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

NCT ID: NCT06749340

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-23

Study Completion Date

2025-12-23

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Coginitive Dysfunction Compensated Liver Cirrhosis Physical Dysfunction Sarcopenia

Keywords

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cirrhosis cognitive dysfunction sarcopenia strengthening telerehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants with liver cirrhosis will be randomly assigned to 3 groups: face-to-face exercise group, home-based exercise group and control group.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
After the first evaluation, participants will determine their groups by choosing closed and opaque envelopes. One of the researchers will perform all outcome measurements and will not know which group the participant falls into.

Study Groups

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Face-to-face Exercise Group

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.

Group Type EXPERIMENTAL

Assigned Interventions

Intervention Type OTHER

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.

Face-to-face Exercise

Intervention Type OTHER

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.

Home-based Exercise Group

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.

Group Type EXPERIMENTAL

Assigned Interventions

Intervention Type OTHER

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.

Home-based Exercise

Intervention Type OTHER

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.

Control Group

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%.

Group Type OTHER

Assigned Interventions

Intervention Type OTHER

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.

Control

Intervention Type OTHER

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%.

Interventions

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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.

Intervention Type 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 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.

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

Intervention Type OTHER

Control

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%.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bahçeşehir University

OTHER

Sponsor Role lead

Responsible Party

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Mustafa Oğuz Kethudaoglu

Pirincipal Investigator; PT, MSc, PhD (c)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pelin Pişirici

Role: STUDY_DIRECTOR

Bahcesehir University, Department of Physiotherapy and Rehabilitation

Mustafa Oğuz Kethüdaoğlu

Role: PRINCIPAL_INVESTIGATOR

Sivas Cumhuriyet University,Department of Physiotherapy and Rehabilitation // Bahçeşehir University, Doctorate Program of Physiotherapy and Rehabilitation

Locations

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Sivas Cumhuriyet University

Sivas, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Mustafa Oğuz Kethüdaoğlu

Role: CONTACT

Phone: +905544169776

Email: [email protected]

Pelin Pişirici

Role: CONTACT

Phone: +905055016076

Email: [email protected]

Facility Contacts

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Mustafa Oğuz Kethüdaoğlu

Role: primary

Mustafa Oğuz Kethüdaoğlu

Role: backup

Other Identifiers

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E-10840098-202.3.02-6055 / 927

Identifier Type: -

Identifier Source: org_study_id