Rajiv Gandhi University of Health Sciences, Karnataka
Bangalore
ANNEXURE-II
PEOFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION
1.
Name of the Candidate &
Address
HIMANSHU PATEL
2.
Name of the Institution
K.T.G. College of Physiotherapy,
Hegganahalli Cross, Peenya 2nd stage,
Sunkadakatte Main Road, V.N.Post
Bangalore-91
3.
Course of Study & Subjects
MASTERS IN PHYSIOTHERAPY
(Cardio-Respiratory Disorders and
Intensive Care)
4.
Date of Admission to the Course
13th Oct 2010
5.
Title of the Topic:
A-13, Marutinandan society,
Near Prayag Flat,
B/H Keya motors, T.P.13,
Chhani jakat naka,
Vadodara-02
“EFFECTS OF PHYSICAL TRAINING
WITH NONINVASIVE POSITIVE PRESSURE VENTILATION AND
PHYSICAL TRAINING ALONE IN COPD SUBJECTS”
6.
BRIEF RESUME OF INTENDED WORK:
6.1 Need of the study:
Chronic obstructive pulmonary disease (COPD) is associated with
progressive airflow obstruction that leads to considerable disability; these
subjects have reduced exercise capacity, associated with mood disturbance and
impaired quality of life 1,2 (Chronic Obstructive Pulmonary Disease) is a major
cause of disability and is the fifth leading cause of death in the united states. It
ranks second only to coronary artery disease in term of overall morbidity
among social disability recipients3. The review of population studies from
India, estimated that total number of adults subjects aged 30 yrs and above in
1996 were 8.15 million males and 4.21 million females. The overall male,
female ratio was 1.6:14
The addition of nasal positive pressure ventilation (NPPV) to longterm
oxygen therapy in hypercapnic COPD subjects has been shown to improve
daytime arterial blood gases and quality of life1,2 . Noninvasive positive
pressure ventilation (NPPV) has been found to be an effective ventilatory
supplement for subjects with acute and chronic ventilatory failure due to
obstructive lung disease or neuromuscular deficits. Noninvasive positive
pressure ventilation (NPPV) has been demonstrated to increase minute
ventilation, tidal volume and reduce respiratory effort and the sensation of
dyspnea5.
Physical training programs that are effective in improving exercise
tolerance also improve quality of life. However, varying effects of training have
been reported, especially in more disabled subjects1,2
Only the subjects in the NPPV + ET group showed a significant
improvement in the fatigue component of the CRDQ. However, there are
practical difficulties in instituting NPPV during exercise training, and another
approach is to use NPPV daily on a domiciliary basis during the training period
to achieve unloading of the respiratory muscles. In subjects with hypercapnic
COPD who have significant nocturnal hypoventilation, NPPV has been shown to
improve sleep quality1,6.
Hypothesis :
Alternate Hypothesis :There will be a significant difference between physical training
with Noninvasive positive pressure ventilation and physical training alone in
COPD subjects.
Null Hypothesis :There will not be a significant difference between physical training
with Noninvasive positive pressure ventilation and physical training alone in
COPD subjects.
6.2 Review of Literature :
M.A.Kolodziej et al (2007) Subjects with severe stable chronic obstructive
pulmonary disease who lack the necessary respiratory reserve to respond to
minimal increases in ventilatory demand due to their altered lung dynamics are
constantly on the verge of respiratory decompensation. Based on this
systematic review, bilevel noninvasive positive pressure ventilation use in a
select proportion of subjects with severe stable chronic obstructive pulmonary
disease can improve gas exchange, exercise tolerance, dyspnoea, work of
breathing (due to lung hyperinflation), frequency of hospitalization, healthrelated quality of life and functional status7
Puhan MA et al (2004) in their study at Switzerland, suggested that physical
exercise has become a cornerstone of management of COPD because it leads to
clinical relevant improvements of exercise capacity and health related quality
of life (HRQL). They did a study on 52 subjects with moderate to severe COPD
to either continuous exercise or interval exercise using a stratified
randomization. Subjects followed 12-15 exercise sessions during
comprehensive inpatient respiratory rehabilitation. Primary end point for
effectiveness is HRQL as measured by CRQ (Chronic respiratory questionnaire)
two weeks after the end of rehabilitation and secondary end point include
additional clinical outcomes such as functional exercise capacity. Other HRQL
measures patient experience of physical exercise as well as physiological
measures of the effects of physical exercise such as cardiopulmonary exercise
testing, and concluded that ‘interval exercise are more effective for COPD
subjects with recovery period’8
Stevenson NJ & Calverley PM (2004) in their study in U.K about the effects of
oxygen on recovery from exercise in subjects with COPD, 18 subjects with
moderate COPD performed symptom limited exercise on a cycle ergometer.
