Benefits of high intensity training in metabolic syndrome

Not yet recruiting

• Conditions: Metabolic Syndrome

• Registration Number: CTRI/2012/12/003274
• Lead Sponsor: Government Medical College Aurangabad

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.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2012-12-31
• Study Start: 2013-01-01

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Male
• Target Recruitment: 80

Inclusion Criteria

• 1.Metabolic syndrome patients as per IDF definition of metabolic syndrome 2.
• Age group: 25 to 40 years.
• Asymptomatic males with a normal baseline ECG.

Exclusion Criteria

• 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.
• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Metabolic Syndrome status:	6 weeks
yes/no dichotomous variable	6 weeks

Secondary Outcome Measures

Name	Time	Method
waist circumference, BMI, blood pressure, lipid profile, insulin resistance, fasting plasma glucose, HbA1c, hsCRP, aerobic capacity	6 weeks

Trial Locations

Locations (1)

Government Medical College, Aurangabad; 🇮🇳 Aurangabad, MAHARASHTRA, India

Government Medical College, Aurangabad

🇮🇳Aurangabad, MAHARASHTRA, India

Dr Khaled Mohsin Badaam

Principal investigator

02402402412

khalid_badaam@yahoo.com