COPDNCT05335304
The Effects of Different Physiotherapy Approaches in Stable COPD Patients.
A study testing intervention group 1, intervention group 2 and intervention group 3 in people with COPD, run by Muğla Sıtkı Koçman University.
Trial summary
In our study, the effects of Kinesio Taping (KT), Rigid Taping (RT), Thoracic Mobilization (TM) and Core Stabilization (KS) approaches on respiratory muscle morphology, respiratory muscle strength, exercise capacity and quality of life will be examined in stable COPD patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- What is being tested?
- intervention group 1, intervention group 2 and intervention group 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- 18 Apr 2022to 15 May 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People with stable COPD,
- Patients with spirometric measurements of GOLD 2-3 according to the new GOLD classification and A, B according to symptoms and exacerbations
- To be 18 years or older,
- No acute exacerbation in the last 3 weeks,
- Alterations in medical treatment and not using any antibiotics in last 3 weeks,
- Not being included in the pulmonary rehabilitation program in the last 6 months,
- Volunteering to participate in study
Who cannot join
- Orthopedic and neuromuscular disorders,
- Advanced heart failure,
- Aortic stenosis, deep vein thrombosis, pacemaker,
- Patients with acute exacerbation of symptoms in the previous three weeks,
- Those with weak cognitive function will be excluded from the study.
- Patients who are unable to cooperate will also be considered ineligible.
- Irritation, infection, allergic reaction, scarred burn or open wound around application area.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effects of Kinesio Taping, Rigid Taping, Thoracic Mobilization and Core Stabilization Approaches on Respiratory Muscle Morphology, Respiratory Muscle Strength, Exercise Capacity and Quality of Life in Stable COPD Patients.
In our study, the effects of Kinesio Taping (KT), Rigid Taping (RT), Thoracic Mobilization (TM) and Core Stabilization (KS) approaches on respiratory muscle morphology, respiratory muscle strength, exercise capacity and quality of life will be examined in stable COPD patients. Study is designed as prospective, single-blinded, randomized-controlled study.
Read the detailed description
The study is planned to compare the effects of different physiotherapy approaches on respiratory muscle morphology, respiratory muscle strength, exercise capacity and quality of life in stable COPD patients over 18 years of age.The study is carried out on 65 patients who applied to Muğla Training and Research Hospital with COPD patients. The patients are divided into 5 groups by randomization method. First group, Kinesio Taping group, inhibitory effect on upper trapezius and scalene muscles, facilitator effect on diaphragm and intercostal muscles will be applied. The second group, Rigid Taping group, inhibitory effect on upper trapezius and scalene muscles, facilitator effect on diaphragm and intercostal muscles will be applied. The third group,Thoracic Mobilization group, Modified Active-Passive Thoracic mobilization will be performed according to the patients' conditions. Thoracic Mobilization techniques will be used to improve thoracic mobility in the upper, middle or lower parts of the chest. The fourth group,In Core Stabilization group, five different trunk stabilization exercises will be performed. Fifth group is the control group and no taping was done. A standard treatment program is applied for the individuals in the whole group. Evaluations is made before and after treatment (3 and 6 weeks). Evaluation parameters is respiratory muscle morphology, respiratory muscle strength, exercise capacity and quality of life.
The respiratory muscle morphology is measured by the radiologist, and all other measurements and treatments were performed by the physiotherapist. Pulmonary function test will be measured using spirometry, respiratory muscle strength using mouth pressure device, functional exercise capacity using 6-minute walk test, quality of life using Leicester Cough Questionnaire, dyspnea using Modified Medical Research Council Dyspnea Scale and, symptoms using COPD Assessment Tests.
The data obtain from the research will be analyzed using the SPSS program. Statistical significance level will be accepted as p<0.05. In the statistical difference analysis between groups, one-way ANOVA test will be used for parametric data and Kruskal- Wallis test will be used for non-parametric data.
- Conditions
- COPD
- Being tested
- intervention group 1, intervention group 2, intervention group 3, intervention group 4, Pulmonary Rehabilitation
- Keywords
- Taping, Muscle morphology, COPD, 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.
intervention group 1Other
Kinesio taping The intervention of this experimental study is therapeutic taping (kinesio tape) on the respiratory muscles of the participants.
intervention group 2Other
Rigid taping The intervention of this experimental study is therapeutic taping (rigid tape) on the respiratory muscles of the participants.
intervention group 3Other
Thoracic Mobilization The intervention of this experimental study is active-passive Thoracic mobilization techniques on the on the upper, middle or lower parts of the chest of the participants
intervention group 4Other
Core Stabilization The intervention of this experimental study is Core Stabilization exercises to the trunk muscles of the participants.
