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NCT Number: NCT03597646

The Effect of Kinesio Taping on Pulmonary Function and Functional Capacity 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.

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Key information

Age range

43 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University Institution of Cardiology

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Kinesio Tape

Device

Other names: Medical Adhesive Tape

Threshold Inspiratory muscle trainer

Device

Primary outcomes

  1. 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.

  2. 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.

  3. 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. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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. 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.

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Collaborators

  • Kinesio Taping Association International

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 24, 2018
Registry last updated
Aug 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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