| CTRI Number |
CTRI/2012/09/002975 [Registered on: 10/09/2012] Trial Registered Prospectively |
| Last Modified On: |
16/10/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Other (Specify) [Exercise] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of effect of High Intensity Exercise with Aerobic exercise on Nerve conduction velocity in Prediabetes |
|
Scientific Title of Study
|
EFFECT OF SPRINT INTERVAL TRAINING ON NERVE CONDUCTION VELOCITY IN PREDIABETES: A RANDOMIZED CONTROLLED TRIAL |
| Trial Acronym |
SIT/AE/NCV/PD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1134-1121 |
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.
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 |
Prediabetes, |
|
|
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. Intervention for 6 weeks |
| Comparator Agent |
Traditional aerobic exercise |
Jogging at moderate speed, 30 minutes a day for 5 days a week. Intervention for 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Male |
| Details |
1) Prediabetes: Impaired fasting glucose (IFG) - FPG 100-125 mg/dl OR Impaired glucose tolerance((IGT)- 2hr PPG 140-199mg/dl
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. 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, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Nerve Conduction Velocity |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Audiovisual reaction time |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/09/2012 |
| 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="12" |
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
|
The present study is being carried out to compare the effects of traditional aerobic training and Sprint Interval Training on Nerve Conduction velocity and Audiovisual reaction time in subjects of Prediabetes. 44 patients of Prediabetes will be enrolled for the study. Diagnosis of prediabetes will be according to American Diabetes Association (ADA) guidelines. By computer generated Randomization and proper allocation concealment and blinding, the study subjects will be allocated to aerobic training and sprint interval training groups. Following parameters will be measured at the beginning of study and after 6 weeks. Primary outcome: NCV, Secondary outcome: Audiovisual Reaction time Statistical analysis will be done to compare the effect of both interventions. |