The Effect of Kinesio Taping on Pulmonary Function and Functional Capacity in Patients With Chronic Heart Failure

NCT03597646 | Completed

• 1 other identifier: A-29
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

This randomised controlled study investigates the effect of Kinesio Taping on pulmonary function, respiratory muscle strength, functional capacity, functional mobility, hand grip strength, quality of life and level of depression in patients with chronic heart failure (CHF). The study also compares effects of Kinesio Taping and Inspiratory Muscle Training (IMT). There were 3 study groups: The experimental group received Kinesio Taping; the breathing exercise group received IMT; and the control group received no interventions.

Conditions

Chronic Heart Failure

Keywords

Kinesio Taping; inspiratory muscle training; respiratory

Outcome Measures

Primary Outcomes (10)

• Forced vital capacity

  Forced vital capacity \[FVC\] (L) was measured with a lung spirometry. This shows the amount of air that the patient can forcefully exhale. The patient sitting on a chair used a nose clips during the test. The patient was asked to take a deep breath from a mouthpiece and then was asked a full forced exhalation for at least 6 seconds. 3 repetitions were performed for each test and best score was accepted.

  4 weeks

• Forced expiratory volume in 1 second

  Forced expiratory volume in 1 second \[FEV1\] (L) was measured with a lung spirometry as it was described for FVC measurement. It shows the amount of air that the patient can forcefully exhale in one second of the FVC test.

  4 weeks

• FEV1/FVC

  FEV1/FVC (%) ratio is a very important parameter to determine whether the type of lung disease is obstructive or restrictive.

  4 weeks

• Peak expiratory flow

  Peak expiratory flow \[PEF\] (L/sec) was measured with a lung spirometry as it was described for FVC and FEV1 measurements.

  4 weeks

• Forced expiratory flow at 25-75% of FVC

  Forced expiratory flow at 25-75% of FVC \[FEF25-75\] (L/sec) was measured with a lung spirometry as it was described for FVC, FEV1 and PEF measurements.

  4 weeks

• Maximal inspiratory pressure

  Maximal inspiratory pressure \[MIP\] (cmH2O) was recorded by using a portable mouth pressure meter as a measure of the inspiratory muscle strength. The patient sat upright and took a deep breath from functional residual capacity through a mouthpiece. 5 repetitions repetitions were performed for the test.

  4 weeks

• Maximal expiratory pressure

  Maximal expiratory pressures \[MEP\] (cmH2O) was recorded by using a portable mouth pressure meter as a measure of the expiratory muscle strength. The patient performed a forced expiration from total lung capacity. 5 repetitions repetitions were performed for the test.

  4 weeks

• Six-minute walk test

  Functional capacity was determined with Six-minute walk test \[6MWT\] (m). 6MWT is a submaximal exercise test. For the test we used a 30-m corridor and measured the distance walked by the patient in 6 minutes. We instructed the patient to walk as far as possible. Higher distance indicate better functional capacity.

  4 weeks

• Short Form-36

  Short Form-36 \[SF-36\] (0-100) was performed to assess generic quality of life (QOL) SF-36 consists of 36 items and 8 subscales. These subscales are physical functioning, role functioning physical, bodily pain, general health perception, vitality, social functioning, role functioning emotional, and mental health and they range from 0 to 100. Higher scores indicate better quality of life.

  4 weeks

• Minnesota Living with Heart Failure Questionnaire

  Minnesota Living with Heart Failure Questionnaire \[MLHFQ\] (0-105) was performed to assess disease-specific QOL. MLHFQ consists of 21 items with a total score of 105. Item-level scores of MLHFQ range from 0-5. 8 questions are related to physical domain and 5 questions are related to emotional domains. Total score was calculated by summing all scores. Lower scores indicate better quality of life.

  4 weeks

Secondary Outcomes (4)

• Level of Depression

  4 weeks

• Handgrip strength

  4 weeks

• Timed up and go test

  4 weeks

• Sit to Stand Test

  4 weeks

Study Arms (3)

Kinesio Taping

EXPERIMENTAL

Kinesio Taping group consisted of 19 patients. Kinesio Tape was applied 2 times a week for a period of 4 weeks. Kinesio Taping was applied for musculus diaphragmaticus, musculus externus obliquus abdominis and internus obliquus abdominis.

Device: Kinesio Tape

Inspiratory Muscle Training (IMT)

ACTIVE COMPARATOR

Inspiratory Muscle Training (IMT) group consisted of 19 patients. IMT sessions were applied 2 sessions/everyday for a period of 4 weeks and 15 minutes for each session. Every session patients performed 5 breathing circles, then rested and continued again. By this way they used the device for 15 minutes each session. The patients visited the clinic every week and the therapist adjusted the IMT device in terms of their maximal inspiratory pressures.

Device: Threshold Inspiratory Muscle Trainer

Control

NO INTERVENTION

Control group also consisted of 19 CHF patients. No interventions were applied for them. Pharmacological treatment of control group continued and they were advised for using their medication properly.

