- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06868602
Effects of Regular Exercise and Psychoeducation on Quality of Life and Depression in the Treatment of Sarcopenia
Effects of Regular Exercise and Psychoeducation on Quality of Life, Depression and Physical Function in the Treatment of Sarcopenia in Elderly Individuals
In this study, it was aimed to observe the effect of psychoeducation, which has not yet been included among the treatment methods of sarcopenia, which affects elderly individuals both physically and psychologically and has been proven to negatively affect their quality of life, on Quality of Life, Depression and Physical Function when applied with exercise therapy.
It is known that exercise programs applied in the treatment of sarcopenia, which has become a common problem in elderly individuals and is known as the trigger of most symptomatic diseases, have positive effects.
However, no psychoeducation program has been applied to date in the treatment of sarcopenia, which is thought to trigger psychological factors as well as physical factors.
In this direction, it is aimed to contribute to sarcopenia treatment and indirectly to geriatric rehabilitation programs according to the results we will obtain in sarcopenic individuals with the psychoeducation program, which we think is lacking.
In addition to all these, sarcopenia, which is a treatable diagnosis and one of the biggest obstacles to the independent life of elderly individuals, is thought to be a preventable condition with preventive rehabilitation programs.
Researchers believe that preventive rehabilitation programs will positively affect the amount spent on elderly care services, which constitute a large portion of our country's health expenses, and Researchers aim to support these issues with the results they will obtain.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study was planned to examine the effectiveness of exercise and psychoeducation programs applied to sarcopenic individuals.
Sarcopenia, which causes muscle strength loss in elderly individuals, is shown as a risk factor for many negative outcomes ranging from fractures to death.
Sarcopenia, which is also shown as the cause of many metabolic diseases, is often a preventable disease, but it is seen that scientific studies on sarcopenia treatment in the academic field are not sufficient.
While the majority of the studies conducted include physiotherapy programs, the psychological dimension of the treatment has been ignored and although it has been associated with depression, no scientific study has been found that includes this psychoeducation program.
The physical problems experienced by sarcopenic individuals are basically movement disorders that occur due to muscle strength loss, along with deterioration in their quality of life and physical functions, and musculoskeletal system diseases.
However, sarcopenia is a multifaceted disease that is not only physical but also causes psychological diseases such as depression.
In addition, it is known that physical function loss, which is one of the symptoms of sarcopenia, has a negative effect on the level of depression, independent of sarcopenia.
In light of all this information, it is thought that if the treatment program prepared for sarcopenic individuals does not include a psychoeducation program together with the physiotherapy program, a part of the treatment will be incomplete.
This study, which researchers designed to investigate the psychoeducation program, the therapeutic effect of which is not yet known on sarcopenia, aims to contribute to this area.
It is aimed to reach a conclusion by comparing the differences between the Physical Function, Quality of Life and Depression parameters of the psychoeducation program combined with the exercise program in sarcopenic individuals and the sarcopenic individuals who only received the exercise program.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Samsun, Turkey, 55400
- Ondokuz Mayıs University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Individuals aged 60 and over who have signed a consent form and agreed to volunteer for the study.
- Individuals classified as sarcopenic according to the criteria of the European Working Group on Sarcopenia (EWGSOP2).
- Individuals who scored 24 points or higher on the Standardized Mini Mental Test.
Exclusion Criteria:
- Individuals with neurological disease,
- Individuals with advanced kidney disease,
- Individuals with pacemakers,
- Individuals with advanced vision and hearing problems,
- Individuals with advanced dementia,
- Individuals with orthopedic disabilities
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: control
This group will be informed about exercise and psychoeducation only once after the sessions are completed.
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|
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Active Comparator: exercise
Physical exercise will be performed for 45 minutes twice a week for eight weeks.
|
Although the literature investigating the effectiveness of exercise programs on quality of life, physical function and depression in sarcopenic individuals is extensive, no studies have been found in which psychoeducation programs are applied to sarcopenic individuals and their effectiveness is investigated.
In this planned study, Researchers aim to observe what kind of results will emerge and in what direction the psychoeducation program will shape the treatment by applying both exercise and psychoeducation programs to sarcopenic individuals.
|
|
Active Comparator: exercise and psychoeducation
A 45-minute exercise program twice a week and a 45-minute psychoeducation program once a week will be implemented for 8 weeks.
|
Although the literature investigating the effectiveness of exercise programs on quality of life, physical function and depression in sarcopenic individuals is extensive, no studies have been found in which psychoeducation programs are applied to sarcopenic individuals and their effectiveness is investigated.
In this planned study, Researchers aim to observe what kind of results will emerge and in what direction the psychoeducation program will shape the treatment by applying both exercise and psychoeducation programs to sarcopenic individuals.
Although the literature investigating the effectiveness of exercise programs on quality of life, physical function and depression in sarcopenic individuals is extensive, no studies have been found in which psychoeducation programs are applied to sarcopenic individuals and their effectiveness is investigated.
In this planned study,Researchers aim to observe what kind of results will emerge and in what direction the psychoeducation program will shape the treatment by applying both exercise and psychoeducation programs to sarcopenic individuals.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
TUG test
Time Frame: Before treatment
|
A chair and a stopwatch are required for the test, which evaluates the risk of falls and mobility in the elderly.
