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CTRI Number  CTRI/2025/05/087977 [Registered on: 30/05/2025] Trial Registered Prospectively
Last Modified On: 30/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Single Arm Study 
Public Title of Study   How Relaxation Techniques Can Boost Heart Health and Prevent Diabetes in College Students 
Scientific Title of Study   The Effectiveness of Progressive Muscle Relaxation Technique in Managing Cardiometabolic and Prediabetic Risk Factors in College Going Students 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ritisha Purohit 
Designation  MPT Student 
Affiliation  Mahatma Gandhi College of Physiotherapy, MGUMST 
Address  Cardiopulmonary Lab, Department of Physiotherapy, Mahatma Gandhi College Physiotherapy, MGUMST, RIICO, Institutional Area, Sitapura,Jaipur, Ramchandpura, Rajasthan 302022

Jaipur
RAJASTHAN
302022
India 
Phone  9672971374  
Fax    
Email  ritishapurohit@mgumst.org  
 
Details of Contact Person
Scientific Query  
Name  Dr Yuthika Rao 
Designation  Associate Professor 
Affiliation  Mahatma Gandhi College of Physiotherapy, MGUMST 
Address  Cardiopulmonary Lab, Department of Physiotherapy, Mahatma Gandhi College Physiotherapy, MGUMST, RIICO, Institutional Area, Sitapura,Jaipur, Ramchandpura, Rajasthan 302022

Jaipur
RAJASTHAN
302022
India 
Phone  9530096172  
Fax    
Email  dryuthikarao@mgumst.org  
 
Details of Contact Person
Public Query  
Name  Dr Yuthika Rao 
Designation  Associate Professor 
Affiliation  Mahatma Gandhi College of Physiotherapy, MGUMST 
Address  Cardiopulmonary Lab, Department of Physiotherapy, Mahatma Gandhi College Physiotherapy, MGUMST, RIICO, Institutional Area, Sitapura,Jaipur, Ramchandpura, Rajasthan 302022

Jaipur
RAJASTHAN
302022
India 
Phone  9530096172  
Fax    
Email  dryuthikarao@mgumst.org  
 
Source of Monetary or Material Support  
Mahatma gandhi college of physiotherapy, Mahatma Gandhi University of Medical Science and Technology, Jaipur 
 
Primary Sponsor  
Name  Ritisha Purohit  
Address  Cardiopulmonary Lab, Department of Physiotherapy, Mahatma Gandhi College of Physiotherapy, MGUMST, RIICO Institutional Area, Sitapura, Jaipur, Ramchandpura, Rajasthan 302022 
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 Yuthika Rao   Mahatma Gandhi College of Physiotherapy, MGUMST   Cardipulmonary lab, Department of Physiotherapy, Mahatma Gandhi College of Physiotherapy, Mahatma Gandhi University of Medical Science and Technology
Jaipur
RAJASTHAN 		 9530096172

dryuthikarao@mgumst.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Mahatma Gandhi College and Hospital MGUMST Jaipr  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Cardiometabolic and Prediabetic Risk Factors  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NA  NA 
Intervention  Progressive Muscle Relaxation Technique   Intervention Duration is 28 days. Involves tensing and releasing muscles, progressing throughout the body, with the focus on the release of the muscle as the relaxation phase. Progressive muscle relaxation can be practiced individually or with the support of a narrator. Find Comfort: Sit or lie down in a quiet space with minimal distractions. Feet: Curl your toes, tense your feet for 5 seconds, then relax for 10 seconds. Focus on the release of tension. Legs: Tense your lower legs, hold for 5 seconds, then relax for 10 seconds. Hips & Buttocks: Tighten the muscles, hold for 5 seconds, then release for 10 seconds. Stomach & Chest: Tense these muscles, hold for 5 seconds, then relax for 10 seconds. Shoulders: Shrug or tense the shoulders, hold for 5 seconds, then release for 10 seconds. Face: Squeeze facial muscles (e.g., eyes), hold for 5 seconds, then relax for 10 seconds. Hands: Make a fist, hold for 5 seconds, then relax for 10 seconds. Repeat the process as needed, focusing on the sensation of relaxation. Note: Be careful not to tense to the point of physical pain, and be mindful to take slow, deep breaths throughout the exercise.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  Students between 18 and 25 years.
Healthy with no known previously diagnosed chronic illnesses.
Participants who are willing to provide written informed consent.
Ability to Follow Instructions: Individuals capable of performing the progressive muscle relaxation (PMR) technique.
Risk Indicators: Prediabetic risk factors : Fasting blood glucose : 100-125mg/dL in accordance to International recognized criteria by the American Diabetes Association.
Cardiometabolic risk factors : Increased BMI, high blood pressure. 
 
