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

Bahçeşehir University

Status: Not yet enrolling

Conditions: Compensated Liver Cirrhosis; Physical Dysfunction; Sarcopenia; Coginitive Dysfunction

Treatments: Other: Control; Other: Home-based Exercise; Other: Face-to-face Exercise; Other: Assigned Interventions

Study type: Interventional

Funder types: Other

Identifiers

NCT06749340

E-10840098-202.3.02-6055 / 927

Details and patient eligibility

About

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. 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 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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 3 patient groups

Face-to-face Exercise Group

Experimental group

Description:

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 into a personalized program according to the tolerance level of the participants in the first session. Exercise intensity will be determined using the OMNI - Resistance Exercise Scale (OMNI - RES). The warm-up and cool-down periods in the exercise program will be carried out at levels 9 - 12 according to the Borg Scale.

Treatment:

Other: Face-to-face Exercise

Other: Assigned Interventions

Home-based Exercise Group

Experimental group

Description:

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 researchers. The progression program will be determined in line with the difficulty and effort felt by the participants through weekly meetings.

Treatment:

Other: Home-based Exercise

Other: Assigned Interventions

Control Group

Other group

Description:

Participants assigned to the control group will have the same evaluation sessions as participants assigned to the experimental groups. The first evaluation will be made at the beginning of the study, the second evaluation after the 8-week period, the third evaluation after the 12-week period, the fourth evaluation after the 6-month follow-up, and the fifth evaluation after the 12-month follow-up. Participants who will not be included in any study sessions during this process will be included in the study program that appears to be effective as a result of the study. Participants in this group will be offered the program recommended by the US Office of Disease Prevention and Health Promotion and used in individuals who have previously had a liver transplant. This program consists of aerobic exercises (walking, cycling, etc.) starting from 60-65% of the maximum heart rate and progressing to 75-80%.

Treatment:

Other: Assigned Interventions

Other: Control