Clinical trial NCT03597646: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Heart Failure
Keywords: Kinesio Taping
inspiratory muscle training
respiratory
Lead sponsor: Istanbul University
Sponsor class: OTHER
Collaborators: name: Kinesio Taping Association International
First posted: 2018-07-24
Enrollment: 57
Sex: ALL
Minimum age (years): 43
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Forced vital capacity
timeFrame: 4 weeks
measure: Forced expiratory volume in 1 second
timeFrame: 4 weeks
measure: FEV1/FVC
timeFrame: 4 weeks
measure: Peak expiratory flow
timeFrame: 4 weeks
measure: Forced expiratory flow at 25-75% of FVC
timeFrame: 4 weeks
measure: Maximal inspiratory pressure
timeFrame: 4 weeks
measure: Maximal expiratory pressure
timeFrame: 4 weeks
measure: Six-minute walk test
timeFrame: 4 weeks
measure: Short Form-36
timeFrame: 4 weeks
measure: Minnesota Living with Heart Failure Questionnaire
timeFrame: 4 weeks
Secondary outcomes:
measure: Level of Depression
timeFrame: 4 weeks
measure: Handgrip strength
timeFrame: 4 weeks
measure: Timed up and go test
timeFrame: 4 weeks
measure: Sit to Stand Test
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Institution of Cardiology
Study officials:
affiliation: Istanbul University Institution of Cardiology, Istanbul, Turkey
name: Baha Naci, MsC
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University Institution of Cardiology, Istanbul, Turkey
name: Rengin Demir, Prof.
role: STUDY_DIRECTOR
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