NCT04241510

Brief Summary

Study will investigate effects of two different kinesio taping techniques on pulmonary parameters of patients with COPD.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
2.2 years until next milestone

Study Start

First participant enrolled

April 20, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2022

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

6 months

First QC Date

January 22, 2020

Last Update Submit

October 31, 2022

Conditions

Keywords

Chronic Obstructive Pulmonary DiseaseMechanical CorrectionFacilitationThoracic TapingKinesio TapingRespiratory Muscle StrengthPulmonary FunctionsFunctional Exercise Capacity

Outcome Measures

Primary Outcomes (4)

  • Pulmonary Function Test

    Pulmonary functions will be evaulated in laboratory conditions. Dynamic lung volumes will be measured using standardized spirometric measurement regulations established by ATS/ERS guidelines.

    30 minutes after every application

  • Respiratory Muscle Strength

    Respiratory muscle strenght will be measured as Maximum Inspiratory Pressure \& Maximum Expiratory Pressure with MicroMPM device. Measuring procedure will be held according to ERS guidelines. Measurements will be interpreted with Black and Hyatt's references.

    30 minutes after every application

  • Functional Exercise Capacity

    Functional exercise capacity will be measured with 6-minute walk test. Cardiovascular paremeters, dyspnea, respiratory rate and fatigue will be evaulated before, during and after the test .

    30 minutes after every application

  • Dyspnea

    Dyspnea in daily living was evaluated by the Modified Medical Research Council Dyspnea Scale. The scale consists in five statements that describe almost the entire range of dyspnea from none (Grade 0) to almost complete incapacity (Grade 4). Higher scores indicates increased dyspnea perception.

    30 minutes after each application

Secondary Outcomes (1)

  • Perception of Disease

    30 minutes after each application.

Study Arms (3)

Facilitation Tape

ACTIVE COMPARATOR

Diaphragm and Intercostal muscles will be taped with facilitation technique. After 30 minutes of application patients will be evaulated for pulmonary parameters, functional exercise capacity and dyspnea.

Device: Kinesio Taping

Mechanical Correction Tape

ACTIVE COMPARATOR

Thorax will be taped with mechanical correction technique. After 30 minutes of application patients will be evaulated for pulmonary parameters, functional exercise capacity and dyspnea.

Device: Kinesio Taping

No Tape

NO INTERVENTION

Patients will be evaulated for pulmonary parameters, functional exercise capacity and dyspnea with no tape.

Interventions

Kinesio Taping is a special taping method developed by Dr. Kenzo Kase in 1973. This technique triggers natural healing responses of human body by activating nervous and circulatory systems. The tapes are thin, latex-free, cotton, porous and anti-allergenic, with equal thickness of epidermis. It has elastic properites which allows the tape to elongate to %55-60 of its original lenght. Tape can be used up to 1 week even after sweating or cleaning with water. There are different application techniques for different purposes. Facilitation technique facilitates muscle contractions and supports muscle function. Mechancial correction technique is used for joint positioning and correcting motion of muscle-joint dynamics.

Facilitation TapeMechanical Correction Tape

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female COPD patients aged between 40-80 years
  • Diagnosed with COPD stage I-II-III-IV according to GOLD 2019 criterias
  • Able to speak, understand and read Turkish language
  • Volunteering to participate in study

You may not qualify if:

  • Unstable or acutely exacerbated patients with COPD
  • Alterations in medical treatment in last 6 months
  • Having comorbidities that affect directly cardiopulmonary system, uncontrolled arterial hypertension, severe congestive heart failure, coronary arterial disease, heart valve disease
  • Orthopaedic, neurological, psychiatric disease, peripheral/central nervous system diseases, mental retardation, antidepressants usage, metabolic impairments, malignancy
  • Unable to cooperate for measurement and treatment techniques used in study
  • Irritation, infection, allergic reaction, scarred burn or open wound around application area
  • Enrolled in a comprehensive pulmonary rehabilitation program before study
  • Application of Kinesio Tape to any body region in the past
  • History of an open heart surgery or other thoracic surgeries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Muğla Sıtkı Koçman University Training and Research Hospital

