Liver Function Tests Clinical Trial
Official title:
Randomized Controlled Study: Investigation of the Effect of Exercise on Liver Function Tests, Fatigue and Quality of Life in Patients With Liver Cirrhosis
This randomized controlled study aimed to determine the effect of the exercise program to be applied in patients with cirrhosis on the patient's biochemistry parameters, quality of life, fatigue level, depression, and sleep quality.
This randomized controlled study aimed to determine the effect of the exercise program to be applied in patients with liver cirrhosis on the patient's biochemistry parameters, quality of life, fatigue level, depression, and sleep quality. The universe of the study consisted of patients with stage I and II liver cirrhosis according to Child-Pugh A and B scores followed-up in Ege University Faculty of Medicine Hospital Gastroenterology Department Hepatology Polyclinic. The sample of the study consisted of a total of 90 patients, including 30 patients in the intervention group, 30 patients in the control group, and 30 patients in the placebo-control group (n=90). The study was completed with a total of 84 patients, including the intervention group (n=27), the control group (n=28), and the placebo control group (n=29). The data collection stage of the study was carried out between August 20, 2019 and March 04, 2020. The data collection forms used in the study were applied to the exercise intervention group at the first polyclinic visit (0th month) by face-to-face interview method. An exercise program (5 minutes warm-up, 30 minutes walking, 5 minutes cooldown) was demonstrated to the patient by the researcher, a booklet containing the exercise information prepared by the researcher was given, and the patient performed the first exercise under the supervision of the researcher. The patient followed a 40-minute exercise program, 3 days a week, for 3 months on his/her own starting from the second exercise. The researcher regularly made motivating and encouraging phone calls to the patient with phone follow-up once a week and also checked whether the patient followed the exercise program during this period. Similarly, the breathing exercise group, which constituted the placebo control group, were first informed by the researcher about the correct breathing techniques and was given an informative training brochure prepared by the researcher containing the correct breathing exercise information. Regularly, the control group was contacted only once a week to check the patients' compliance with the treatment, to encourage them to express their problems, if any, and to motivate them for the treatment process. The forms used to collect the research data were Personal Information Form, 6-Minute Walking Test, Body Mass Index Assessment Form, SF-36 Quality of Life Scale, Biochemistry Parameters Assessment Form, Child-Pugh Score Assessment Form, Beck's Depression Inventory, Fatigue Severity Scale, Pittsburgh Sleep Quality Index (PSQI), and these were applied to the patients by face-to-face interview method. Data collection forms other than Personal Information Form were applied twice at the beginning of the study and the end of the 12th week. Statistical analyses were performed using IBM SPSS Statistics 25.0 (IBM SPSS Statistics for Windows, Version 25.0. Armonk, NY: IBM Corp.). Descriptive statistics of the data were given as mean, standard deviation, median, minimum, maximum, frequency, and percentage values. The assumption of normality of quantitative data was checked by the Shapiro-Wilk test. For the case in which the assumption of normality was not met, the non-parametric Brunner-Langer model was tested using the R 4.0.2 software (R software, version 4.0.2, package: nparLD, R Foundation for Statistical Computing, Vienna, Austria; http://r-project.org) in numerical data using the 'group effect', 'time effect', and 'group-time interaction' (F1-LD-F1 design). ;