To compare the effects of Manual Diaphragm Manipulation and Diaphragm Release Technique on pulmonary functions, dyspnea, chest expansion and exercise capacity in COPD.
Design
60 participants will be recruited. Two parallel groups, double blinded, randomized clinical trial with pre and post assessment.
Settings and conduct
Pulmonology ward, Saleem Memorial Hospital Lahore
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Patients with COPD according to the GOLD criteria,
Age ranged from 45-65 years
Moderate COPD (50% <Forced expiratory volume in first second "FEV1"<80%, Forced expiratory volume in first second per forced vital capacity FEV1/FVC <70% of predicted reversible airway obstruction)
Person who is not involved in any rehabilitation program at least 4 months prior to the study
No recent infectious exacerbations for the 2 months preceding the study
Exclusion Criteria:
History of gastroesophageal reflux of any degree
Persistent hiccups within the previous three months
History of serious injury to the spine or thorax, including costal or spinal fractures or history of diaphragm surgery
Receiving long-term oxygen therapy
Patients with unstable hemodynamic parameters (HR, BP, Cardiac output and Stroke volume)
Patients who have undergone recent cardiothoracic or abdominal surgery
Patients with a recent history of chest wall or abdominal trauma
History of psychiatric illness
Intervention groups
Group A: It will be treated by Manual Diaphragm Manipulation
Group B: It will be treated with Diaphragm Release Technique
Main outcome variables
Dyspnea measured using Modified Medical Research Council (MMRC) scale, Chest Expansion measured using Measuring tape, Pulmonary Function Tests using Diagnostic Spirometer and Exercise capacity with Six Minute Walk Test (6MWT)
General information
Reason for update
Acronym
Effects Of Manual Diaphragm Manipulation And Diaphragm Release In COPD
IRCT registration information
IRCT registration number:IRCT20191117045462N20
Registration date:2024-07-27, 1403/05/06
Registration timing:retrospective
Last update:2024-07-27, 1403/05/06
Update count:0
Registration date
2024-07-27, 1403/05/06
Registrant information
Name
Wajeeha Zia
Name of organization / entity
Riphah International University
Country
Pakistan
Phone
+92 42 35126110
Email address
wajeeha_z@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-16, 1403/04/26
Expected recruitment end date
2024-07-16, 1403/04/26
Actual recruitment start date
2024-07-16, 1403/04/26
Actual recruitment end date
2024-07-16, 1403/04/26
Trial completion date
2024-07-16, 1403/04/26
Scientific title
Effects of Manual Diaphragm Manipulation and Diaphragm Release Technique in COPD
Public title
Effects of Manual Diaphragm Manipulation and Diaphragm Release Technique in COPD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with COPD according to the GOLD criteria
Age ranged from 45-65 years
Moderate COPD (50% <Forced expiratory volume in first second "FEV1"<80%, Forced expiratory volume in first second per forced vital capacity FEV1/FVC <70% of predicted reversible airway obstruction)
Person who is not involved in any rehabilitation program at least 4 months prior to the study
No recent infectious exacerbations for the 2 months preceding the study
Exclusion criteria:
History of gastroesophageal reflux of any degree
Persistent hiccups within the previous three months
History of serious injury to the spine or thorax, including costal or spinal fractures or history of diaphragm surgery
Receiving long-term oxygen therapy
Patients with unstable hemodynamic parameters (HR, BP, Cardiac output and Stroke volume)
Patients who have undergone recent cardiothoracic or abdominal surgery
Patients with a recent history of chest wall or abdominal trauma
History of psychiatric illness
Age
From 45 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Taking into account the above mentioned inclusion and exclusion criteria, patients will be recruited into two groups labeled as 0 for group A and 1 for group B by simple random sampling through sealed opaque enveloped
Blinding (investigator's opinion)
Double blinded
Blinding description
The assessor physiotherapist and the patient both will be blinded. Although the consent form will be taken from the patient. But the patient will not be aware of the study. Accessor physiotherapist will be involved in the study. He or She must have 2 or 3 year experience in relevant domain. He will access the patient by defined outcome measure tools before the start of study at the end.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Riphah college of rehabilitation & Allied Health Sciences
