Chronic Obstructive Pulmonary DiseaseCOPDNCT05258175
Effects of Kinesiotaping Technique on Lung Function & Functional Capacity of Chronic Obstructive Lung Disease Patients
A study testing KT and Standardized physiotherapy protocol in people with Chronic Obstructive Pulmonary Disease, run by Riphah International University at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- KT and Standardized physiotherapy protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Sep 2022to 28 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Pak Medical Center Hospital
Peshawar, Khyber Pukhtunkhwa, 25000
About this study
Official title: Effects of Thoracic Kinesiotaping on Pulmonary Function and Functional Capacity of COPD Patients
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.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- KT, Standardized physiotherapy protocol
- Keywords
- Chronic Obstructive Pulmonary Disease, Functional capacity, Pulmonary function, Thoracic Kinesiotaping
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KTOther
Kinesio tapping will be applied in three session and it will be changed on every fifth day in total 15 days.
Standardized physiotherapy protocolOther
3 sets with five repetitions per day for total of 15 days.
| Study group | Role | What they receive |
|---|---|---|
| Kinesio taping muscle facilitation technique along with standardized physiotherapy protocol | Experimental | 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 Receives: Other: KT; Other: Standardized physiotherapy protocol |
| Standardized physiotherapy protocol | Active comparator | 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. Receives: Other: Standardized physiotherapy protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 days
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.
Measured: 15 days
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.
Measured: 15 days
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.
Measured: 15 days
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.
Measured: 15 days
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.
Measured: 15 days
Secondary outcomes (1)
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.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start15 Sep 2022
- Primary completion15 Dec 2022
- Study completion28 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suman Sheraz, PhD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05258175
- Sponsor's protocol ID
- Umra Ihsan
- Acronym
- COPD
- Status last verified
- Feb 2023
- First submitted
- 20 Feb 2022
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Thoracic Kinesiotaping on Pulmonary Function and Functional Capacity of COPD Patients
- ClinicalTrials.gov ID
- NCT05258175
- Acronym / sponsor ID
- COPD / Umra Ihsan
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic Obstructive Pulmonary Disease, Functional capacity, Pulmonary function, Thoracic Kinesiotaping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 28 Dec 2022 (actual)
- First posted
- 28 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kinesio taping muscle facilitation technique along with standardized physiotherapy protocol | Experimental | Other: KT, Other: Standardized physiotherapy protocolOn 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 |
| Standardized physiotherapy protocol | Active comparator | Other: Standardized physiotherapy protocolPursed 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. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KTKinesio tapping will be applied in three session and it will be changed on every fifth day in total 15 days. | Other | Kinesio taping muscle facilitation technique along with standardized physiotherapy protocol |
| Standardized physiotherapy protocol3 sets with five repetitions per day for total of 15 days. | Other | Kinesio taping muscle facilitation technique along with standardized physiotherapy protocol, Standardized physiotherapy protocol |
Primary outcome
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.
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.
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.
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.
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.
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.
1 secondary outcome
Craniovertebral angle (CVA)
Time frame: 15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suman Sheraz, PhD* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KT and Standardized physiotherapy protocol in people with Chronic Obstructive Pulmonary Disease, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak expiratory flow rate (PEFR) Peak expiratory flow rate (PEFR) (time frame: 15 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.