| 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
|
|
|
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
|
|
|
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 |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
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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
|
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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. |