Effect of Exercise on Liver Cirrhosis

NCT05612334 | Completed

• 1 other identifier: EGE UNIVERSTIY
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Function Tests

Keywords

Liver Function Tests; Liver Cirrhosis; Exercise; Fatigue; Quality of Life

Outcome Measures

Primary Outcomes (9)

• Information Form

  The Information Form, developed by the researcher in line with the literature, consists of 15 items inquiring about age, gender, marital status, education status, health insurance, occupation, smoking and alcohol use, drugs used, presence of concomitant diseases, cirrhosis etiology, duration since diagnosis, and disease stage.

  10 minutes

• 6-Minute Walk Test (6-MWT)

  It is a test used in the follow-up of chronic cardio-pulmonary diseases and in the reliable evaluation of functional performance. It is based on the patient's walking for 6 minutes along a corridor, usually 30 meters long, with marked start and end points

  6 minutes

• Body Mass Index Evaluation Form

  It is a form in which weight, height, and thigh circumference measurements of the patients were recorded at follow-up months 0, 2, and 3.

  3 minutes

• SF-36 Quality of Life Scale

  It is among the general scales commonly used to measure quality of life.

  10 minutes

• Biochemistry Parameters Evaluation Form

  It is the form that includes information, collected at the 1st and 12th weeks, about the follow-up of laboratory tests such as AST, ALT, GGT, ALP, LDH, Total Protein, Albumin, Total Bilirubin, and Direct Bilirubin, which is called the liver function tests performed in the routine outpatient clinic controls of patients with liver cirrhosis.

  5 minutes

• Child-Pugh Score Evaluation Form

  Child class is associated with the likelihood of developing complications of cirrhosis. For example, patients with Child class C cirrhosis are more likely to have variceal bleeding than those with class A cirrhosis.

  7 minutes

• Beck Depression Inventory

  It was developed by Beck et al. in 1961 to measure the behavioral manifestations of depression in adolescents and adults, and its validity and reliability study in Turkey was performed by Hisli (Beck et al., 2015)(Hisli, 1989). Patients were asked to mark their status for the last week, including the then-current day. It consists of 21 items related to depressive symptoms such as guilt, pessimism, sense of failure, dissatisfaction, fatigue, sleep, and appetite, and each item is scored between 0 and 3. An increased score indicates that the severity of depression is higher. The total score is 63. According to this scale, 1-10 points are considered normal, 11-16 points indicate mild mental distress, 17-20 points indicate borderline clinical depression, 21-30 points indicate moderate depression, 31-40 points indicate severe depression, and above 40 points indicate very severe depression (Hisli, 1989).

  10 minutes

• Fatigue Severity Scale

  The Fatigue Severity Scale, which is used to evaluate the level of fatigue, was developed by Krupp et al., and its Turkish validity and reliability were verified by Armutlu et al. (Annex XIII). The scale consists of 9 items, and each item is scored as 1 (strongly disagree) - 7 (totally agree). The total score of the scale is the average of the value given to all questions. A high score indicates increased fatigue severity. An average score of 4 or above indicates severe fatigue (Krupp et al., 1989)(Armutlu et al., 2007).

  10 minutes

• Pittsburgh Sleep Quality Index (PSQI)

  The Pittsburg Sleep Quality Index (PSQI) is a 19-item self-report scale that evaluates sleep quality and disorder, and was developed by Buysse et al. in 1989. Turkish validity and reliability was established by Ağargün et al. (Buysse et al., 1989)(Ağargün, 1996). The questionnaire consists of 18 items and 7 components (subjective sleep quality, sleep duration, sleep disturbance, sleep latency, habitual sleep efficiency, sleep medication use, and daytime dysfunction). Score of each component is calculated by taking into account the scores obtained from the related items. In line with these questions, information about the frequency, severity, and sleep latency of the person's sleep-related problems is obtained. The total score is obtained by summing up the 7 components. A total score of 0-21 is obtained. A score greater than 5 indicates poor sleep quality. An increase in the score indicates deterioration in sleep quality.

  10 minutes

Study Arms (3)

Experimental

EXPERIMENTAL

The data collection forms used in the research were applied in the treatment group at the first polyclinic visit (0. month) via face-to-face interviews. 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.

Behavioral: exercise (5 minutes warm-up-30 minutes walking-5 minutes cooling down)

Placebo

PLACEBO COMPARATOR

The breathing exercise group, which constitutes the placebo-control group, was first informed about correct breathing techniques by the researcher, and an informative training brochure prepared by the researcher, containing correct breathing exercise information, was given to them. The exercise was performed by the researcher and shown to the patient. The first exercise was performed by the patient under the supervision of the researcher. They were informed about the continuation of the breathing exercise program for 3 months, once a day for 10 minutes, starting from the 2nd exercise. Regular phone calls were made once a week.

Behavioral: exercise (5 minutes warm-up-30 minutes walking-5 minutes cooling down)

No intervention

NO INTERVENTION

The control group was contacted by regular phone calls once a week to monitor their compliance with the treatment, to encourage them to express their problems, if any, and to motivate them for the treatment process.

Interventions

exercise (5 minutes warm-up-30 minutes walking-5 minutes cooling down) BEHAVIORAL

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.

Also known as: Behavioral, breathing exercise

Experimental; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• xygen 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

Sponsors & Collaborators

• HULYA KESKIN: lead

Study Sites (1)

Hülya Keskin

Mardin, 47000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Liver Cirrhosis; Motor Activity; Fatigue

Interventions

Exercise; Breathing Exercises

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• HÜLYA KESKİN

  Mardin Artuklu University, Faculty of Health Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Asst. Prof.

Model Details: 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.

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: November 10, 2022
• Study Start: January 20, 2019
• Primary Completion: December 22, 2020
• Study Completion: December 22, 2020
• Last Updated: November 15, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: data will be shared as long as they are published
• Access Criteria: publication page

Locations

TU (1)