| 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
|
|
|
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
|
|
|
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: - To analyze the effects of microcurrent combined with resistance training on back muscles in terms of percentage MVIC.
- To investigate the additive effects of microcurrent with resistance training on back muscle isometric strength.
- 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: - Group A: Progressive Resistance Training only.
- 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: - Counter Movement Jump (CMJ): Measures explosive strength through vertical jump height.
- Gait ON® Posture Analysis: Assesses body alignment and posture.
- Back Held Dynamometer: Measures isometric strength of back muscles.
- 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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