COPDNCT03496376
Effects of Thoracic Kinesio Taping on COPD Patients
A study testing Kinesio Taping and Deep Breathing Exercises in people with COPD, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study was to investigate the effect of kinseio taping on functional capacity, pulmonary functions, respiratory muscle strength, severity of dyspnea, severity of fatigue in Chronic Obstructive Pulmonary Disease (COPD). Assessment of patients was done baseline and 6th week. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- COPD
- What is being tested?
- Kinesio Taping and Deep Breathing Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 May 2017to 7 Jun 2018
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 40 years and older,
- having stage II-III COPD diagnosis according to GOLD system and BODE Index by chest physician,
- unwilling to participate in any kind of pulmonary rehabilitation program for COPD,
- able to read, write, and understand Turkish; and
- willing and able to attend the study.
Who cannot join
- being in COPD exacerbation period,
- having neurological or musculoskeletal problems that would affect physical mobility,
- having unstable, severe heart disease(s) (heart failure, unstable hypertension, previous angina pectoris or myocardial infarction, heart valve problems),
- having scar, lesion or incision in the area of kinesio tape application,
- previous use of kinesio tape,
- having skin sensitivity against kinesio tape,
- malignancy,
- having mental and cognitive disorders that would affect cooperation.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dokuz Eylül Üniversitesi School of Physical Therapy and Rehabilitation
Izmir, 35340
About this study
Official title: Effects of Thoracic Kinesio Taping on Pulmonary Functions, Respiratory Muscle Strength and Functional Capacity in COPD Patients
The purpose of this study was to investigate the effect of kinseio taping on functional capacity, pulmonary functions, respiratory muscle strength, severity of dyspnea, severity of fatigue in Chronic Obstructive Pulmonary Disease (COPD). Assessment of patients was done baseline and 6th week.
Eligible patients for the study randomly allocated to Kinesio Taping Group (KTG), or Control Group (CG). Both groups received three different deep breathing exercises (diaphragmatic, thoracic, and lateral basal), each consisting of three sets of 10 repetitions, with 30 seconds of rest between each set. KTG also received thoracic kinesio taping application.
- Conditions
- COPD
- Being tested
- Kinesio Taping, Deep Breathing Exercises
- Keywords
- kinesio taping, COPD, functional capacity, pulmonary functions, pulmonary rehabilitation
- 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.
Kinesio TapingOther
The material used for thoracic kinesio taping application was Kinesio® Tex Gold™ (Kinesio Holding. Patients were 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 was applied anteriorly and posteriorly to facilitate respiratory muscles (primarily diaphragm) along the subcostal area. Additionally, two more kinesio tapes were applied to upper trapezius and scalene muscles' area which lies between neck and acromion at both sides (left and right).
Deep Breathing ExercisesOther
Three different deep breathing exercises (diaphragmatic, thoracic, and lateral basal), each consisting of three sets of 10 repetitions, with 30 seconds of rest between each set.
| Study group | Role | What they receive |
|---|---|---|
| Kinesio Taping Group | Experimental | Kinesio Taping Group received three different deep breathing exercises (diaphragmatic, thoracic, and lateral basal), each consisting of three sets of 10 repetitions, with 30 seconds of rest between each set plus thoracic kinesio taping application. Receives: Other: Kinesio Taping; Other: Deep Breathing Exercises |
| Control Group | Active comparator | Control Group received three different deep breathing exercises (diaphragmatic, thoracic, and lateral basal), each consisting of three sets of 10 repetitions, with 30 seconds of rest between each set. Receives: Other: Deep Breathing Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in functional capacity
Six-minute walk test (6MWT) is a valid, reliable and useful test for assessing functional capacity of COPD patients. This test assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance.
Measured: Baseline, 6th week
Secondary outcomes (4)
Change in pulmonary functions
Pulmonary function test (PFT) is a generic term used to indicate a battery of studies or maneuvers that may be performed using standardized equipment to measure lung function.
Measured: Baseline, 6th week
Change in respiratory muscle strength
Measurement of respiratory muscle strength is useful in order to detect respiratory muscle weakness and to quantify its severity. Respiratory muscle strength is assessed by mouth pressures sustained for 1 s during maximaş static manoeuvre against a closed shutter.
Measured: Baseline, 6th week
Change in severity of dyspnoea
Modified Medical Research Council (mMRC) dyspnea scale is a valid and reliable test for measuring the severity of dyspnea of COPD patients. This scale ranges from 0 to 4. A higher value represents a worse outcome.
