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
|
|
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
|
|
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. |