Pulmonary RehabilitationOther
Pulmonary Rehabilitation respiratory rehabilitation, stretching exercises, posture correction exercises
| Study group | Role | What they receive |
|---|---|---|
| intervention group 1 | Active comparator | Kinesio taping and standard treatment program Receives: Other: intervention group 1; Other: Pulmonary Rehabilitation |
| intervention group 2 | Active comparator | Rigid taping and standard treatment program Receives: Other: intervention group 2; Other: Pulmonary Rehabilitation |
| intervention group 3 | Active comparator | Thoracic Mobilization and standard treatment program Receives: Other: intervention group 3; Other: Pulmonary Rehabilitation |
| intervention group 4 | Active comparator | Core Stabilization and standard treatment program Receives: Other: intervention group 4; Other: Pulmonary Rehabilitation |
| Control group | Other | No intervention, only standard treatment program Receives: Other: Pulmonary Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory muscle morphology
Respiratory muscle morphology measurement will be made by the radiologist with the US imaging method. It will be applied to the diaphragm, intercostal muscles, upper trapezius and scalene muscles.
Measured: Change in muscle thickness at 6 week
Respiratory muscle strength
Maximum inspiratory pressure (Pimax) and maximum expiratory pressure (PEmax) will be evaluated using an electronic pressure transducer.Measurements will be made according to the guidelines of the American Thoracic Society/European Respiratory Society.
Pimax at residual volume and PEmax from Total lung capacity, Maximal inspiratory pressure will be determined by placing a nose clip instructed to exhale to residual volume followed by maximum inspiration.
To assess maximal expiratory pressure, the patient is instructed to inhale until total lung capacity is reached, followed by a forced exhalation. Three evaluations will be recorded and the best value will be used.
Measured: Change in MİP and MEP at 6 week
6-minute walk test
It will be held in a 30 m barrier-free corridor. The measurement will be made according to the guidelines of the American Thoracic Society. The 6MWT will be repeated 2 times and the result will be given as a percentage of the predicted values. Patients will rest for 30 minutes between tests and the maximum distance will be recorded.
Measured: Change in distance at 6 week
Leicester Cough Questionnaire
It consists of 19 items in 3 subcategories (physical, psychological, social) assessing the quality of life associated with chronic cough. Each question is evaluated using a 7-point Likert-type scoring system. The total score is obtained by summing the 3 sub-category scores. High scores are indicative of good quality of life.
Measured: Change in quality of life at 6 week
Secondary outcomes (7)
Modified Borg Scale
It is a scale used to evaluate the severity of dyspnea on exertion and the severity of dyspnea at rest. It consists of ten items describing the severity of dyspnea according to their degrees. 0 scales as no dyspnea, 10 as very severe dyspnea
Measured: Change in dyspnea at 6 week
COPD Assessment Test (CAT)
It was developed to measure the health status and to evaluate the disease effect and severity in COPD. The CAT consists of eight questions, covering problems such as shortness of breath, cough, sputum production, as well as symptoms such as fatigue and sleep problems. Perfect health: 0 points (minimum), worst health: 40 points. (max score)
Measured: Change in healty status at 6 week
Static and dynamic lung volumes Pulmonary Function Tests
In order to evaluate pulmonary functions, FVC, FEV1, FEV1/FVC, Peak flow rate (PEF), 25-75% (FEF 25-75%) flow rate of forced expiratory volume will be taken in sitting position according to ATS/ERS criteria. Pulmonary function test parameters will be expressed as a percentage of actual values and expected values.
Measured: Change in lung volumes at 6 week.
Modified Medical Research Council
The dyspnea scale will be used to evaluate the severity of dyspnea during activities of daily living. It will be graded from 0 (absence of dyspnea during strenuous exercise) to 4 (dyspnea during daily activities). The dyspnea perception scale will be questioned to what extent the patients have perceived dyspnea in daily activities in the last week.
