The Effects of Different Physiotherapy Approaches in Stable COPD Patients.
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.
1 other identifier
interventional
65
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2022
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2022
CompletedStudy Start
First participant enrolled
April 18, 2022
CompletedFirst Posted
Study publicly available on registry
April 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 15, 2023
CompletedApril 19, 2022
April 1, 2022
11 months
April 13, 2022
April 13, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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.
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.
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.
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.
Change in quality of life at 6 week
Secondary Outcomes (7)
Modified Borg Scale
Change in dyspnea 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 Medical Research Council
Change in perception of dyspnea at 6 week
COPD and Asthma Fatigue Scale
Change in fatigue score at 6 week
- +2 more secondary outcomes
Study Arms (5)
intervention group 1
ACTIVE COMPARATORKinesio taping and standard treatment program
intervention group 2
ACTIVE COMPARATORRigid taping and standard treatment program
intervention group 3
ACTIVE COMPARATORThoracic Mobilization and standard treatment program
intervention group 4
ACTIVE COMPARATORCore Stabilization and standard treatment program
Control group
OTHERNo intervention, only standard treatment program
Interventions
Kinesio taping The intervention of this experimental study is therapeutic taping (kinesio tape) on the respiratory muscles of the participants.
Rigid taping The intervention of this experimental study is therapeutic taping (rigid tape) on the respiratory muscles of the participants.
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
Core Stabilization The intervention of this experimental study is Core Stabilization exercises to the trunk muscles of the participants.
Pulmonary Rehabilitation respiratory rehabilitation, stretching exercises, posture correction exercises
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Baki Umut Tuğay
Muğla Sıtkı Koçman University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- Only the investigator who perform muscle thickness and muscle morphology measurements is blinded
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- physiotherapist
Study Record Dates
First Submitted
April 13, 2022
First Posted
April 19, 2022
Study Start
April 18, 2022
Primary Completion
March 15, 2023
Study Completion
May 15, 2023
Last Updated
April 19, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share