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Effects of Kinesiotaping Technique on Lung Function & Functional Capacity of Chronic Obstructive Lung Disease Patients (COPD)

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
KT
Standardized physiotherapy protocol
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic Obstructive Pulmonary Disease, Functional capacity, Pulmonary function, Thoracic Kinesiotaping

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed patients of COPD falling in stage I-III according to The Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria.
  • GOLD 1 -mild: Forced Expiratory Volume in 1 sec (FEV1) ≥80%, GOLD 2 - moderate: 50% ≤ FEV1 <80% predicted and GOLD 3 - severe: 30% ≤ FEV1 <50% predicted
  • Age between 40-70 years.
  • Both genders
  • Volunteering to participate in study

Exclusion Criteria:

  • COPD exacerbation within last 4 weeks
  • Allergic reaction to the taping material,
  • Patients with recent chest wall trauma, surgery, deformity having scar, lesion, or incision in area of KT application.
  • Uncontrolled arterial hypertension and diabetes mellitus.
  • Patients with neurological, musculoskeletal, cardiac, pulmonary disease with physical impairment and history of psychiatric illness

Sites / Locations

  • Pak Medical Center Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Kinesio taping muscle facilitation technique along with standardized physiotherapy protocol

Standardized physiotherapy protocol

Arm Description

On the diaphragmatic muscle, muscle facilitation technique will be applied from proximal to distal with 10-15% tension when the participant is standing and exhaled out and the body is in extension. The base of the tape will be about 1 inch below the xiphoid area. Then the one tail of tape applied with 10% tension on the rib cage with maximum deep inspiration followed by expiration and the other tail of tape will be applied to the subcostal area in forward bending position while taking deep breath with arms adduct and being crossed. The tape will be changed on every fifth day and assessment will be done at baseline and 2nd week of intervention Total number of sessions: 3

Pursed lip breathing exercise: Patient instructed to breathe through nose and inspiration should be slowly and expiration is done through mouth by pursing the lips slowly such that if flame is held in front, then the flame should be bended but not blow off. 3 sets a day for 15 days. Diaphragmatic breathing exercise: Patient sitting comfortably, with knees bent and shoulders, head and neck relaxed. Patient will be instructed to place one hand on upper chest and the other just below your rib cage. Breathe in slowly through nose so that stomach moves out against your hand. 3 sets a day for 15 days. Deep breathing exercise: Patient instructed to take "slow and deep breaths, inhaling through the nose and exhaling through the mouth". Participant is asked to place their hand on their abdomen and expand their abdomen to lift their hand during inhalation. 3 sets a day for 15 days.

Outcomes

Primary Outcome Measures

Peak expiratory flow rate (PEFR) Peak expiratory flow rate (PEFR)
Peak expiratory flow rate (PEFR) Peak expiratory flow rate (PEFR) measured through digital spirometer. Peak Expiratory Flow Rate (PEFR) measured through digital spirometer. Three zones of measurement are commonly used to interpret peak flow rates. Normal value of PEFR is (80-100%). Green zone indicates 80 to 100 percent of the usual or normal peak flow reading, yellow zone indicates 50 to 79 percent of the usual or normal peak flow readings, and red zone indicates less than 50 percent of the usual or normal peak flow readings. Changes in PEFR from baseline to 5th and after 15th day of intervention will be assessed.
Forced vital capacity (FVC)
Forced vital capacity (FVC) measured through digital spirometer. If the value of FVC is within 80% of the reference value, the results are considered normal. Changes in FVC from baseline to 5th and after 15th day of intervention will be assessed.
Forced expiratory volume in 1sec (FEV1)
Forced expiratory volume in 1sec (FEV1) measured through digital spirometer. If the value of FEV1 is within 80% of the reference value, the results are considered normal. Changes in FEV1 from baseline to 5th and after 15th day of intervention will be assessed.
FVC/FEV1
FVC/FEV1 measured through digital spirometer. The normal value for the FEV1/FVC ratio is 70% (and 65% in persons older than age 65). Changes in FVC/FEV1 from baseline to 5th and after 15th day of intervention will be assessed.
Six-minute walk test (6MWT)
The six-minute walk test (6MWT) is a submaximal exercise test for assessing physical functional capacity in patients with COPD. It is a test that measures how far a person can walk in 6 minutes. Changes in 6MWT from baseline to 5th and after 15th day of intervention will be assessed.
Modified Medical Research Council Dyspnea Scale (mMRC)
The mMRC dyspnea score is a 5-point (0-4) scale based on the severity of dyspnea. 0, no breathlessness except on strenuous exercise and and 4, too breathless to leave the house, or breathless when dressing or undressing. Changes in mMRC scale from baseline to 5th and after 15th day of intervention will be assessed.

