| CTRI Number |
CTRI/2025/03/081828 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
01/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Randomised Control Trial] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study the effect of "High
intensity interval training versus Moderate intensity continuous training Exercise" on pulmonary function in college students
|
|
Scientific Title of Study
|
Study the effect of high intensity interval training and moderate
intensity continuous training on Pulmonary functions in College Students |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manish Kumar |
| Designation |
Junior Resident |
| Affiliation |
King Georges Medical University |
| Address |
Room Number 204A Gautam Buddha Hostel KGMU Lucknow-226003
King Georges Medical University Shah Mina Road chowk Lucknow UP 226003
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9901896645 |
| Fax |
|
| Email |
manishkmr45@kgmcindia.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Archna Ghildiyal |
| Designation |
Professor |
| Affiliation |
King Georges Medical University |
| Address |
Department of Physiology
KGMU Lucknow UP
King Georges Medical University Shah Mina Road chowk Lucknow UP 226003
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8825168651 |
| Fax |
|
| Email |
drarchana06@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Shraddha Singh |
| Designation |
Professor and Head |
| Affiliation |
King Georges Medical University |
| Address |
Department of Physiology
KGMU Lucknow UP
King Georges Medical University Shah Mina Road chowk Lucknow UP 226003
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9901896645 |
| Fax |
|
| Email |
drshraddhasingh@yahoo.com |
|
|
Source of Monetary or Material Support
|
| King george medical university Lucknow UP 226033 India |
|
|
Primary Sponsor
|
| Name |
King Georges Medical University colege |
| Address |
King Georges Medical University Shah Mina Road chowk Lucknow UP 226003 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Manish Kumar |
KGMU |
Exercise LAB,Department of Physiology,KGMU
Lucknow
UTTAR PRADESH |
9901896645
manishkmr45@kgmcindia.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KGMU Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Heathy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
High intensity interval training exercise |
8-12 rounds/30 second spaced by 90 second of rest in between for 20-30 minutes/day/3 days/ week for 8 weeks at 75-95 % (MHR)
|
| Intervention |
Moderate intensity continuous training exercise |
30-40 minute/day/5 days/week for 8 weeks at 50-75% (MHR)
|
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Age 20 to 35 Years
BMI 18.5 to 24.9 (RefCDC)
Status Healthy individual
Habit Non-alcoholic, Non-Smoker, Non-tobacco,
not on any medicine
Disease None
|
|
| ExclusionCriteria |
| Details |
Subject not giving informed consent and criteria mentioned other than inclusion criteria |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the the effects of High intensity interval training(HIIT) & Moderate-intensity continuous training(MICT) on pulmonary functions in college students. |
Baseline parameters before strating of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the importance of HIIT & MICT on pulmonary function (pre & post interventions) in college students age between 20-35yrs. |
After 8 weeks of intervention |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
15/03/2025 |
| 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 importance of this study hes in its potential to inform exercise recommendations for college students who wish to improve their pulmonary function. While many college students engage in physical activity. Not all forms of exercises are equally effective at improving pulmonary function. HIIT and MICT are both popular forms of exercise among college students, but it is unclear which one is more effective at improving pulmonary function. By comparing the effects of these two types of exercise on pulmonary function, this study aims to provide evidence-based recommendations for college students who wish to improve their lung functions.To achieve these objectives, this study will employ a randomized controlled trial design. Participants will be recruited from a local college campus, and they will be assign to either the HIIT or MICT group based on the exercise tolerance of each participants. Both groups will engage in exercise sessions three to five times per week for eight weeks, and their pulmonary function will be assessed using spirometry before and after the intervention period |