During recovery they received either air or oxygen at identical flow rates in a
randomized, single blind crossover design. When oxygen was given, the time
taken for resolution of dynamic hyperinflation was significantly shorter and
concluded that oxygen reduces the degree of dynamic hyperinflation during
recovery from exercise but does not make the patient feel less breathless than
breathing air9
Rochester C L (2003) in his study at USA, suggested that, exercise and activity
limitation are characteristic features of COPD. Exercise intolerance may result
from ventilators limitation, cardiovascular impairment, and skeletal muscle
dysfunction. Exercise training is a core component of pulmonary rehabilitation
to improve the exercise capacity of subjects with COPD, in spite of the
irreversible abnormality in lung function. Dyspnea and health related quality of
life also improved following pulmonary rehabilitation. Both high and low
intensity exercise lead to increased exercise endurance, but only high intensity
training lead to physiologic gains in aerobic fitness10
Puente Maser L et al (2003) in their study at Spain on COPD subjects,
endurance training on tolerance to several high intensity work rates was given
to establish the relationship between power and its tolerable duration. This
study was done on 27 subjects, before and after the intervention, the subjects
randomly underwent 4 high intensity constant exercise tests, ventilation
reaches approximately the same level in each of the tests. They suggested that
neither an incremental nor a single endurance test at constant work provides
an adequate characterization of exercise tolerance at other powers11
Mehta et al (2001) noninvasive positive pressure ventilation (NPPV) has been
found to be an effective ventilatory supplement for subjects with acute and
chronic ventilatory failure due to obstructive lung diseases or neuromuscular
deficits5
Bestall J C et al (1999) in their study in London suggested that classifying
COPD depends largely upon spirometric measurements, but disability is only
weakly related to measurements of lung functions. In this study they examined
the validity of MRC Dyspnea scale for COPD. This study was done on 100
subjects; assessment included the MRC Dyspnea scale, spiromerty tests, blood
gas analysis, shuttle walking test and Borg’s scores for perceived
breathlessness before and after exercise. Health was assessed using chronic
respiratory questionnaire (CRQ), St.George Respiratory questionnaire and
concluded that MRC Dyspnea scale is a simple and valid method of categorizing
subjects with COPD in terms of their disability that could be used in
compliment FEV1 in the classification of COPD severity12
Oga T et al (1998) in their study at Japan on COPD subjects, endurance test at
high versus moderate intensity was performed on 37 subjects. They performed
cycle endurance tests at high and moderate sub maximal work loads
representing 80% & 60% of the maximum work rate reached with progressive
cycle ergometry respectively and concluded that when using the endurance
time as an outcome, the high intensity endurance test is preferable to the
moderate intensity endurance test, as the high intensity test demonstrated
shorter exercise time, less variability and higher sensitivity13
Meecham et al (1995) studied the role of domiciliary noninvasive
intermittent positive pressure ventilation (NPPV) as an adjunct to pulmonary
rehabilitation in subjects with severe COPD. We have shown support for the
hypothesis that NPPV augments the benefits of exercise training in subjects
with severe COPD. The results of this study show significant improvements in
exercise tolerance and quality of life after training in conjunction with NPPV,
when compared with exercise training alone. Only the group treated with
NPPV showed a significant improvement in inspiratory muscle
strength. Our study design enabled us to identify the point at which differences
between the two groups occurred. We found that after 4 wk of training
improvements in exercise tolerance were similar between the groups, but after
this time, the NPPV-treated group continued to improve while the exerciseonly group showed no further change. Previous trials of NPPV have generally
shown improvements in quality of life and arterial blood gases in patient With