Secondary Outcome Measures

Craniovertebral angle (CVA)
CVA is measured by taking 2 lateral photographs of the subject in a relaxed seated position without a back support. Spinous process of C7 and the tragus of ear are marked with a body marker. A horizontal line is drawn passing through C7 making a right angle with the vertical. Then, the angle between the line connecting C7 spinous process with the tragus of the ear and the horizontal line, is measured using goniometer. Craniovertebral angle of less than 50 degrees while standing is commonly considered forward head posture. It will be assessed from baseline to 5th day and after 15th day of intervention.

Full Information

First Posted
February 20, 2022
Last Updated
February 28, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05258175
Brief Title
Effects of Kinesiotaping Technique on Lung Function & Functional Capacity of Chronic Obstructive Lung Disease Patients
Acronym
COPD
Official Title
Effects of Thoracic Kinesiotaping on Pulmonary Function and Functional Capacity of COPD Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
September 15, 2022 (Actual)
Primary Completion Date
December 15, 2022 (Actual)
Study Completion Date
December 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is designed to determine the effects of diaphragmatic kinesiotaping (KT) facilitation technique on pulmonary function, functional capacity and forward head posture of chronic obstructive lung diseases (COPD) patients. The application of KT as an adjunct to conventional protocol in COPD patients if proven effective can enhance the symptom control in COPD patients for improving lung function, posture reducing the perception of dyspnea as well as improving functional capacity.
Detailed Description
The Global Initiative for Chronic Obstructive Lung Disease 2019 report defines Chronic Obstructive Pulmonary Disorders (COPD) as a "common, preventable and treatable disease that is characterized by persistent respiratory symptoms and airflow limitation that is due to airway or alveolar abnormalities, usually caused by significant exposure to noxious particles or gases". COPD is one of the leading causes of morbidity and mortality and will become the third leading cause of death and the fifth commonest cause of disability in the world. The airway obstruction in COPD cause mechanical disadvantage and increased respiratory work and dyspnea symptoms, limitations in exercise, and reduced Physical Activity Level. Patients with COPD experience muscle wasting particularly of skeletal muscle and also shortens the length of inspiratory muscles, particularly the diaphragm, resulting in functional muscle dysfunction and weakness which then results in a reduction in functional capacity, quality of life. Different managements for COPD are provided in the literature, which includes bed rest, pharmacological therapy, oxygen therapy, and physical therapy. Physical therapy management include breathing exercises and early mobilization to restore or maintain muscle function in COPD stages. Kinesiotaping is relatively new band aid method used worldwide for the treatment of musculoskeletal disorder symptoms. Kinesiotaping applied on certain region stimulate proprioceptive awareness and re educate the patient to adopt its normal posture during their normal life activity and thus normalize the muscles overactivity in the patients. KT is said to promote the respiratory muscle activation specifically the diaphragm muscle and also reduce the tension on muscle.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Chronic Obstructive Pulmonary Disease, Functional capacity, Pulmonary function, Thoracic Kinesiotaping

