBody 570 device (In-body, Seoul, South Korea). To perform the measurements, after the subjects' palms and soles were removed from the sensors, the subjects stood on the footing electrodes and held the sensing handles with two hands. During the measurements, the subjects kept their arms open and left their bodies at an angle of 30° without speaking or moving. The subjects also fasted for at least 8 h before the test. The body fat were meansure
  measure: Body composition_muscle mass
  time frame: up to 8 weeks
  description: The multi-frequency principle was applied to measure body composition by using a bioelectrical impedance analyzer (BIA) on an InBody 570 device (In-body, Seoul, South Korea). To perform the measurements, after the subjects' palms and soles were removed from the sensors, the subjects stood on the footing electrodes and held the sensing handles with two hands. During the measurements, the subjects kept their arms open and left their bodies at an angle of 30° without speaking or moving. The subjects also fasted for at least 8 h before the test. The muscle mass were meansure
  measure: Grip strength
  time frame: up to 8 weeks
  description: Use the armed grip machine (T.K.K.5401, Takei Scientific Instruments Co.,Ltd, Niigata, Japan) to measure, hold each of the left and right hands three times until they are weak, and record the maximum value
  measure: The Countermovement Jump (CMJ) Test
  time frame: up to 8 weeks
  description: The CMJ test is a practical, effective, reliable, and simple method of measuring lower limb strength, which is related to the maximum speed, strength and explosive force of the lower limbs. For this test, participants stood on the Kistler force measurement platform (9260AA, Kistler Co., Ltd., Switzerland) on both feet and performed to inspection. During the test, they were asked to put their hands on their hips and remain on the platform. After that, they were asked to squat down until the knees bent 90 degrees and then to immediately jump as high as possible. The average power (MF), were recorded during the jump. Each participant repeated the test 3 times, and CMJ data were obtained at the designated points. The instrument was calibrated for each individual's weight.
  measure: Clinical Biochemistry of lactate level
  time frame: After 8 weeks of EMS
  description: For assessment of fatigue-related indices, volunteers fasted for at least 8 h before the 60% VO2max fixed intensity exercise challenge. Blood samples were collected with an arm venous catheter at indicated time points during exercise and recovery periods, including baseline (0), 30 (E30) min during the exercise phase, and 60 (R60) min in the recovery phase. Serum lactate (mmol/L), were assessed for monitoring physiological adaptation. All biochemical indices were assessed using an autoanalyzer (Hitachi 7060, Tokyo, Japan).
  measure: Clinical Biochemistry of ammonia level
  time frame: After 8 weeks of EMS
  description: For assessment of fatigue-related indices, volunteers fasted for at least 8 h before the 60% VO2max fixed intensity exercise challenge. Blood samples were collected with an arm venous catheter at indicated time points during exercise and recovery periods, including baseline (0), 30 (E30) min during the exercise phase, and 60 (R60) min in the recovery phase. Serum ammonia (umol/L), were assessed for monitoring physiological adaptation. All biochemical indices were assessed using an autoanalyzer (Hitachi 7060, Tokyo, Japan).
  measure: Clinical Biochemistry of glucose level
  time frame: After 8 weeks of EMS
  description: For assessment of fatigue-related indices, volunteers fasted for at least 8 h before the 60% VO2max fixed intensity exercise challenge. Blood samples were collected with an arm venous catheter at indicated time points during exercise and recovery periods, including baseline (0), 30 (E30) min during the exercise phase, and 60 (R60) min in the recovery phase. Serum glucose (mg/dL), were assessed for monitoring physiological adaptation. All biochemical indices were assessed using an autoanalyzer (Hitachi 7060, Tokyo, Japan).
  measure: Safety assessment - AST
  time frame: baseline, 4 week and 8 week
  description: Safety is assessed function of liver such as AST (8-38 IU/L).
  measure: Safety assessment - ALT
  time frame: baseline, 4 week and 8 week
  description: Safety is assessed function of liver such as ALT (4-44 IU/L).
  measure: Safety assessment - BUN
  time frame: baseline, 4 week and 8 week
  description: Safety is assessed function of kidney such as Bun (6-20 mg/dl)
  measure: Safety assessment - Creatinine
  time frame: baseline, 4 week and 8 week
  description: Safety is assessed function of kidney such as Creatinine (0.6-1.3 mg/dl)
  measure: Safety assessment - Uric Acid
  time frame: baseline, 4 week and 8 week
  description: Safety is assessed function of kidney such as Uric Acid (3.4-7.6 mg/dl)
  measure: Safety assessment - total protein
  time frame: baseline, 4 week and 8 week
  description: Safety is assessed function of kidney such as total protein (6.4-8.9 g/dl)
  measure: Safety assessment - free fatty acid
  time frame: baseline, 4 week and 8 week
  description: Safety is assessed function of lipid metabolism such as free fatty acid (0.1-0.9 mmol/L)
  arm group label: No EMS
  arm group type: No Intervention
  arm group label: EMS
  arm group type: Experimental
  intervention type: Device
  intervention name: electrical muscle stimulation
  description: The electric muscle stimulator (EMS) used in this study was from Funcare (Funcare Co., Ltd, Taichung, Taiwan). EMS electrodes were attached to the biceps of both hands, the abdomen, and the quadriceps of both legs sequentially. Each part was stimulated once a day for 30 minutes.
  arm group label: EMS
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 40 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Taiwan
  responsible party type: Principal Investigator
  investigator affiliation: National Taiwan Sport University
  investigator full name: Chi-Chang Huang
  investigator title: Distinguished Professor