Muğla, Menteşe, 48000, Turkey (Türkiye)

Location

Related Publications (23)

  • Global Initiative for Chronic Obstructive Lung Disease (2019 Report). 2019;2-14

    BACKGROUND
  • Orozco-Levi M. Structure and function of the respiratory muscles in patients with COPD: impairment or adaptation? Eur Respir J Suppl. 2003 Nov;46:41s-51s. doi: 10.1183/09031936.03.00004607.

    PMID: 14621106BACKGROUND
  • Kaneko H, Shiranita S, Horie J, Hayashi S. Reduced Chest and Abdominal Wall Mobility and Their Relationship to Lung Function, Respiratory Muscle Strength, and Exercise Tolerance in Subjects With COPD. Respir Care. 2016 Nov;61(11):1472-1480. doi: 10.4187/respcare.04742. Epub 2016 Oct 18.

    PMID: 27794081BACKGROUND
  • Kenso Kase, Jim Wallis, Tsuyoshi Kase - Clinical Therapeutic Application Kinesio® Taping Manual. 2nd ed. Kinesio; 2003. 12-39 p.

    BACKGROUND
  • Kase K. Kenzo Kase. - Illustrated Kinesio Taping. In: 4th ed. p. 6-12, 72-5.

    BACKGROUND
  • American Thoracic Society/European Respiratory Society. ATS/ERS Statement on respiratory muscle testing. Am J Respir Crit Care Med. 2002 Aug 15;166(4):518-624. doi: 10.1164/rccm.166.4.518. No abstract available.

    PMID: 12186831BACKGROUND
  • Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.

    PMID: 16055882BACKGROUND
  • Rostagno C, Gensini GF. Six minute walk test: a simple and useful test to evaluate functional capacity in patients with heart failure. Intern Emerg Med. 2008 Sep;3(3):205-12. doi: 10.1007/s11739-008-0130-6. Epub 2008 Feb 26.

    PMID: 18299800BACKGROUND
  • Cheng SL, Lin CH, Wang CC, Chan MC, Hsu JY, Hang LW, Perng DW, Yu CJ, Wang HC; Taiwan Clinical Trial Consortium for Respiratory Disease (TCORE). Comparison between COPD Assessment Test (CAT) and modified Medical Research Council (mMRC) dyspnea scores for evaluation of clinical symptoms, comorbidities and medical resources utilization in COPD patients. J Formos Med Assoc. 2019 Jan;118(1 Pt 3):429-435. doi: 10.1016/j.jfma.2018.06.018. Epub 2018 Aug 25.

    PMID: 30150099BACKGROUND
  • Rabe KF, Hurd S, Anzueto A, Barnes PJ, Buist SA, Calverley P, Fukuchi Y, Jenkins C, Rodriguez-Roisin R, van Weel C, Zielinski J; Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2007 Sep 15;176(6):532-55. doi: 10.1164/rccm.200703-456SO. Epub 2007 May 16.

    PMID: 17507545BACKGROUND
  • Yorgancioglu A, Polatli M, Aydemir O, Yilmaz Demirci N, Kirkil G, Nayci Atis S, Kokturk N, Uysal A, Akdemir SE, Ozgur ES, Gunakan G. [Reliability and validity of Turkish version of COPD assessment test]. Tuberk Toraks. 2012;60(4):314-20. doi: 10.5578/tt.4321. Turkish.

    PMID: 23289460BACKGROUND
  • Kinesio Tape® Applied to the Thorax Augments Ventilatory Efficiency during Heavy Exercise. Int J Exerc Sci. 2013;6(2):8.

