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CTRI Number  CTRI/2023/03/050847 [Registered on: 20/03/2023] Trial Registered Prospectively
Last Modified On: 17/03/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Effect of different Aerobic exercise single session on Short and Long term heart Autonomic Recovery in person with high blood pressure 
Scientific Title of Study   Effect of various Aerobic exercise bout on Short and Long term cardiac Autonomic Recovery in Hypertensive individuals 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mohd Shahid Raza 
Designation  Assistant Professor 
Affiliation  Jamia Millia Islamia (Central university) 
Address  Room NO: 106, First Floor, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia

New Delhi
DELHI
110025
India 
Phone  9212156165  
Fax    
Email  mraza1@jmi.ac.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mohd Shahid Raza 
Designation  Assistant Professor 
Affiliation  Jamia Millia Islamia (Central university) 
Address  Room no: 106, First floor, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia

New Delhi
DELHI
110025
India 
Phone  9212156165  
Fax    
Email  mraza1@jmi.ac.in  
 
Details of Contact Person
Public Query
 
Name  Homa Nausheen 
Designation  Postgraduate Student 
Affiliation  Jamia Millia Islamia 
Address  Room No: 02, Ground floor, Ph.D. Research Lab, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia.

New Delhi
DELHI
110025
India 
Phone  8448763486  
Fax    
Email  homanausheen@gmail.com  
 
Source of Monetary or Material Support  
Centre for Physiotherapy and Rehabilitation Sciences Jamia Millia Islamia New Delhi-110025 India 
 
Primary Sponsor  
Name  CPRS, Jamia Millia Islamia 
Address  Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia University New Delhi-110025 India 
Type of Sponsor  Other [Central University] 
 
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 
Mohd Shahid Raza  Centre for Physiotherapy and Rehabilitation Sciences   Room NO: 02, Ph.D. Research Lab, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia
South
DELHI 
9212156165

mraza1@jmi.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Jamia Millia Islamia  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D759||Disease of blood and blood-formingorgans, unspecified, (2) ICD-10 Condition: I10||Essential (primary) hypertension,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Moderate Intensity continuous Exercise (MICE), Low Volume- High Intensity Interval Training (LV-HIIT), High Volume- High Intensity Interval Training (HV-HIIT)  Hypertensive ( Elevated and Stage 2) individuals will be asked to perform 3 aerobic exercises of different volume and intensities (MICT, LV-HIIT, HV-HIIT) on treadmill and their Heart Rate Variability (HRV) Recovery will be collected at the 10th minute, 15th minute, 20th minute, 1 hour, 24 hours, and 48 hours after the exercise is stopped. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  59.00 Year(s)
Gender  Both 
Details  Hypertensive individuals (elevated and stage 1)
Elevated hypertension (120–129 systolic and <80 mm Hg diastolic)
stage 1 hypertension (130–139 systolic or 80–89 mm Hg diastolic) ( as per ACC/AHA;
Able to do his/her physical daily activity independently. 
 
ExclusionCriteria 
Details  Patient with known cardiovascular, cerebrovascular, or metabolic disease except hypertension;
Normotensive (SBP <120mm Hg, DBP<80 mmHg)
Stage 2 hypertension (SBP≥140 or DBP ≥90 mm Hg) and Uncontrolled Hypertensive ( SBP >180mmHg and DBP> 110mmHg) patient;
Any musculoskeletal condition that limits the ability to exercise at moderate and high intensities (e.g. osteoarticular problem, pain);
Smoking/ Alcohol consumption 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1) Cardiac autonomic function - Heart Rate
variability ( Average heart rate, SDNN, RMSSD, pNN50, Total power, LF, HF and LF/HF Ratio) 
1. Short-term recovery:
A) Initial 20 minutes (10, 15 and 20 minutes ) after exercise
2. Long term recovery :
A) 24 hours after exercise
B) 48 hours after exercise 
 
Secondary Outcome  
Outcome  TimePoints 
Blood Pressure  Pre-exercise and Post-exercise 
 
Target Sample Size   Total Sample Size="26"
Sample Size from India="26" 
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)   29/03/2023 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

High blood pressure is one of the main risk factors for cardiovascular disease (CVD), which counts to the maximum number of deaths.  High blood pressure is responsible for around 54% of strokes and 47% of coronary heart illnesses globally (Wu et al., 2015). Resting HRV reduction is a sensitive biomarker of cardiac autonomic dysfunction and is linked to an increased risk of Cardio Vascular Disease (CVD) morbidity and mortality (Vanderlie et al., 2009). Acute myocardial infarction and cardiac arrhythmias are more likely with intense physical exercise or within one hour after it (Willich et al., 1993; Paterson et al., 1996). The recovery pattern of cardiac autonomic control from acute aerobic exercise (AE) may provide useful information about the risks and benefits of the various exercise modes. All these have been linked to decreased parasympathetic activity (Singer et al., 1988). There is no evidence that describes how alterations in the components of an exercise bout (i.e., intensity, volume) influence post-exercise autonomic dynamics in individuals with hypertension, who are more prone to cardiovascular disease. Short-term and long-term HRV recovery time for different intensity training is needed to favor clinical interpretation and exercise prescription.

 
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