| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J988||Other specified respiratory disorders, |
|
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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.
|
|
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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. |