| 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
|
|
|
Primary Sponsor
|
| Name |
sonali rajopadhye |
| Address |
pravara institute of medical sciences loni |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
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
|
|
|
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 |