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CTRI Number  CTRI/2025/08/093889 [Registered on: 29/08/2025] Trial Registered Prospectively
Last Modified On: 07/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Manual Diaphragm Release Technique on diaphragm efficiency, dyspnea and arterial blood gases in patients with Respiratory Failure a randomized controlled trial 
Scientific Title of Study   Effect of Manual Diaphragm Release Technique on diaphragmatic excursion dyspnea and arterial blood gases in patients with Respiratory Failure a randomized controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sonali Rajopadhye 
Designation  PG student 
Affiliation   
Address  Dr APJ abdul kalam college of physiotherapy loni

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  9403007933  
Fax    
Email  sonalirajopadhye@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Saumi Sinha 
Designation  Professor  
Affiliation   
Address  Dr APJ Abdul kalam college of physiotherapy
Dr APJ Abdul kalam college of physiotherapy
Ahmadnagar
MAHARASHTRA
413736
India 
Phone  9403007933  
Fax    
Email  drsaumi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sonali Rajopadhye 
Designation  PG student 
Affiliation   
Address  Dr APJ Abdul kalam college of physiotherapy
Dr APJ Abdul kalam college of physiotherapy
Ahmadnagar
MAHARASHTRA
413736
India 
Phone  9403007933  
Fax    
Email  sonalirajopadhye@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  sonali rajopadhye 
Address  pravara institute of medical sciences loni 
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 
Sonali Rajopadhye  Dr Vitthalrao Vikhe patil pravara rural hospital loni  hospital medicine ward and medical ICU
Ahmadnagar
MAHARASHTRA 
9403007933

sonalirajopadhye@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
EthicsCommitteePIMS DU   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J962||Acute and chronic respiratory failure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  conventional chest physiotherapy   percussion vibration respiratory PNF techniques intercostal stretch posterior basal lift 
Intervention  manual diaphragm release technique   The participant lay supine with relaxed limbs Positioned at the head of the participant the therapist made manual contact with the pisiform hypothenar region and the last three fingers bilaterally to the underside of the seventh to tenth rib costal cartilages with the therapist forearms aligned toward the participant shoulders In the inspiratory phase the therapist gently pulled the points of contact with both hands in the direction of the head and slightly laterally accompanying the elevation of the ribs During exhalation the therapist deepened contact toward the inner costal margin maintaining resistance In the subsequent respiratory cycles the therapist progressively increased the depth of contact inside the costal margin The manoeuvre is performed in two sets of 10 deep breaths with a 1 minute interval between them  
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients diagnosed of respiratory failure with following
Patients having Dyspnea grade more than 2 on MMRC
Patients with reduced chest expansion
Reduced Diaphragmatic Excursion on MED scale score more than 2
Patients with mild to moderate hypoxemia less than 80 -60 mmHg Po2 both Type I and II respiratory failure patients will be included
Both Intubated and spontaneously breathing patients to be included
 
 
ExclusionCriteria 
Details  Presence of any other cardiac diseases
Lack of consent, and inability to understand the verbal commands necessary for the outcome assessments
Patients who have undergone recent cardiothoracic or abdominal surgery
Patients who have a recent history of chest wall or abdominal trauma substantial chest wall deformity
 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Diaphragm excursion measured on The Diaphragm Muscle Manual Evaluation Scale
 
2 weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
Dyspnea Measured on MMRC scale

 
at end of 2 weeks 
Arterial Blood Gas Analysis reports
 
at end of 2 weeks 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "45"
Final Enrollment numbers achieved (India)="45" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   20/01/2026 
Date of Study Completion (India) 10/02/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 10/02/2026 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
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  

Introduction
Respiratory failure is defined as the failure of the pulmonary system to meet the metabolic demands of the body that is ventilation and oxygenation
The end stage of respiratory failure results in a progressive increase in airway resistance work of breathing oxygen consumption and carbon dioxide production
Acidemia from respiratory causes with a pH of less than 7.25 is often harmful Conversely hypoventilation is equally harmful and pH elevations greater than 7.5 may cause neurological and cardiovascular complications
The principles of management of acute respiratory failure are based on interventions that will enhance oxygen transport ie oxygen delivery oxygen consumption and oxygen extraction and facilitate carbon dioxide removal
RF is a syndrome caused by a multitude of pathological states and can be life threatening and may need a quick diagnosis and emergency medical treatment in a hospital Emergency treatment aims to improve breathing and provide oxygen to body to prevent organ damage Clinically patients are treated with ventilator therapy in most cases which can significantly reduce the respiratory power consumption of patients and reduce the risk of treatment
Respiratory failure may develop when the respiratory muscles are weak and when there is failure of pump mechanism which draws air in and out of lungs The respiratory muscles have to work harder to expand the rib cage and lungs when the ribs pleurae or lungs are abnormally stiff and they may eventually eventually become the main biochemical stimulus to respiration Respiratory muscle activity may cause changes in chest wall compliance
The treatment of Respiratory Failure includes a standardized physiotherapy protocol to maintain normal lung ventilation and air exchanging functions through physical measures such as assessment of pulmonary conditions percussion on back aerosol inhalation vibration postural drainage and sputum suction which is commonly used in the treatment of patients in intensive care unit
In previously conducted study the manual diaphragm release technique has been to shown a significant effect on diaphragm excursion chest expansion and on lung volume and capacities in patients with respiratory diseases
In this study the application effects of manual diaphragm release technique on patients with respiratory failure will be explored in order to provide references for clinical treatment

