| CTRI Number |
CTRI/2012/12/003274 [Registered on: 31/12/2012] Trial Registered Prospectively |
| Last Modified On: |
31/12/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Exercise Intervention] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Benefits of high intensity training in metabolic syndrome |
|
Scientific Title of Study
|
EFFECT OF SPRINT INTERVAL TRAINING ON OUTCOME OF METABOLIC SYNDROME: A RANDOMIZED CONTROLLED TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1138-1563 |
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,
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. |
| 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 |
Metabolic Syndrome, |
|
|
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 for a total of 6 weeks |
| Comparator Agent |
Traditional aerobic exercise |
30 minutes a day aerobic exercise for 5 days a week for a total of 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Male |
| Details |
1.Metabolic syndrome patients as per IDF definition of metabolic syndrome
2. Age group: 25 to 40 years.
3. Asymptomatic males with a normal baseline ECG
|
|
| ExclusionCriteria |
| Details |
1. Resting blood pressure greater than or equal to 160/100 mm Hg
2. 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
3. Unable or willing to communicate with staff, to provide written informed consent, or accept the randomized assignment
4. Failure to complete behavioral run-in and baseline testing
5. Not physically capable of performing the exercise required of the study protocols
6. Plans to be away in the next 6 weeks
7. Significant weight loss in the past year (>20 kg) or current use of weight loss medications
8. Current diagnosis of schizophrenia, or other psychotic disorders, or bipolar disorder
9. History of bariatric surgery within last 3 years
10. Other temporary intervening event, such as sick spouse, bereavement, or recent move
11. Underlying diseases or conditions likely to limit lifespan and/or affect the safety of the intervention
12. Self-report HIV or tuberculosis
13. History or evidence of serious arrhythmias, cardiomyopathy, congestive heart failure, aortic aneurysm, or heart transplantation
14. Renal disease: currently receiving dialysis
15. Type I diabetes mellitus
16. 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
17. Any other medical condition or disease that is life threatening or that can interfere with or be aggravated by exercise
18. Chronic obstructive lung disease, peripheral vascular disease or angina that limits ability to follow exercise protocol
19. Advanced neuropathy or retinopathy
20. 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 |
Metabolic Syndrome status:
yes/no dichotomous variable |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| waist circumference, BMI, blood pressure, lipid profile, insulin resistance, fasting plasma glucose, HbA1c, hsCRP, aerobic capacity |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
01/01/2013 |
| 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="1"
Days="12" |
|
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 outcome of metabolic syndrome.
80 patients of Metabolic syndrome will be enrolled for the study. By computer generated Randomization and proper allocation concealment and blinding, the study subjects will be allocated to regular aerobic training and sprint interval training groups. Following parameters will be measured at the beginning of study and after 6 weeks. Primary outcome: Metabolic syndrome status as Yes/No dichotomous variable.
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. |