Not yet recruiting NCT06749340

Examining the Effects of Different Resistive Exercise Programs in Individuals With Compensated Liver Cirrhosis

No phase Interventional Coginitive Dysfunction Compensated Liver Cirrhosis Physical Dysfunction Sarcopenia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Assigned Interventions, Face-to-face Exercise, Home-based Exercise.
Who it may be relevant to: Registry conditions: Coginitive Dysfunction, Compensated Liver Cirrhosis, Physical Dysfunction, Sarcopenia. Basic parameters: 40 years — 65 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Turkey (Türkiye)
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Official title

Examination of the Effects of Face-to-Face and Home-Based Resistive Exercise Program on Muscle Strength, Muscle Mass and Cognitive Functions in Individuals With Compensated Liver Cirrhosis: Randomized Controlled Single -Blind Study

Overview

Detailed description

Reasons such as sleep disorders, depression, decreased independence in daily living activities and decreased quality of life, which are seen in the majority of liver cirrhosis patients, can cause cognitive dysfunction, especially attention. And also, the most typical finding of hepatic encephalopathy is cognitive dysfunction. It is known that hepatic encephalopathy impairs attention, orientation, coordination abilities and slows down information processing processes. It is known that physical dysfunctions are observed in patients with liver cirrhosis along with cognitive dysfunction. Sarcopenia is the most important of these dysfunctions. Sarcopenia is the progressive, widespread loss of muscle mass, function and strength. The European Working Group on Sarcopenia in Older People defined sarcopenia in 2010 as a syndrome characterized by progressive and widespread loss of muscle mass and strength, associated with risks such as physical disability, low quality of life, and death. The rate of sarcopenia development in individuals with liver cirrhosis is around 70%. Sarcopenia has been described primarily in association with old age. Sarcopenia seen in cirrhosis is classified as secondary sarcopenia associated with disease, insufficient physical activity or malnutrition. Exercise may be the most effective intervention for sarcopenic individuals. It is well known that exercise has a positive effect on muscle mass, muscle strength and physical performance. And also, exercise has been proven to be effective in improving cognitive functions, which can improve mental state such as depression and insomnia stress. The aim of this study is to determine the effects of face-to-face and home-based progressive strengthening exercise program performed 3 times a week for 12 weeks on muscle strength, muscle mass, functionality and cognitive functions in individuals with liver cirrhosis. It is also aimed to test the feasibility and effectiveness of the home-based exercise method in individuals with liver cirrhosis. Another aim of our study is to determine the exercise dose required to improve muscle strength, muscle mass, functionality and cognitive functions in individuals with liver cirrhosis and the duration of treatment effectiveness through follow-up.

Interventions

Other Assigned Interventions
Psychometric Hepatic Encephalopathy Scoring (PHES) Test * Digit Symbol Test * Number Combination Test-A * Number Combination Test-B * Serial Punctuation Test * Line Drawing Test 6 Minute Walk Test 5 Times Sit and Stand Test Manual Muscle Test Hand Grip Strength Test Quadriceps muscle thickness measurement with ultrasonography All evaluations will be repeated 5 times.
Other Face-to-face Exercise
Participants will undergo exercise sessions 3 days a week for 12 weeks. Sessions will include a warm-up, upper and lower extremity strengthening (1/3 set - 8/12 repetitions) and cool-down program. Theraband will be used in strengthening exercises. Theraband offers different resistance levels with its different colors. In order from lightest to heaviest; skin color, yellow, red, green, blue, black, grey, gold. Exercises (theraband color, intensity, number of sets and repetitions) will be made int
Other Home-based Exercise
Participants will follow the same program as in the face-to-face exercise group. The first meeting with the participants will be held face to face and the details of the study will be explained. Home-based exercises will be carried out with the Fiziu (Fiziu Sağlık Hizmetleri Teknoloji A.Ş., Istanbul, Türkiye) program and the exercise program will be delivered to the participants through this program. Therabands with which the participants will do their exercises will be provided by the researche

Primary outcome measures

Cognitive Dysfunction Evaluation - Digit Symbol Test [Time frame: Baseline, after 8th week, after 12th week, 6 months follow-up, 12 months follow-up]
Cognitive Dysfunction Evaluation - Number Combination Test-A [Time frame: Baseline, after 8th week, after 12th week, 6 months follow-up, 12 months follow-up]
Cognitive Dysfunction Evaluation - Number Combination Test-B [Time frame: Baseline, after 8th week, after 12th week, 6 months follow-up, 12 months follow-up]
Cognitive Dysfunction Evaluation - Serial Punctuation Test [Time frame: Baseline, after 8th week, after 12th week, 6 months follow-up, 12 months follow-up]
Cognitive Dysfunction Evaluation - Line Drawing Test [Time frame: Baseline, after 8th week, after 12th week, 6 months follow-up, 12 months follow-up]

Secondary outcome measures (4)

Muscle Strength [Time frame: Baseline, after 8th week, after 12th week, 6 months follow-up, 12 months follow-up]
Muscle Mass [Time frame: Baseline, after 8th week, after 12th week, 6 months follow-up, 12 months follow-up]
Functionality - 6 Minute Walk Test [Time frame: Baseline, after 8th week, after 12th week, 6 months follow-up, 12 months follow-up]
Functionality - 5 Times Sit and Stand Test [Time frame: Baseline, after 8th week, after 12th week, 6 months follow-up, 12 months follow-up]

Eligibility criteria

Inclusion criteria

Being between the ages of 40 and 65;
Being diagnosed with liver cirrhosis;
Not having had a liver transplant;
Being cooperative;
Volunteering to participate in the study;
Having a smart device (phone/tablet/computer);
Having internet access;
Modified Child-Turcotte-Pugh Score to be A and B.

Exclusion criteria

Having a disease that may affect cognitive functions;
Having an orthopedic, neurological, psychological, cardiac, renal or pulmonary disease;
Having a physical or mental disability;
Having a communication problem;
Being unable to read or write;
Modified Child-Turcotte-Pugh Score to be C.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Single blind
Primary purpose: Treatment

Study locations

Turkey (Türkiye) · 1 center

Sivas Cumhuriyet University — Sivas

Identifiers

NCT: NCT06749340 · E-10840098-202.3.02-6055 / 927

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