| CTRI Number |
CTRI/2011/12/002312 [Registered on: 30/12/2011] Trial Registered Prospectively |
| Last Modified On: |
28/08/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Other (Specify) [Training Protocol] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Changes in Pulmonary Function Tests and Physical Fitness Index after traditional aerobic exercise and sprint interval training |
|
Scientific Title of Study
|
Comparative study of Traditional Aerobic Exercise versus Sprint Interval Training with respect to Pulmonary Function Tests and Physical Fitness Index in young sedentary males : A Randomized Controlled Trial |
| Trial Acronym |
SITPFT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1126-7019 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Khaled Mohsin Badaam |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College, Aurangabad |
| Address |
Department of Physiology,
Government Medical College,
Panchakki Road,
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
02402402412 |
| Fax |
|
| Email |
khalid_badaam@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Khaled Mohsin Badaam |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College, Aurangabad |
| Address |
Department of Physiology,
Government Medical College,
Panchakki Road,
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
02402402412 |
| Fax |
|
| Email |
khalid_badaam@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Khaled Mohsin Badaam |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College, Aurangabad |
| Address |
Department of Physiology,
Government Medical College,
Panchakki Road,
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
02402402412 |
| Fax |
|
| Email |
khalid_badaam@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Government Medical College Aurangabad |
| Address |
Department of Physiology,
Government Medical College,
Panchakki Road,
Aurangabad. |
| 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 Khaled Mohsin Badaam |
Government Medical College, Aurangabad. |
Department of Physiology,
Government Medical College,
Panchakki Road,
Aurangabad
MAHARASHTRA |
02402402412
khalid_badaam@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Government Medical College, Aurangabad. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
young sedentary males |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Sprint Interval Training |
One minute full speed running followed by interval of one and half minute of walking.
So 4 cycles of two and a half minutes each.
Total of 10 minutes a day for 3 days a week. |
| Comparator Agent |
Traditional aerobic exercise |
Jogging at moderate speed, 30 minutes a day for 5 days a week. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Male |
| Details |
-Young sedentary healthy males giving consentÂ
-Asymptomatic males with a normal baseline ECG
|
|
| ExclusionCriteria |
| Details |
-EXCLUSION CRITERIA:
-Not giving consentÂ
-Smokers
-Any history of cardiac, respiratory, hepatic renal or any major disease
-Sportspersons or doing athletic activity
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Forced Vital Capacity
Maximum Voluntary Ventilation |
3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Physical Fitness Index |
3 weeks |
|
|
Target Sample Size
|
Total Sample Size="14"
Sample Size from India="14"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/12/2011 |
| 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="0"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized, open label, parallel group, trial comparing the traditional aerobic exercise 30 minutes a day for 5 days a week
in 7 young sedentary males and sprint interval training for 10 minutes a day for 3 days a week in 7 young sedentary males that will be conducted at Government Medical College, Aurangabad , Maharashtra, India. The primary outcome measures will be change in Forced Vital capacity , Maximum Voluntary Ventilation at 3 weeks. The secondary outcome will be change in Physical Fitness Index at 3 weeks. |