Measured: Baseline, 6th week
Change in severity of fatigue
Modified Borg Scale (MBS) is a useful scale for severity of fatigue. This scale ranges from 0 to 10. A higher value represents a worse outcome (0=not at all, 10=maximal).
Measured: Baseline, 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start2 May 2017
- Primary completion31 May 2018
- Study completion7 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- 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
- Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murat TOMRUK, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03496376
- Sponsor's protocol ID
- 1925-GOA
- Status last verified
- Jul 2018
- First submitted
- 26 Mar 2018
- Last updated
- 24 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Thoracic Kinesio Taping on Pulmonary Functions, Respiratory Muscle Strength and Functional Capacity in COPD Patients
- ClinicalTrials.gov ID
- NCT03496376
- Acronym / sponsor ID
- 1925-GOA
- Conditions
- COPD
- Keywords
- kinesio taping, COPD, functional capacity, pulmonary functions, pulmonary rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 2 May 2017 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 7 Jun 2018 (actual)
- First posted
- 12 Apr 2018 (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.
The purpose of this study was to investigate the effect of kinseio taping on functional capacity, pulmonary functions, respiratory muscle strength, severity of dyspnea, severity of fatigue in Chronic Obstructive Pulmonary Disease (COPD). Assessment of patients was done baseline and 6th week.
Eligible patients for the study randomly allocated to Kinesio Taping Group (KTG), or Control Group (CG). Both groups received three different deep breathing exercises (diaphragmatic, thoracic, and lateral basal), each consisting of three sets of 10 repetitions, with 30 seconds of rest between each set. KTG also received thoracic kinesio taping application.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kinesio Taping Group | Experimental | Other: Kinesio Taping, Other: Deep Breathing ExercisesKinesio Taping Group received three different deep breathing exercises (diaphragmatic, thoracic, and lateral basal), each consisting of three sets of 10 repetitions, with 30 seconds of rest between each set plus thoracic kinesio taping application. |
| Control Group | Active comparator | Other: Deep Breathing ExercisesControl Group received three different deep breathing exercises (diaphragmatic, thoracic, and lateral basal), each consisting of three sets of 10 repetitions, with 30 seconds of rest between each set. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- aged 40 years and older,
- having stage II-III COPD diagnosis according to GOLD system and BODE Index by chest physician,
- unwilling to participate in any kind of pulmonary rehabilitation program for COPD,
- able to read, write, and understand Turkish; and
- willing and able to attend the study.
Key exclusion criteria (8 listed)
- being in COPD exacerbation period,
- having neurological or musculoskeletal problems that would affect physical mobility,
- having unstable, severe heart disease(s) (heart failure, unstable hypertension, previous angina pectoris or myocardial infarction, heart valve problems),
- having scar, lesion or incision in the area of kinesio tape application,
- previous use of kinesio tape,
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 |
|---|---|---|
| Kinesio TapingThe material used for thoracic kinesio taping application was Kinesio® Tex Gold™ (Kinesio Holding. Patients were 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 was applied anteriorly and posteriorly to facilitate respiratory muscles (primarily diaphragm) along the subcostal area. Additionally, two more kinesio tapes were applied to upper trapezius and scalene muscles' area which lies between neck and acromion at both sides (left and right). | Other | Kinesio Taping Group |
| Deep Breathing ExercisesThree different deep breathing exercises (diaphragmatic, thoracic, and lateral basal), each consisting of three sets of 10 repetitions, with 30 seconds of rest between each set. | Other | Control Group, Kinesio Taping Group |
Primary outcome
Change in functional capacity
Time frame: Baseline, 6th week
Six-minute walk test (6MWT) is a valid, reliable and useful test for assessing functional capacity of COPD patients. This test assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance.
4 secondary outcomes
Change in pulmonary functions
Time frame: Baseline, 6th week
Change in respiratory muscle strength
Time frame: Baseline, 6th week
Change in severity of dyspnoea
Time frame: Baseline, 6th week
Change in severity of fatigue
Time frame: Baseline, 6th week
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 24 Jul 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesio Taping and Deep Breathing Exercises in people with COPD, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
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 8 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 24 Jul 2018. 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 Turkey (Türkiye). 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?
Change in functional capacity (time frame: Baseline, 6th week). 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 24 Jul 2018.