Clinical trial NCT05335304: The Effects of Different Physiotherapy Approaches in Stable COPD Patients.
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COPD
Keywords: Taping, Muscle morphology, COPD, Pulmonary rehabilitation
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
First posted: 2022-04-19
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. People with stable COPD,
2. Patients with spirometric measurements of GOLD 2-3 according to the new GOLD classification and A, B according to symptoms and exacerbations
3. To be 18 years or older,
4. No acute exacerbation in the last 3 weeks,
5. Alterations in medical treatment and not using any antibiotics in last 3 weeks,
6. Not being included in the pulmonary rehabilitation program in the last 6 months,
7. Volunteering to participate in study

Exclusion Criteria:

1. Orthopedic and neuromuscular disorders,
2. Advanced heart failure,
3. Aortic stenosis, deep vein thrombosis, pacemaker,
4. Patients with acute exacerbation of symptoms in the previous three weeks,
5. Those with weak cognitive function will be excluded from the study.
6. Patients who are unable to cooperate will also be considered ineligible.
7. Irritation, infection, allergic reaction, scarred burn or open wound around application area.

Primary outcomes:
measure: Respiratory muscle morphology
timeFrame: Change in muscle thickness at 6 week
measure: Respiratory muscle strength
timeFrame: Change in MİP and MEP at 6 week
measure: 6-minute walk test
timeFrame: Change in distance at 6 week
measure: Leicester Cough Questionnaire
timeFrame: Change in quality of life at 6 week
Secondary outcomes:
measure: Modified Borg Scale
timeFrame: Change in dyspnea at 6 week
measure: COPD Assessment Test (CAT)
timeFrame: Change in healty status at 6 week
measure: Static and dynamic lung volumes Pulmonary Function Tests
timeFrame: Change in lung volumes at 6 week.
measure: Modified Medical Research Council
timeFrame: Change in perception of dyspnea at 6 week
measure: COPD and Asthma Fatigue Scale
timeFrame: Change in fatigue score at 6 week
measure: Posture analysis
timeFrame: Change in posture at 6 week
measure: Chest anterior-posterior diameter measurement
timeFrame: Change in chest diameter at 6 week
Other outcomes:
Locations:
Study officials:
affiliation: Muğla Sıtkı Koçman University
name: Baki Umut Tuğay
role: STUDY_CHAIR
References: