RAJIVGANDHIUNIVERSITY OF HEALTH SCEINECS, BANGALORE
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1 / Name of the candidate.Address (in Block Letters). / Dr. PARIMALA VIDYA SAGAR
w/o Dr. VIDYA SAGAR G. V.
# 338, 6TH CROSS, 1ST STAGE, 2ND BLOCK, KALYAN NAGAR, NAGARABAVI,
BANGALORE – 560072
2 / Name of the Institution / Kempegowda Institute ofMedical Sciences,
Bangalore.
3 / Course of Study and Subject / M.D. in PHYSIOLOGY
4 / Date of Admission to Course / 30thMAY 2009.
5 / Title of the Topic / “A STUDY OF PARASYMPATHETIC FUNCTION BY HEART RATE RECOVERY (HRR) AFTER EXERCISE IN NORMAL, OVER WEIGHT AND OBESE ADULTS.”
6 / Brief resume of the intended work:
6.1 Need for the Study
6.2 Review of Literature
6.3 Objectives of the Study / Enclosed
Enclosed
Enclosed
7 / Material and Methods
7.1 Source of Data
7.2 Method of collection of data(including Samplingprocedure ,if any)
7.3 Does this study require
Any investigations orInterventions to beconducted on patients orother humans or animals?If so, describe briefly.
7.4 Has ethical clearance been Obtained from your
institution in case of 7.3 / Enclosed
Enclosed
Enclosed
Enclosed
8 / List Of References / Enclosed
9 / Signature of the Candidate
10 / Remarks of the Guide / This study would be of benefit to overweight & obese individuals. This study helps to identify at risk group of cardiovascular and metabolic complications.
11 / Name and Designation of
(in block Letters)
11.1 Guide
11.2 Signature
11.3 Co-Guide(if any)
11.4 Signature
11.5 Head of the
Department
11.6. Signature / Dr. B.N. RAMDEV
PROFESSOR AND HOD,
DEPT. OF PHYSIOLOGY,
KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES, BANGALORE.
Dr. H.V. NATRAJU
PROFESSOR,
DEPT. OF MEDICINE,
KIMS, BANGALORE.
Dr. B.N. RAMDEV
PROFESSOR AND HOD,
DEPT. OF PHYSIOLOGY,
KIMS, BANGALORE.
12 / 12.1 Remarks of the
Chairman & Principal
12.1 Signature
6.0BRIEF RESUME OF THE INTENDED WORK:
6.1NEED FOR THE STUDY:
Parasympathetic function is assessed by Heart Rate Recovery (HRR) afterexercise.Parasympathetic tone dominates the resting state. During exercise there is sympathetic activation with the withdrawal of vagal tone. After cessation of exercise, heart rate recovers to the normal level by parasympathetic reactivation. Therefore delayed HRR after exercise implies parasympathetic dysfunction1.
Attenuated HRR after exercise which reflects parasympathetic dysfunction has been found to be associated with type 2 diabetes2, carotid atherosclerosis3, metabolic syndrome1,4, a predictor of overall mortality1,5, and is associated with adverse cardiovascular events1,6.
Delayed HRR after exercise is seen in children with higher BMI (overweight and obese) who have lower exercise endurance7.
The prevalence of overweight and obesity among young adults is rapidly increasing worldwide. Both obese and overweight are proved to be the risk factor of cardiovascular and metabolic disorders8.
There are few studies relating to heart rate recovery (parasympathetic function) and obesity in adults. This study aims at evaluating the relationship between HRR and obesity in young adults.
This study may also create awareness among overweight and obese individuals regarding raised BMI and its associated complications, there by instigating them to change over and to follow healthier life style, aiming towards normal body weight.
6.2 REVIEW OF LITERATURE:
Jidong Sung, Yoon-Ho Choi, Jeong Bae Park had performed a cross sectionalstudy1 in Korea on 1,434 apparently healthy subjects of mean age 51±9yrs, performed symptom limited exercise stress test to evaluate HRR and concluded that delayed HRR is associated with metabolic syndrome.
Sae Young Jae,Mereedes R. Carnethon, Kevin S Heffernan, Bo Fernhall, Moon-Kyu Lee, Won Hah Park2, performed longitudinal Study on HRR after exercise in 1813 healthy nonsmoking men in Korea and in the follow up period of 6.4 years found slow HRR after exercise to be associated with the development of type 2 diabetes Mellitus.
Jae SY, Carnethon MR,Kevin S Heffernan,Yoon-Ho Choi,Moon-KyuLeeWonHahPark, Bo Fernhall3, in his cross sectional study of 12,712 middle aged men concluded that slow HRR after exercise is associated with carotid atherosclerosis.
