Protocol summary

Study aim
To determine significant effectiveness of teach back training intervention with breathing exercises including diaphragmatic breathing , pursed lip breathing and effective cough to improve the pulmonary functions in COPD patients.
Design
Randomized Control Trial with parallel groups , Single blinded with pre and post treatment readings
Settings and conduct
Fatima Memorial Hospital, Jinnah Hospital And Services Hospital
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Age from 18 to 75 years old ,Male and Female, Diagnosed COPD with FEV1/FVC ratio <70% ,Lack of cognitive impairment ,Ability to attend training session, Clinical diagnosis of COPD confirmed by smoking history Exclusion Criteria: Long Term Bed Rest, Inability To Perform 6-minute Walk Test, Malignancy, Cardiovascular disease (Angina, MI),Stroke, Immunocompromised conditions, Cardiac and pulmonary surgical History
Intervention groups
Interventional Group(A):Teach Back training with breathing exercises along with Conventional treatment and educational session protocols among COPD patients. Control Group(B):Breathing Exercises with Conventional Training among COPD patients
Main outcome variables
Pulmonary Function Assessment using Digital Spirometry and Borg Dyspnea Scale

General information

Reason for update
Acronym
Randomized Control Trial
IRCT registration information
IRCT registration number: IRCT20191117045462N25
Registration date: 2025-04-23, 1404/02/03
Registration timing: retrospective

Last update: 2025-04-23, 1404/02/03
Update count: 0
Registration date
2025-04-23, 1404/02/03
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
2024-03-08, 1402/12/18
Expected recruitment end date
2024-07-10, 1403/04/20
Actual recruitment start date
2024-03-08, 1402/12/18
Actual recruitment end date
2024-07-10, 1403/04/20
Trial completion date
2024-07-10, 1403/04/20
Scientific title
Effects of TEACH Back Training Intervention on Pulmonary Functions in COPD Patients
Public title
Effects of TEACH Back Training Intervention on Pulmonary Functions in COPD Patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Clinically diagnosed COPD patient with long chain smoking history Diagnosed COPD with FEV1/FVC ratio <70% Ability to attend training session Lack of cognitive impairment Both Male and female 18-75 years old Individuals
Exclusion criteria:
Long Term Bed Rest Inability To Perform 6-minute Walk Test Cardiovascular Disease(Angina, Myocardial Infarction) Stroke Immunocompromised Conditions Cardiac, Pulmonary Surgery History
Age
From 18 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
  • Investigator
Sample size
Target sample size: 45
More than 1 sample in each individual
Number of samples in each individual: 45
English
Actual sample size reached: 40
More than 1 sample in each individual
Actual sample size in each individual: 40
English
Randomization (investigator's opinion)
Randomized
Randomization description
Patient will be recruited in the study through non-probability convenience sampling technique and then will be randomly assigned to each group through random sampling sealed opaque enveloped. Group 1 allocated as A and group 2 allocated as B. Half enveloped will be labeled with A and a half with labeled with B. If a patient gets the envelop with label 1 then will be in group A and if a patient gets the envelop with label 2 that will be treated as Group B
Blinding (investigator's opinion)
Single blinded
Blinding description
Investigator will be blinded .Assessment will be done by another 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
25 Raza Saeed Road,Babra Block M Gulberg 3,Lahore,Punjab 25-Block Lahore
City
Lahore
Postal code
54000
Approval date
2023-11-20, 1402/08/29
Ethics committee reference number
RCR&AHS/REC/MS-CPPT

Health conditions studied

1

Description of health condition studied
Chronic Obstructive Pulmonary Condition
ICD-10 code
J44.9
ICD-10 code description
Chronic obstructive pulmonary disease, unspecified

Primary outcomes

1

Description
Pulmonary Function Testing
Timepoint
Pre & Post Treatment
Method of measurement
Digital Spirometer

Secondary outcomes

1

Description
Dyspnea
Timepoint
Pre-Post Treatment
Method of measurement
Borg Dyspnea Scale

Intervention groups

1

Description
Intervention Group: Teach Back training with pursed lip and diaphragmatic breathing along with Conventional treatment and educational session protocols among COPD patients.3 Times/week with 10 repetitions/3 set/session/day
Category
Rehabilitation

2

Description
Control group: Recieved Conventional Treatment along with breathing exercises(Pursed lip breathing & diapgragmatic breathing).
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Riphah College of Rehabilitation & Allied Health Sciences
Full name of responsible person
Hira Nadeem Bhatti
Street address
25 Raza Saeed Road,Bhabra Block M Gulberg 3,Lahore ,Punjab 25 -Block Lahore
City
Lahore
Postal code
54000
Phone
+92 42 111 747 424
Email
wajeeha_z@yahoo.com
Web page address
https://www.riphah.edu.pk

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Riphah International University
Full name of responsible person
Wajeeha
Street address
25 Raza Saeed Road,Bhabra Block Gulberg 3,Lahore,Punjab 25-block Lahore
City
Lahore
Postal code
54000
Phone
+92 42 111 747 424
Email
wajeeha_z@yahoo.com
Web page address
https://www.riphah.edu.pk
Grant name
Educational
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
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
Wajeeha
Position
Senior Lecturer
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
25 Raza Saeed Road, Bhabra Block M Gulberg 3,Lahore,Punjab 25-Block Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 111 747 424
Email
wajeeha_z@yahoo.com
Web page address
https://www.riphah.edu.pk

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
25 Raza Saeed Road, Bhabra block M Gulberg 3,Lahore, Punjab 25-Block Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 111 747 424
Email
wajeeha_z@yahoo.com
Web page address
https://www.riphah.edu.pk

Person responsible for updating data

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
25 Raza Saeed Road, Bhabra Block M Gulberg 3,Lahore,Punjab 25-Block Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 111 747 424
Email
wajeeha_z@yahoo.com
Web page address
https://www.riphah.edu.pk

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
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