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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
BANGALORE, KARNATAKA
ANNEXURE- II
PROFORMA FOR REGISTRATION OF SUBJECT FOR
DISSERTATION
1
NAME OF THE CANDIDATE
AND ADDRESS
TINTU PAPPACHAN
D/O K. J. PAPPACHAN
KALAPARMBATH (H)
ALANGAD P.O ALUVA
ERNAKULAM DIST
KERALA
2
NAME OF THE
INSTITUTION
THE OXFORD COLLEGE OF
PHYSIOTHERAPY
J.P NAGAR IST PHASE, BANGALORE.
3
COURSE OF STUDY AND
SUBJECT
MASTER OF PHYSIOTHERAPY
(Physiotherapy in Cardio-Respiratory
Disorders & Intensive Care)
4
DATE OF ADMISSION TO
THE COURSE
14th MAY 2006
TITLE OF THE STUDY:
“A STUDY TO ANALYZE THE EFFECT OF BODY POSITION ON
MAXIMAL EXPIRATORY PRESSURE AND PEAK EXPIRATORY FLOW
5
RATE IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY
DISEASE”
6. BRIEF RESUME OF THE INTENDED WORK
6.1 NEED OF THE STUDY
COPD is an ill defined term applied to patients who have chronic
bronchitis and emphysema or combination both.1
Chronic bronchitis results from long term irritation of tracheobronchial
tree, especially caused by smoking, which stimulates the goblet cells and mucous glands to
secrete excessive mucous, and it also inhibit mucociliary action, which lead to impaired
mucous transport and productive cough with tenacious sputum with difficult to expectorate
which further lead to airway obstruction.2
In fact the abnormal amount of mucous increase the risk of respiratory
infection and also increase the length of recovery time from these infection 2
And in emphysema, patients will have airway obstruction, caused by loss
of elastic recoil and destruction of alveolar walls.2
Because of long term airway disease, mucocillary transport will get
disrupted in these patients, therefore, in the presence of pulmonary infection, and increased
production of pulmonary secretion, secretion removal can be a significant problem for the
patient.
The principle aim of management of patients with COPD will be airway
clearance intervention such as mobilization, postural drainage, coordinated with breathing
control and expiratory maneuvers, to facilitate removal of secretion and optimize coughing
and expectoration.2
Expiratory maneuvers include, coughing and huffing that use high
expiratory pressures and flow rates to aid with secretion clearance.3
Coughing follows a deep inspiration and involves the generation of high
intra thoracic pressure against a closed glottis, which is then suddenly opened to allow rapid
expiration.4
Huffing follows an inspiration and is a sharp forced expiratory maneuver
where the glottis remains open .It can be from a range of lung volumes, which may clear
various segments of the airways.3
Performance of cough and huff by patients is influenced by lung volumes,
sensitivity of airway reflexes, muscle biomechanics, medications, pain, and the patient’s state
of mind.5
High expiratory flow rates and expiratory pressures are required for the
production of strong and effective expiratory maneuvers. 2 Maximum expiratory pressure and
PEFR have been used as surrogate measures of cough and huff strong respectively.6
Higher lung volumes will give better expiratory muscle length-tension
relationship and improved expiratory pressure and flow rate. 7 At higher lung volumes there is
greater elastic recoil of the lungs and chest wall2 and the expiratory muscles are at a more
optimal part of the length tension relationship curve and thus are capable of generating higher
intrathoracic pressure7 .the change in lung volumes and muscle mechanics influences MEP,
which in turn influences PEFR thus the same mechanics will influence PEFR.
The change in body position has been shown to affect lung volumes and
muscle biomechanics.2,7,8.Thus both MEP and PEFR are influenced by lung volumes and
muscle length –tension relationship which in turn influenced by body position
Subjects with chronic airflow obstruction will have altered respiratory
mechanics. They are usually hyper inflated and have altered muscle length tension
