SarcopeniaNCT06012422
Sarcopenia Screening in Elderly Individuals
A study testing evaluation group in people with Sarcopenia, run by Kırıkkale University.
Trial summary
In this study, it is aimed to evaluate parameters such as sarcopenia screening, muscle mass measurement, loss of strength that may develop due to sarcopenia, loss of balance and related fall, decrease in functionality, fragility and decreased physical activity in individuals aged 65 years and older in Kırıkkale city… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- evaluation group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 843 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 1 Jan 2024
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Individuals aged 65 and over
- Their willingness to participate in the study
- A score of 24 or higher on the Mini Mental State Test (MMDT)
Who cannot join
- Individuals under the age of 65
- Individuals who cannot communicate well
- Elderly individuals who cannot walk independently, have any orthopedic or neurological problems
- Individuals who do not want to participate in the study
- Individuals not eligible for bioimpedance analysis (pregnant individuals with pacemakers).
About this study
Official title: Sarcopenia Screening in Elderly Individuals Living in Kirikkale Province
In this study, it is aimed to evaluate parameters such as sarcopenia screening, muscle mass measurement, loss of strength that may develop due to sarcopenia, loss of balance and related fall, decrease in functionality, fragility and decreased physical activity in individuals aged 65 years and older in Kırıkkale city center.
Read the detailed description
Although aging occurs in all periods in the human body, physical, mental and physical aging becomes visible as you get older. This situation is caused by physiological aging, environmental factors, existing chronic diseases and related symptoms. Today, increasing life expectancy and aging population must be taken into account. Since the age-related symptoms of elderly individuals are compatible with the consequences of aging, they can be ignored as a natural process, and therefore its progression cannot be prevented. With our project, it is aimed that screening for sarcopenia will be an exemplary study throughout Turkey and this type of screening will be widespread. In addition, it is aimed to divide elderly individuals into groups as presarcopenia, sarcopenia and severe sarcopenia, and to provide necessary guidance, protective and prevention approaches, strengthening and exercise training.
Demographic data of elderly individuals (age, gender, height, weight, BMI (Body mass index will be obtained by dividing body weight (kg), height (m) squared) occupation, etc.), chronic diseases (hypertension, diabetes, chronic obstructive pulmonary disease) (COPD), rheumatic diseases), drugs used, smoking, alcohol habits, and assistive device use, and the 'Clinical Vulnerability Scale' to evaluate the cognitive status of individuals through the 'Mini Nutritional Assessment form (MNA)'. 'Standardized Mini-Mental Test' to assess balance and walking, 'Tinetti balance and walking test' to evaluate balance and walking, 'Falling Risk Self-Assessment Scale' to assess falls, 'Functional Independence and Challenge Scale' to measure functional independence in activities of daily living. 'Short Physical Performance Test' (KFPT), Sarcopenia screening test (SA) to assess physical fitness RC-F), it is planned to use the Physical Activity Scale for the Elderly (PASE) to evaluate the level of physical activity, to use hand dynamometer, to evaluate muscle strength, and to measure the muscle mass of individuals with an inbody bioimpedance device.
- Conditions
- Sarcopenia
- Being tested
- evaluation group
- Keywords
- rehabilitation, physical inactivity, fragility
- