Liver Function TestsNCT05612334
Effect of Exercise on Liver Cirrhosis
A study testing exercise (5 minutes warm-up-30 minutes walking-5 minutes cooling down) in people with Liver Function Tests, run by HULYA KESKIN at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Function Tests
- What is being tested?
- exercise (5 minutes warm-up-30 minutes walking-5 minutes cooling down)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jan 2019to 22 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 0xygen 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Study: Investigation of the Effect of Exercise on Liver Function Tests, Fatigue and Quality of Life in Patients With Liver Cirrhosis
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.
Read the detailed description
This randomized controlled study aimed to determine the effect of the exercise program to be applied in patients with liver cirrhosis on the patient's biochemistry parameters, quality of life, fatigue level, depression, and sleep quality. The universe of the study consisted of patients with stage I and II liver cirrhosis according to Child-Pugh A and B scores followed-up in Ege University Faculty of Medicine Hospital Gastroenterology Department Hepatology Polyclinic. The sample of the study consisted of a total of 90 patients, including 30 patients in the intervention group, 30 patients in the control group, and 30 patients in the placebo-control group (n=90). The study was completed with a total of 84 patients, including the intervention group (n=27), the control group (n=28), and the placebo control group (n=29). The data collection stage of the study was carried out between August 20, 2019 and March 04, 2020. The data collection forms used in the study were applied to the exercise intervention group at the first polyclinic visit (0th month) by face-to-face interview method. An exercise program (5 minutes warm-up, 30 minutes walking, 5 minutes cooldown) was demonstrated to the patient by the researcher, a booklet containing the exercise information prepared by the researcher was given, and the patient performed the first exercise under the supervision of the researcher. The patient followed a 40-minute exercise program, 3 days a week, for 3 months on his/her own starting from the second exercise. The researcher regularly made motivating and encouraging phone calls to the patient with phone follow-up once a week and also checked whether the patient followed the exercise program during this period. Similarly, 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. Regularly, the control group was contacted only once a week to check the patients' compliance with the treatment, to encourage them to express their problems, if any, and to motivate them for the treatment process. The forms used to collect the research data were Personal Information Form, 6-Minute Walking Test, Body Mass Index Assessment Form, SF-36 Quality of Life Scale, Biochemistry Parameters Assessment Form, Child-Pugh Score Assessment Form, Beck's Depression Inventory, Fatigue Severity Scale, Pittsburgh Sleep Quality Index (PSQI), and these were applied to the patients by face-to-face interview method. Data collection forms other than Personal Information Form were applied twice at the beginning of the study and the end of the 12th week. Statistical analyses were performed using IBM SPSS Statistics 25.0 (IBM SPSS Statistics for Windows, Version 25.0. Armonk, NY: IBM Corp.). Descriptive statistics of the data were given as mean, standard deviation, median, minimum, maximum, frequency, and percentage values. The assumption of normality of quantitative data was checked by the Shapiro-Wilk test. For the case in which the assumption of normality was not met, the non-parametric Brunner-Langer model was tested using the R 4.0.2 software (R software, version 4.0.2, package: nparLD, R Foundation for Statistical Computing, Vienna, Austria; http://r-project.org) in numerical data using the 'group effect', 'time effect', and 'group-time interaction' (F1-LD-F1 design).
- Conditions
- Liver Function Tests
- Being tested
- exercise (5 minutes warm-up-30 minutes walking-5 minutes cooling down)
- Keywords
- Liver Function Tests, Liver Cirrhosis, Exercise, Fatigue, Quality of Life
- Medical subject headings
- Liver Cirrhosis, Motor Activity, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise (5 minutes warm-up-30 minutes walking-5 minutes cooling down)Behavioural
Also called Behavioral, breathing exercise
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 3 minutes
SF-36 Quality of Life Scale
It is among the general scales commonly used to measure quality of life.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start20 Jan 2019
- Primary completion22 Dec 2020
- Study completion22 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Function TestsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- HULYA KESKIN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, HULYA KESKIN, Mardin Artuklu University
- Investigators
- HÜLYA KESKİN, Principal investigator, Mardin Artuklu University, Faculty of Health Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05612334
- Sponsor's protocol ID
- EGE UNIVERSTIY
- Status last verified
- Nov 2022
- First submitted
- 27 Oct 2022
- Last updated
- 15 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study can be reviewed by other researchers after the study has been published.
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study: Investigation of the Effect of Exercise on Liver Function Tests, Fatigue and Quality of Life in Patients With Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT05612334
- Acronym / sponsor ID
- EGE UNIVERSTIY
- Conditions
- Liver Function Tests
- Keywords
- Liver Function Tests, Liver Cirrhosis, Exercise, Fatigue, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- HULYA KESKINUniversity, hospital or other
- Study start
- 20 Jan 2019 (actual)
- Primary completion
- 22 Dec 2020 (actual)
- Study completion
- 22 Dec 2020 (actual)
- First posted
- 10 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This randomized controlled study aimed to determine the effect of the exercise program to be applied in patients with liver cirrhosis on the patient's biochemistry parameters, quality of life, fatigue level, depression, and sleep quality. The universe of the study consisted of patients with stage I and II liver cirrhosis according to Child-Pugh A and B scores followed-up in Ege University Faculty of Medicine Hospital Gastroenterology Department Hepatology Polyclinic. The sample of the study consisted of a total of 90 patients, including 30 patients in the intervention group, 30 patients in the control group, and 30 patients in the placebo-control group (n=90). The study was completed with a total of 84 patients, including the intervention group (n=27), the control group (n=28), and the placebo control group (n=29). The data collection stage of the study was carried out between August 20, 2019 and March 04, 2020. The data collection forms used in the study were applied to the exercise intervention group at the first polyclinic visit (0th month) by face-to-face interview method. An exercise program (5 minutes warm-up, 30 minutes walking, 5 minutes cooldown) was demonstrated to the patient by the researcher, a booklet containing the exercise information prepared by the researcher was given, and the patient performed the first exercise under the supervision of the researcher. The patient followed a 40-minute exercise program, 3 days a week, for 3 months on his/her own starting from the second exercise. The researcher regularly made motivating and encouraging phone calls to the patient with phone follow-up once a week and also checked whether the patient followed the exercise program during this period. Similarly, 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. Regularly, the control group was contacted only once a week to check the patients' compliance with the treatment, to encourage them to express their problems, if any, and to motivate them for the treatment process. The forms used to collect the research data were Personal Information Form, 6-Minute Walking Test, Body Mass Index Assessment Form, SF-36 Quality of Life Scale, Biochemistry Parameters Assessment Form, Child-Pugh Score Assessment Form, Beck's Depression Inventory, Fatigue Severity Scale, Pittsburgh Sleep Quality Index (PSQI), and these were applied to the patients by face-to-face interview method. Data collection forms other than Personal Information Form were applied twice at the beginning of the study and the end of the 12th week. Statistical analyses were performed using IBM SPSS Statistics 25.0 (IBM SPSS Statistics for Windows, Version 25.0. Armonk, NY: IBM Corp.). Descriptive statistics of the data were given as mean, standard deviation, median, minimum, maximum, frequency, and percentage values. The assumption of normality of quantitative data was checked by the Shapiro-Wilk test. For the case in which the assumption of normality was not met, the non-parametric Brunner-Langer model was tested using the R 4.0.2 software (R software, version 4.0.2, package: nparLD, R Foundation for Statistical Computing, Vienna, Austria; http://r-project.org) in numerical data using the 'group effect', 'time effect', and 'group-time interaction' (F1-LD-F1 design).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: exercise (5 minutes warm-up-30 minutes walking-5 minutes cooling down)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. |
| Placebo | Placebo comparator | Behavioral: exercise (5 minutes warm-up-30 minutes walking-5 minutes cooling down)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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise (5 minutes warm-up-30 minutes walking-5 minutes cooling down)Also: Behavioral, breathing exercisethe 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. | Behavioural | Experimental, Placebo |
Primary outcome
Information Form
Time frame: 10 minutes
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.
6-Minute Walk Test (6-MWT)
Time frame: 6 minutes
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
Body Mass Index Evaluation Form
Time frame: 3 minutes
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.
SF-36 Quality of Life Scale
Time frame: 10 minutes
It is among the general scales commonly used to measure quality of life.
Biochemistry Parameters Evaluation Form
Time frame: 5 minutes
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.
Child-Pugh Score Evaluation Form
Time frame: 7 minutes
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.
Beck Depression Inventory
Time frame: 10 minutes
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).
Fatigue Severity Scale
Time frame: 10 minutes
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).
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 10 minutes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
- Individual participant dataSharing planned: Yes. The study can be reviewed by other researchers after the study has been published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
HÜLYA KESKİN principal investigator
Mardin Artuklu University, Faculty of Health Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise (5 minutes warm-up-30 minutes walking-5 minutes cooling down) in people with Liver Function Tests, run by HULYA KESKIN at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Information Form (time frame: 10 minutes). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2022.