To find out Effects of Inspiratory Muscles training in improving Dyspnea and quality
of life in moderate COPD patients during Pulmonary Rehabilitation.
Design
Two parallel group , single blinded, randomized control trial with pre and post assessment
Settings and conduct
Pulmonology Ward/Intensive Care unit Nishtar
Medical University and Hospital Multan
Participants/Inclusion and exclusion criteria
Inclusion criteria,
•Moderate cases of COPD as per Gold Criteria
•Moderate cases FEV1 =50–79
•Participants routinely visiting the OPD
•Participants with significant history of smoking
•Well controlled DM or HTN, if they have
•Age 20 to 40 years.
Exclusion criteria,
•Pregnancy
• History Of Recent Trauma/Fall Or Fracture
•Red Flags Like: Fever, Night Sweats, Malaise Etc.
• Patients Having History Of Pneumonectomy
• Lobectomy In Previous 6 Months
• Risk Of Pneumothorax/Presence Of Bulla
• Rib Fracture
• Acute Exacerbation Of COPD
• Having History Of Drug Abuse
• Unstable Cardiovascular Diseases
• Unstable Orthopedic Problems
Intervention groups
Standardized pulmonary rehabilitation program along with Inspiratory muscle training
Main outcome variables
Multidimensional Dyspnoea Profile (MDP)
•Assessment of quality of life using the SGRQ (Saint George Respiratory Questionnaire)
• Pulmonary function changes by Inspiratory capacity at rest and inspiratory capacity at the end
of the 6MWT using a portable spirometer.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191117045462N2
Registration date:2021-04-19, 1400/01/30
Registration timing:prospective
Last update:2021-04-19, 1400/01/30
Update count:0
Registration date
2021-04-19, 1400/01/30
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
2021-04-29, 1400/02/09
Expected recruitment end date
2021-06-30, 1400/04/09
Actual recruitment start date
2021-04-29, 1400/02/09
Actual recruitment end date
2021-06-30, 1400/04/09
Trial completion date
2021-07-10, 1400/04/19
Scientific title
Effects Of Inspiratory Muscles Training On Dyspnea In Moderate Chronic obstructive pulmonary disease (COPD) Patients During Pulmonary Rehabilitation
Public title
Effects Of Inspiratory Muscles Training On Dyspnea In Moderate Chronic obstructive pulmonary disease (COPD) Patients During Pulmonary Rehabilitation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Moderate cases of Chronic obstructive pulmonary disease (COPD) as per Gold Criteria
Moderate cases forced expiratory volume in 1 second ( FEV1) =50–79
Participants routinely visiting the Hospital
Participants with significant history of smoking
Well controlled Diabetes or Blood Pressure if they have
Age 20 to 40 years
Exclusion criteria:
Pregnancy History Of Recent Trauma/Fall Or Fracture
Red Flags Like: Fever, Night Sweats, Malaise etc.
Patients Having History Of Pneumonectomy
Lobectomy In Previous 6 Months
Risk Of Pneumothorax/Presence Of Bulla
Rib Fracture
cute Exacerbation Of COPD
Having History Of Drug Abuse
Unstable Cardiovascular Diseases
Unstable Orthopedic Problems
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Sample size
Target sample size:
58
Actual sample size reached:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Taking into account the above mentioned inclusion and exclusion criteria, patients will be
recruited in the study through convenient sampling technique and then will be randomly
assigned to each group through Random Sampling sealed opaque enveloped. Labeled as 1 group A and 2 for group b
Blinding (investigator's opinion)
Single blinded
Blinding description
Investigator will be blind.
Assesmnt will be done by 2nd therapist who will not be involved in treatment and data analysis.
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
13-14-C-civic center, township near Hamdard Chowk, Lahore
City
Lahore
Postal code
54000
Approval date
2642-02-16, 2020/11/27
Ethics committee reference number
RCR&AHS/REC/MS-CPPT
Health conditions studied
1
Description of health condition studied
moderate COPD patients
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
5 Times Sit to Stand Test for dyspnea
Timepoint
Pre- Post treatment
Method of measurement
London Chest Activity of Daily Living scale for daily life
Secondary outcomes
1
Description
dyspnea
Timepoint
Pre-Post Treatment
Method of measurement
Multidimensional Dyspnoea Profile (MDP)
Intervention groups
1
Description
Intervention group: Standardized pulmonary rehabilitation program along with Inspiratory muscle training
Category
Rehabilitation
2
Description
Control group: Standardized pulmonary rehabilitation program
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Riphah college of rehabilitation & Allied Health Sciences
Full name of responsible person
Riphah college of rehabilitation & Allied Health Sciences
Street address
13-14-C-civic center, township near Hamdard Chowk, Lahore
City
Lahore
Postal code
54000
Phone
+92 42 35126110
Email
mahnoorejaz76@gmail.com
Web page address
2
Recruitment center
Name of recruitment center
Riphah college of rehabilitation & Allied Health Sciences
Full name of responsible person
Mahnoor Ejaz
Street address
13-14-C-civic center, township near Hamdard Chowk, Lahore
City
Lahore
Postal code
54000
Phone
+92 42 35126110
Email
mahnoorejaz76@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Riphah International University
Full name of responsible person
Wajeeha
Street address
13-14-C-civic center, township near Hamdard Chowk, Lahore
City
Lahore
Postal code
54000
Phone
+92 42 35126110
Email
wajeeha_z@yahoo.com
Grant name
Educational
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
100
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
Mahnoor Ejaz
Position
student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
13-14-C-civic center, township near Hamdard Chowk, Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 35126110
Email
wajeeha_z@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Wajeeha
Position
Senior Lecturer
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
13-14-C-civic center, township near Hamdard Chowk, Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 35126110
Email
wajeeha_z@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Mahnoor Ejaz
Position
student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
13-14-C-civic center, township near Hamdard Chowk, Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 35126110
Email
mahnoorejaz76@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