| CTRI Number |
CTRI/2019/05/019236 [Registered on: 20/05/2019] Trial Registered Prospectively |
| Last Modified On: |
14/11/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Circadian Rhythm and performance |
|
Scientific Title of Study
|
Timing of interval training and its association with Oxygen uptake, cardiac autonomic function and Physical performance in healthy human subjects: Role of circadian variation. |
| Trial Acronym |
HIIT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof M Ejaz Hussain |
| Designation |
Professor |
| Affiliation |
Jamia Millia Islamia |
| Address |
Centre for Physiotherapy and Rehabilitation Sciences,
Jamia Millia Islamia
Jamia Nagar, New Delhi
South
DELHI
1100255
India |
| Phone |
9899339816 |
| Fax |
|
| Email |
ehusain@jmi.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof M Ejaz Hussain |
| Designation |
Professor |
| Affiliation |
Jamia Millia Islamia |
| Address |
Centre for Physiotherapy and Rehabilitation Sciences,
Jamia Millia Islamia
Jamia Nagar, New Delhi
South
DELHI
1100255
India |
| Phone |
9899339816 |
| Fax |
|
| Email |
ehusain@jmi.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Moazzam Hussain Khan |
| Designation |
Assistant Professor |
| Affiliation |
Jamia Millia Islamia |
| Address |
Room No. 112, Centre for Physiotherapy and Rehabilitation Sciences,
Jamia Millia Islamia
Jamia Nagar, New Delhi
South
DELHI
110025
India |
| Phone |
9990307150 |
| Fax |
|
| Email |
mkhan47@jmi.ac.in |
|
|
Source of Monetary or Material Support
|
| Centre for Physiotherapy and Rehabilitation Sciences
Jamia Millia Islamia,
Jamia Nagar new Delhi 110025 |
|
|
Primary Sponsor
|
| Name |
Centre for Physiotherapy and Rehabilitation Sciences |
| Address |
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia Jamia Nagar New Delhi |
| Type of Sponsor |
Other [Centre for Physiotherapy and Rehabilitation Sciences] |
|
|
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 |
| Prof M Ejaz Hussain |
Centre for Physiotherapy and Rehablitation Sciences |
Room No. 01
Centre for Physiotherapy and Rehablitation Sciences, Jamia Millia Islamia Jamia Nagar
South
DELHI |
9899339816
ehusain@jmi.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethetics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy subjects |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
High Intensity Interval training protocol |
High Intensity Interval training protocol 4x4 minutes interval at 90 to 95% max HR
Evening Type evening exercise and evening type morning exercise |
| Comparator Agent |
High Intensity Interval training protocol |
High Intensity Interval training protocol 4x4 minutes interval at 90 to 95% max HR
Morning type morninge exercise and morning type eveneing exercise |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Male |
| Details |
Male Healthy subjects
Age: 18-30 years
B.P 120/80
BMI: 18.5 – 25
Morning type and Evening Type on the basis of Horne Ostberg Morningness – Eveningness Questionnaire (1976),
Subjects having basic understanding of English language and volunteering to participate in the study
|
|
| ExclusionCriteria |
| Details |
Receiving any Exercise training from last 3 months
Any Musculoskeletal Injury
Any Medical Condition Contraindicating physical exercise
History or evidence of cardiovascular disease (history of angina, shortness of breath, uncontrolled hypertension)
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Oxygen uptake: VO2max
Cardiac autonomic function: Heart rate recovery (HRR)
Heart rate variability (HRV)
Physical performance: Agility, Sprint and Vertical jump
Sleep Quality: Pittsburgh Sleep Quality Index (PSQI)
Biochemical Marker : Melatonin, Cortisol, testosterone, Oxidative stress (Catalase Superoxide Dismutase)
|
12 weeks of exercised training protocol, Pre and post training data |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NOT APPLICABLE |
NOT APPLICABLE |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="52" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
24/05/2019 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="5" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
2 conference paper presentations
1 Scopus journal publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
52 Healthy subjects will be recruited in this study on the basis of inclusion and exclusion criteria. i.e Morning Type and Evening Type on the basis of Questionnaire. Morning type subjects will be randomly allocated into two groups, Group A (Morning type Morning Exercise) and Group B(Morning type Evening Exercise), Evening type subjects will be also randomly allocated in two groups, Group C (Evening type Morning Exercise ) and Group D (Evening type Evening exercise). All the four groups will be given 10 minutes of warm up and 3 minutes of cool down followed by high intensity interval training (4 x 4min intervals at 90-95% of maximum Heart Rate, each interval separated by 3 minutes at 70%, twice a week for 3 months), |