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CTRI Number  CTRI/2025/09/094684 [Registered on: 12/09/2025] Trial Registered Prospectively
Last Modified On: 06/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing exercise on a stationary bike and treadmill for balancing front and back thigh muscle strength in young people  
Scientific Title of Study   Effects of Ergo Cycling vs Treadmill Training on Hamstring to Quadriceps (H/Q) Strength Ratio in Young Individuals: A Comparative Study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shruti Sudhir Gaikwad 
Designation  Postgraduate Student 
Affiliation  Parul Institute of Physiotherapy 
Address  Parul University,307 Parul Institute of Physiotherapy Post Limda, Waghodia, Gujarat 391760 India


GUJARAT
391760
Other 
Phone  7715856546  
Fax    
Email  g.shruti1002@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Bhavana Gadhavi 
Designation  Dean and Principal 
Affiliation  Parul Institute of Physiotherapy 
Address  Parul University Post Limda, Waghodia, Gujarat 391760.



391760
Other 
Phone  9727729787  
Fax    
Email  bhavana.gadhavi28222@paruluniversity.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr. Bhavana Gadhavi 
Designation  Dean and Principal 
Affiliation  Parul Institute of Physiotherapy 
Address  Parul University Post Limda, Waghodia, Gujarat 391760.


GUJARAT
391760
Other 
Phone  9727729787  
Fax    
Email  bhavana.gadhavi28222@paruluniversity.ac.in  
 
Source of Monetary or Material Support  
Parul University, Parul Institute of Physiotherapy. 308, Post Limda, Waghodia, Gujarat 391760, India. 
 
Primary Sponsor  
Name  none 
Address  none 
Type of Sponsor  Other [] 
 
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 Bhavana Gadhavi  PARUL UNIVERSITY  Parul Institute of Physiotherapy, 3rd floor , Room no,308, Post Limda, Waghodia, Gujarat 391760.
Vadodara
GUJARAT 		 09727729787
912668260201
bhavana.gadhavi28222@paruluniversity.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Parul University Institutional Ethics Committee for Human Research   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Young Healthy Individuals Aged 18 years to 25 years  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ergo Cycling Training Program   Participants will undergo a 4-week Ergo Cycling protocol, 3 sessions per week. Warm-up (5 min): Light cycling at 40–50% MHR. Week 1: 50–60% MHR (10 min) + 5 min recovery at 30–40% MHR + 50–60% MHR (10 min). Week 2: 60–70% MHR (10 min) + 5 min recovery at 30–40% MHR + 60–70% MHR (10 min). Week 3: 65–75% MHR (10 min) + 5 min recovery at 30–40% MHR + 65–75% MHR (10 min). Week 4: 70–80% MHR (10 min) + 5 min recovery at 30–40% MHR + 70–80% MHR (10 min). Cool-down (5 min): Static stretching for hamstrings and quadriceps (20–30 sec hold, 2–3 repetitions).  
Comparator Agent  Treadmill Training Program   Participants will undergo a 4-week Treadmill Training protocol, 3 sessions per week. Warm-up (5 min): Walking/jogging at 40–50% MHR. Week 1: 50–60% MHR (10 min) + 5 min recovery at 30–40% MHR + 50–60% MHR (10 min). Week 2: 60–70% MHR (10 min) + 5 min recovery at 30–40% MHR + 60–70% MHR (10 min). Week 3: 65–75% MHR (10 min) + 5 min recovery at 30–40% MHR + 65–75% MHR (10 min). Week 4: 70–80% MHR (10 min) + 5 min recovery at 30–40% MHR + 70–80% MHR (10 min). Cool-down (5 min): Static stretching for hamstrings and quadriceps (20–30 sec hold, 2–3 repetitions).  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  Age between 18years-25years
Willing to participate and adhere to the study protocol.
No prior experience with structured cycling or treadmill training programs.
Not currently involved in competitive sports or elite athletic programs.
 
 
ExclusionCriteria 
Details  Use of medications such as blood thinners, steroids, or drugs affecting muscle function (e.g. statins, beta-blockers).
Current or recent lower limb injuries or surgeries (within the last 6 months).
Neurological or musculoskeletal disorders affecting lower limb function.
Systemic illnesses affecting muscle function.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Hamstring to Quadriceps (H/Q) Strength Ratio  Hamstring to Quadriceps (H/Q) Strength Ratio to be measured
At Baseline and After 4 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
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)   21/09/2025 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [g.shruti1002@gmail.com].

  6. For how long will this data be available start date provided 09-01-2026 and end date provided 08-03-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study compares the impact of Ergo Cycling and Treadmill Training on the Hamstring to Quadriceps (H/Q) Strength Ratio in young individuals aged 18 to 25 years. Eighty-four participants will be recruited through systematic random sampling from Parul University. The 4-week intervention consists of three training sessions per week. Group A will perform a structured Ergo Cycling protocol with gradually increasing intensity, while Group B will follow a matched Treadmill Training program. Both groups include warm-up, exercise intervals based on percentages of Maximum Heart Rate, recovery phases, and cool-down stretching exercises. The main outcome measure is- the H/Q Strength Ratio, assessed using a digital dynamometer. 
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