| CTRI Number |
CTRI/2024/07/070413 [Registered on: 10/07/2024] Trial Registered Prospectively |
| Last Modified On: |
08/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [single bout of 10 minutes walking ] |
| Study Design |
Other |
|
Public Title of Study
|
The effect of Walking on Heart rate, Blood Pressure & stress |
|
Scientific Title of Study
|
The effect of a Brief, Single Bout of Walking on Cardiovascular & Cortisol
Stress Reactivity in Young Adults. |
| Trial Acronym |
nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jeetendra Singh |
| Designation |
Junior resident (post graduate) |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of physiology
Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
9887544680 |
| Fax |
|
| Email |
jeetumathur90@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mona Bedi |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of physiology
Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
9990499927 |
| Fax |
|
| Email |
drmonabedi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mona Bedi |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of physiology
Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
9990499927 |
| Fax |
|
| Email |
drmonabedi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maualana Aad Medical College
New Delhi-110002 India |
|
|
Primary Sponsor
|
| Name |
Maualana Aad Medical College |
| Address |
Bahadurshah zafar road
New Delhi-110002 |
| Type of Sponsor |
Government medical college |
|
|
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 Jeetendra Singh |
Maulana Azad Medica College |
Department of Physiology,
MAMC, New Delhi
Central
DELHI |
988754680
jeetumathur90@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Maulana Azad Medical College and associated hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal Young adult |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
10 minuts single bout of walking |
During the study walking take 10 minutes to complete. The process of measuring heart rate, blood pressure
and saliva sample collection 4 times for cardiovascular and cortisol stress response
assessment in the Autonomic Nervous System (ANS) laboratory in the Department of
Physiology, Maulana Azad Medical College, New Delhi, India. Two times five minutes mental
arithmetic test
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Apparently healthy young adults
Age group:18-30years |
|
| ExclusionCriteria |
| Details |
1.Subjects who indulge in regular physical exercise
2.Subjects who exercised within five hours or consumed caffeine within three hours of
the laboratory visit
3.Individuals with diagnosed neuropsychiatric and orthopedic problems
4.Individuals who are regular practitioners of meditation & yoga
5.Individuals with family history of Hypertension, Diabetes Mellitus and Thyroid
disorders
6.Individuals with substance abuse
7.Individuals with acute heart diseases and those who are equipped with pacemaker
devices.
8.Individuals with asthma and COPD
Individual with oral cavity problems |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Systolic Blood Pressure
2. Diastolic Blood Pressure
3. Heart rate reactivity
4. Salivary Cortisol |
Pre and Post walk |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
22/07/2024 |
| 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 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
|
The present study aims to bridge these lacunae by intervene the specific influence of a brief,
single bout of walking on Cardiovascular Reactivity to mental stress in young adult.
The study will be conducted in the Department of Physiology Maulana Azad Medical Colllege New -Delhi |