    RESULT
  • Metin Okmen B, Sengoren Dikis O, Okmen K, Altan L, Yildiz T. Investigation of the effect of kinesiotaping on the respiratory function and depression in male patients with chronic obstructive pulmonary disease: a prospective, randomized, controlled, and single-blind study. Aging Male. 2020 Dec;23(5):648-654. doi: 10.1080/13685538.2019.1567703. Epub 2019 Feb 10.

  • Aydoğan Arslan S, Daşkapan AD, Özünlü Pekyavaş N, Sakızlı E. Effects of Kinesio Taping Applied to Diaphragm Muscle on Aerobic Exercise Capacity and Pulmonary Function in Sedentary Individuals. Anadolu Klin Tıp Bilim Derg. 2018;23(2):68-72.

    RESULT
  • Zübeyir S, Nilüfer K, Burcu C, Onur A, Bahar K, Ufuk YS, et al. The Effect of Kinesiology Taping on Respiratory Muscle Strength. J Phys Ther Sci. 2012;24(3):241-4.

    RESULT
  • Tomruk M, Keles E, Ozalevli S, Alpaydin AO. Effects of thoracic kinesio taping on pulmonary functions, respiratory muscle strength and functional capacity in patients with chronic obstructive pulmonary disease: A randomized controlled trial. Explore (NY). 2020 Sep-Oct;16(5):332-338. doi: 10.1016/j.explore.2019.08.018. Epub 2019 Sep 18.

  • Yoshida A, Kahanov L. The effect of kinesio taping on lower trunk range of motions. Res Sports Med. 2007 Apr-Jun;15(2):103-12. doi: 10.1080/15438620701405206.

  • Halseth T, McChesney JW, Debeliso M, Vaughn R, Lien J. The effects of kinesio taping on proprioception at the ankle. J Sports Sci Med. 2004 Mar 1;3(1):1-7. eCollection 2004 Mar.

  • Bostancı N., Yiğit Z., Baltacı G., Gürses H. Effects of kinesio taping method on pulmonary function, respiratory muscle strength and functional capacity in patients with chronic heart failure. Am J Respir Crit Care Med. 2018;197.

    RESULT
  • Shih YF, Lee YF, Chen WY. Effects of Kinesiology Taping on Scapular Reposition Accuracy, Kinematics, and Muscle Activity in Athletes With Shoulder Impingement Syndrome: A Randomized Controlled Study. J Sport Rehabil. 2018 Nov 1;27(6):560-569. doi: 10.1123/jsr.2017-0043. Epub 2018 Oct 15.

  • Han JT, Lee JH, Yoon CH. The mechanical effect of kinesiology tape on rounded shoulder posture in seated male workers: a single-blinded randomized controlled pilot study. Physiother Theory Pract. 2015 Feb;31(2):120-5. doi: 10.3109/09593985.2014.960054. Epub 2014 Sep 29.

  • Cools AM, Witvrouw EE, Danneels LA, Cambier DC. Does taping influence electromyographic muscle activity in the scapular rotators in healthy shoulders? Man Ther. 2002 Aug;7(3):154-62. doi: 10.1054/math.2002.0464.

  • Wang JS, Cho KH, Park SJ. The immediate effect of diaphragm taping with breathing exercise on muscle tone and stiffness of respiratory muscles and SpO2 in stroke patient. J Phys Ther Sci. 2017 Jun;29(6):970-973. doi: 10.1589/jpts.29.970. Epub 2017 Jun 7.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Burcu Camcıoğlu Yılmaz, PT, PhD

    Muğla Sıtkı Koçman University

    STUDY DIRECTOR
  • Metehan Sarıkaya, MSc. Student

    Muğla Sıtkı Koçman University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Evaluation of patients after taping application will be done by another physiotherapist who does not know the taping techniques and also cannot see the taped area by clothes of patients.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Prospective, Double-Blinded, Randomized Crossover Study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT, PhD

Study Record Dates

First Submitted

January 22, 2020

First Posted

January 27, 2020

Study Start

April 20, 2022

Primary Completion

October 31, 2022

Study Completion

October 31, 2022

Last Updated

November 1, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations