| CTRI Number |
CTRI/2024/08/072315 [Registered on: 12/08/2024] Trial Registered Prospectively |
| Last Modified On: |
09/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
Muscle energy technique versus neuro-physiological technique in improving shortness of breath and lung function among patient with lung condition. |
|
Scientific Title of Study
|
Effectiveness of muscle energy technique versus neuro-physiological facilitation technique on pulmonary function and dyspnea among patient with 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 |
Shradha Gupta |
| Designation |
BPT Undergraduate student |
| Affiliation |
Maharishi Markandeshwar Medical Collage and Hospital Kumarhatti, Solan |
| Address |
Maharishi Markandeshwar University, Department of Orthopaedics, Physiotherapy OPD, Room number 510, Kumarhatti, Solan
Maharishi Markandeshwar Medical Collage and Hospital Kumarhatti, Solan, Himachal Pradesh 173229
Solan
HIMACHAL PRADESH
173229
India |
| Phone |
7876740052 |
| Fax |
|
| Email |
shradhagupta753@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deeksha Sharma |
| Designation |
Assistant Professor |
| Affiliation |
Maharishi Markandeshwar Medical Collage and Hospital Kumarhatti, Solan |
| Address |
Maharishi Markandeshwar University, Department of Orthopaedics, Physiotherapy OPD, Room number 510, Kumarhatti, Solan
Maharishi Markandeshwar Medical Collage and Hospital Kumarhatti, Solan, Himachal Pradesh, 173229
Solan
HIMACHAL PRADESH
173229
India |
| Phone |
8146966176 |
| Fax |
|
| Email |
deeksha0075sharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arushi Mishra |
| Designation |
Assistant Professor |
| Affiliation |
Maharishi Markandeshwar Medical Collage and Hospital Kumarhatti, Solan |
| Address |
Maharishi Markandeshwar University, Department of Orthopaedics, Physiotherapy OPD, Room number 510, Kumarhatti, Solan
Maharishi Markandeshwar Medical Collage and Hospital Kumarhatti, Solan, Himachal Pradesh, 173229
Solan
HIMACHAL PRADESH
173229
India |
| Phone |
8219368147 |
| Fax |
|
| Email |
arushimishra799@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar Medical Collage and Hospital Kumarhatti, Solan, Himachal Pradesh, 173229 |
|
|
Primary Sponsor
|
| Name |
Shradha Gupta |
| Address |
Maharishi Markandeshwar Medical Collage and Hospital Kumarhatti, Solan |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Deeksha Sharma |
Maharishi Markandeshwar Medical Collage and Hospital Kumarhatti, Solan |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Deeksha sharma |
Maharishi Markandeshwar Medical Collage and Hospital Kumarhatti, solan, 173229 |
Room no 725
Department of Respiratory Medicine
Solan
HIMACHAL PRADESH |
8146966176
deeksha0075sharma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee maharishi markandeshwar medical collage and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Muscle energy technique along with conventional physiotherapy |
Muscle Energy Technique (Day 1 to Day 14) will be given in following muscle pectoralis major short pectoralis major sternocleidomastoid upper trapezius scalenus posticous middle fibres of scalene anterior fibres of the scalene.
Dosimetry- 5 repetitions 10 second hold
Conventional physiotherapy will include
Pursed lip breathing
Diaphragmatic breathing
Thoracic expansion exercise
Dosimetry- 5 repetitions of two sets, twice a day for 2 weeks. |
| Intervention |
Neuro-physiological Facilitation technique along with conventional physiotherapy |
Neuro-physiological Facilitation technique (DAY 1 TO DAY 14) Perioral pressure intercostal stretch thoracic vertebral pressure co-contraction of the abdomen applied manual pressure Dosimetry- 5 repetitions of two sets, twice a day for 2 weeks
Conventional physiotherapy will include
Pursed lip breathing
Diaphragmatic breathing
Thoracic expansion exercise
Dosimetry- 5 repetitions of two sets, twice a day for 2 weeks. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed cases of COPD.
Both Genders.
Age between 40 to 60 years.
Patient with symptoms of shortness of breath (Dyspnea).
Patient with an exacerbation of COPD.
Value of pulmonary function test below normal value FEV1 greater than equals to more 80% predicted.
|
|
| ExclusionCriteria |
| Details |
Individuals suffering from severe spine-related orthopedic issues, neurological disorders impacting the respiratory muscles, unstable cardiac conditions etc.
Patients with no additional disorder such as pneumonia, lung Carcinoma.
Patients with Multidrug Resistant for COPD.
Mentally unstable patients.
Un-cooperative patients. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pulmonary Function Test |
Two point measurements(At Day 1 and At Day 14) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Dyspnea 12 Questionnaire |
Two point measurement (At Day 1 & At Day 14) |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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
|
N/A |
|
Date of First Enrollment (India)
|
27/09/2024 |
| 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="0"
Months="6"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [shradhagupta753@gmail.com].
- For how long will this data be available start date provided 29-01-2025 and end date provided 27-12-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Not Applicable
|
|
Brief Summary
|
Chronic obstructive pulmonary disease (COPD)is a heterogeneous lung condition characterized by chronic respiratory symptoms (Dyspnea, cough, fatigue and expectoration) leads to limitation in lung airflow. The most typical symptoms of COPD are Dyspnea and fatigue which is debilitating for patients and also associated with a deterioration in their physical activity. A total of 64 patients with COPD based on inclusion criteria will be selected. Patients will be divided into 2 groups (32patients in each) by lottery method. Group A will receive Muscle energy technique and conventional physiotherapy whereas Group B will receive Neuro-physiological facilitation technique combined with conventional physiotherapy. On Day 1 Pulmonary function test (PFT) and Dyspnea-12 questionnaire (D-12) will be used as outcome measures and on the Day 14 Pulmonary function test (PFT) and Dyspnea-12 questionnaire (D-12) will be reassessed. The main goal of the treatment is to facilitate excretion of secretions.
|