FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/07/071405 [Registered on: 26/07/2024] Trial Registered Prospectively
Last Modified On: 25/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized Factorial Trial 
Public Title of Study   The Immediate Effects of Postural Correction vs Diaphragm Release Technique on Pulmonary Function Tests in Individuals with Chronic Obstructive Pulmonary Disease. 
Scientific Title of Study   Immediate Effects of Diaphragm Release Technique vs Postural Correction on Pulmonary Function Test in Chronic Obstructive Pulmonary Disease. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sneha M Belavalad 
Designation  Postgraduate Student 
Affiliation  SDM College of Physiotherapy Dharwad 
Address  OPD Number 13 Cardiorespiratory Physiotherapy Department SDM College of Physiotherapy , SDM College of Medical Sciences and Hospital Manjushree Nagar Sattur Dharwad

Dharwad
KARNATAKA
580009
India 
Phone  9731536792  
Fax    
Email  kaveri.sneha19@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sneha M Belavalad 
Designation  Postgraduate Student 
Affiliation  SDM College of Physiotherapy Dharwad 
Address  OPD Number 13 Cardiorespiratory Physiotherapy Department SDM College of Physiotherapy , SDM College of Medical Sciences and Hospital Manjushree Nagar Sattur Dharwad

Dharwad
KARNATAKA
580009
India 
Phone  9731536792  
Fax    
Email  kaveri.sneha19@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shubha Akadas 
Designation  Assistant Professor and PG Guide  
Affiliation  SDM College of Physiotherapy Dharwad 
Address  OPD Number 13 Cardiorespiratory Physiotherapy Department SDM College of Physiotherapy , SDM College of Medical Sciences and Hospital Manjushree Nagar Sattur Dharwad

Dharwad
KARNATAKA
580009
India 
Phone  9739488007  
Fax    
Email  shubhaakadas@gmail.com  
 
Source of Monetary or Material Support  
SDM College of Medical Sciences and Hospital. SDM College of Physiotherapy Manjushree Nagar Sattur Dharwad, Karnataka - 580009 India 
 
Primary Sponsor  
Name  Sneha M Belavalad 
Address  SDM College of Medical Sciences and Hospital. SDM College of Physiotherapy Manjushree Nagar Sattur Dharwad, Karnataka - 580009 India. 
Type of Sponsor  Other [[Self]] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sneha M Belavalad  Shri Dharmasthala Manjunatheshwara Hospital  OPD Number 13 Cardiorespiratory Physiotherapy Department. SDM College of Physiotherapy, SDM University Dharwad.
Dharwad
KARNATAKA 
9731536792

kaveri.sneha19@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SDM Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Postural correction by Rigid strapping tape.  Individuals/participants of group A will be assessed for demographic data, FEV1/FVC, and diaphragmatic excursion by percussion method(Pre test). Individuals in Group A will be undergoing postural correction by Rigid strapping tape- Rigid strapping taping will be performed by applying standardized rigid tape bilaterally, from the anterior aspect of the shoulder to the T6 area with a pull into retraction and the second rigid tape from just below the coracoid in the anterior aspect of the shoulder to the T10 area with an initial pull up and then back. Immediately after which they will be assessed for their lung function (FEV1/FVC),diaphragmatic excursion and interscapular distance. 
Intervention  The Diaphragm Release Technique  Individuals/participants of group B will be assessed for demographic data, FEV1/FVC, and diaphragmatic excursion by percussion method(Pre test).Individuals in Group B will be undergoing diaphragm release technique – The Diaphragm Release Technique will be performed according to the protocol described by Rocha et al. The participant remains in the supine position so that the therapist is able to maintain manual contact with the bottom edge of the rib cage during inspiration, the therapist exerts traction after the natural rib-cage movement, then deepens the manual contact and maintains the resistance exerted in the previous phase throughout exhalation. The technique was applied in 2 series of 10 deep respiratory cycles, with a 1-minute interval between the series, under the therapist’s verbal command. Immediately after which they will be assessed for their lung function (FEV1/FVC) and diaphragmatic excursion. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Individuals diagnosed with chronic obstructive
pulmonary disease by physician/ pulmonologist.
2. Haemodynamically stable chronic obstructive
pulmonary disease patients (mild – moderate )
3. Individuals who are not dependent on oxygen.
4. Age between 40 years to 75 years and either of
gender.
5. Smokers and non-smokers
6. Chronic obstructive pulmonary disease
individuals with stable co-morbidities like
Hypertension, Diabetes mellitus, Chronic kidney
disease with precautions and on medications for the same.
7. Individuals who have forward head posture. 
 
