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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05258175
Other study ID # Umra Ihsan
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 15, 2022
Est. completion date December 28, 2022

Study information

Verified date February 2023
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date December 28, 2022
Est. primary completion date December 15, 2022
Accepts healthy volunteers No
Gender All
Age group 30 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
KT
Kinesio tapping will be applied in three session and it will be changed on every fifth day in total 15 days.
Standardized physiotherapy protocol
3 sets with five repetitions per day for total of 15 days.

Locations

Country Name City State
Pakistan Pak Medical Center Hospital Peshawar Khyber Pukhtunkhwa

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
15 days
Primary 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.
15 days
Primary 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.
15 days
Primary 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.
15 days
Primary 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.
15 days
Primary 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.
15 days
Secondary 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.
15 days
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