combined effects of diaphragmatic breathing and thoracic kinesio taping on pulmonary functions, dyspnea, thoracoabdominal mobility and quality of life in Chronic obstructive Pulmonary Disease
To determine Combined Effects of diaphragmatic breathing and Thoracic Kinesio Taping on Pulmonary functions, dyspnea, Thoracoabdominal mobility and quality of life in mild to moderate COPD Chronic Obstructive Pulmonary Disease patients .
Design
Two parallel group ,single blinded ,Randomized Controlled Trial with pre and post assessment
Settings and conduct
Pulmonology ward : Ittefaq hospital Lahore
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
●Mild to moderate level COPD patients
●Both male and female gender
●Age between 40-60 years
●Vitally stable patient
●Individuals with no prior experience with thoracic Kinesio taping
Exclusion Criteria:
● Participants with unstable medical conditions (e.g., cardiovascular instability)
● Individuals with cognitive impairments
●Pregnant women
● Participants with known allergies to tape
● Participants with known respiratory conditions other than COPD
● Diabetic patients
Intervention groups
Thoracic Kinesio Taping along with diaphragmatic breathing
Main outcome variables
• Dyspnea 12 Questionnaire will be used to assess change in Dyspnea
• Digital Spirometer will be used to assess Pulmonary functions changes
• St. George's Respiratory Questionnaire for COPD pauients (SGRQ-C) will be used to assess quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191117045462N19
Registration date:2024-07-23, 1403/05/02
Registration timing:prospective
Last update:2024-07-23, 1403/05/02
Update count:0
Registration date
2024-07-23, 1403/05/02
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
2024-08-15, 1403/05/25
Expected recruitment end date
2024-12-15, 1403/09/25
Actual recruitment start date
2024-08-15, 1403/05/25
Actual recruitment end date
2024-12-15, 1403/09/25
Trial completion date
2024-12-25, 1403/10/05
Scientific title
combined effects of diaphragmatic breathing and thoracic kinesio taping on pulmonary functions, dyspnea, thoracoabdominal mobility and quality of life in Chronic obstructive Pulmonary Disease
Public title
combined effects of diaphragmatic breathing and Thoracic Kinesio Taping on Pulmonary functions, dyspnea,thoracoabdominal mobility and quality of life in Chronic Obstructive Pulmonary Disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Mild to moderate level COPD patients
Both male and female gender
Age between 40-60 years
Vitally stable patient
Individuals with no prior experience with thoracic Kinesio taping
Exclusion criteria:
Participants with unstable medical conditions (e.g., cardiovascular instability)
Individuals with cognitive impairments
Pregnant women
Participants with known allergies to tape
Participants with known respiratory conditions other than COPD
Diabetic patients
Age
From 40 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Sample size
Target sample size:
74
Actual sample size reached:
74
Randomization (investigator's opinion)
Randomized
Randomization description
Taking into account the aforementioned inclusion and exclusion criteria patients will be divided into two groups by convenient sampling and allocated to 2 groups by simple randomization process by sealed opaque envelope method and labeled as 0 for group A and 1 for group B.
Blinding (investigator's opinion)
Single blinded
Blinding description
Investigator will be blind.Assesment 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
25 Raza Saeed Rd, Bhabra Block M Gulberg III, Lahore, Punjab
Experimental group will receive thoracic kinesio taping and diaphragmatic breathing exercises.Diaphragmatic breathing exercises will be performed by assuming flat position. Be sure to flex your knees and support your head.• Put one hand over your breastbone in the center of your chest, and the other just below your rib.Take a calm, deep breath in through your nose.• Squeeze out with your lips pursed and tense the muscles directly beneath your ribs.• Advice: Tighten your muscles while using the hand you placed below your ribs to gently push in and up. • Participant will be scheduled to attend 20 treatment sessions (5 sessions every week for 4 weeks,35 minutes each session)Assessment will be done on 0 weeks, 2nd week, and 4th week• Thoracic Kinesio Taping will be performed by this process :The material to be used for thoracic KT application will be 100% cotton, latex-free, 5-cm wide, elastic tape. Patients will be instructed to sit upright on an armless chair with no back support, with knees flexed to 90 degrees, feet on the floor and arms relaxed. Kinesio tape will be applied anteriorly and posteriorly to facilitate respiratory muscles (primarily diaphragm) along the subcostal area. Anteriorly, the base point of an “I” shaped kinesio tape will be applied on xiphoid process with 50-75% tension only on the linea alba and the tails of the tape will be applied towards subcostal curvature with no tension. Posteriorly, a second “I” shaped kinesio tape will be applied from the back. The base point of the tape will be applied on the projection of 12th Thoracic vertebra with 50-75% tension and the tails will be applied toward the ribs without any tension. Additionally, two more kinesio tapes will be applied to upper trapezius area which lies between neck and acromion at both sides (left and right).• Patient will be taped for about 48 hours• Participant will be scheduled to attend 12 treatment sessions (3 sessions every week for 4 weeks, 35mints each session)• Assessment will be done on 0-week, 2nd week, and 4th week. Treatment evaluation will be done by measuring severity of dyspnea by dyspnea-12 scale,quality of life will be measured by st. george questionnaire and pulmonary function by spirometry.
Category
Rehabilitation
2
Description
Control group: will receive diaphragmatic breathing exercises.Diaphragmatic breathing exercises will be performed by assuming flat position. Be sure to flex your knees and support your head.• Put one hand over your breastbone in the center of your chest, and the other just below your rib.Take a calm, deep breath in through your nose.• Squeeze out with your lips pursed and tense the muscles directly beneath your ribs.• Advice: Tighten your muscles while using the hand you placed below your ribs to gently push in and up. • Participant will be scheduled to attend 20 treatment sessions (5 sessions every week for 4 weeks,35 minutes each session)Assessment will be done on 0 weeks, 2nd week, and 4th week• Treatment evaluation will be done by measuring severity of dyspnea by dyspnea-12 scale,quality of life will be measured by st. george questionnaire and pulmonary function by spirometry.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Riphah College of Rehab & Allied health sciences
Full name of responsible person
Riphah College of Rehab & Allied health sciences
Street address
25 Raza Saeed Rd, Bhabra Block M Gulberg III, Lahore, Punjab
City
Lahore
Postal code
54000
Phone
+92 42 35126110
Email
arfamin87@gmail.com
2
Recruitment center
Name of recruitment center
Riphah College of Rehab &Allied health science
Full name of responsible person
Arfa Amin
Street address
25 Raza Saeed Rd, Bhabra Block M Gulberg III, Lahore, Punjab
City
Lahore
Postal code
54000
Phone
+92 42 35126112
Email
arfamin87@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Riphah international university
Full name of responsible person
Wajeeha
Street address
25 Raza Saeed Rd, Bhabra Block M Gulberg III, Lahore, Punjab
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
Arfa Amin
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
25 Raza Saeed Rd, Bhabra Block M Gulberg III, Lahore, Punjab
City
Lahore
Province
Punjab
Postal code
54000
Phone
803000720844
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
25 Raza Saeed Rd, Bhabra Block M Gulberg III, Lahore, Punjab
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 35126102
Email
wajeeha_z@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Riphah international university
Full name of responsible person
Arfa Amin
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
25 Raza Saeed Rd, Bhabra Block M Gulberg III, Lahore, Punjab
City
Lahore
Province
Punjab
Postal code
54660
Phone
803000720844
Email
wajeeha_z@yahoo.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