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CTRI Number  CTRI/2024/05/066947 [Registered on: 07/05/2024] Trial Registered Prospectively
Last Modified On: 05/05/2024
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   Effect of exercises for lower back and pelvis on core strength, performance and number of cycling revolutions per minute in beginner cyclists: An Experimental Study 
Scientific Title of Study   Effect of Lumbopelvic Exercise Training on core strength, performance and cadence in Amateur cyclists: An Experimental 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  Anushka Ravindra Patil 
Designation  Post Graduate Resident 
Affiliation  Sancheti Institute for Orthopaedics and Rehabilitation, College of Physiotherapy 
Address  Musculoskeletal and Sports Physiotherapy Department.Sancheti Institute for Orthopaedics and Rehabilitation, College of Physiotherapy. 11/12 Thube Park, Shivajinagar, Pune

Pune
MAHARASHTRA
411005
India 
Phone  9370268306  
Fax    
Email  patilanushka090@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anand Gangwal 
Designation  Associate Professor, Musculoskeletal and Sports Physiotherapy Department 
Affiliation  Sancheti Institute for Orthopaedics and Rehabilitation, College of Physiotherapy 
Address  Musculoskeletal and Sports Physiotherapy Department.Sancheti Institute for Orthopaedics and Rehabilitation, College of Physiotherapy. 11/12 Thube Park, Shivajinagar, Pune

Pune
MAHARASHTRA
411005
India 
Phone  9960323333  
Fax    
Email  anandgangwal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Anand Gangwal 
Designation  Associate Professor, Musculoskeletal and Sports Physiotherapy Department 
Affiliation  Sancheti Institute for Orthopaedics and Rehabilitation, College of Physiotherapy 
Address  Musculoskeletal and Sports Physiotherapy Department.Sancheti Institute for Orthopaedics and Rehabilitation, College of Physiotherapy. 11/12 Thube Park, Shivajinagar, Pune

Pune
MAHARASHTRA
411005
India 
Phone  9960323333  
Fax    
Email  anandgangwal@gmail.com  
 
Source of Monetary or Material Support  
Sancheti Institute for Orthopaedics and Rehabilitation, College of Physiotherapy, Shivajinagar, Pune-411005 Maharashtra, India 
 
Primary Sponsor  
Name  Sancheti Institute for Orthopaedics and Rehabilitation, College of Physiotherapy 
Address  Sancheti Institute for Orthopaedics and Rehabilitation, College of Physiotherapy. 11/12, Thube Park, Shivajinagar, Pune- 411005 
Type of Sponsor  Private 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 Anushka Patil  Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy  1st floor, Department of Musculoskeletal and Sports Physiotherapy, Sancheti Institute for Orthopaedics and Rehabilitation, College of Physiotherapy,11/12 Thube Park, Shivajinagar, Pune- 411005
Pune
MAHARASHTRA 		 9370268306

patilanushka090@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sancheti Institute for Orthopaedics and Rehabilitaion, College of Physiotherapy, Pune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Cyclists 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Lumbopelvic exercise training along with regular exercise training regime  The intervention group will receive exercises focusing on global and local muscles important for the cyclists performance. These will include exercises like bird dog, front and side planks, pelvic bridging, lateral step ups, back extension exercise, bilateral leg lifts. These will be given for 8 repetitions 2 sets with 30 seconds rest between each set and 3 sessions for 4 weeks. Progression of the exercises will be done from the 3rd week. Training program will also include warmup and cool down. 
Comparator Agent  Regular Exercise Training Regime  Regular training regime will include speed training, strength training and endurance training  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  Cyclists between the age group 18 to 25 years and willing to participate
Those who train 3- 7 times per week with daily training volume of 60 -120 minutes
Cyclists who compete about 20 times a year
 
 
ExclusionCriteria 
Details  Cyclists not willing to participate
Acute or subacute lower limb injuries
Fractures of upper or lower extremities in past six months
Surgery for upper or lower extremity in past six months
• Cyclists with any neurological deficits
• Those already doing the exercises included in this study

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Cadence (Cadence sensors in Wattbike)
 		 At baseline (0 week)
Post intervention (after 4 weeks)
 
 
Secondary Outcome  
Outcome  TimePoints 
Core strength (Pressure biofeedback)  At baseline (0 week)
Post intervention (after 4 weeks)
 
Performance (1.5km time trial)  At baseline (0 week)
Post intervention (after 4 weeks)
 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "52"
Final Enrollment numbers achieved (India)="52" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   20/05/2024 
Date of Study Completion (India) 02/04/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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   Cycling demands repeated hip flexion and pelvic stability to act as an anchor. Its efficiency relies on core strength and stability, which also improves leverage for pedal power generation. A stable core can provide balance which helps maintaining aerodynamic position leading to effective cycling output. The core consists of abdominal muscles, the lumbar, pelvic muscles, hip musculature and the iliopsoas component. During cycling various positions are used to achieve proper aerodynamics, one of which is sustained lumbar spine flexion position, to increase efficiency. This position in cyclists places the core musculature in strained position. Thus, cycling position may be impacted directly by a weak core resulting in decreased performance.  This study includes lumbopelvic training for cyclists for a duration of 4 weeks. They will be explained about the purpose of the study along with the possible risks and benefits in the language of their understanding. A signed informed consent form will be taken before recruiting them for the trial. All the recruited subjects will be assessed at baseline for core strength (pressure biofeedback), performance (1.5km time trial) and cadence (cadence sensors) by a blinded assessor. The subjects will be then randomly allocated into either of the two groups by a computer-generated random number table. Group A (experimental) will receive lumbopelvic exercise training by the researcher and group B (control) will undergo their regular exercise training regime. The patients will receive 3 sessions per week for a period of 4 weeks (a total of 12 sessions). Post-intervention assessment (at the end of 4 weeks) will be carried out by the same blinded assessor. The data collected will be analysed.

 
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