ExclusionCriteria 
Details  Pre-existing Chronic Conditions:
Cardiovascular Diseases: Such as coronary artery disease, arrhythmias, or heart failure.
Diabetes Mellitus: Diagnosed or treated. • Respiratory Disorders: Asthma, COPD, or other chronic lung diseases.
Regular use of recreational drugs, smoking, or excessive alcohol consumption that may independently influence cardiopulmonary or stress parameters.
Mental Health Disorders: History of severe anxiety, depression, or psychiatric illnesses that could interfere with the intervention.
Physical Limitations: Musculoskeletal injuries or disorders (e.g., arthritis, severe back pain) and Neurological conditions (e.g., epilepsy, Parkinson’s disease).
Participants involved in structured fitness programs, yoga, meditation, or other interventions that could interfere with or bias the study results. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Preceived Stress Scale (PSS). Stress TMT test.
Blood Pressure.
Blood Glucose Levels.
Body Mass Index (BMI). 		 28 Days 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   01/07/2025 
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="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   The eligibility of the participants will be taken on the basis of the inclusion criteria of this research study. 

OUTCOME MEASURES 
Preceived Stress Scale (PSS). 
Stress TMT test. 
Blood Pressure. 
Blood Glucose Levels.
Body Mass Index (BMI).

PROCEDURE

Pre-Test Intervention Select participants aged 18-25 years based on inclusion criteria. Assess eligibility using the Indian Diabetes Risk Score (IDRS) for prediabetic risk.  Following vitals will be assessed-: Body Mass Index (BMI). 
Blood Pressure (BP): Record systolic and diastolic BP using sphygmomanometer. 
Heart Rate (HR): Measure resting HR using a pulse oximeter or ECG monitor. 
Blood Glucose Levels: Use a glucometer to record fasting. 
Oxygen Saturation (SpO2): Record pre- and post-exercise SpO2 using a pulse oximeter. 
Perceived Stress Levels: Administer the Perceived Stress Scale (PSS) questionnaire to assess stress levels. 
Stress Test (TMT): ECG Monitoring During Stress Test: A 12-lead ECG will be recorded continuously throughout the stress test to monitor cardiac function during exercise and assess exercise-induced changes.

Treatment Protocol 
Involves tensing and releasing muscles, progressing throughout the body, with the focus on the release of the muscle as the relaxation phase. Progressive muscle relaxation can be practiced individually or with the support of a narrator. 
Find Comfort: Sit or lie down in a quiet space with minimal distractions. 
Feet: Curl your toes, tense your feet for 5 seconds, then relax for 10 seconds. Focus on the release of tension. 
Legs: Tense your lower legs, hold for 5 seconds, then relax for 10 seconds. 
Hips & Buttocks: Tighten the muscles, hold for 5 seconds, then release for 10 seconds. 
Stomach & Chest: Tense these muscles, hold for 5 seconds, then relax for 10 seconds. 
Shoulders: Shrug or tense the shoulders, hold for 5 seconds, then release for 10 seconds. 
Face: Squeeze facial muscles (e.g., eyes), hold for 5 seconds, then relax for 10 seconds. 
Hands: Make a fist, hold for 5 seconds, then relax for 10 seconds. 
Repeat the process as needed, focusing on the sensation of relaxation. 
Note: Be careful not to tense to the point of physical pain, and be mindful to take slow, deep breaths throughout the exercise. 

Post-Test Intervention 
After the intervention period, repeat all pre-test measurements using the same methods to ensure consistency: BMI, BP, HR, and SpO2 at rest and post-exercise. 
Blood glucose levels (fasting and postprandial). 
Stress TMT for cardiorespiratory fitness. 
PSS questionnaire for stress levels. Recording Interval: Post-exercise parameters will be measured precisely one minute after activity to ensure reliable comparison with baseline data. 
Compare pre and post intervention results for each parameter. Analyze changes in cardiometabolic and prediabetic risk factors using statistical methods. 
Participant Feedback and Counseling Conduct feedback sessions to understand participants’ experiences with PMR. 
Provide recommendations for long-term management of cardiometabolic health.
 
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