The test is performed with the shoes the individual always uses.
A 3-meter area is determined in front of the chair.
The individual is asked to get up from the chair, walk this distance, and sit down again.
|
Before treatment
|
|
SF-12 Test
Time Frame: Before treatment
|
It is an abbreviated form for assessing quality of life.
This form, developed by Ware et al. (1995), is not specific to any age or type of disease, but is a scale that assesses the person's quality of life over the last four weeks.
SF-12; It includes the sub-elements of physical functioning, physical role, pain, general health, emotional role, mental health, social functioning and vitality and consists of 12 questions.
|
Before treatment
|
|
GDS
Time Frame: Before treatment
|
This scale was developed by Yesavage et al. (1983).
The Turkish adaptation of the scale was made by Ertan et al.
The scale is self-reporting, aimed at the elderly, easy to answer and consists of 30 questions.
A higher score indicates a higher level of depression.
|
Before treatment
|
|
Bioelectrical impedance analysis (BIA)
Time Frame: Before treatment
|
Bioelectrical impedance analysis (BIA) measurement; It is a non-invasive measurement.
It takes advantage of the different resistance of different tissues in the body to currents.
A weak electric current is directed to the body and the impedance is measured.
It is used to estimate body composition parameters such as total body water and fat-free mass.
|
Before treatment
|
|
SARC-F
Time Frame: Before treatment
|
SARC-F; It allows health professionals to quickly and easily assess the risk of sarcopenia in primary health care.
It asks 5 questions about "strength, assistance while walking, getting up from a chair, climbing stairs and falling".
The SARC-F score range is from 0 to 10, with a score range of 0-3 representing a healthy condition and a score range of 4 and above representing a symptomatic condition.
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Before treatment
|
|
Standardized Mini Mental Test (SMMT)
Time Frame: Before treatment , pre test only
|
Mini Mental Test developed by Folstein et al. (1975) allows for cognitive assessment in a short time.
In this respect, SMMT is a short, easy-to-apply and standardized test used to determine the cognitive level globally.
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Before treatment , pre test only
|
|
Handgrip strength assessment
Time Frame: Before treatment
|
During the assessment, the individual is seated upright on a chair without surface support for the arm being assessed.
The arm to be measured is positioned in a free position, with the knee angle and elbow angle at 90 degrees.
The subject is asked to squeeze the dynamometer with their fingers as hard and tight as possible.
The measurements are repeated 3 times, with 10 seconds between them and each measurement being no less than 5 seconds, and any interventions that may affect the measurements during the assessment are avoided.
|
Before treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
TUG test
Time Frame: Within a week of the end of treatment (within 1 week of the completion of the 8-week treatment)
|
A chair and a stopwatch are required for the test, which evaluates the risk of falls and mobility in the elderly.
The test is performed with the shoes the individual always uses.
A 3-meter area is determined in front of the chair.
The individual is asked to get up from the chair, walk this distance, and sit down again.
|
Within a week of the end of treatment (within 1 week of the completion of the 8-week treatment)
|
|
SF-12 Test
Time Frame: Within a week of the end of treatment (within 1 week of the completion of the 8-week treatment)
|
It is an abbreviated form for assessing quality of life.
This form, developed by Ware et al. (1995), is not specific to any age or type of disease, but is a scale that assesses the person's quality of life over the last four weeks.
SF-12; It includes the sub-elements of physical functioning, physical role, pain, general health, emotional role, mental health, social functioning and vitality and consists of 12 questions.
|
Within a week of the end of treatment (within 1 week of the completion of the 8-week treatment)
|
|
GDS
Time Frame: Within a week of the end of treatment (within 1 week of the completion of the 8-week treatment)
|
This scale was developed by Yesavage et al. (1983).
The Turkish adaptation of the scale was made by Ertan et al.
The scale is self-reporting, aimed at the elderly, easy to answer and consists of 30 questions.
A higher score indicates a higher level of depression.
|
Within a week of the end of treatment (within 1 week of the completion of the 8-week treatment)
|
|
Bioelectrical impedance analysis (BIA)
Time Frame: Within a week of the end of treatment (within 1 week of the completion of the 8-week treatment)
|
Bioelectrical impedance analysis (BIA) measurement; It is a non-invasive measurement.
It takes advantage of the different resistance of different tissues in the body to currents.
A weak electric current is directed to the body and the impedance is measured.
It is used to estimate body composition parameters such as total body water and fat-free mass.
|
Within a week of the end of treatment (within 1 week of the completion of the 8-week treatment)
|
|
Handgrip strength assessment
Time Frame: Within a week of the end of treatment (within 1 week of the completion of the 8-week treatment)
|
During the assessment, the individual is seated upright on a chair without surface support for the arm being assessed.
The arm to be measured is positioned in a free position, with the knee angle and elbow angle at 90 degrees.
The subject is asked to squeeze the dynamometer with their fingers as hard and tight as possible.
The measurements are repeated 3 times, with 10 seconds between them and each measurement being no less than 5 seconds, and any interventions that may affect the measurements during the assessment are avoided.
|
Within a week of the end of treatment (within 1 week of the completion of the 8-week treatment)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Esra Erdoğan, Ondokuz Mayıs University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-664
- BAP01-2024-5152 (Other Grant/Funding Number: Ondokuz Mayıs University)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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