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CTRI Number  CTRI/2025/02/081211 [Registered on: 24/02/2025] Trial Registered Prospectively
Last Modified On: 22/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Study on effects of Short-term Head-Down Tilt and Handgrip on Heart Rate and Blood Pressure changes in Active and Sedentary Young Adults. 
Scientific Title of Study   An Experimental study for Assessment of effects of Short-term 6 degree Head-Down Tilt with/without superimposed Isometric handgrip on Cardiovascular Variabilities in Physically Active and Sedentary Young Adults 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashutosh Kashyap 
Designation  Junior Resident 
Affiliation  AIIMS Rishikesh 
Address  Department of Physiology, AIIMS Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  7742069221  
Fax    
Email  akashyap265@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Poorvi Kulshreshtha 
Designation  Professor 
Affiliation  AIIMS Rishikesh 
Address  Department of Physiology, AIIMS Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  8126182374  
Fax    
Email  poorvi.physio@aiimsrishikesh.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Ashutosh Kashyap 
Designation  Junior Resident 
Affiliation  AIIMS Rishikesh 
Address  Department of Physiology, AIIMS Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  7742069221  
Fax    
Email  akashyap265@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Rishikesh 
 
Primary Sponsor  
Name  AIIMS Rishikesh 
Address  Rishikesh Uttarakhand 
Type of Sponsor  Research institution and hospital 
 
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 Ashutosh Kashyap  AIIMS Rishikesh  Department of Physiology, AIIMS Rishikesh
Dehradun
UTTARANCHAL 		 7742069221

akashyap265@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee AIIMS Rishikesh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  NA 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  6 degree Head-down Tilt   5 minutes 
Intervention  6 degree head-down tilt superimposed with isometric handgrip  5 minutes 
Comparator Agent  Supine position  5 minutes 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Male 
Details  Healthy individuals willing to participate in study 
 
ExclusionCriteria 
Details  Systolic BP more than 140mmHg and Diastolic BP more than 90 mm Hg.
Complaints of syncope.
Symptoms of Autonomic function disorder(Screening through questionnaire)
Structural heart disease or any other CVS disorder (Myocardial infarction, Congestive Heart Failure).
Chronic illness (Diabetes Mellitus, Chronic kidney disease, Chronic liver disease)
Major surgeries in past 6 months.
History of increased intraocular pressure/ocular surgery in past 6 months.
Intake of drugs that have effect on autonomic nervous system.
Professional athletes (vigorous exercise more than 1 hour in a day)  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in heart rate and blood pressure during 6 degree Head-down tilt.  At baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Change in Heart Rate Variability (HRV), Blood Pressure Variability (BPV), & Baroreceptor Sensitivity (BRS) during a 6° Head-down Tilt.
Effect of isometric handgrip on HRV, BPV, & BRS during 6° HDT  		 At baseline 
 
Target Sample Size   Total Sample Size="102"
Sample Size from India="102" 
Final Enrollment numbers achieved (Total)= "82"
Final Enrollment numbers achieved (India)="82" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/03/2025 
Date of Study Completion (India) 10/02/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 10/02/2026 
Estimated Duration of Trial   Years="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [akashyap265@gmail.com].

  6. For how long will this data be available start date provided 01-04-2026 and end date provided 01-04-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study is a non-randomized, parallel group experimental trial comparing the autonomic and cardiovascular responses between sedentary and physically active individuals during a 46-minute protocol. The primary objective is to assess heart rate variability (HRV), blood pressure variability (BPV), and baroreflex sensitivity (BRS) in both groups under different conditions: supine rest, 6-degree head-down tilt, isometric handgrip, and isometric handgrip superimposed with head-down tilt. The study will involve 102 participants, with 51 sedentary individuals and 51 physically active individuals. The secondary outcomes will include the comparison of HRV, BPV, and BRS between both groups under each experimental condition, as well as analysis of the interaction between isometric grip and head-down tilt in modifying autonomic and cardiovascular responses. 
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