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

NCT ID: NCT03597646

Last Updated: 2018-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-08

Study Completion Date

2017-02-10

Brief Summary

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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.

Detailed Description

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Individuals with chronic heart failure (CHF) have been found to have poor respiratory muscle strength and endurance. The reduction of respiratory muscle strength may be a sign of increased work of breathing in CHF. Exercise intolerance and dyspnea are common symptoms of patients with CHF and are relevant with a poor functional capacity and quality of life. The primary aim of cardiac rehabilitation programs for CHF patients is to increase their exercise tolerance and quality of life. Patients with CHF have decreased lung volume, increased work of breathing, and greater oxygen consumption. Pulmonary rehabilitation may improve quality of life and exercise capacity in patients with CHF. It has been shown that inspiratory muscle training is beneficial for improving respiratory muscle strength, functional capacity, and dyspnea in patients with stable heart failure and respiratory muscle weakness.

It has been found that inspiratory muscle training (IMT) results in improvement in inspiratory muscle strength, functional capacity and quality of life of patients with CHF and inspiratory muscle weakness. Previous studies have shown that the diaphragm has circulatory functions in addition to its better known respiratory functions, that diaphragm strength and endurance diminish in CHF.

Kinesio taping is a relatively new bandaging technique usually applied to normalize muscle function, increase lymph and blood circulation, decrease pain and/or aid the correction of joint misalignment. In literature there are several studies demonstrating results of inspiratory muscle training on pulmonary function in patients with CHF. But we haven't found any studies demonstrating effects of kinesio taping on respiratory mechanics and exercise capacity in patients with CHF. The study we designed therefore may contribute to the literature and may inform future studies.We hypothesized that KT methods used for respiratory muscles would be effective on improving pulmonary function, respiratory muscle strength, quality of life, functional capacity of CHF patients.

Clinically stable 57 CHF patients with New York Heart Association (NYHA) functional class II-III, between the ages 43 and 89 participated in the study. All participants were recruited between September 2016 and February 2017. All the assessments and treatments were performed in the same hospital, Istanbul University Institution of Cardiology, by the same person. The experimental group received Kinesio Taping; the breathing exercise group received IMT; and the control group received no interventions. The Kinesio Taping group received KT facilitation technique for musculus diaphragmaticus (ventral and dorsal parts) and for musculus obliquus internus-externus abdominis (bilateral) to improve inspiratory and forced expiratory muscle activity, respectively. KT was applied twice a week during a 4-week period. By combination of these muscle techniques we investigated the changes in pulmonary functions, respiratory muscle strength, functional exercise capacity, functional mobility, hand grip strength, quality of life and level of depression. All the assessments were performed at baseline and four weeks after treatment.

Conditions

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Chronic Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Kinesio Taping

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.

Group Type EXPERIMENTAL

Kinesio Tape

Intervention Type DEVICE

Inspiratory Muscle Training (IMT)

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.

Group Type ACTIVE_COMPARATOR

Threshold Inspiratory Muscle Trainer

Intervention Type DEVICE

Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Kinesio Tape

Intervention Type DEVICE

Threshold Inspiratory Muscle Trainer

Intervention Type DEVICE

Other Intervention Names

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Medical Adhesive Tape

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Acute decompensated heart failure
* Uncontrolled hypertension
* Unstable angina
* Significant cardiac arrhythmias
* Severe cognitive impairment
Minimum Eligible Age

43 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kinesio Taping Association International

UNKNOWN

Sponsor Role collaborator

Istanbul University

OTHER

Sponsor Role lead

Responsible Party

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Baha Naci

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Baha Naci, MsC

Role: PRINCIPAL_INVESTIGATOR

Istanbul University Institution of Cardiology, Istanbul, Turkey

Rengin Demir, Prof.

Role: STUDY_DIRECTOR

Istanbul University Institution of Cardiology, Istanbul, Turkey

Locations

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Istanbul University Institution of Cardiology

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 1489142 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6790504 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1516204 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24634346 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 16563194 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22993500 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16487841 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7805234 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15580060 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24464736 (View on PubMed)

Other Identifiers

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A-29

Identifier Type: -

Identifier Source: org_study_id

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