Street address
25 Raza Saeed Rd, Bhabra Block M Gulberg III, Lahore, Punjab 25-M Block, Lahore
City
Lahore
Postal code
54660
Approval date
2024-07-16, 1403/04/26
Ethics committee reference number
RCS&AHS/REC/MS-CPPT
Health conditions studied
1
Description of health condition studied
Chronic Obstructive Pulmonary Disease
ICD-10 code
J44.8
ICD-10 code description
Chronic bronchitis
Primary outcomes
1
Description
Pulmonary function
Timepoint
Pre- Post Treatment
Method of measurement
Spirometer ( Diagnostic)
2
Description
Dyspnea
Timepoint
Pre- Post Treatment
Method of measurement
Modified Medical Research Council Scale (MMRC)
3
Description
Chest expansion
Timepoint
Pre- Post Treatment
Method of measurement
Measuring Tape
4
Description
Exercise capacity
Timepoint
Pre- Post Treatment
Method of measurement
Six Minute Walk Test (6MWT)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group A: Manual Diaphragm Manipulation: Manual Diaphragm Manipulation will be performed four days a week on a regular basis for four weeks. Each session will consist of three sets of four repetitions, with a two minute break in between each set. Patient will be in supine position۔ Therapist positioned at the head side of the patient ۔ The therapist’s forearms will aligned towards the patient shoulders. Therapist made manual contact with the hypothenar region and the last three fingers bilaterally on the underside of the seventh to tenth rib costal cartilages. During the inspiratory phase, the therapist gently pulled the points of contact with both hands in the direction of the head and slightly laterally, facilitating the elevation of the ribs. During exhalation, the therapist deepened the contact towards the inner costal margin, maintaining resistance. In the subsequent respiratory cycles, the therapist further deepened the contact inside the costal margin, adjusting it at specific points to ensure proper technique and effectiveness.
Category
Rehabilitation
2
Description
Intervention group B: Diaphragm Release Technique: Diaphragm release techniques focus on stretching and mobilizing the diaphragm muscle to enhance its flexibility and function. This can include stretching exercises such as Breath-hold Stretch، side stretch، seated diaphragmatic stretch، deep breathing and other therapeutic interventions aimed at improving diaphragmatic excursion and respiratory efficiency. The diaphragm release technique will be performed four days a week, with a rest period of two minutes in between each set of three sets of four repetitions. Every patient will be instructed to breathe as deeply and quietly as possible throughout the sessions, and they will all be attentively watched to look for any indicators that could compromise the study's ongoing continuity.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Saleem Memorial Hospital Lahore
Full name of responsible person
Rubab khalid
Street address
Satluj Block Green Forts 2, Lahore, Punjab
City
Lahore
Postal code
54660
Phone
+92 42 34509999
Email
rubabkhalid51@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Riphah International University
Full name of responsible person
Wajeeha Zia
Street address
25 Raza Saeed Rd, Bhabra Block M Gulberg III, Lahore, Punjab 25-M Block, Lahore
City
Lahore
Postal code
54660
Phone
+92 42 111 747 424
Email
wajeeha_z@yahoo.com
Grant name
Nill
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Riphah International University
Proportion provided by this source
15
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Muhammad Umer Arshad
Position
Vice Principal-Allied Health Sciences-Diploma Courses, Avicenna Medical College and Hospital Lahore.
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
EXPERT CONSULTANT CLINIC 627, Khayaban e Jinnah, Iqbal Avenue Cooperative Housing Society - Phase 1, Airline Society, Lahore Punjab.
City
Lahore
Province
Punjab
Postal code
57600
Phone
+92 42 111 747 424
Email
omerkhushi0101@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Wajeeha Zia
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
25 Raza Saeed Rd, Bhabra Block M Gulberg III, Lahore, Punjab 25-M Block, Lahore
City
Lahore
Province
Punjab
Postal code
54660
Phone
+92 42 111 747 424
Email
wajeeha_z@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Rubab Khalid
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
25 Raza Saeed Rd, Bhabra Block M Gulberg III, Lahore, Punjab 25-M Block, Lahore
City
Lahore
Province
Punjab
Postal code
54660
Phone
+92 42 111 747 424
Email
rubabkhalid51@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available