Clinical trial NCT05612334: Effect of Exercise on Liver Cirrhosis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Function Tests
Keywords: Liver Function Tests
Liver Cirrhosis
Exercise
Fatigue
Quality of Life
Lead sponsor: Mardin Artuklu University
Sponsor class: OTHER
First posted: 2022-11-10
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: First, they were informed about the benefits of exercise and walking. They were also informed about the duration and type of exercise and what should be considered before, during, and after exercises. Then, an informative training booklet prepared by the researcher containing the same information was given to them. An exercise program (5 minutes warm-up-30 minutes walking-5 minutes cooling down) was demonstrated to the patient by the researcher, and then the patient performed the first exercise under the supervision of the researcher. Beginning with the second exercise, the patient performed a 40-minute exercise program, 3 days a week, for 3 months. During this period, the researcher regularly made phone calls once a week to motivate the patient and check whether the patient performed the exercise program.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* Be 18 years old and over
* Cirrhosis of Stage I or Stage II results (Child pugh A: 5-6 (good) compensated disease) -B:7-9 Serious clinical clinical)
* Absence of specific musculoskeletal limitations (history of arthritis, joint swelling)
* No history of falls (≥3 falls in the past year)
* Absence of advanced cerebrovascular and peripheral vascular insufficiency
* Willingness to participate in the study

Exclusion Criteria:

* Be younger than 18 years old
* Child pugh C diagnosed with stage III or stage IV liver cirrhosis
* Platelet \<20.000mm3/blood
* Hemoglobin \<8 g/dl
* Heart rate \<50 or \>100
* Blood pressure systolic \>160 mmHg and diastolic \>85 mmHg
* 0xygen saturation \<92%
* Specific musculoskeletal limitations (history of arthritis, joint swelling)
* History of falls (≥3 falls in the past year)
* Blood glucose below 70 mg/dl
* Uncontrollable metabolic disease
* Presence of advanced cerebrovascular and peripheral vascular insufficiency
* Not being willing to participate in the study

Primary outcomes:
measure: Information Form
timeFrame: 10 minutes
measure: 6-Minute Walk Test (6-MWT)
timeFrame: 6 minutes
measure: Body Mass Index Evaluation Form
timeFrame: 3 minutes
measure: SF-36 Quality of Life Scale
timeFrame: 10 minutes
measure: Biochemistry Parameters Evaluation Form
timeFrame: 5 minutes
measure: Child-Pugh Score Evaluation Form
timeFrame: 7 minutes
measure: Beck Depression Inventory
timeFrame: 10 minutes
measure: Fatigue Severity Scale
timeFrame: 10 minutes
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Mardi̇n
country: Turkey
facility: Hülya Keskin
Study officials:
affiliation: Mardin Artuklu University, Faculty of Health Science
name: HÜLYA KESKİN
role: PRINCIPAL_INVESTIGATOR
References: