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

Chronic Heart Failure Clinical Trial

Official title:

The Effect of Kinesio Taping Method and Breathing Exercises on Pulmonary Function, Respiratory Muscle Strength, Functional Capacity and Quality of Life in Patients With Chronic Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03597646
• Other study ID #: A-29
• Status: Completed
• Phase: N/A
• Start date: September 8, 2016
• Est. completion date: February 10, 2017

Study information

• Verified date: August 2018
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: February 10, 2017
• Est. primary completion date: January 13, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 43 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

Device:
• Kinesio Tape

• Threshold Inspiratory Muscle Trainer

Locations

Country	Name	City	State
Turkey	Istanbul University Institution of Cardiology	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Istanbul University	Kinesio Taping Association International

Country where clinical trial is conducted

Turkey, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2006 Jan 26. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	FEV1/FVC	FEV1/FVC (%) ratio is a very important parameter to determine whether the type of lung disease is obstructive or restrictive.	4 weeks
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Level of Depression	Measured with Beck Depression Inventory. This is a 21-item scale and each question has four possible answers with a score of 0 to 3, and a total score of 0 to 63. A score of 10 or above indicates depression.	4 weeks
Secondary	Handgrip strength	Handgrip strength (kg) was measured by using a hand dynamometer. Patient held the dynamometer in the hand which would be tested. Then the patient squeezed the device with maximum effort in standing position. Then the subject performed this test with the other hand. 3 repetitions were performed for both hands.	4 weeks
Secondary	Timed up and go test	Functional mobility was measured with Timed up and go test [TUGT] (sec). The patient sitting on chair stood up with the instruction of physiotherapist and walked 3 meters as fast as possible, walked back to the chair and sat down again. The total duration was recorded in seconds. Lower time reflects better functional mobility. TUGT was performed with 3 repetitions.	4 weeks
Secondary	Sit to Stand Test	Sit to Stand Test [STS test] (repetitions in 30 seconds) was also used to measure functional mobility. Patient sitting on a 48 cm height armless chair folded their arms across their chests. They stood up completely and then sat down with full contact for a period of 30 seconds. Standing up and sitting down on the chair is one cycle. We calculated the total cycle the patient performed in 30 seconds. Higher score indicates better functional mobility.	4 weeks