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Clinical Trials/NCT05335304
NCT05335304
Unknown
Not Applicable

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.

Muğla Sıtkı Koçman University0 sites65 target enrollmentApril 18, 2022
ConditionsCOPD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COPD
Sponsor
Muğla Sıtkı Koçman University
Enrollment
65
Primary Endpoint
Respiratory muscle morphology
Last Updated
4 years ago

Overview

Brief 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. 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.

Registry
clinicaltrials.gov
Start Date
April 18, 2022
End Date
May 15, 2023
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Muğla Sıtkı Koçman University
Responsible Party
Principal Investigator
Principal Investigator

Emine Korkmaz

physiotherapist

Muğla Sıtkı Koçman University

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • COPD and Asthma Fatigue Scale(Change in fatigue score at 6 week)
  • COPD Assessment Test (CAT)(Change in healty status at 6 week)
  • Static and dynamic lung volumes Pulmonary Function Tests(Change in lung volumes at 6 week.)
  • Modified Borg Scale(Change in dyspnea at 6 week)
  • Posture analysis(Change in posture at 6 week)
  • Modified Medical Research Council(Change in perception of dyspnea at 6 week)
  • Chest anterior-posterior diameter measurement(Change in chest diameter at 6 week)

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