hypercapnic COPD, although the addition of NPPV did not improve exercise
tolerance1
Punzal PA et al (1991) in their study at California studied that high intensity
symptom limited endurance exercise training in 50 subjects with COPD
participating in pulmonary rehabilitation programme. The patient had
moderate to severe airway obstruction and reduced exercise tolerance with
ventilatory limitations. At training weeks 1, 4 and 8 they were trained at 85, 84
and 86% respectively of baseline maximum. After rehabilitation there was
increase in the maximal treadmill workload, VO2 max and endurance exercise
time and decrease in the perceived symptoms. It was concluded that subjects
with moderate to severe COPD can perform exercise training successfully at
intensity targets which represents higher percentage of maximum then
typically recommended in normal individual or other subjects14
Christensen EF et al (March 1990) in their study in Denmark on COPD with
chest PT with or without positive expiratory pressure ( PEP ) by mask, selected
43 subjects and randomly allocated 20 to PEP treatment group and the
remaining 20 to conventional chest physiotherapy (control) group. Subjects
were treated twice daily for 12 months. The PEP group had significantly less
cough and less mucous production and finally they concluded that treatment
with a simple PEP device can reduce morbidity in subjects with chronic
bronchitis and may preserve lung function from a more rapid decline15
Objectives of the study :
6.3
The Objectives of the studies are :
 To find the effect of physical training with NPPV in COPD subjects.
 To find the effect of physical training alone in COPD subjects.
7
 To compare the effect of physical training with NPPV and physical training
alone in COPD subjects.
7.1 Source of Data :
Study will be conducted from at Bankers Heart Institute, Old
padra road, Baroda, Gujarat.
7.2
Methods of Collection of Data :
Study design :
This study is an experimental design involving the comparative
analysis of two groups treated with physical training with NPPV & physical
training alone.
Sample Size & Technique :
30 subjects with severe COPD aged between 30-70 years were
selected according to convenience (purposive) sampling based on a selection
criteria.
Material used :

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Spirometer
Stopwatch
Pulseoxymetry
Noninvasive positive pressure ventilation (NPPV)
Inclusion criteria :






Subjects clinically diagnosed as severe COPD.
Male & Female both are allowed.
Age group from 30-70 years.
Subjects had history of severe COPD.
Subjects had no previous exposure to NPPV.
Subjects had limited exercise tolerance.
Exclusion Criteria :
 Subjects had unstable angina.
 Subjects intermittent claudication.
 Subjects had other mobility limiting condition.
Evaluation Tools :
 Spirometer
 Pulseoxymeter
 Shuttle walk test
Outcome Measure :
 Arterial blood gasses will be expressed in mmHg units.
Arterial oxygen saturation will be expressed in percentage. Inspiratory &
expiratory muscle strength expressed in cmH2O.
Intervention to be carried on participants(Methodology) :
30 subjects clinically diagnosed as severe COPD were selected
according to inclusion and exclusion criteria and divided randomly into two
groups; namely experimental group A and experimental group B, consisting of
15 subjects each. Both the groups were assessed before the training session to
exclude any pre-existing pulmonary and cardiac conditions.
Treatment Procedure :
Before starting the treatment, Partial pressure of arterial blood,
forced expiratory volume, Inspiratory & expiratory muscle strength will be
measure by using blood gas analyzer and spirometer respectively for all
subjects of both the groups and this will be recorded as the pre test measure.
Group -A :Experimental group A was treated with noninvasive positive
pressure ventilation(NPPV) with physical training. subjects in the NPPV + ET
group were fitted with noninvasive positive pressure ventilation using the
BiPAP ventilator and instructed to use the ventilator and physical training for
at least 8 h daily throughout the whole study period. All subjects underwent a
4-wk run-in period.14
Group –B : Experimental group B was treated with physical training alone.
