RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
KARNATAKA, BANGALORE
SYNOPSIS
OF
DISSERTATION
“A COMPARATIVE STUDY OF PULMONARY FUNCTION TESTS AND BODY MASS INDEX IN YOUNG ADULT MALES”
SUBMITTED BY
Dr. SWAROOP B P
POST GRADUATE STUDENT
DEPARTMENT OF PHYSIOLOGY
ADICHUNCHANAGIRI INSTITUTE OF MEDICAL SCIENCES
B.G.NAGARA – 571 448
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA,
BANGALORE.
ANNEXURE II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1 / Name of the Candidate and Address (in block letters) / Dr. SWAROOP B P#1490/2, BANDIGOWDA LAYOUT,
M C ROAD. MANDYA-571 401
2. / Name of the Institution / ADICHUNCHANAGIRI INSTITUTE OF MEDICAL SCIENCES,
B G NAGAR—571 401
3. / Course of study and subject / M.D. (PHYSIOLOGY)
4. / Date of admission to Course / 31.05.2010
5. / Title of the Topic / “A COMPARATIVE STUDY OF PULMONARY FUNCTION TESTS AND BODY MASS INDEX IN YOUNG ADULT MALES”
6. /
Brief resume of intended work:
6.1 Need for the study6.2 Review of literature
6.3 Objectives of the study / ANNEXURE – I
ANNEXURE – II
ANNEXURE – III
7. / Materials and methods:
7.1 Source of data
7.2 Method of collection of data
(including sampling procedure,
if any)
7.3 Does the study require any
investigations or interventions
to be conducted on patients or
other animals? If so please
describe briefly.
7.4 Has ethical clearance been
obtained from your institution
in case of 7.3 /
ANNEXURE – IV
ANNEXURE - VNOT APPLICABLE
NOT APPLICABLE
8. /
List of references (About 4 – 6) / ANNEXURE – VI
9. / Signature of candidate
10. / Remarks of the guide / SYNOPSIS IS PREPARED AS PER ACCEPTED STANDARD AND REQUIREMENT
11. / Name & Designation of
(in block letters)
11.1 Guide
11.2 Signature:
11.3 Co-Guide (if any)
11.4 Signature:
11.5 Head of Department
11.6 Signature:
/ Dr.K N NARASIMHA SWAMY
PROFESSOR AND HEAD
DEPARTMENT OF PHYSIOLOGY
A I M S .B G NAGAR-571 448
------
------
Dr K N NARASIMHA SWAMY
PROFESSOR AND HEAD
DEPARTMENT OF PHYSIOLOGY
A I M S. B G NAGAR-571 448
12. / 12.1 Remarks of the Chairman & Principal
12.2 Signature:
ANNEXURE-I
6. Brief resume of the intended work
6.1 Need for the study
Obesity has become so common in developed and developing nations
that presently it replaces undernutrition and infectious diseases as the most significant contributor to illhealth1. Globally it is assumed that there are more than 1 billion overweight adults and at least 300 million of them are obese2 . In the developed countries obesity is found more in lower socioeconomic groups while in developing countries obesity is more prevalent in affluent class 3 .A number of factors contributes towards becoming overweight. They are genetic, lifestyle habits. In some instances endocrine problems, genetic syndromes and medications can be associated with excessive weight gain4.
Obesity has proved to be a major risk factor for a whole range of cardiorespiratory disorders5. Obesity can profoundly alter pulmonary function and diminish exercise capacity by its adverse effects on respiratory mechanics, respiratory muscle function, lung volumes, work and energy cost of breathing and gas exchange6 . It is the most common precipitating factor for obstructive sleep apnea and obesity hypoventilation syndrome, both of which are associated with substantial morbidity and increased mortality6.
Thus obesity has a direct effect on the mechanical behaviour of the respiratory system by altering lung volumes, airway caliber or respiratory muscle strength7. Hence the effect of obesity on lung functions is well established. But there has never been a large scale study which shows correlation between overweight and lung functions in this geographical area (B.G.NAGAR).
This study intends to find the alteration in the pulmonary functions in overweight individuals as compared with the normal weight individuals (based on World Health Organisation criteria for Body Mass Index )
ANNEXURE-II
6.2 Review of literature
Studies supporting the hypothesis
1) Adiposity showed a significant inverse relationship with both spirometry and static lung volumes8 .
2) Clinical, laboratory and epidemiological observation have established links between obesity and severe breathing problems including obstructive sleep apnea, obesity hypoventilation syndrome and asthma 5.
3) Obesity has effects on lung function that can reduce respiratory well being, even in the absence of specific respiratory disease and may also exaggerate the effects of existing airway disease9.
4) We have found a positive independent relationship between lung function impairment and metabolic syndrome in both the sexes, predominantly due to abdominal obesity10.
5) Patients with obesity commonly develop hypoventilation and sleep apnea syndromes with attenuated hypoxia and hypercapnic ventillatory responsiveness. The final result is hypoxemia, pulmonary hypertension and progressive worsening of disabilities11.
6) Obesity represents a mechanical load to the respiratory system because the added weight on the rib cage and abdomen serves to reduce the compliance of the chest wall12.
ANNEXURE-III
6.3 Objectives of the study
1) To record the pulmonary function test parameters in normal weight and overweight young adults. That is
--- - Forced Vital Capacity (FVC)
----- Forced Expiratory Volume in first second (FEV1 )
----- Peak Expiratory Flow Rate (PEFR)
2) To compare these parameters recorded between normal weight and overweight young adults.
3) To observe the pattern of changes in the pulmonary functions with increase in Body Mass Index.
ANNEXURE-IV and V
7.Materials and methods
7.1 Source of data
Data is collected from 60 normal weight and 60 overweight young adults of B.G.Nagar selected by simple random sampling method.
7.2 Method of collection of data (including sampling procedures, if any)
The study group is selected based on the Inclusion /Exclusion criteria
Inclusion criteria
1. Age 18-25 years.
2. Subjects who has given written consent.
3. Individuals falling within the range of normal and overweight Body
Mass Index.
4. Healthy individuals
Exclusion criteria
1. Those who have physical deformities of chest wall.
2. Individuals suffering from respiratory diseases such as chronic obstructive pulmonary disease, bronchiectasis and interstitial lung diseases that might affect the pulmonary function.
3. Individuals with present or past (in the last three months) upper respiratory tract or lower respiratory tract infections.
4. Individuals with history of chronic exposure to substances which results in altered pulmonary functions.
5. Smokers and individuals suffering from hypertension.
6. Alcoholics and individuals suffering from Diabetes Mellitus.
The selected group of subjects are categorised into normal weight and overweight based on World Health Organization categorisation of body mass index.
Body Mass Index Scale
B M I / STATUS<18.5 / Under weight
18.5 to 24.99 / Normal weight
25 to 29.99 / Over weight
30 and above / Obesity
The preliminary data of the selected group of subjects, that is height in centimeters and weight in kilograms (rounded off to the nearest whole number) is measured using a measuring tape and a weighing machine respectively.
Then the body mass index is calculated using the formula,
B M I= weight (in kgs) / (height)2 (in mts)
The selected group of subjects are explained about the procedure of the test and its importance. They are also instructed to practice the procedure of pulmonary function test as demonstrated so as to become accurate with the procedure before the recording is obtained. After the subjects have attained near perfection in performing the procedure the pulmonary function test data is recorded by using computerized spirometer, following a standard protocol as explained below .
1) The subjects are instructed on the previous day of the test,to have a light breakfast on the morning of the test.
2) The test is performed after 1-2 hours following breakfast,that is between 10:00-11:00 AM.
The data thus obtained is tabulated and subjected to statistical analysis.
______
7.3 Does the study require any investigation or interventions to be conducted on patients
or humans or animals? If so please describe briefly
NOT APPLICABLE
______
7.4 Has ethical clearance has been obtained from your institution in case of 7.3
NOT APPLICABLE
ANNEXURE-VI
8. List of references(about 4 to 6) :
1) Prof Pal GK. Text book of medical physiology. 2nd ed. New delhi, Ahuja publishing house. 2010. p. 1060.
2) Obesity and overweight. [online]. [2010?]; Available from: URL:http://www.who.int/dietphysicalactivity/publications/facts/obesity/en/
3) Sujith chaudhuri K. Concise medical physiology. 6th ed. Kolkata, New central book agency (P) ltd. 2008. p.436 .
4) Overweight and obesity. [online]. [5screens]. Available from: URL:http://kids health.org/parent/general/body/overweight_obesity.html#
5) Jubber AS. Respiratory complications of obesity. Int J Clin Pract. 2004 Jun;58(6):573-80.
6) Koeing SM. Pulmonary complications of obesity. Am J Med Sci. 2001 Apr;321(4):249-79.
7) Ulger Z, Demir E, Tanac R, Goksen D, Gulen F, Darcan S et al. The effect of childhood obesity on respiratory function tests and airway hyperresponsiveness. [online]. Available from: URLhttp://www.turkishjournalpediatrics.org/pediatrics/pdf/pdf_tjp_301.pdf
8) Collins LC, Hoberty PD, Walker JF, Flecther EC, Peiris AN. The effect of body fat distribution on pulmonary function tests. Chest. 1995 May;107(5):1298-302.
9) Salome CM, King GG, Berend N. Physiology of obesity and effects on lung function. J Appl Physiol. 2010 Jan;108(1):206-11. Epub 2009 oct 29.
10) Leone N, Courbon D, Thomas F, Bean k, Jego B, Leynaert B et al. Lung function impairment and metabolic syndrome:the critical role of abdominal obesity. Am J Respir Crit Care Med. 2009 Mar 15;179(6):509-16.Epub 2009 Jan 8.
11) Parameshwaran K, Todd DC, Soth M. Altered respiratory physiology in obesity. Can Respir J. 2006 May-Jun;13(4):203-10.
12) Fauci, Braunwald, Kasper, Hauser, Longo, Jameson et al. Harrisons principles of internal medicine. 17th ed. USA . Mc Graw Hill companies. 2008. p. 1664. vol
II .
ANNEXURE VII
Summary of the project:
Exessive amount of adipose tissue in children and adolescents and simple obesity in particular constitute a growing health problem throughout the world. As a chronic disease prevalent in both developed and developing countries, it is one of the most significant contributor to illhealth. It has been estimated to affect 20-40% of the adults and 10-20% of the children and adolescents in developed countries.
The non fatal but debilitating health problems associated with obesity includes respiratory difficulties, chronic musculoskeletal problems, skin problems and infertility. Obesity can affect diaphragm, thoracic and abdominal muscles. Increased respiratory effort and impairment of gas transport system can result in altered pulmonary functions even though the lungs are normal.
Obesity places the patient at risk of aspiration pneumonia, pulmonary thromboembolism and respiratory failure. It is the most common precipitating factor for obstructive sleep apnea and obesity hypoventilation syndrome, both of which are associated with substantial morbidity and mortality. Increased risk of cardiovascular morbidity and mortality has been related to both lung function impairment and metabolic syndrome.
The major respiratory complications of obesity includes a hightened demand for ventilation, elevated work of breathing, respiratory muscle insufficiency and diminished respiratory compliance. Thus the effect of obesity on pulmonary functions is well established. But there has been no large studies which demonstrates the effect of overweight on the pulmonary functions in this geographical area (B G Nagar).
So this study is undertaken to demonstrate the effect of overweight on the Pulmonary function tests
PROFORMA APPLICATION FOR ETHICS COMMITTEE APPROVAL
SECTION – A
a. Title of the study / “A COMPARATIVE STUDY OF PULMONARY FUNCTION TESTS AND BODY MASS INDEX IN YOUNG ADULT MALES”b. Principal investigator (Name & Designation) / Dr. SWAROOP B P
P.G. in PHYSIOLOGY
c. Co investigator (Name & Designation) / NIL
d. Name of Collaborating department/ institutions / NIL
e. Whether permission has been obtained from the
head of the collaborating partments/institutions
SECTION B – Summary of the project
SECTION C – Objectives of the study
SECTION D – Methodology / NA
ANNEXURE – VII
ANNEXURE – III
ANNEXURE – IV & V
a. Where the proposed study will be undertaken / RURAL COMMUNITY OF B G NAGAR
b. Duration of project / 12 months
c. Nature of subject
Does the study involve adult patients?
Does the study involve children?
Does the study involve normal volunteers?
Doses the study involve Psychiatric patients?
Does the study involve pregnant women? / Yes
NO
Yes
No
No
d. If the study involve healthy volunteered
1. Will they be institute students?
2. Will they be institute employees?
3. Will they be paid?
4. If they are to paid, how much per session? / No
No
No
Not applicable
e. Is the study a part of a multicentral trail? / NO
f. If yes, who is the coordinator?
(Name and designation) has the real been
approved by the ethics committees of the other
centres?
If they study involves the use of drugs, please
indicate whether,
1. The drug is marketed in India for the indication in which it will be used in the study.
2. The drug is marketed in India for the indication in which it is proposed to be used.
3. The drug is marketed in India, but not for the indication in which it is proposed to be used.
4. Clearance from the Drugs Controller of India has been obtained for.
- Use of drug in healthy volunteers
- Use of drug in patients for a necessary indication
- Phase one and two clinical trails
- Experimental use in patients and healthy volunteers. / Not applicable
g. How do you propose to obtain in the drugs to be
used in the study?
- Gift from a drug company
- Hospital supplies
- Patients will be asked to purchase
- Other sources (Explain) / Not applicable
h. Funding (if any) for the project
Please state
- None
- Amount
- Source
- To whom payable / No
i. Does any agency have a vested interest in the
outcome of the project? / No
j. Will the data relating to subjects/Controls be
stored in a computer? /
Yes
k. Will the data analysis be done by:- The researcher?
- The funding agency?
- / The researcher
l. Will technical /nursing help be required from the
staff of hospital. If yes, will it interfere with their
duties?
Will you recruit other staff for the duration of the
study?
If yes, give details of
1. Designation
2. Qualification
3. Number
4. Duration of employment / Not applicable
m. Will informed consent be taken? If yes,
Will it be written informed consent
Will it be oral consent?
Will it be taken from the subject them selves?
Will it form the legal guardian?
If no, give reasons: / Yes
Yes
No
Yes
No
n. Describe design, methodology and techniques
(use a separate sheet) / Annexure IV & V
Date: Chairman
PG Training – Cum – Research Committee
AIMS, B.G.Nagara – 571 448