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

August 6, 2018 updated by: Baha Naci, Istanbul University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Istanbul University Institution of Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

39 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: Kinesio Tape
Other Names:
  • Medical Adhesive Tape
Active Comparator: 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.
Device: Threshold Inspiratory Muscle Trainer
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Forced vital capacity
Time Frame: 4 weeks
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
Time Frame: 4 weeks
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
Time Frame: 4 weeks
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
Time Frame: 4 weeks
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
Time Frame: 4 weeks
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
Time Frame: 4 weeks
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
Time Frame: 4 weeks
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
Time Frame: 4 weeks
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
Time Frame: 4 weeks
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
Time Frame: 4 weeks

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of Depression
Time Frame: 4 weeks
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
Handgrip strength
Time Frame: 4 weeks
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
Timed up and go test
Time Frame: 4 weeks
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
Sit to Stand Test
Time Frame: 4 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Collaborators

Kinesio Taping Association International

Investigators

  • Principal Investigator: Baha Naci, MsC, Istanbul University Institution of Cardiology, Istanbul, Turkey
  • Study Director: Rengin Demir, Prof., Istanbul University Institution of Cardiology, Istanbul, Turkey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 8, 2016

Primary Completion (Actual)

January 13, 2017

Study Completion (Actual)

February 10, 2017

Study Registration Dates

First Submitted

July 1, 2018

First Submitted That Met QC Criteria

July 13, 2018

First Posted (Actual)

July 24, 2018

Study Record Updates

Last Update Posted (Actual)

August 8, 2018

Last Update Submitted That Met QC Criteria

August 6, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-29

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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