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临床试验/NCT03597646
NCT03597646已完成不适用

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

Istanbul University1 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2016年9月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
57
试验地点
1
主要终点
Maximal inspiratory pressure

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
43 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Diagnosed with New York Heart Association Functional Class II-III
  • •Ejection fraction less than 50
  • •Stable Chronic Heart Failure patients

排除标准

  • •Acute decompensated heart failure
  • •Uncontrolled hypertension
  • •Unstable angina
  • •Significant cardiac arrhythmias
  • •Severe cognitive impairment

研究组 & 干预措施

Kinesio Taping

Experimental

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.

干预措施: Kinesio Tape (Device)

Inspiratory Muscle Training (IMT)

Active Comparator

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.

干预措施: Threshold Inspiratory Muscle Trainer (Device)

Control

No Intervention

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.

结局指标

主要结局

Maximal inspiratory pressure

时间窗: 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.

Forced expiratory volume in 1 second

时间窗: 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.

Forced vital capacity

时间窗: 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.

FEV1/FVC

时间窗: 4 weeks

FEV1/FVC (%) ratio is a very important parameter to determine whether the type of lung disease is obstructive or restrictive.

Peak expiratory flow

时间窗: 4 weeks

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

时间窗: 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.

Six-minute walk test

时间窗: 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.

Short Form-36

时间窗: 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.

Minnesota Living with Heart Failure Questionnaire

时间窗: 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.

Maximal expiratory pressure

时间窗: 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.

次要结局

  • Timed up and go test(4 weeks)
  • Level of Depression(4 weeks)
  • Handgrip strength(4 weeks)
  • Sit to Stand Test(4 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Baha Naci

Principal Investigator

Istanbul University

研究点 (1)

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