Effects of Regular Exercise and Psychoeducation on Quality of Life and Depression in the Treatment of Sarcopenia

NCT06868602 | Completed

• 2 other identifiers: 2023-664BAP01-2024-5152
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia in Elderly

Keywords

sarcopenia; exercise; psychoeducation

Outcome Measures

Primary Outcomes (7)

• TUG test

  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

  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

  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)

  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

  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.

  Before treatment

• Standardized Mini Mental Test (SMMT)

  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.

  Before treatment , pre test only

• Handgrip strength assessment

  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 Outcomes (5)

• TUG test

  Within a week of the end of treatment (within 1 week of the completion of the 8-week treatment)

• SF-12 Test

  Within a week of the end of treatment (within 1 week of the completion of the 8-week treatment)

• GDS

  Within a week of the end of treatment (within 1 week of the completion of the 8-week treatment)

• Bioelectrical impedance analysis (BIA)

  Within a week of the end of treatment (within 1 week of the completion of the 8-week treatment)

• Handgrip strength assessment

  Within a week of the end of treatment (within 1 week of the completion of the 8-week treatment)

Study Arms (3)

control

NO INTERVENTION

This group will be informed about exercise and psychoeducation only once after the sessions are completed.

exercise

ACTIVE COMPARATOR

Physical exercise will be performed for 45 minutes twice a week for eight weeks.

Other: Exercise

exercise and psychoeducation

ACTIVE COMPARATOR

A 45-minute exercise program twice a week and a 45-minute psychoeducation program once a week will be implemented for 8 weeks.

Other: psychoeducation; Other: Exercise

Interventions

psychoeducation OTHER

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.

Also known as: exercise

exercise and psychoeducation

Exercise OTHER

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.

exercise; exercise and psychoeducation

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Lokman Hekim University: lead

Study Sites (1)

Ondokuz Mayıs University

Samsun, 55400, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sarcopenia; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Esra Erdoğan

  Ondokuz Mayıs University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical physiotherapist

Model Details: 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.

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 11, 2025
• Study Start: June 1, 2024
• Primary Completion: June 15, 2024
• Study Completion: September 28, 2024
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)