ExclusionCriteria 
Details  1. Individuals who are unable to follow commands. 2. Individuals not willing to participate.
3. Individuals who have had recent
thoracic/abdominal surgeries.
4. Individuals having ribs fracture.
5. Individuals with skin infection over the back. 6. Individuals with structural forward shoulder
posture.
7. Hemodynamically unstable patients.
8. Open wounds/ bruises over the back
9. Previous allergic reaction to taping. 10.Individuals having active infection or lung
infection and Pneumonia.
11. Individuals having chest deformity. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To find out the immediate
effects of diaphragm release technique on improving pulmonary function test in individuals with chronic obstructive pulmonary
disease. 
Pre and post test done on the same day of intervention. 
 
Secondary Outcome  
Outcome  TimePoints 
To find out the immediate effects of postural correction on improving diaphragmatic excursion in individuals with chronic obstructive pulmonary disease.
 
Pre and post test done on the same day of intervention. 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   20/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
The term Chronic Obstructive Pulmonary Disease refers to a disease state characterized by the presence of airflow obstruction that does not reverse completely after bronchodilator treatment. The GOLD guidelines define chronic obstructive pulmonary disease as follows: Chronic Obstructive Pulmonary Disease is a common, preventable, and treatable disease characterized by persistent respiratory symptoms and airflow limitation caused by airway or alveolar abnormalities, usually caused by significant exposure to noxious particles or gases. The chronic airflow limitation that is characteristic of Chronic Obstructive Pulmonary Disease is caused by a mixture of small airways disease (e.g., obstructive bronchiolitis) and parenchymal destruction (emphysema), the relative contributions of which vary from one person to another person.1
The two major diseases that encompass Chronic Obstructive Pulmonary Disease — Emphysema and Chronic bronchitis.
Emphysema is defined in anatomic terms as a condition characterized by abnormal, permanent enlargement of the airspaces beyond the terminal bronchiole, accompanied by destruction of the walls
of the airspaces and loss of elastance.
1. Pan lobular emphysema is associated with a deficit in a1-antitrypsin, and result of dilation or destruction of all the lobules.
2. Centrilobular emphysema is a result of the dilation or destruction of respiratory bronchioles.
Chronic bronchitis is defined in clinical terms as a condition in which chronic productive cough is present for at least 3 months per year for at least 2 consecutive years.2
People with Chronic Obstructive Pulmonary Disease must work harder to breathe, which can lead to shortness of breath and/or feeling tired. Early in the disease, people with chronic obstructive pulmonary disease may feel short of breath when they exercise. “Air trapping” or the inability to fully exhale, leads to abnormal expansion or hyperinflation of the lungs. The risk factors of chronic obstructive pulmonary disease are: Genetic, tobacco , smoke, second hand smoker, outdoor air pollutants, aging, occupational dusts and fumes, infections, socioeconomic ,individuals with history of childhood respiratory infections, history of asthma and related factors.3 These factors could lead to abnormalities in vascular, such as damage to alveolar capillary endothelial cells, destruction of alveolar cells, and alveolar space enlargement, which play 
an important role of contributors in progression of chronic obstructive pulmonary disease.
Global Initiative for chronic obstructive lung disease classification by severity
STAGE CHARACTERISTICS
0: At Risk
ï‚· Lung function Normal
ï‚· Spirometry is Normal
ï‚· It can be described as with or without chronic symptoms like cough, sputum production.
Stage I: Mild COPD
ï‚· Lung function Abnormal
ï‚· Mild airway flow limitation
ï‚· FEV1/FVC < 70%
 FEV1 ≥ 80% predicted
ï‚· It can be described by with or without chronic symptoms like cough, sputum production.
Stage II: Severe COPD
ï‚· Severe airflow limitation
ï‚· FEV1/FVC < 70%
ï‚· FEV1 < 30% predicted
ï‚· It can be described by the presence signs of respiratory failure or clinical signs of right heart failure; quality of life is impaired; exacerbations can be life threatening.
Stage III: Severe COPD
ï‚· Severe airflow limitation
ï‚· FEV1/FVC < 70%
ï‚· FEV1 < 30% predicted
ï‚· It can be described by the presence signs of respiratory failure or clinical signs of with or without chronic symptoms like cough, sputum production.
Stage IV: Very Severe COPD
ï‚· Very severe air flow limitation
ï‚· FEV1/FVC<70%
ï‚· FEV1<30% predicted or FEV1<50% predicted
ï‚· Plus chronic respiratory failure (PaO2<8.0 kPa with or without PaCO2 6.7 kPa while breathing air at sea level).
FVC = Forced vital capacity or amount of air exhaled in complete breath; FEV1 = Forced Expiratory Volume in one second or volume of air exhaled in one second; FEV1/FVC = ratio of vital capacity that the person can exhale in first second of forced expiration. Clinical signs and symptoms of chronic obstructive pulmonary disease include dyspnoea, dry or wet cough, wheezing ,fatigue or inability to