Measured: Change in perception of dyspnea at 6 week
COPD and Asthma Fatigue Scale
The original scale consists of 12 items and a Likert-type scale (1=never, 2=rarely, 3=sometimes, 4=often, 5=very often) is used for responses. Scoring of the scale is in a five-point Likert type and a total value between 12 and 60 points is obtained.
Measured: Change in fatigue score at 6 week
Posture analysis
"Posture Screen Mobile" mobile application will be used via smart phone to evaluate static posture.
Measured: Change in posture at 6 week
Chest anterior-posterior diameter measurement
Rib cage measurements Anterior and posterior diameter will be measured using a caliper.
Measured: Change in chest diameter at 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start18 Apr 2022 (estimated)
- Primary completion15 Mar 2023 (estimated)
- Study completion15 May 2023 (estimated)
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
- Investigator
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Korkmaz, Muğla Sıtkı Koçman University
- Investigators
- Baki Umut Tuğay, Study chair, Muğla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05335304
- Sponsor's protocol ID
- physiotherapy approaches
- Status last verified
- Apr 2022
- First submitted
- 13 Apr 2022
- Last updated
- 19 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Kinesio Taping, Rigid Taping, Thoracic Mobilization and Core Stabilization Approaches on Respiratory Muscle Morphology, Respiratory Muscle Strength, Exercise Capacity and Quality of Life in Stable COPD Patients.
- ClinicalTrials.gov ID
- NCT05335304
- Acronym / sponsor ID
- physiotherapy approaches
- Conditions
- COPD
- Keywords
- Taping, Muscle morphology, COPD, Pulmonary rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 18 Apr 2022 (estimated)
- Primary completion
- 15 Mar 2023 (estimated)
- Study completion
- 15 May 2023 (estimated)
- First posted
- 19 Apr 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.
In our study, the effects of Kinesio Taping (KT), Rigid Taping (RT), Thoracic Mobilization (TM) and Core Stabilization (KS) approaches on respiratory muscle morphology, respiratory muscle strength, exercise capacity and quality of life will be examined in stable COPD patients. Study is designed as prospective, single-blinded, randomized-controlled study.
Detailed description
The study is planned to compare the effects of different physiotherapy approaches on respiratory muscle morphology, respiratory muscle strength, exercise capacity and quality of life in stable COPD patients over 18 years of age.The study is carried out on 65 patients who applied to Muğla Training and Research Hospital with COPD patients. The patients are divided into 5 groups by randomization method. First group, Kinesio Taping group, inhibitory effect on upper trapezius and scalene muscles, facilitator effect on diaphragm and intercostal muscles will be applied. The second group, Rigid Taping group, inhibitory effect on upper trapezius and scalene muscles, facilitator effect on diaphragm and intercostal muscles will be applied. The third group,Thoracic Mobilization group, Modified Active-Passive Thoracic mobilization will be performed according to the patients' conditions. Thoracic Mobilization techniques will be used to improve thoracic mobility in the upper, middle or lower parts of the chest. The fourth group,In Core Stabilization group, five different trunk stabilization exercises will be performed. Fifth group is the control group and no taping was done. A standard treatment program is applied for the individuals in the whole group. Evaluations is made before and after treatment (3 and 6 weeks). Evaluation parameters is respiratory muscle morphology, respiratory muscle strength, exercise capacity and quality of life.
The respiratory muscle morphology is measured by the radiologist, and all other measurements and treatments were performed by the physiotherapist. Pulmonary function test will be measured using spirometry, respiratory muscle strength using mouth pressure device, functional exercise capacity using 6-minute walk test, quality of life using Leicester Cough Questionnaire, dyspnea using Modified Medical Research Council Dyspnea Scale and, symptoms using COPD Assessment Tests.