Interventions

Kinesio Tape DEVICE

Also known as: Medical Adhesive Tape

Kinesio Taping

Threshold Inspiratory Muscle Trainer DEVICE

Inspiratory Muscle Training (IMT)

Eligibility Criteria

• Age: 43 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18
• Diagnosed with New York Heart Association Functional Class II-III
• Ejection fraction less than 50
• Stable Chronic Heart Failure patients

You may not qualify if:

• Acute decompensated heart failure
• Uncontrolled hypertension
• Unstable angina
• Significant cardiac arrhythmias
• Severe cognitive impairment

Sponsors & Collaborators

• Istanbul University: lead
• Kinesio Taping Association International: collaborator

Study Sites (1)

Istanbul University Institution of Cardiology

Istanbul, Turkey (Türkiye)

Location

Related Publications (10)

• McParland C, Krishnan B, Wang Y, Gallagher CG. Inspiratory muscle weakness and dyspnea in chronic heart failure. Am Rev Respir Dis. 1992 Aug;146(2):467-72. doi: 10.1164/ajrccm/146.2.467.

  PMID: 1489142 BACKGROUND

• Aubier M, Trippenbach T, Roussos C. Respiratory muscle fatigue during cardiogenic shock. J Appl Physiol Respir Environ Exerc Physiol. 1981 Aug;51(2):499-508. doi: 10.1152/jappl.1981.51.2.499.

  PMID: 6790504 BACKGROUND

• Mancini DM, Henson D, LaManca J, Levine S. Respiratory muscle function and dyspnea in patients with chronic congestive heart failure. Circulation. 1992 Sep;86(3):909-18. doi: 10.1161/01.cir.86.3.909.

  PMID: 1516204 BACKGROUND

• Adamopoulos S, Schmid JP, Dendale P, Poerschke D, Hansen D, Dritsas A, Kouloubinis A, Alders T, Gkouziouta A, Reyckers I, Vartela V, Plessas N, Doulaptsis C, Saner H, Laoutaris ID. Combined aerobic/inspiratory muscle training vs. aerobic training in patients with chronic heart failure: The Vent-HeFT trial: a European prospective multicentre randomized trial. Eur J Heart Fail. 2014 May;16(5):574-82. doi: 10.1002/ejhf.70. Epub 2014 Mar 14.

  PMID: 24634346 BACKGROUND

• Figueroa MS, Peters JI. Congestive heart failure: Diagnosis, pathophysiology, therapy, and implications for respiratory care. Respir Care. 2006 Apr;51(4):403-12.

  PMID: 16563194 BACKGROUND

• Lin SJ, McElfresh J, Hall B, Bloom R, Farrell K. Inspiratory muscle training in patients with heart failure: a systematic review. Cardiopulm Phys Ther J. 2012 Sep;23(3):29-36.

  PMID: 22993500 BACKGROUND

• Dall'Ago P, Chiappa GR, Guths H, Stein R, Ribeiro JP. Inspiratory muscle training in patients with heart failure and inspiratory muscle weakness: a randomized trial. J Am Coll Cardiol. 2006 Feb 21;47(4):757-63. doi: 10.1016/j.jacc.2005.09.052. Epub 2006 Jan 26.

  PMID: 16487841 BACKGROUND

• Mancini DM, Henson D, La Manca J, Donchez L, Levine S. Benefit of selective respiratory muscle training on exercise capacity in patients with chronic congestive heart failure. Circulation. 1995 Jan 15;91(2):320-9. doi: 10.1161/01.cir.91.2.320.

  PMID: 7805234 BACKGROUND

• Laoutaris I, Dritsas A, Brown MD, Manginas A, Alivizatos PA, Cokkinos DV. Inspiratory muscle training using an incremental endurance test alleviates dyspnea and improves functional status in patients with chronic heart failure. Eur J Cardiovasc Prev Rehabil. 2004 Dec;11(6):489-96. doi: 10.1097/01.hjr.0000152242.51327.63.

  PMID: 15580060 BACKGROUND

• Beeler R, Schoenenberger AW, Bauer P, Kobza R, Bergner M, Mueller X, Schlaepfer R, Zuber M, Erne S, Erne P. Improvement of cardiac function with device-based diaphragmatic stimulation in chronic heart failure patients: the randomized, open-label, crossover Epiphrenic II Pilot Trial. Eur J Heart Fail. 2014 Mar;16(3):342-9. doi: 10.1002/ejhf.20. Epub 2013 Dec 6.

  PMID: 24464736 BACKGROUND

MeSH Terms

Interventions

Athletic Tape

Intervention Hierarchy (Ancestors)

Bandages; Equipment and Supplies; Orthotic Devices; Orthopedic Equipment; Surgical Equipment

Study Officials

• Baha Naci, MsC

  Istanbul University Institution of Cardiology, Istanbul, Turkey

  PRINCIPAL INVESTIGATOR

• Rengin Demir, Prof.

  Istanbul University Institution of Cardiology, Istanbul, Turkey

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 1, 2018
• First Posted: July 24, 2018
• Study Start: September 8, 2016
• Primary Completion: January 13, 2017
• Study Completion: February 10, 2017
• Last Updated: August 8, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)