relationship 2.Further they will have lower forced expiratory volume in one second and lower
PEFR.7 Thus their need to clear secretion is compromised by altered respiratory mechanics.
Studies on the effects of different body positions like supine, side lying, semi
fowlers position, sitting and standing on MEP and PEFR in patients with COPD are limited.
By distinguishing the position which generates highest MEP and PEFR, physiotherapist can
better advise their patients on positional changes that may help in maximizing or increasing
the strength and efficiency of huffing and coughing .So the study aims to distinguish the
different body positions which leads to the generation of highest MEP and PEFR in COPD
patients
.
6.2. REVIEW OF LITERATURE
Guyton and Hall(2003) In their book “Text book of medical physiology” explains that
coughing follows deep inspiration and involves the generation of high intra thoracic pressure
against a closed glottis and then suddenly opened to allow rapid expiration.4
Prayor JA and Webber BA (2004) in their book “Physiotherapy for Respiratory and
cardiac problems” Huffing follows an inspiration and is sharp forced expiratory maneuver
where the glottis remains open. 2
Hardy KA(1994) in his book “A review of airway clearance ; new techniques ,
indications , and recommendation” explains that performance of cough and huff by
the patients is influenced by lung volumes, sensitivity of airway reflexes, muscle
biomechanics, medications, pain, and the patients state of mind.5
MC Cool FD and Leith DE (1987) in pathophysiology of cough explains that higher lung
volumes linked with better expiratory muscle length-tension relationships9
.
Alexander Hough (2001)in his book “physiotherapy in respiratory care, an evidence based
approach” explains that body position has affect on lung volumes.7
Francisco morno and Harold A Lyons (1961) in their study “Effect of body posture on
lung volumes” explains that, lung volumes changes with different body position but not the
respiratory frequency8
A Michels et al (1991) in their study on healthy smokers and non smokers explains that
lung volume (VC and ERV) change with body position 10
Lapier, et al (1999) in their study explains that FVC, FEV1\FVC ratio, PEF are affected in
sitting and standing position in patients with COPD.11
.
Elkins Mark R, Alison Jennifer and Bye Peter T.P (2005) in their study explains that,
maximum expiratory flow rate are used as surrogate measures of cough and huff strength.6
Shirasu Akiko et al (2003) in their study explains the influence of body posture and
manual assisted coughing technique on coughing ability and they suggest that cough ability is
strongly affected by posture.12
Robert J Smyth et al (1984) in their study gave the normal published values for MEP in
adult male subjects ranging from 130 to 247 cm of H2O.13
Dave Thomas and Riek D Angelo(1997) in merium instrument explains that, U-tube
manometer is earliest pressure measuring instruments is still in wide use today because of its
inherent accuracy and simplicity of operation.14
6.3. OBJECTIVES OF THE STUDY
1) To analyze the effect of different body position on MEP and PEFR in patients
with COPD
2) To find out the most effective body position on MEP and PEFR in patients with
COPD.
6.4. HYPOTHESIS
A) Null hypothesis
There is no significant difference between the effects of different body position on
MEPand PEFR in patients with COPD.
B) Alternative hypothesis
There is significant difference between the effect of different body position on MEP and
PEFR in patients with CPOD.
7. Materials and methods
7.1 . STUDY DESIGN AND SETTING :
7.1.1. Study design:
Correlation study
7.1.2. Source of data:
The Oxford College of physiotherapy, outpatient department.
Jayanagar general hospital – Bangalore.
Rajashekar hospital-Bangalore.
7.2. METHODOLOGY:
7.2.1. Population:
COPD Patients aged 40-70years.
7.2.2. Selection criteria:
1. Inclusion criteria:

Patient diagnosed with COPD

Patient aged between 40-70 years

Patient with FEV1- 50-60% predicted.7

Patient who are willing to perform the test

Patient who are medically stable and free of respiratory infections at least
the previous two week

Patient less than grade III dysponea3
II .Exclusion criteria:

Patient with any other lung pathology except COPD.

Patient who had undergone previous thoracic surgery.13

Patient who are bedridden or paralysed, spinal cord injury patients (above
T12 level) 16 patient who had undergone recent upper abdominal
surgery15, patients with myopathic disease like muscular dystrophy16,
mysthania gravis, GB syndrome.
7.2.3. SAMPLING:
Sampling method:
Random sampling.
Sample size:
N= 30 (COPD patients)
7.2.4. PROCEDURE:
30 subjects who fulfill the inclusion criteria will be taken for the study, after obtaining
the consent. Different positions will be used for the study. They are,
1. Standing: - The subject will be asked to adopt a comfortable stance.
2. Upright sitting: - The subject will be asked to sit on a chair with no armrest and will be
instructed neither to slouch forward nor to lean either side.
3. Supine: - The subject will be asked to lie on his or her back on a padded plinth. A
pillow will be placed under the head.
4. Side lying: - The subject will be positioned lying on the right side on padded plinth
.The hip will flexed to 45 degrees and the knees to 90 degrees. A pillow will be placed
under the head.
5. Semi fowler’s position: - The subject will be positioned on padded plinth, the top part
which will be positioned at 45 degrees angle and the upper body will be resting on
back on the segment of the plinth which is angled.
After explaining about the equipment and procedures, the subjected will be allowed to
practice the MEP and PEFR maneuvers.
PEFR value will be measured by using a peak flow meter ; Each subject will be asked
to take a deep inspiration , and then asked to blow out through the peak flow meter by short
forceful expiration .A minimum of three trials will be performed . Among which the highest
value will be recorded 17
MEP will be measured by using a vertical U- tube manometer 13,14,2which is connected
to an expiratory mask via flexible plastic tube. Patient will be asked to give a forceful cough
followed by a deep inspiration and displacement of water in the tube will be recorded. A
minimum of three trials will be performed, from which the highest value will be recorded.17
Each subject will be allowed to take rest, between each trial, as and when desired by the
subject.
A) Duration of the study:
Six weeks (including data collection)
B) Materials used:
1. Peak flow meter.
2. Pressure manometer.
7.3. OUTCOME MEASURES:
1. Peak expiratory flow rate.
2. Maximal expiratory pressure.
7.3.1
STASTICAL ANALYSIS:

Repeated measures ANOVA.

Student‘t’ test (paired) with Bonferroni correction.

Pearson’s correlation.

Regression analysis.
7.4.
a) Does the study requires any investigations/ interventions to be conducted
on patients or other humans or animals?
Yes, it requires an investigation that i.e maximal respiratory pressure and peak flow
measurement using peak flow meter and pressure manometer in COPD patients. This
investigation if done with proper inclusion and exclusion criteria screening does not cause
any harm to the children.
b) Has ethical clearance been obtained from your institution?
Yes, ethical clearance has been obtained from my institution.
Ethical clearance form attached.
8. REFERENCES:
1. Staurt B Porter ,Tidy’s physiotherapy, thirteenth edition 2003 ,14:292-295 Elsevier
science pvt ltd
2. Donna Frown Felter ,Elizabeth Dean ,principles and practice of cardiopulmonary
physical therapy Third edition 1996 Mosber year book 21:368-372, 27:476-479,
18:300_305.
3. Pryor JA, Ammani Prasad S, Physiotherapy for respiratory and cardiac problems
.Adults and pediatrics .3rd edition 2004,Churchill living stone 6:191-192.1:74,1:6
4. Guyton and Hall, Textbook of medical physiology, Third edition 2003 Elsevier
science limited.37:441.
5. Hardy KA, A review of airway clearance new techniques, indications and
recommendations .respiratory care 1994, 39:440-456.
6. Elkins Mark R, Alison, Jenifer A, Bye peter T.P, Effect of body position on NEP and
flow in adults with cystic fibrosis.Peadiatric pulmonology 2005 vol 40 385 -391.
7. Alexandra Hough , Physiotherapy in respiratory care an evidence based approach to
respiratory and cardiac management .Third edition 2001 Nelson Thornes Ltd. 2:5561,3:70-71,1:3-6.
8. Francisco Moreno and Harold A Lyons Effect of body posture on lung volumes
.Journal of applied physiology 1961, 16:27-29.
9. Mc CoolFD and Leith De Pathophysiology of cough clinics in chest medicine1987
10. A Michels K e tal Influence of posture on lung volumes and impedance of respiratory
system in healthy smokers and non smokers .Journal of applied physiology 1991,
71:294-299.
11. Lapier ,Tanya Kinney, Donovan,Claire,Sitting and standing position affect pulmonary
function in patients with COPD:A preliminary study ,Cardiopulmonary physiotherapy
journal ,Winter 1999
12. Shirasu Akkiko etal Influence of body posture on cough ability and effect of manual
assisted coughing technique on cough ability .British journal of Anesthesia. 2003 7986.
13. Robert J Smyth etal Maximal inspiratory and expiratory pressure in adolescents
Normal values. Chest journal 1984.4:568-572.
14. Dve Thomas and Riek D Angelo, Manometer basics Merium instrument 1997.
15. Scot win, Jan Stephen,twecklin cardiopulmonary physical therapy 4th edition Mosby
.20:386, 21:395,14:260.
16. Carolyn Kisner, Lyn Allen Colby .Therapeutic exercises Foundations and techniques
edition 2002, Jayapee Brothers pvt Ltd 19:758.
17. M R miller et al standardization of spirometry European respiratory journal
2005.26:319-338.
18. D Gothi et al Clinical profile of disease causing chronic airflow limitation in a tertiary
centre in India www.Japi.org 2007
9.
Signature of the candidate
10.
Remarks of the guide
11.
Name and designation of the
guide
11.1 Guide
Mr. C. Dinesh M.P.T.
Assistant Professor
11.2 Signature
11.3 Co-guide
11.4 Signature
11.5 Head of the Department
Mrs. AN.Sivagamasundari M.P.T
Assistant professor
The oxford college of physiotherapy.
11.6 Signature
12.
Remarks of chairman and
principal
12.1 Signature
Mr.K.G.Kirubakaran M.P.T
APPENDIX- 1
THE OXFORD COLLEGE OF PHYSIOTHERAPY,
J.P.NAGAR, I PHASE, BANGALORE-560078.
Review Board on Ethics for Research
We here by declare that the project titled, “A study to analyze the effect of body
position on maximal expiratory pressure and peak expiratory flow rate in patients
with chronic obstructive pulmonary disease.,,
Carried out by Ms. Tintu Pappachan of 1st Year M.P.T. has been brought forward
for scrutiny to the board members. After analyzing the objectives, subjects involved and
the methodology of the project, the following conclusions were drawn.
The project does not cause any mental or physical harm to the subjects involved and
there are no risks involved in the study. The performance of the study procedure will not
cause any injury to the subjects. The board has evaluated and confirmed that the
experimenter is trained and qualified in measuring outcome. The informed consent form
ensures that the experimenter explains the procedure of the study to the subjects, their
voluntary participations is confirmed and the identification of subjects is maintained
confidential.
More over the finding of the study will benefit similar subjects, the profession and
the society.
Hence the review board has no objections on the conduct of the study.
Chairman of Departmental Review Board
Project Guide
Principal
APPENDIX II
CONSENT FORM
TITLE: “A STUDY TO ANALYZE THE EFFECT OF BODY POSITION ON
MAXIMAL EXPIRATORY PRESSURE AND PEAK EXPIRATORY FLOW
RATE IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY
DISEASE.,,
INVESTIGATOR: Ms. Tintu Pappachan (post graduate student)
PURPOSE OF THE RESEARCH
SUBJECT’S CONSENT:
I Mr. / Mrs. ……………………. agree to participate in the study. I have understood
the procedure of the study as explained to me by the investigator of the study.
This study will help the health care professionals to know about the effect of different
body positions on MEP and PEFR in COPD patients.
PROCEDURE:
I understand that I will be undergoing two tests measuring my maximal expiratory
pressure and peak expiratory flow rate using pressure manometer and peak flow meter.
I also understand that this will be done under physiotherapist’s supervision. I will be
repeating the test procedure thrice and I will be allowed to take rest as and when I want.
DISCOMFORT:
During the test if he/ she feels any discomfort Ms Tintu Pappachan will take
appropriate care to safeguard the welfare and best interests of the patients.
BENEFITS:
This test will bring about the knowledge about the effect of different body position
on MEP and PEFR. This will give better information to the physiotherapist can advice
their patients on positional changes that may help in maximizing the strength and
efficiency of huffing and coughing
ALTERNATIVES:
I have been informed of assessing other parameters like vital signs and pulmonary
function test reports and other relevant investigations.
CONFIDENTIALITY:
I understand that the medical information produced by this study will be
confidential. If the data are used for the publication in the medical literature or for
teaching purpose no name will be used.
PHOTOGRAPHY CONSENT DOCUMENT:
I………….. have been explained by Ms.Tintu Pappachan that photograph are
required in order to illustrate various aspect of the study for the thesis and other article,
and at presentation and conference. These images may also be converted to electronic
format for use in multimedia presentation and document accessible to other by computer
for the purpose of sharing the result of the study and for promoting this research. By
giving my consent authorize her to use any of the photographs taken in printed format, in
slides for presentation, and in electronic format. If the photograph is use the face will be
taped to prevent identification.
REQUEST FOR MORE INFORMATION
I understand that I am encouraged to discuss any concerns regarding this study at any
time. Ms Tintu Pappachan is available to answer my question to the best of her
knowledge. A copy of this consent form will be given to me for my careful reading.
REFUSAL OR WITHDRAWAL OF PARTICIPATION:
I understand that my participation is voluntary and I may withdraw consent and
discontinue participation any time without fear of prejudice. My decision whether or not
to participate will not affect relationship with (agency, heath care provider, etc.) I also
understand that she may terminate my participation in the study after she has explained
the reason for doing so.
INJURY STATEMENT
I understand that in the unlikely event of injury resulting directly from the
participation in the study, medical treatment would be available, but no further
compensation will be provided. I understand my agreement to participate in the study and
I am not waiving any of the legal rights for the same.
I have explained to Mr/Mrs…………………..the purpose of the research, the
procedures required and possible risks and benefits associated, to the best of my ability.
INESTIGATOR
DATE:
I confirm that Ms Tintu Pappachan has explained me the purpose of this research,
the study procedure and the possible risks and benefits associated that I may experience. I
have read and understood this consent form to let myself participate as a subject in this
research project and I am giving the consent willfully.
SUBJECT
SIGNATURE OF WITNESS
DATE:
DATE:
APPENDIX III
SUBJECT RECRUITMENT FORM
PATIENT NAME:
AGE:
SEX:
CONTACT NUMBER:
HOSPITAL NAME:
DATE OF ASSESSMENT:
RECRUITMENT DETAILS:
Inclusion criteria:
VITAL SIGNS:
BLOOD PRESSURE
TEMPERATURE
PULSE
RESPIRATORY RATE
1) Whether the subject is willing to participate?
2) Whether the subject is diagnosed to have COPD?
Yes or No
Yes or No
3) Whether subject is aged between 40-70 years?
Yes or No
4) Whether subject’s EEV1 is 50-60% of predicted value? Yes or No
5) Whether subject’s dysponea is less than grade III?
Yes or No
Exclusion criteria:
1) Whether patient is diagnosed to have any other lung pathology? Yes or No
2) Whether patient has undergone any other thoracic surgery?
Yes or No
3) Whether patient has undergone recent upper abdominal surgery? Yes or No
4) Patient suffering from following conditions:
I)
Spinal cord injury above T12 level. Yes or No
II)
G B syndrome.
Yes or No
III)
Myasthenia gravis.
Yes or No
ANY OTHER COMPLAINTS
Signature of subject: -
signature of investigator:-