exercise etc are more severe in the early morning and evening affecting the patient’s quality of life. The prognosis of chronic obstructive pulmonary disease is found out by measuring forced expiratory
volume in one second. Chronic Obstructive Pulmonary Disease can also affect the prognosis of other diseases like covid-19, mental health conditions, cardiovascular diseases, carcinoma, gastrointestinal
disorders, and musculoskeletal disorders.Globally, chronic obstructive pulmonary disease is one of the leading causes of morbidity and mortality. Chronic obstructive pulmonary disease was estimated to be the sixth leading cause of death in 2019 According to the 2017 Global Burden of Disease study, of all the chronic respiratory diseases, chronic obstructive pulmonary disease contributed 50% of all cases and 69% of years lived with disability. More than 90% of chronic obstructive pulmonary disease - related deaths occur in low- and middle-income countries (LMICs). Apart from causing a huge economic burden, chronic obstructive pulmonary disease causes disability and impairs the quality of life, loss of productivity, increased hospital admissions, and premature mortality. The global prevalence of chronic obstructive pulmonary
disease, as per the estimates by Adeloye et al. is 11.37%.5, 6 Some studies show that between 20 and 40% of all chronic obstructive pulmonary disease patients in the world are non smokers. Although smoking continues to be the main risk factor for chronic obstructive pulmonary disease, other conditions have to be considered too.7 Chronic obstructive pulmonary disease is underestimated as most symptoms such as cough and dyspnea are ignored by the patients until they worsen, and are not confirmed by objective lung function tests. 8 Pulmonary function test is a very important diagnostic test for Chronic obstructive pulmonary disease. These tests include Lung Volumes, Diffusion Capacity, Maximal Voluntary Ventilation (MVV). Other tests are Maximal Inspiratory Pressure (Pimax), Maximal Expiratory Pressure (Pe max), Arterial Blood Gas (ABG), Walking Oximetry, and Broncho challenge Tests. Chronic obstructive pulmonary disease has two main components: increased resistance, which is due to airway obstruction, and a loss of the elastic recoil pressure of the lung, which is due to parenchymal destruction.9 Hyperinflation has a significant negative impact on respiratory muscles, particularly the diaphragm. In chronic obstructive pulmonary disease hyperinflation increases the contribution of rib cage and neck muscles and decreases efficiency of the diaphragm. The effect of hyperinflation on diaphragmatic length is the main mechanism by which affects the force generating capacity of the diaphragm. If lungs are chronically over inflated with air the rib cage stays partially expanded all the time .This makes rib cage rounded like barrel shape in which there increase in the anteroposterior diameter of the chest. Then the ribs become more horizontal and dorsal kyphosis is present in majority of cases, specially in emphysema. Due to which there will be prominent sternum, and widened intercostals spaces, rounded shoulder posture. This posture is assumed due to the shortening of the pectoralis major muscle. Forward shoulder or rounded shoulder is one of the numerous deviations from the normal or standard posture observed in Chronic obstructive pulmonary disease.10The posture adopted by the individual has a great influence on the ventilatory pattern and distribution of ventilation during quiet breathing, as it may alter the ability of muscles to participate in respiration. This change in muscle function may be due to the competition between postural and respiratory functions.12 Studies have shown taping to cause improvement in shortness of breath and certain pulmonary functions in these individuals. To correct posture in chronic obstructive pulmonary disease taping technique may help in improving the pulmonary function and also reduces the shortness of breath.13 Two striking features in chronic obstructive pulmonary disease, air trapping and lung hyperinflation, impair the function of the diaphragm, shortening its operating length and changing the mechanical linkage between its various parts thereby placing it at mechanical disadvantage. These pathological changes affect the diaphragm’s ability of raising and expanding the lower rib cage which may lead to a decrease in the transverse diameter of the lower ribcage during inspiration. These changes cause an increase in the work of breathing and reduce the functional capacity. Manual diaphragm release technique is shown to improve diaphragmatic movement by stretching muscle fibers and thereby restoring diaphragm mobility and allowing it to lengthen.14 In chronic obstructive pulmonary disease there is also increase in the volume of air in the lungs at the end of exhalation keeping the respiratory muscles in a mechanical disadvantage, which decreases their ability to generate inspiratory pressures. Studies have shown improvement in the thoracic mobility by Diaphragmatic release technique. Currently there are no evidence of immediate effects of diaphragm release technique vs postural correction on pulmonary functions with individuals in chronic obstructive pulmonary disease. Therefore, we would like to find out the immediate effects of the diaphragm release technique compared to immediate effects of postural correction on pulmonary function with individuals in chronic obstructive pulmonary disease.
 
Close