- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05258175
Effects of Kinesiotaping Technique on Lung Function & Functional Capacity of Chronic Obstructive Lung Disease Patients (COPD)
Effects of Thoracic Kinesiotaping on Pulmonary Function and Functional Capacity of COPD Patients
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Khyber Pukhtunkhwa
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Peshawar, Khyber Pukhtunkhwa, Pakistan, 25000
- Pak Medical Center Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Kinesio taping muscle facilitation technique along with standardized physiotherapy protocol
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 |
Kinesio tapping will be applied in three session and it will be changed on every fifth day in total 15 days.
3 sets with five repetitions per day for total of 15 days.
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Active Comparator: Standardized physiotherapy protocol
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. |
3 sets with five repetitions per day for total of 15 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peak expiratory flow rate (PEFR) Peak expiratory flow rate (PEFR)
Time Frame: 15 days
|
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. |
15 days
|
Forced vital capacity (FVC)
Time Frame: 15 days
|
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. |
15 days
|
Forced expiratory volume in 1sec (FEV1)
Time Frame: 15 days
|
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. |
15 days
|
FVC/FEV1
Time Frame: 15 days
|
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. |
15 days
|
Six-minute walk test (6MWT)
Time Frame: 15 days
|
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. |
15 days
|
Modified Medical Research Council Dyspnea Scale (mMRC)
Time Frame: 15 days
|
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. |
15 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Craniovertebral angle (CVA)
Time Frame: 15 days
|
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. |
15 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Umra Ihsan
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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