FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/03/083098 [Registered on: 21/03/2025] Trial Registered Prospectively
Last Modified On: 20/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Exercise using dumbbells]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing the Effects of Two Types of Exercise on Heart Health and Body Fat in Healthy Adult Males: A Randomized Study 
Scientific Title of Study   Effect of eight weeks of concentric and eccentric exercises on cardiac autonomic functions and body composition in healthy young individuals- a randomised control trial 
Trial Acronym  N/A 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ayushi Parmar 
Designation  PG Student 
Affiliation  All India Institute of Medical Sciences(AIIMS), Rajkot 
Address  Department of Physiology All India Institute of Medical Sciences(AIIMS), Rajkot

Rajkot
GUJARAT
360006
India 
Phone  7016113941  
Fax    
Email  ayushiparmar1098@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vivek Kumar Sharma 
Designation  Head of Department of Physiology 
Affiliation  AIIMS Rajkot 
Address  Department of Physiology AIIMS Rajkot
AIIMS Rajkot
Rajkot
GUJARAT
360006
India 
Phone  8668117030  
Fax    
Email  drviveksharmazen@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vivek Kumar Sharma 
Designation  Head of Department of Physiology 
Affiliation  AIIMS Rajkot 
Address  Department of Physiology AIIMS Rajkot
AIIMS Rajkot
Rajkot
GUJARAT
360006
India 
Phone  8668117030  
Fax    
Email  drviveksharmazen@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences (AIIMS), Khanderi, Para Pipaliya, Rajkot, Gujarat, India, 360006 
 
Primary Sponsor  
Name  Dr Ayushi Parmar 
Address  Department of Physiology All India Institute of Medical Sciences (AIIMS), Khanderi, Para Pipaliya, Rajkot, Gujarat, India, 360006 
Type of Sponsor  Government medical college 
 
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 
Dr Ayushi Parmar  All India Institute of Medical Sciences (AIIMS) Hospital  Department of Physiology 1st Floor Academic Block All India Institute of Medical Sciences (AIIMS), Khanderi, Para Pipaliya, Rajkot, Gujarat, India, 360006
Rajkot
GUJARAT 		 07016113941

ayushiparmar1098@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC AIIMS Rajkot  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Concentric Exercises using dumbbell  fully extend elbow passively, then the weight will be given by a supporter. Flexion of the arm from 0 degree to 150 degree with a velocity of 6 seconds/contraction.The sessions will be conducted twice a week for a duration of 8 weeks using a weight of 30% MVIC with 3 sets of 10 repetitions (6 seconds for 1 repetition) having 3-minute rest between each session and the same procedure will be repeated which will give 2 seconds rest between each repetition 
Intervention  Eccentric exercise using dumbbell  fully flex elbow passively, then the weight will be given by a supporter. Extension of the arm from 150 degree to 0 degree with a velocity of 6 seconds/contraction. At full extension, object will be removed and subject will be allowed to full flexion without load.The sessions will be conducted twice a week for a duration of 8 weeks using a weight of 30% MVIC with 3 sets of 10 repetitions (6 seconds for 1 repetition) having 3-minute rest between each session and the same procedure will be repeated which will give 2 seconds rest between each repetition 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Male 
Details  Inclusion Criteria:
Healthy young adult males, aged 18-40 years.
Body Mass Index (BMI) between 18.5 – 29.9.
Non-alcoholic, non-smoker.
Providing written informed consent.
 
 
ExclusionCriteria 
Details  Exclusion Criteria:
Individuals with orthopaedic, neurological disease or any disorder that would limit the exercise.
History of chronic disorder or acute disorder and on medications for the same.
History of cardiovascular or systemic disease like Diabetes Mellitus and hypertension.
Having participated in any structured physical activity(exercises) in last 6 months
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate and compare the effect of eccentric and concentric exercises on cardiovascular parameters, autonomic functions, body composition and muscle strength in healthy young adult males.   Baseline, 4 weeks and at 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the effect of eccentric & concentric exercises on heart rate recovery after eccentric & concentric exercises.  Baseline,4 weeks & 8 weeks 
 
Target Sample Size   Total Sample Size="78"
Sample Size from India="78" 
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    
Date of First Enrollment (India)   01/04/2025 
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="2"
Months="0"
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   This study is planned to explore the effects of eccentric exercise on autonomic functions, cardiovascular responses and body composition compared to concentric/traditional exercise in healthy Indian population not involved in any previous structured exercise training. This will also shed a light on the comparable effects of eccentric and concentric exercise on healthy Indian population, thereby assisting the health care professionals in prescribing eccentric training modalities for beneficial outcomes in clients with reduced exercise tolerance, obese individuals, healthy individuals and in rehabilitation for patients with co-morbidities.  
Close