purpose for study

Respiratory failure is most often the result of an imbalance between the muscular pump and the mechanical load placed upon it
When hypoxemia is noted treatment consists of oxygen therapy CPAP or BIPAP and alleviation of cause of hypoxemia if possible This may be achieved by means of airway clearance techniques or medication in addition to oxygen therapy or mechanical ventilation
Conventional physiotherapy techniques have limited extent and newer techniques should be incorporated in treating patients with respiratory failure
Some evidence suggests that manual therapy has the potential to affect and change respiratory mechanics in certain chronic pulmonary diseases such as chronic asthma and COPD which includes an increase in flexibility of the chest wall and thoracic excursion This can indirectly lead to an improvement in exercise capacity and lung function
The diaphragm is the main muscle of respiration and if it is shortened it can alter both its contraction force and lung volumes and capacities since lung volume can be considered as the length index of the respiratory muscle Therefore improvement of muscle length may be influenced by manual therapy MT techniques
Although this technique is widely used in clinical practice in some regions it is believed that to date there are no quantitative studies or clinical trials evaluating the effects of this technique 2
Previous studies showed that manual diaphragm release technique could affect the respiratory muscle and adjunct fascia
The effects of a manual diaphragm release technique on patients with respiratory failure have not been evaluated
Hence this study needs to be conducted to see effect of manual diaphragm release technique in patients with respiratory failure

Manual diaphragm release technique
The manual diaphragm release technique is an intervention intended to directly stretch the diaphragmatic muscle fibers 2
The manual diaphragm release technique was developed to indirectly elongate tight diaphragmatic muscle fibers while promoting greater and more efficient muscle contraction It has been used in clinical practice to enhance pulmonary function and to improve thoracic mobility in patients 2 The manual diaphragm release technique improves diaphragmatic contraction pulmonary function dyspnoea and exercise capacity
Treatment with the diaphragmatic release technique is directed to optimize the function of the diaphragm by means of stretching its fibers and releasing it from the surrounding tissues
Procedure
The participant lay supine with relaxed limbs Positioned at the head of the participant the therapist made manual contact with the pisiform hypothenar region and the last three fingers bilaterally to the underside of the seventh to tenth rib costal cartilages with the therapist forearms aligned toward the participant shoulders
In the inspiratory phase the therapist gently pulled the points of contact with both hands in the direction of the head and slightly laterally accompanying the elevation of the ribs
During exhalation the therapist deepened contact toward the inner costal margin maintaining resistance
In the subsequent respiratory cycles the therapist progressively increased the depth of contact inside the costal margin
The manoeuvre is performed in two sets of 10 deep breaths with a 1 minute interval between them 2

Aim To investigate the effect of manual diaphragm release technique on diaphragmatic excursion dyspnoea and arterial blood gases in patients with respiratory failure
Primary objective
To find effectiveness of manual diaphragm release technique on diaphragmatic excursion in patients with respiratory failure
Secondary objective
To find effectiveness of manual diaphragm release technique on dyspnoea and arterial blood gases in patients with respiratory failure

Methodology
Source of data Pravara Medical Trust Loni
Study setting Intensive Care Unit Pravara Rural Hospital Loni
Study design Parallel group randomized controlled trial
Study duration 2 years
Method of data collection Data collection will be done by investigator
Study type single blinded randomized controlled trial
Sample size 40
Sampling method Simple random sampling
Study population patients with respiratory failure
Material to be used
1 Consent form
2 The diaphragm muscle manual evaluation scale
3 Assessment sheet

Primary outcomes
1 Diaphragm excursion measured on the diaphragm muscle manual evaluation scale

Secondary outcome measures
1 Dyspnea measured on MMRC scale
2 Arterial blood gas analysis reports

Procedure
Target population is patients with respiratory failure and participants will be taken from Intensive Care Unit of Pravara Rural Hospital Loni
A written consent will be obtained from the patients if conscious and from the nearest relative of the patient if unconscious
Simple random sampling will be used to select the sample
Subjects will be explained about the study and written inform consent form will be obtained from each of them
Subjects will be divided in 2 groups intervention group n20 and control group n20 using simple random sampling
Conscious subjects will be explained about the interventions to be given
Outcome measures will be recorded

 
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