| CTRI Number |
CTRI/2013/02/003346 [Registered on: 05/02/2013] Trial Registered Prospectively |
| Last Modified On: |
04/02/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Behavioral |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect of High intensity training on Lung function in Obese people |
|
Scientific Title of Study
|
EFFECT OF SPRINT INTERVAL TRAINING ON PULMONARY FUNCTION TESTS IN OBESE INDIVIDUALS: A RANDOMIZED CONTROLLED TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1138-8789 |
UTN |
| SIT/PFT/Ob/PHYSIO/2012 |
Protocol Number |
|
|
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,
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,
MAHARASHTRA
431001
India |
| Phone |
02402402412 |
| Fax |
|
| Email |
khalid_badaam@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College Aurangabad |
|
|
Primary Sponsor
|
| Name |
Government Medical College Aurangabad |
| Address |
Department of Physiology, Government Medical College, Panchakki Road Aurangabad MAHARASHTRA
Aurangabad
MAHARASHTRA |
| 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 |
| Patients |
Obesity, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Aerobic Training |
30 minutes a day for 5 days a week at 40 to 60% of maximal heart rate for 3 months.
|
| Comparator Agent |
Control group |
NO intervention |
| 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. Intervention for 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Male |
| Details |
Obese individuals with BMI>28kg/m 2
Age group: 25 to 40 years.
Asymptomatic males with a normal baseline ECG
|
|
| ExclusionCriteria |
| Details |
1.Resting blood pressure greater than or equal to 160/100 mm Hg
2. Triglycerides greater than or equal to 500 mg/dL
3. Factors that may limit adherence to intervention or affect conduct of the trial such as lack of time, amount of travel, and/or work or family stressors
4. Unable or willing to communicate with staff, to provide written informed consent, or accept the randomized assignment
5. Failure to complete behavioral run-in and baseline testing
6. Not physically capable of performing the exercise required of the study protocols
7. Plans to be away >4 weeks in the next 6 months
8. Lack of support from primary health care provider or family members
9. Significant weight loss in the past year (>20 kg) or current use of weight loss medications
10. Current diagnosis of schizophrenia, or other psychotic disorders, or bipolar disorder
11. History of bariatric surgery within last 3 years
12. Other temporary intervening event, such as sick spouse, bereavement, or recent move
13. Other medical, psychiatric, or behavioral limitations that in the view of the principal investigator may interfere with study participation or the ability to follow the intervention protocol
14. Underlying diseases or conditions likely to limit lifespan and/or affect the safety of the intervention
15. Self-report HIV or tuberculosis
16. History or evidence of serious arrhythmias, cardiomyopathy, congestive heart failure, aortic aneurysm, or heart transplantation
17. Renal disease: currently receiving dialysis
18. Type I diabetes mellitus
19. Type 2 diabetes mellitus, defined as: Fasting plasma glucose levels greater than or equal to 126 mg/dL 2-hour postprandial Oral Glucose Tolerance Test results greater than or equal to 200 mg/dL
20. Any other medical condition or disease that is life threatening or that can interfere with or be aggravated by exercise
21. Chronic obstructive lung disease, peripheral vascular disease or angina that limits ability to follow exercise protocol
22. Advanced neuropathy or retinopathy
23. Consuming alcoholic beverages, Smoker or have used nicotine/tobacco products within the last 12 months
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. FVC
2. MVV |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| waist circumference, BMI, blood pressure, lipid profile, insulin resistance, fasting plasma glucose, HbA1c, hsCRP, aerobic capacity |
3 months |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
06/02/2013 |
| 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="3"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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)?
|
|
Brief Summary
|
The present study is being carried out to compare the effects of traditional aerobic training and Sprint Interval Training on Pulmonary function tests, waist circumference, BMI, blood pressure, lipid
profile, insulin resistance, fasting plasma glucose, HbA1c, hsCRP, aerobic
capacity in obese individuals 120 obese males of 25 to 40 years age group will be enrolled for the study. By computer generated Randomization and proper allocation concealment and blinding, the study subjects will be allocated to control group, aerobic training and sprint interval training groups. Following parameters will be measured at the beginning of study and after 3 months. Primary outcome: FVC & MVV, Secondary outcome: waist circumference, BMI, blood pressure, lipid
profile, insulin resistance, fasting plasma glucose, HbA1c, hsCRP, aerobic
capacity Statistical analysis will be done to compare the effect of both interventions. |