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

Primary Purpose

Chronic Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Kinesio Tape
Threshold Inspiratory Muscle Trainer
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Heart Failure focused on measuring Kinesio Taping, inspiratory muscle training, respiratory

Eligibility Criteria

43 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istanbul University Institution of Cardiology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Kinesio Taping

Inspiratory Muscle Training (IMT)

Control

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
FEV1/FVC
FEV1/FVC (%) ratio is a very important parameter to determine whether the type of lung disease is obstructive or restrictive.
Peak expiratory flow
Peak expiratory flow [PEF] (L/sec) was measured with a lung spirometry as it was described for FVC and FEV1 measurements.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
July 1, 2018
Last Updated
August 6, 2018
Sponsor
Istanbul University
Collaborators
Kinesio Taping Association International
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1. Study Identification

Unique Protocol Identification Number
NCT03597646
Brief Title
The Effect of Kinesio Taping on Pulmonary Function and Functional Capacity in Patients With Chronic Heart Failure
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
September 8, 2016 (Actual)
Primary Completion Date
January 13, 2017 (Actual)
Study Completion Date
February 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University
Collaborators
Kinesio Taping Association International

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure
Keywords
Kinesio Taping, inspiratory muscle training, respiratory

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Kinesio Taping
Arm Type
Experimental
Arm Description
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.
Arm Title
Inspiratory Muscle Training (IMT)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Kinesio Tape
Other Intervention Name(s)
Medical Adhesive Tape
Intervention Type
Device
Intervention Name(s)
Threshold Inspiratory Muscle Trainer
Primary Outcome Measure Information:
Title
Forced vital capacity
Description
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.
Time Frame
4 weeks
Title
Forced expiratory volume in 1 second
Description
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.
Time Frame
4 weeks
Title
FEV1/FVC
Description
FEV1/FVC (%) ratio is a very important parameter to determine whether the type of lung disease is obstructive or restrictive.
Time Frame
4 weeks
Title
Peak expiratory flow
Description
Peak expiratory flow [PEF] (L/sec) was measured with a lung spirometry as it was described for FVC and FEV1 measurements.
Time Frame
4 weeks
Title
Forced expiratory flow at 25-75% of FVC
Description
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.
Time Frame
4 weeks
Title
Maximal inspiratory pressure
Description
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.
Time Frame
4 weeks
Title
Maximal expiratory pressure
Description
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.
Time Frame
4 weeks
Title
Six-minute walk test
Description
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.
Time Frame
4 weeks
Title
Short Form-36
Description
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.
Time Frame
4 weeks
Title
Minnesota Living with Heart Failure Questionnaire
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Level of Depression
Description
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.
Time Frame
4 weeks
Title
Handgrip strength
Description
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.
Time Frame
4 weeks
Title
Timed up and go test
Description
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.
Time Frame
4 weeks
Title
Sit to Stand Test
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
43 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Baha Naci, MsC
Organizational Affiliation
Istanbul University Institution of Cardiology, Istanbul, Turkey
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rengin Demir, Prof.
Organizational Affiliation
Istanbul University Institution of Cardiology, Istanbul, Turkey
Official's Role
Study Director
Facility Information:
Facility Name
Istanbul University Institution of Cardiology
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
1489142
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. doi: 10.1164/ajrccm/146.2.467.
Results Reference
background
PubMed Identifier
6790504
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. doi: 10.1152/jappl.1981.51.2.499.
Results Reference
background
PubMed Identifier
1516204
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. doi: 10.1161/01.cir.86.3.909.
Results Reference
background
PubMed Identifier
24634346
Citation
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.
Results Reference
background
PubMed Identifier
16563194
Citation
Figueroa MS, Peters JI. Congestive heart failure: Diagnosis, pathophysiology, therapy, and implications for respiratory care. Respir Care. 2006 Apr;51(4):403-12.
Results Reference
background
PubMed Identifier
22993500
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.
Results Reference
background
PubMed Identifier
16487841
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. doi: 10.1016/j.jacc.2005.09.052. Epub 2006 Jan 26.
Results Reference
background
PubMed Identifier
7805234
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. doi: 10.1161/01.cir.91.2.320.
Results Reference
background
PubMed Identifier
15580060
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. doi: 10.1097/01.hjr.0000152242.51327.63.
Results Reference
background
PubMed Identifier
24464736
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.
Results Reference
background

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

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