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CTRI Number  CTRI/2024/12/078049 [Registered on: 12/12/2024] Trial Registered Prospectively
Last Modified On: 11/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Microcurrent Stimulation , A physiotherapy adjunct beneficial in Maximizing Performance in Athletes 
Scientific Title of Study   Comparison of combining microcurrent with resistance training versus resistance training alone on performance variables of university athletes:A Randomized controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Saurabh Sharma  
Designation  Associate Professor  
Affiliation  Jamia Millia Islamia 
Address  Room No 202 First Floor Centre for Physiotherapy and Rehabilitation Sciences Jamia Millia Islamia Mohammad Ali Marg Jamia Nagar New Delhi 110025 India

South
DELHI
110025
India 
Phone  9899214134  
Fax    
Email  ssharma@jmi.ac.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr.Saurabh Sharma  
Designation  Associate Professor  
Affiliation  Jamia Millia Islamia 
Address  Room No 202 First Floor Centre for Physiotherapy and Rehabilitation Sciences Jamia Millia Islamia Mohammad Ali Marg Jamia Nagar New Delhi 110025 India

South
DELHI
110025
India 
Phone  9899214134  
Fax    
Email  ssharma@jmi.ac.in  
 
Details of Contact Person
Public Query
 
Name  Mansi Dixit 
Designation  Student 
Affiliation  Centre for Physiotherapy and Rehabilitation Sciences Jamia Millia Islamia 
Address  Room No 116 Ist Floor Centre for Physiotherapy and Rehabilitation Sciences Jamia Millia Islamia Mohammad Ali Marg Jamia Nagar New Delhi

South
DELHI
110025
India 
Phone  9811898426  
Fax    
Email  dixitmansi97@gmail.com  
 
Source of Monetary or Material Support  
Centre for Physiotherapy and Rehabilitation Sciences Jamia Millia Islamia Mohammad Ali Marg Jamia Nagar New Delhi 110025 India 
 
Primary Sponsor  
Name  Jamia Millia Islamia 
Address  Jamia Nagar, Okhla Vihar, New Delhi 110025 
Type of Sponsor  Contract research organization 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrSourabh Sharma  Jamia Millia Islamia  Room no 08 Physiotherapy OPD Centre for Physiotherapy and Rehabilitation Sciences Jamia Millia Islamia Mohammad Ali Marg Jamia Nagar New Delhi 110025 India South DELHI
South
DELHI 
9899214134

ssharma@jmi.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, JAMIA MILLIA ISLAMIA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  healthy university level athletes  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Microcurrent + resistance training   microcurrent with reistance training given to university athletes for 6 week ( 3 days × 40-min (per session)with theraband core strengthening exercise. 
Comparator Agent  resistance training   reistance training given to university athletes for 6 week ( 3 days × 40-min (per session) with theraband core strengthening exercise. 
 
Inclusion Criteria  
Age From  19.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  University athletes involved in any sports must have at least 2 years of playing experience with or without exposure to resistance training.

Age 19 to 28 years

No prior experience of microcurrent training.

Working knowledge of English language .

BMI- 18.5-24.9

Participants should be involved in sport-specific training on at least 2 days per week. 
 
ExclusionCriteria 
Details  Any cardiovascular, respiratory, abdominal, urinary, gynecologically, neurological, musculoskeletal, or other chronic diseases

Use of medications that could affect the musculoskeletal system

Any lower extremity surgery in past 1year or musculoskeletal disorders that would prohibit the subject to participate in sports. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
joint angles and posture analysis
muscle activation
vertical jump
muscle strength 
At day 0 and at week 6 
 
Secondary Outcome  
Outcome  TimePoints 
joint angles and posture analysis
counter vertical jump
 
At day 0 and at week 6 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/12/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Summary of the Study on Microcurrent Therapy and Resistance Training

Introduction: Microcurrent Therapy (MCT) is a non-invasive electrotherapy using low-intensity currents (less than 1 mA), similar to natural bioelectric currents produced by the human body. Developed in the 1970s, MCT has been shown to promote tissue repair, increase mitochondrial ATP production, and enhance muscle recovery. The therapy has applications in increasing muscle protein synthesis, improving endurance, reducing muscle soreness, and aiding in fat reduction. However, research regarding the optimal parameters for MCT, such as intensity, frequency, and treatment duration, remains limited.

Research Gap: While some studies suggest benefits from combining MCT with exercise, there is insufficient evidence regarding the specific dosage and parameters that optimize the effectiveness of MCT when combined with resistance training. Poor research design and inconsistent sample types in past studies have hindered clear conclusions. This study aims to address these gaps and investigate the effects of MCT alongside resistance exercise.


Significance of the Study: This study aims to contribute to existing literature by determining the additive effects of microcurrent in resistance training, specifically targeting back muscles. The findings may offer insight into optimal intervention protocols and highlight MCT’s potential as a tool for improving athletic performance, reducing fatigue, and alleviating delayed-onset muscle soreness (DOMS).

Research Questions:

  • Does microcurrent provide additional benefits when combined with resistance training in terms of maximum voluntary isometric contraction (MVIC), isometric strength, and explosive performance?

Objectives:

  1. To analyze the effects of microcurrent combined with resistance training on back muscles in terms of percentage MVIC.
  2. To investigate the additive effects of microcurrent with resistance training on back muscle isometric strength.
  3. To identify the optimal training method for enhancing strength and explosive performance in university athletes.

This study aims to determine whether microcurrent therapy enhances resistance training outcomes and to establish the most effective protocols for combining these two modalities in athletic training.

Study Summary:

Objective:
The study investigates whether combining microcurrent therapy with progressive resistance training improves back muscle strength and performance (MVIC, isometric strength, and explosive strength) more than resistance training alone in university athletes.

Hypotheses:

  • Null Hypothesis: No significant difference in muscle strength or performance between the two training methods.
  • Alternate Hypothesis: Microcurrent combined with resistance training results in significant improvements.

Study Design:

  • Type: Pre- and post-randomized controlled trial with two groups.
  • Duration: 6 weeks.
  • Sample Size: 30 participants (calculated with G Power to accommodate potential dropouts).
  • Location: Jamia Millia Islamia, New Delhi.

Participants:

  • Inclusion: University athletes aged 19-28 years, 2+ years of sports experience, BMI 18.5-24.9, no previous microcurrent exposure.
  • Exclusion: Individuals with cardiovascular, respiratory, or musculoskeletal issues, or who had recent surgeries.

Randomization:
Participants are randomly divided into two groups:

  1. Group A: Progressive Resistance Training only.
  2. Group B: Microcurrent + Progressive Resistance Training.

Training Protocol:

  • Progressive Resistance Training: 3 sessions per week, each lasting 40 minutes, using TheraBand for core exercises (e.g., curl-ups, bridges, push-ups).
  • Microcurrent Protocol (Group B): Same as Group A but with additional microcurrent therapy at 8 Hz frequency and 25 microamperes intensity for 40 minutes.

Outcome Measures:

  1. Counter Movement Jump (CMJ): Measures explosive strength through vertical jump height.
  2. Gait ON® Posture Analysis: Assesses body alignment and posture.
  3. Back Held Dynamometer: Measures isometric strength of back muscles.
  4. EMG (Electromyography): Monitors muscle activation to assess %MVIC.

Instrumentation:
Includes a stadiometer, digital scale, cones, TheraBand, EMG system, microcurrent device, and dynamometer.

Data Collection:

  • Pre-study: Informed consent, familiarization with tests, and baseline measurements (height, weight, muscle strength, EMG).
  • Post-study: Follow-up assessments after 6 weeks of training.

Conclusion:
This study aims to compare the effects of microcurrent therapy combined with progressive resistance training versus resistance training alone on strength and performance in athletes, using several key measures of muscle function.




 
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