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CTRI Number  CTRI/2025/03/083111 [Registered on: 21/03/2025] Trial Registered Prospectively
Last Modified On: 16/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing effects of diaphragm muscle release technique and chest mobilization on breathlessness and expansion of chest in patients with obstructive lung disease 
Scientific Title of Study   Comparative effects of Manual Diaphragm Technique and Chest Mobilization Techniques on Dyspnea and Chest Excursion in patients with Chronic Obstructive Pulmonary Disease: 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  Himanshika Gautam 
Designation  Student 
Affiliation  Maharishi Markandeshwar Medical College and Hospital, Kumarhatti, Solan 
Address  Room no 510,Physiotherapy OPD, Orthopedics department, Kumarhatti, Solan, Himachal Pradesh

Solan
HIMACHAL PRADESH
173229
India 
Phone  6230226218  
Fax    
Email  ghimanshika@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Geetanjali Kaul 
Designation  Assistant Professor 
Affiliation  Maharishi Markandeshwar Medical College and Hospital, Kumarhatti, Solan 
Address  Room no 510,Physiotherapy OPD, Orthopedics department, Kumarhatti, Solan, Himachal Pradesh

Solan
HIMACHAL PRADESH
173229
India 
Phone  7018518005  
Fax    
Email  drgeetanjalikaul@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Geetanjali Kaul 
Designation  Assistant Professor 
Affiliation  Maharishi Markandeshwar Medical College and Hospital, Kumarhatti, Solan 
Address  Room no 510,Physiotherapy OPD, Orthopedics department, Kumarhatti, Solan, Himachal Pradesh


HIMACHAL PRADESH
173229
India 
Phone  7018518005  
Fax    
Email  drgeetanjalikaul@gmail.com  
 
Source of Monetary or Material Support  
Maharishi Markandeshwar Medical College and Hospital, Kumarhatti, Solan, Himachal Pradesh, 173229 
 
Primary Sponsor  
Name  Himanshika Gautam 
Address  Maharishi Markandeshwar Medical College and Hospital, Kumarhatti, Solan, Himachal Pradesh, 173229 
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 
Himanshika Gautam  Maharishi Markandeshwar University  Orthopedics department, Physiotherapy OPD, Room no 510, Kumarhatti, Solan, Himachal Pradesh
Solan
HIMACHAL PRADESH 
6230226218

ghimanshika@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee MM Medical College and Hospital Solan  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J988||Other specified respiratory disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Chest Mobilization Technique  Rib rotation: As the patient breathes in, the therapist gradually applied a rotational force to the ribs, promoting lateral movement. During the exhalation phase, the therapist can deepen their touch and apply gentle resistance to enhance the mobilization effect. lateral flexion: Therapist was instructed the patient to take a deep breath in, expanding the chest. As the patient exhales, the therapist was gently guiding the patient into lateral flexion. This was done by placing one hand on the patient’s shoulder and the other hand on their opposite hip to provide support and assistance. Hold the position for a few seconds to allow the patient to feel the stretch and then slowly return to the starting position. thoracic extension: Therapist was instructed the patient to take a deep breath in, allowing their chest to expand. As the patient exhales, the therapist was gently guide them into thoracic extension by placing their hands on the patient’s shoulders or upper back, encouraging them to lean back slightly, therapist promoted a smooth and controlled movement, ensuring the patient was not be overextending or strain their back. Hold the extended position for a few seconds to allow the patient to feel the stretch in the thoracic region, then guide them back to the starting position. thoracic flexion: Therapist was instructed the patient to take a deep breath in, allowing their chest to expand. As the patient exhales, the therapist was gently guide them into thoracic flexion. This was done by encouraging the patient to round their shoulders forward and tuck their chin slightly to their chest. duration: 05 repetitions/1 week.  
Intervention  Manual Diaphragm Release technique  Patient’s Position: Patients were instructed to lie on their backs with their limbs relaxed. Ensure that the patient is comfortable and does not experience pain during the movement. Monitor the patients breathing and encourage them to breathe normally throughout the exercise. Therapist’s position: The therapist was positioned at the patient’s head, using their hypothenar region and the last three fingers bilaterally to make contact beneath the costal cartilages of the seventh to tenth ribs. The therapists forearms were directed toward the patients shoulders. Technique: As the patient inhales, therapist gently pulls and lifts the ribs outward at the contact points during the inhalation phase. When the patient exhales, the therapist applies deeper pressure toward the inner costal margin while maintaining resistance. This connection continued to deepen with each respiratory cycle. Patient was encouraged to breathe progressively deeper with each set, aiming for maximum diaphragmatic movement and stretch. It is important for the therapist to keep a firm grip on the lower thoracic area throughout the procedure. duration: 03 sets of 05 repetitions, with a 1-minute rest between sets, for 1 week.  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Diagnosed cases of COPD using Gold Standard method.
2. Both Male and Female.
3. Age group between 40 years to 70 years.
4. Patients with an exacerbation of COPD.
5. Value of Pulmonary Function Test below normal value.
6. Patients with symptoms of shortness of breath. 
 
ExclusionCriteria 
Details  1. Patients with unstable vitals
2. Patients with any active lung infections or any other respiratory conditions such as pneumonia, lung carcinoma
3. Patients with uncontrolled Diabetes Mellites
4. Patients of progressive diseases seriously influencing waling ability, amputation, muscular dystrophies, paralysis
5. Patients with multidrug resistance COPD
6. Patients with psychological disorders
7. Patients who are non – cooperative
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Single breath count 2. Chest excursion 3. PFT 4. COPD assessment test  at baseline and after one week 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   31/03/2025 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Closed to Recruitment of Participants 
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  

Chronic obstructive pulmonary disease (COPD) is defined by ongoing and typically worsening restrictions in airflow. The primary risk factor is smoking, but the condition is also linked to environmental pollution, workplace exposures, genetic changes, and the effects of aging. It is a diverse lung condition characterized by chronic respiratory symptoms. It results from problems with the air sacs and air passages. It ultimately results in a disruption of airflow that is persistent occasionally gets worsened. However, early detection and treatment of COPD, in addition to lifestyle modifications like discontinuing smoking and exercising regularly, improves the quality of life for those who are affected and minimizes the disease’s progression. This is a diverse condition that exhibits significant differences in how it progresses. It leads to sudden worsening of respiratory symptoms that is linked to varying levels of physiological decline. The MDRT and CMT are effective clinical approaches for managing patients with COPD. They aid in alleviating symptoms such as dyspnea and enhancing chest excursion. Additionally, these techniques have proven beneficial for other conditions like asthma and Neuromuscular Disorders (NMD), positively impacting cardiorespiratory and physiological functions. There is a notable gap in comprehensive evaluations of their effectiveness. This lack of published literature and rigorous assessment makes it challenging to determine how well the techniques work compared to other interventions or therapies. More research is needed to establish clear evidence of their benefits and to understand role in the management of respiratory conditions. There is a need for research to compare the efficacy of both techniques. Identifying which method is more effective could allow healthcare providers to incorporate it alongside standard exercises for these patients. This integration aims to improve their quality of life, shorten hospital stays, and boost lung capacity for those dealing with respiratory challenges.

 
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