The data obtain from the research will be analyzed using the SPSS program. Statistical significance level will be accepted as p<0.05. In the statistical difference analysis between groups, one-way ANOVA test will be used for parametric data and Kruskal- Wallis test will be used for non-parametric data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| intervention group 1 | Active comparator | Other: intervention group 1, Other: Pulmonary RehabilitationKinesio taping and standard treatment program |
| intervention group 2 | Active comparator | Other: intervention group 2, Other: Pulmonary RehabilitationRigid taping and standard treatment program |
| intervention group 3 | Active comparator | Other: intervention group 3, Other: Pulmonary RehabilitationThoracic Mobilization and standard treatment program |
| intervention group 4 | Active comparator | Other: intervention group 4, Other: Pulmonary RehabilitationCore Stabilization and standard treatment program |
| Control group | Other | Other: Pulmonary RehabilitationNo intervention, only standard treatment program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- People with stable COPD,
- Patients with spirometric measurements of GOLD 2-3 according to the new GOLD classification and A, B according to symptoms and exacerbations
- To be 18 years or older,
- No acute exacerbation in the last 3 weeks,
- Alterations in medical treatment and not using any antibiotics in last 3 weeks,
Key exclusion criteria (7 listed)
- Orthopedic and neuromuscular disorders,
- Advanced heart failure,
- Aortic stenosis, deep vein thrombosis, pacemaker,
- Patients with acute exacerbation of symptoms in the previous three weeks,
- Those with weak cognitive function will be excluded from the study.
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 |
|---|---|---|
| intervention group 1Kinesio taping The intervention of this experimental study is therapeutic taping (kinesio tape) on the respiratory muscles of the participants. | Other | intervention group 1 |
| intervention group 2Rigid taping The intervention of this experimental study is therapeutic taping (rigid tape) on the respiratory muscles of the participants. | Other | intervention group 2 |
| intervention group 3Thoracic Mobilization The intervention of this experimental study is active-passive Thoracic mobilization techniques on the on the upper, middle or lower parts of the chest of the participants | Other | intervention group 3 |
| intervention group 4Core Stabilization The intervention of this experimental study is Core Stabilization exercises to the trunk muscles of the participants. | Other | intervention group 4 |
| Pulmonary RehabilitationPulmonary Rehabilitation respiratory rehabilitation, stretching exercises, posture correction exercises | Other | Control group, intervention group 1, intervention group 2, intervention group 3, intervention group 4 |
Primary outcome
Respiratory muscle morphology
Time frame: Change in muscle thickness at 6 week
Respiratory muscle morphology measurement will be made by the radiologist with the US imaging method. It will be applied to the diaphragm, intercostal muscles, upper trapezius and scalene muscles.
Respiratory muscle strength
Time frame: Change in MİP and MEP at 6 week
Maximum inspiratory pressure (Pimax) and maximum expiratory pressure (PEmax) will be evaluated using an electronic pressure transducer.Measurements will be made according to the guidelines of the American Thoracic Society/European Respiratory Society. Pimax at residual volume and PEmax from Total lung capacity, Maximal inspiratory pressure will be determined by placing a nose clip instructed to exhale to residual volume followed by maximum inspiration. To assess maximal expiratory pressure, the patient is instructed to inhale until total lung capacity is reached, followed by a forced exhalation. Three evaluations will be recorded and the best value will be used.
6-minute walk test
Time frame: Change in distance at 6 week
It will be held in a 30 m barrier-free corridor. The measurement will be made according to the guidelines of the American Thoracic Society. The 6MWT will be repeated 2 times and the result will be given as a percentage of the predicted values. Patients will rest for 30 minutes between tests and the maximum distance will be recorded.
Leicester Cough Questionnaire
Time frame: Change in quality of life at 6 week
It consists of 19 items in 3 subcategories (physical, psychological, social) assessing the quality of life associated with chronic cough. Each question is evaluated using a 7-point Likert-type scoring system. The total score is obtained by summing the 3 sub-category scores. High scores are indicative of good quality of life.
7 secondary outcomes
Modified Borg Scale
Time frame: Change in dyspnea at 6 week
COPD Assessment Test (CAT)
Time frame: Change in healty status at 6 week
Static and dynamic lung volumes Pulmonary Function Tests
Time frame: Change in lung volumes at 6 week.
Modified Medical Research Council
Time frame: Change in perception of dyspnea at 6 week
COPD and Asthma Fatigue Scale
Time frame: Change in fatigue score at 6 week
Posture analysis
Time frame: Change in posture at 6 week
Chest anterior-posterior diameter measurement
Time frame: Change in chest diameter at 6 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
- 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.
Baki Umut Tuğay study chair
Muğla Sıtkı Koçman University
Questions about this trial
What is this clinical trial studying?
A study testing intervention group 1, intervention group 2 and intervention group 3 in people with COPD, run by Muğla Sıtkı Koçman University.
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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 19 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emine Korkmaz (5077476873, eminekorkmazfzt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory muscle morphology (time frame: Change in muscle thickness at 6 week). The study lists 4 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 19 Apr 2022.