Subjects in the ET group were given no special instructions and were contacted
only once. The pulmonary rehabilitation program consisted of 16 hourly
sessions of physical training supervised by an experienced physiotherapist,
followed by an education program standardized for both groups.14
Both the group subjects’ will be measured again for Partial pressure
of arterial blood, forced expiratory volume, Inspiratory & expiratory muscle
strength will be measured as post test measure. Then, the pre & post test
measures will be considered for statistical analysis.
7.4 Statistical Analysis:
Differences between the groups in response to rehabilitation
were identified using the unpaired Student’s t test, while changes within
groups were measured using the paired Student’s t test. Repeated measures
analysis of variance was performed on the 30 subjects who underwent all
assessments and post paired and unpaired Student’s t tests were then
performed to identify where changes occurred in those 30 subjects.
7.5Ethical clearance:
As the study includes subjects ethical clearance is obtained from
research and ethical committee of institution. Also a written consent will be
taken from each subjects who participates in the study.
8.
List of References :
1. Meecham, Jones J.,E.A.Paul,P.W.Jones,and J.A.Wedzicha 1995. Nasal pressure
support ventilation plus oxygen compared with Oxygen therapy alone in
hypercapnic COPD. Am.J.Respir.Crit.Care Med.152:538-44.
2. Perrin, C., Y. El Far, F. Vandenbos, R.Tamisier, M.C.Dumon, F.Lemoigne,
J.Mouroux, and B.Blaive.1997. Domiciliary nasal Intermittent positive pressure
ventilation in severe COPD: effects on lung function and quality of life.
Eur.Respir.J.10:2835-2839.
3. Ries, AL Position paper of the American association of cardio vascular and
Pulmonary rehabilitation.J cardiopulm rehabil 1990;10,418-441.
4. Jindal SK, Aggarwal AN, Gupta D; Indian Journal of chest disease & allied
science; A review of population studies from India to estimate national
burden of COPD & its association with smoking; 2001.
5. Mehta,S, Hill, NS Noninvasive ventilation. Am J Respir Crit Care Med
2001;163, 540-577.
6. Elliott, M. W., A. K. Simonds, M. P. Carroll, J. A. Wedzicha, and
M. A. Branthwaite. 1992. Domiciliary nocturnal nasal intermittent positive
pressure ventilation in hypercapnic respiratory failure due to chronic
obstructive lung disease: effects on sleep and quality of life. Thorax 47:342–
348.
7. M.A.Kolodziej, L. Jensen, B. Rowe, D. Sin, Systemic review of Noninvasive
positive pressure ventilation in severe stable COPD Eur Respir
J2007;30,293-306.
8. Puhan MA; Internal versus continuous exercise in COPD subjects; Med; Aug,
2004; 13:(1)5.
9. Stevenson NJ, Calverly; Effects of Oxygen on recovery from exercise in
subjects with COPD; Aug, 2004.
10.Rochester CL; Exercise and activity limitation are characteristics features
of COPD; Sep, 2003.
11.Puente Master; Endurance training on tolerance to several high intensity
work rates given to establish the relationship between power and its
tolerable duration; 2003.
12.Bestall JC, Classifying COPD subjects depending upon spirometric
measurem- ents ; 1999.
13.Oga T, Nishimura K; Endurance test at high versus moderate intensity on
COPD subjects; 1998.
14.Punzal PA, Ries AL; High intensity symptom limited endurance exercise
training with COPD subjects in pulmonary rehabilitation; 1991.
15.Christensen EF, Nedergard T; COPD with chest physiotherapy with or
without positive expiratory pressure by mask; Mar, 1990.
7.
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8.
9.
Signature of the Candidate:
10. Remarks of the Guide:
11. Name and Designation of
(in Block Letters)
11.1 Guide
SAI KUMAR .N
11.2 Signature
11.3 Co-Guide(if any)
11.4 Signature
11.5 Head of the Department
11.6 Signature
12. 12.1 Remarks of the Principal
12.2 Signature
SAI KUMAR .N