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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Cognitive Dysfunction Evaluation - Digit Symbol Test
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Face-to-face Exercise (Other)
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.
干预措施: Assigned Interventions (Other)
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.
干预措施: Assigned Interventions (Other)
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.
干预措施: Home-based Exercise (Other)
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%.
干预措施: Assigned Interventions (Other)
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%.
干预措施: Control (Other)
结局指标
主要结局
Cognitive Dysfunction Evaluation - Digit Symbol Test
时间窗: Baseline, after 8th week, after 12th week, 6 months follow-up, 12 months follow-up
DST is a neurophysiological test that is sensitive to brain damage, dementia and depression. It consists of a table and a list of numbers, with a symbol corresponding to each number. Under each number there is a box where the symbol corresponding to that number will be drawn. The aim is to draw as many symbols correctly as possible in the allotted time. The participant is given the page containing the digit symbol test and the following is said to the participant: "In this test, you will be shown numbers from 1 to 9 and 9 shapes corresponding to each number. We want you to draw the shape under each number in the empty box under the numbers in the table below. First, you will be asked to fill in a line for practice purposes, and then the same process will be done by keeping time. Our goal is to see how many boxes you can fill in 90 seconds." The number of symbols drawn correctly by the participant at the end of the given time is recorded.
Cognitive Dysfunction Evaluation - Number Combination Test-A
时间窗: Baseline, after 8th week, after 12th week, 6 months follow-up, 12 months follow-up
NCT-A is a test that measures conscious motor ability. NCT-A measures visuospatial orientation and psychomotor speed. The patient is given two pages of NCT-A, first with the practice test and then with the actual test. "In this test, what you are asked to do is to combine the mixed numbers from 1 to 25 by drawing a line with a pencil in numerical order. The point you need to pay attention to while doing this is not to raise your hand and skip the number sequence while drawing." Then the test begins. There is no time keeping in the practice test. Afterwards, it is recorded how long it took to complete the second test.
Cognitive Dysfunction Evaluation - Number Combination Test-B
时间窗: Baseline, after 8th week, after 12th week, 6 months follow-up, 12 months follow-up
In addition to NCT-A, NCT-B also evaluates the ability to sustain attention. The participant is given the page containing the NCT-B test. "In this test, similar to the NCT-A test, there are numbers from 1 to 13 and letters from A to I. What you are asked to do is to combine the mixed numbers and letters with lines in the form of one number and one letter. The point you need to pay attention to while doing this is not to raise your hand while drawing and not to skip the number-letter sequence." Then the test begins. It is recorded how long it took the participant to complete the test.
Cognitive Dysfunction Evaluation - Serial Punctuation Test
时间窗: Baseline, after 8th week, after 12th week, 6 months follow-up, 12 months follow-up
SPT is a neurophysiological test that evaluates the neuromuscular system and motor control. It measures speed similarly to the LDT. The participant is given the page containing the SPT. "In this test, you are asked to put a dot in the middle of the round boxes. The point you need to pay attention to is not to skip the circles and when the line ends, continue from the left on the next line." It is recorded how many seconds the participant takes to complete the test.
Cognitive Dysfunction Evaluation - Line Drawing Test
时间窗: Baseline, after 8th week, after 12th week, 6 months follow-up, 12 months follow-up
LDT, like SPT, is a test that measures motor control and speed. The participant is given the page containing the LDT. "In this test, what is required of you is to draw a path with a pencil without extending between the two lines. The point you need to pay attention to is to continue throughout the entire page without raising your hand and when you make a mistake, do not go back and try to correct it." In this test, unlike the others, both how many seconds the participants took to complete the test and how many mistakes they made are recorded as two separate parameters.
次要结局
- Muscle Strength(Baseline, after 8th week, after 12th week, 6 months follow-up, 12 months follow-up)
- Muscle Mass(Baseline, after 8th week, after 12th week, 6 months follow-up, 12 months follow-up)
- Functionality - 6 Minute Walk Test(Baseline, after 8th week, after 12th week, 6 months follow-up, 12 months follow-up)
- Functionality - 5 Times Sit and Stand Test(Baseline, after 8th week, after 12th week, 6 months follow-up, 12 months follow-up)
研究者
Mustafa Oğuz Kethudaoglu
Pirincipal Investigator; PT, MSc, PhD (c)
Bahçeşehir University