According to CARDIA study by Kizilbash MA,Carnethon MR, Chan C, Jacobs DR, Sidney S, Liu K4 done on 4319 participants aged between 18 to 30years, reported that slower HRR dose not precede to the development of the metabolic syndrome, but appears in whom the syndrome components are already present.
Lian-Yun Lin, Hsu-Ko Kuo, Ling-Ping Lai,Jiunn-Lee Lin, Ciiuen-Den Tseng, Juey-Jen Hwang,5performed analytical study based on NHANES 1999-2002 on 993 healthy children and adolescents aged between 12-19 years for HRR parameters 1-3 minutes after exercise and found that metabolic risks are inversely associated with HRR and suggested that there is a link between metabolic risks and autonomic nervous system in healthy young individuals.
ChristopherR.Cole, Eugene H. Blackstone, Fredric J. Pashkow, Claire E. Snader, Michael S. Lauer,6 performed a longitudinal follow up study for 6 years on 2428 adults of mean age 57 ±12 years and concluded that a delayed HRR after exercise, to be powerful predictor of overall mortality, independent of work load, the presence or absence of myocardial perfusion, defects and changes in the heart rate during exercise.
Singh, Tajinder P, Rhodes, Jonathan, Gauvereau, Kimberlee7 did a study on apparently healthy 485 children and concluded that one minute HRR after exercise is attenuated with age in children with higher BMI, particularly those who are over weight and those with lower exercise endurance, have slower 1 min. HRR.
Brink Worth G D, Noakes M, Buckley JD, Clifton PM12 performed a study of HRR and range of cardiovascular risk factors on 42 over weights and obese men with no symptoms of cardiovascular disease, but had components of metabolic syndrome, before and after 12 wks of weight reduction.They found that weight loss improves HRR in overweight and obese men with features of metabolic syndrome.
6.3 OBJECTIVES OF THE STUDY:
To assess and compare the parasympathetic function by estimating Heart RateRecoveryafter exercise innormal, overweight and obese young adults.
7.MATERIALS AND METHODS:
7.1Source of data:
The Subjects are selected among students and staff of Kempegowda Institute Of Medical Sciences and VokkaligaraSanghaDentalCollege.
7.2 Method of collection of data:
A. Study period: 1year6 months.
B. Sampling procedure: Purposive sampling.
C. Study design: Descriptive study.
D. Sample size: 150 young adults, 50 in each of the three groups, with BMI: 18.5-24.9(Normal), 25-29.9(Overweight) and >30 (Obese).
E. Exercise Test: Individuals in each study group will be subjected to symptom limited graded treadmill exercise (GTX) according to modified Bruce protocol10. Standardized Treadmill automatically displays time duration,speed of workout and heart rate duringworkout.
F STUDY PARAMETERS: Height and weight of thesubjects are recorded to calculate their BMI.Resting HR, Peak HR during exercise and HR at 1 min aftercessation of exercise and BPat restare recorded.
G. INCLUSION CRITERIA:
Young adult individuals (both men and women) of age group 18 to 30 years.
Individuals with BMI 18.5-24.9 (normal), 25-29.9 (over weight) and >30(obese).
H. EXCLUSION CRITERIA:
Individuals with Diabetes Mellitus, Hypertension, heart diseases and other metabolic disorders.
Patients with respiratory diseases / disorders.
Individuals suffering from any infective diseases.
Age <18yrs and >30 years.
Individuals taking drugs which alter autonomic functions like beta blockers.
All conditions where treadmill exercises cannot be performed / those who develop cardio vascular symptoms during exercise.
Chronic smokers and Alcoholics.
Those with family history of premature cardiac deaths among first degree relatives.
I. METHOD OF STUDY:
Informed written consent is takenfrom the subjectsafter explaining to them about need for the study, aims and objectives of the study and the procedure.
Particulars of subject, present/past medicalsurgical history, family history, personal history (diet, habits, sleepand drugs) are recorded.
Weight is the most commonly recorded anthropometric variable and is generally measured with sufficient accuracy. The subject is weighed in minimal clothing using an accurate scale and weight is expressed inkilograms. The scale used for recording will be a digital scale with 0.1kgs precision.
Height of the subject is recorded without footwear using a vertically mobile scale.
Height and weight of individuals are measuredto calculatethe BMI of the subject using the formula-Weightin kilograms divided by the square of the height in meters(kg/m2)–Quetelet’s Index9.
Maximum heart rate (HRMAX) that can be reached by an individual is calculated by using the formula:
HRMAX = 205.8 − (0.685 × age) 11.
Initially, subject’s resting heart rate and blood pressure are recorded in supine position, after a minimum of 30 minutes of quite rest in the study lab. Later they are subjected to symptom limited graded treadmill exercise (GXT) according to modified Bruce protocol10.
Once peak heart rate (HRMAX as calculated) is reached, subject is asked to exercise at speed of 1.2 mph and 0% inclination,as this is considered as cessation point.Then HR is recorded after 1 minute of peak heart rate(HR1min)2.
Heart Rate Recovery (HRR) is calculated as the difference between maximum heart rate during test and heart rate after 1min(HR1min) of cessation of exercise. It is considered as delayed HRR if it is ≤ 12beats per min2.
J. Statistical analysis:
The data collected in this study will be analyzed statistically by computing descriptive statistics. For the inferential statistics the following statistical tests will be used:
- Analysis of variance for testing equality of means between groups.
- Repeated measures of ANOVA for HRR.
- Bonferony/Tukies HSD for pair wise comparison between groups.
7.3 Does the study require any investigations or interventions to be conducted on patients or other humans or animals? If so, please describe briefly.
This study requires treadmill test to be done as an investigation procedure on voluntaryindividuals.
Study does not include any animal experiments.
The study involves measurement of heart rate and BP in voluntaryindividuals.
Informed written consent will be taken to avoid any ethical issues.
7.4 Has ethical clearance been obtained from your institution in case of 7.3?
Yes (Enclosed)
8. LIST OF REFERENCES:
1. Jidong Sung, Yoon-Ho Chon, JeongBaePark; Metabolic Syndrome is associated with delayed heart rate recovery after exercise. J Korean Med Sci 2006; 21: 621-6.
2. Sae Young Jae, Mercedes R. Carnethon, Kevin S. Heffernan, Bo Fernhall, Moon-Kyu Lee, Won Hah Park; Heart rate recovery after exercise and incidence of type 2 diabetes in men. Clin Auton Res (2009); 19:189–192.
3. Jae SY, Carnethon MR, Heffernan KS, Choi YH, Lee MK, Park WH, Fernhall B; Slow heart rate recovery after exercise is associated with carotid atherosclerosis. Atherosclerosis. 2008 Jan; 196(1):256-61.
4. Kizilbash MA, Carnethon MR, Chan C, Jacobs DR, Sidney S, Liu K; The temporal relationship between heart rate recovery immediately after exercise and the metabolic syndrome: the CARDIA study. Eur Heart J. 2006 Jul; 27(13):1592-6.
5. Lian-Yu Lin, Hsu-Ko Kuo, Ling-Ping Lai, Jiunn-Lee Lin, Ciiuen-Den Tseng, Juey-Jen Hwang; Inverse correlation between heart rate recovery and metabolic risks in healthy childern and adolesents. Diabetic care 2008; 31:1015-1020.
6. Christopher R. Cole, Eugene H. Blackstone, Fredric J. Pashkow, Claire E. Snader, Michael S. Lauer; Heart-Rate Recovery Immediately after Exercise as a predictor of mortality. N Engl J Med1999; Volume 341:1351-1357.
7.Singh Tajinder P, Rhodes Jonathan, Gauvreu kimberlee; Determinants of heart rate recovery following exercise in children. Medicine & Science in Sports & Exercise 2008; 40: 601-605.
8. Ivana Rabbone, Adriana Bobbio, Franco Rabbia, Maria Cristina Bertello,Maria Giovanna Ignaccolo, Elisa Saglio; Early cardiovascular autonomic dysfunction, b cell function and insulin resistance in obese adolescents. ACTA BIOMED 2009; 80: 29-35.
9. TG Lohman, AF Roche, R Martorelleds. Human Kinetic Books, Champaign, Illinois,Anthropometric standardization references manual 1988..
10.WALTER I. BERMAN, MD; An overview of cardiac rehabilitation and exercise rehabilitation. BUMC Proceedings 1999; 12:29-33.
11. Inbar, O. Oten, A., Scheinowitz, M., Rotstein, A., Dlin, R. and Casaburi, R. Normal cardiopulmonaryresponses during incremental exercise in 20-70 yrs old men. Med Sci Sport Exerc 1994; 26(5):538-546.
12.Brink Worth G D, Noakes M, Buckley JD, and Clifton PM; Weight loss improves heart rate recovery in overweight &obese men with features of the metabolic syndrome. Am Heart J 2006 Oct; 152(4):693.e1-6.