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
single
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Kinesio taping muscle facilitation technique along with standardized physiotherapy protocol
Arm Type
Experimental
Arm Description
On the diaphragmatic muscle, muscle facilitation technique will be applied from proximal to distal with 10-15% tension when the participant is standing and exhaled out and the body is in extension. The base of the tape will be about 1 inch below the xiphoid area. Then the one tail of tape applied with 10% tension on the rib cage with maximum deep inspiration followed by expiration and the other tail of tape will be applied to the subcostal area in forward bending position while taking deep breath with arms adduct and being crossed. The tape will be changed on every fifth day and assessment will be done at baseline and 2nd week of intervention Total number of sessions: 3
Arm Title
Standardized physiotherapy protocol
Arm Type
Active Comparator
Arm Description
Pursed lip breathing exercise: Patient instructed to breathe through nose and inspiration should be slowly and expiration is done through mouth by pursing the lips slowly such that if flame is held in front, then the flame should be bended but not blow off. 3 sets a day for 15 days. Diaphragmatic breathing exercise: Patient sitting comfortably, with knees bent and shoulders, head and neck relaxed. Patient will be instructed to place one hand on upper chest and the other just below your rib cage. Breathe in slowly through nose so that stomach moves out against your hand. 3 sets a day for 15 days. Deep breathing exercise: Patient instructed to take "slow and deep breaths, inhaling through the nose and exhaling through the mouth". Participant is asked to place their hand on their abdomen and expand their abdomen to lift their hand during inhalation. 3 sets a day for 15 days.
Intervention Type
Other
Intervention Name(s)
KT
Intervention Description
Kinesio tapping will be applied in three session and it will be changed on every fifth day in total 15 days.
Intervention Type
Other
Intervention Name(s)
Standardized physiotherapy protocol
Intervention Description
3 sets with five repetitions per day for total of 15 days.
Primary Outcome Measure Information:
Title
Peak expiratory flow rate (PEFR) Peak expiratory flow rate (PEFR)
Description
Peak expiratory flow rate (PEFR) Peak expiratory flow rate (PEFR) measured through digital spirometer. Peak Expiratory Flow Rate (PEFR) measured through digital spirometer. Three zones of measurement are commonly used to interpret peak flow rates. Normal value of PEFR is (80-100%). Green zone indicates 80 to 100 percent of the usual or normal peak flow reading, yellow zone indicates 50 to 79 percent of the usual or normal peak flow readings, and red zone indicates less than 50 percent of the usual or normal peak flow readings. Changes in PEFR from baseline to 5th and after 15th day of intervention will be assessed.
Time Frame
15 days
Title
Forced vital capacity (FVC)
Description
Forced vital capacity (FVC) measured through digital spirometer. If the value of FVC is within 80% of the reference value, the results are considered normal. Changes in FVC from baseline to 5th and after 15th day of intervention will be assessed.
Time Frame
15 days
Title
Forced expiratory volume in 1sec (FEV1)
Description
Forced expiratory volume in 1sec (FEV1) measured through digital spirometer. If the value of FEV1 is within 80% of the reference value, the results are considered normal. Changes in FEV1 from baseline to 5th and after 15th day of intervention will be assessed.
Time Frame
15 days
Title
FVC/FEV1
Description
FVC/FEV1 measured through digital spirometer. The normal value for the FEV1/FVC ratio is 70% (and 65% in persons older than age 65). Changes in FVC/FEV1 from baseline to 5th and after 15th day of intervention will be assessed.
Time Frame
15 days
Title
Six-minute walk test (6MWT)
Description
The six-minute walk test (6MWT) is a submaximal exercise test for assessing physical functional capacity in patients with COPD. It is a test that measures how far a person can walk in 6 minutes. Changes in 6MWT from baseline to 5th and after 15th day of intervention will be assessed.
Time Frame
15 days
Title
Modified Medical Research Council Dyspnea Scale (mMRC)
Description
The mMRC dyspnea score is a 5-point (0-4) scale based on the severity of dyspnea. 0, no breathlessness except on strenuous exercise and and 4, too breathless to leave the house, or breathless when dressing or undressing. Changes in mMRC scale from baseline to 5th and after 15th day of intervention will be assessed.
Time Frame
15 days
Secondary Outcome Measure Information:
Title
Craniovertebral angle (CVA)
Description
CVA is measured by taking 2 lateral photographs of the subject in a relaxed seated position without a back support. Spinous process of C7 and the tragus of ear are marked with a body marker. A horizontal line is drawn passing through C7 making a right angle with the vertical. Then, the angle between the line connecting C7 spinous process with the tragus of the ear and the horizontal line, is measured using goniometer. Craniovertebral angle of less than 50 degrees while standing is commonly considered forward head posture. It will be assessed from baseline to 5th day and after 15th day of intervention.
Time Frame
15 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed patients of COPD falling in stage I-III according to The Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria. GOLD 1 -mild: Forced Expiratory Volume in 1 sec (FEV1) ≥80%, GOLD 2 - moderate: 50% ≤ FEV1 <80% predicted and GOLD 3 - severe: 30% ≤ FEV1 <50% predicted Age between 40-70 years. Both genders Volunteering to participate in study Exclusion Criteria: COPD exacerbation within last 4 weeks Allergic reaction to the taping material, Patients with recent chest wall trauma, surgery, deformity having scar, lesion, or incision in area of KT application. Uncontrolled arterial hypertension and diabetes mellitus. Patients with neurological, musculoskeletal, cardiac, pulmonary disease with physical impairment and history of psychiatric illness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suman Sheraz, PhD*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pak Medical Center Hospital
City
Peshawar
State/Province
Khyber Pukhtunkhwa
ZIP/Postal Code
25000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of Kinesiotaping Technique on Lung Function & Functional Capacity of Chronic Obstructive Lung Disease Patients

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