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CTRI Number  CTRI/2026/02/103631 [Registered on: 11/02/2026] Trial Registered Prospectively
Last Modified On: 10/02/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study to evaluate whether exercise and lifestyle modification can reduce flat foot in overweight and obese individuals 
Scientific Title of Study   'Investigating the Effects of Weight Reduction Exercises and Lifestyle Modifications in Reducing the Severity of Flat Foot among Overweight and Obese Individuals A Novel Method of Interventional 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  Vijayakumar K 
Designation  Associate Professor 
Affiliation  Symbiosis Medical College 
Address  No: 404, 4th floor, Symbiosis Medical College for Women Quarters
Symbiosis Medical College for Women Quarters lavale talmulshi
Pune
MAHARASHTRA
412115
India 
Phone  9940695046  
Fax    
Email  kvijay.india@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Vijayakumar K 
Designation  Associate Professor 
Affiliation  Symbiosis Medical College 
Address  No: 404, 4th floor, Symbiosis Medical College for Women Quarters
Symbiosis Medical College for Women Quarters lavale talmulshi
Pune
MAHARASHTRA
412115
India 
Phone  9940695046  
Fax    
Email  kvijay.india@gmail.com  
 
Details of Contact Person
Public Query  
Name  Vijayakumar K 
Designation  Associate Professor 
Affiliation  Symbiosis Medical College 
Address  No: 404, 4th floor, Symbiosis Medical College for Women Quarters
Symbiosis Medical College for Women Quarters lavale talmulshi
Pune
MAHARASHTRA
412115
India 
Phone  9940695046  
Fax    
Email  kvijay.india@gmail.com  
 
Source of Monetary or Material Support  
Symbiosis Medical College for Women and Symbiosis University Hospital and Research Centre (SUHRC) are providing infrastructural support for conducting this study. Address: Symbiosis Medical College for Women (SMCW) Symbiosis University Hospital and Research Centre (SUHRC) Symbiosis International (Deemed University) Gram: Lavale, Taluka: Mulshi District: Pune – 412115 Maharashtra, India 
 
Primary Sponsor  
Name  Symbiosis Medical College for Women Institute 
Address  Symbiosis Medical College for Women (SMCW) Symbiosis University Hospital and Research Centre (SUHRC) Symbiosis International (Deemed University) Gram: Lavale, Taluka: Mulshi District: Pune – 412115 Maharashtra, India 
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 K Vijayakumar   Symbiosis University Hospital and Research Centre (SUHRC)  Department of Anatomy, Symbiosis Medical College for Women. Symbiosis University Hospital and Research Centre (SUHRC) Gram: Lavale, Taluka: Mulshi District: Pune – 412115 Maharashtra, India
Pune
MAHARASHTRA 		 09940695046

kvijay.india@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Individuals with ideal body weight and obese individuals 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Exercise intervention Group A  Participants with obesity and grade 3 pes planus will be divided into two groups. Group A will be provided with intervention The weight reduction exercises will be designed and executed for the participants for twelve months per the FitIndia guidelines and recommendations Based on the physical rehabilitations recommendations exercises will be given to strengthen the key muscles of the arches of the foot The fitness evaluation and foot assessment were carried out every three months and any changes were noted The exercise intensity was modified based on the participants performance  
Comparator Agent  No intervention Group B  Participants in Group B will not receive any structured exercise or lifestyle intervention. They will continue their routine daily activities without supervised exercise training. Fitness and foot assessments will be carried out at the same intervals as the intervention group for comparison. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  76 subjects aged 18 to 35 had a body mass index BMI of 25 and above and were diagnosed with pes planus grade 3 
 
ExclusionCriteria 
Details  Recent fractures and open wounds in the lower extremities
Vitamin D disorder which causes bone deformities like bow legs
Stroke end stage kidney disease requiring hemodialysis or widespread malignant disease gallbladder disease
Uncontrolled hypertension systolic blood pressure greater than 180 or diastolic blood pressure greater than100 mmHg and other cardiovascular diseases
Any major active rheumatologic pulmonary hepatic renal dermatologic disease or inflammatory condition
Central nervous system disorders like hemiplegia paraplegia meningitis and other demyelinating diseases
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in severity of pes planus (flat foot) measured using a self-designed podoscope, quantified by plantar surface area (PSA) index–based grading.  Baseline (pre-intervention), and at 3 months, 6 months, 9 months, and 12 months post-intervention. 
 
Secondary Outcome  
Outcome  TimePoints 
Change in body weight and Body Mass Index (BMI) following exercise and lifestyle modification.  Baseline (pre-intervention), and at 3 months, 6 months, 9 months, and 12 months. 
 
Target Sample Size   Total Sample Size="76"
Sample Size from India="76" 
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   Phase 2 
Date of First Enrollment (India)   01/03/2026 
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="1"
Months="0"
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 - NO
Brief Summary   This study is a randomized parallel group interventional study designed to evaluate the effect of weight reduction exercises and lifestyle modifications on the severity of flat foot among overweight and obese individuals. Participants aged 18 to 35 years with grade 3 pes planus will be randomly allocated into an intervention group and a control group. The intervention group will receive structured weight reduction exercises and lifestyle modification guidance based on Fit India recommendations for a duration of twelve months while the control group will receive no structured intervention. The primary outcome of the study is the change in severity of pes planus measured using a self designed podoscope. Secondary outcomes include changes in body mass index physical fitness levels and postural parameters. The study hypothesizes that weight reduction exercises and lifestyle modifications will significantly reduce the severity of flat foot in overweight and obese individuals. 
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