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CTRI Number  CTRI/2025/04/085441 [Registered on: 23/04/2025] Trial Registered Prospectively
Last Modified On: 22/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Impact of Tele-Rehab Based Aerobic Exercise vs. Pilates Combined with the DASH Diet on Metabolic Syndrome: A Comparative Study 
Scientific Title of Study   A Comparative Analysis of the Effects of Aerobic Exercise versus Pilates in a Tele- Rehab Program, combined with the DASH Diet on Metabolic Syndrome. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Harshita 
Designation  MPT student 
Affiliation  Gurugram University 
Address  Department of Physiotherapy, Gurugram University, Sector 87, Kankrola Village, Gurugram,Haryana

Gurgaon
HARYANA
122505
India 
Phone  8882678714  
Fax    
Email  harshita9013@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sonia 
Designation  Assistant Professor 
Affiliation  Gurugram University 
Address  Department of Physiotherapy, Gurugram University, sector 87, Gurugram

Gurgaon
HARYANA
122505
India 
Phone  9416414362  
Fax    
Email  sonia@gurugramuniversity.ac.in  
 
Details of Contact Person
Public Query
 
Name  Harshita 
Designation  MPT Student 
Affiliation  Gurugram University 
Address  Department of Physiotherapy, Gurugram University, Sector 87, Kankrola Village, Gurugram,Haryana

Gurgaon
HARYANA
122505
India 
Phone  8882678714  
Fax    
Email  harshita9013@gmail.com  
 
Source of Monetary or Material Support  
Department of Physiotherapy, Gurugram University, Kankrola Village, Sector 87, Gurugram, Haryana, 122505 
 
Primary Sponsor  
Name  Gurugram University 
Address  Gurugram University, Sector 87, Gurugram, 122505 
Type of Sponsor  Research institution 
 
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 Harshita  Endocare Superspeciality Clinic  Endocare Superspeciality Clinic Flat No. 50, Rihayshi Apartment, Sector 12, Pocket 7, Dwarka, New Delhi
South West
DELHI 
8882678714

harshita9013@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethical Committee, Department of Physiotherapy, Gurugram University  Approved 
Institutional Ethical Committee, Department of Physiotherapy, Gurugram University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E70-E88||Metabolic disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Aerobic Exercises with DASH Diet  Aerobic Exercises with DASH Diet Performed by Metabolic Syndrome Patients for 5 days per week for 6 weeks 
Comparator Agent  Pilates with DASH Diet  Pilates with DASH Diet Performed by Metabolic Syndrome Patients for 5 days per week for 6 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  i. Must meet at least three of the diagnostic criteria [BMI more than 25kg per m2, BP more than 120(SBP) and 80 (DBP), HBA1C more than or equal to 5.7mmol per mol, Total Cholesterol more than or equal to 200mg/dl]
ii. Participants aged between 18 and 55 years.
iii. Sedentary or minimally active individuals (defined as light or moderate exercise for up to 30 minutes, no more than twice per week, in past 90 days).
iv. Willingness to follow the DASH diet as prescribed during the study period.
v. Medically stable and able to participate in moderate-intensity physical activity, as determined by a physician. 
 
ExclusionCriteria 
Details  i. Participants who are not willing to provide informed written consent to participate in the study.
ii. Participants engaged in structured exercise program and not adhering to standardized medication regimen for metabolic syndrome.
iii. Musculoskeletal, neurological, or other conditions that prevent safe participation in aerobic exercise or Pilates.
iv. Pregnancy, breastfeeding, or intention to conceive during the study period.
v. Participation in another clinical trial within the last 30 days that could interfere with this study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Blood Pressure
High Density Lipoproteins
Fasting Blood Sugar
Non-Fasting Blood Sugar 
6 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Body Mass Index
Waist to Hip Ratio 
6 weeks 
 
Target Sample Size   Total Sample Size="34"
Sample Size from India="34" 
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)   03/05/2025 
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="1"
Days="14" 
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  

Metabolic Syndrome is a cluster of interrelated risk factors, including central obesity, insulin resistance, high blood pressure and abnormal lipid levels, that together significantly increase the likelihood of developing cardiovascular disease and type 2 diabetes. The syndrome is becoming increasingly prevalent, affecting around 34.2 percent of adults and 5.2 percent of adolescents, with higher rates observed in males, urban populations, and individuals from higher socioeconomic groups.

Lifestyle modifications remain the first line approach for preventing and managing metabolic syndrome. Among dietary interventions, the DASH diet is widely recommended due to its effectiveness in improving cardiovascular and metabolic health. In terms of physical activity, both aerobic exercise and pilates have shown potential benefits in enhancing metabolic function and overall well being. However, there is limited evidence comparing the effectiveness of these exercise forms when combined with the DASH diet. This study aims to address this gap by evaluating and comparing the effects of aerobic training and pilates, both in conjunction with the DASH diet, on individuals with metabolic syndrome. The findings from this research may contribute valuable insights toward developing more effective lifestyle based management strategies for individuals at risk of chronic metabolic and cardiovascular diseases.

 
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