Clinical trial NCT06868602: Effects of Regular Exercise and Psychoeducation on Quality of Life and Depression in the Treatment of Sarcopenia
Official title: Effects of Regular Exercise and Psychoeducation on Quality of Life, Depression and Physical Function in the Treatment of Sarcopenia in Elderly Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia in Elderly
Keywords: sarcopenia
exercise
psychoeducation
Lead sponsor: Lokman Hekim Üniversitesi
Sponsor class: OTHER_GOV
First posted: 2025-03-11
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this study, a pre-test-post-test randomized control and placebo group quasi-experimental research design will be used.

In order to determine whether elderly individuals who voluntarily accept to participate in the study are sarcopenic according to the definitive diagnostic criteria of the European Working Group (EWGSOP2), muscle strength assessment (with a handheld dynamometer), muscle mass assessment (with a Bioelectrical Impedance (BIA) device) and Physical performance assessment (with the Timed Up and Go test and SARC-F test) will be performed; then, the SMMT will be applied to sarcopenic individuals and those who score 24 points and above and meet the inclusion criteria will be included in the study.

Elderly individuals who meet the inclusion criteria will be assigned to the group where exercise will be performed, the group where exercise and psychoeducation will be done together, and the control group.
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: TUG test
timeFrame: Before treatment
measure: SF-12 Test
timeFrame: Before treatment
measure: GDS
timeFrame: Before treatment
measure: Bioelectrical impedance analysis (BIA)
timeFrame: Before treatment
measure: SARC-F
timeFrame: Before treatment
measure: Standardized Mini Mental Test (SMMT)
timeFrame: Before treatment , pre test only
measure: Handgrip strength assessment
timeFrame: Before treatment
Secondary outcomes:
measure: TUG test
timeFrame: Within a week of the end of treatment (within 1 week of the completion of the 8-week treatment)
measure: SF-12 Test
timeFrame: Within a week of the end of treatment (within 1 week of the completion of the 8-week treatment)
measure: GDS
timeFrame: Within a week of the end of treatment (within 1 week of the completion of the 8-week treatment)
measure: Bioelectrical impedance analysis (BIA)
timeFrame: Within a week of the end of treatment (within 1 week of the completion of the 8-week treatment)
measure: Handgrip strength assessment
timeFrame: Within a week of the end of treatment (within 1 week of the completion of the 8-week treatment)
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ondokuz Mayıs University
Study officials:
affiliation: Ondokuz Mayıs University
name: Esra Erdoğan
role: STUDY_DIRECTOR
References: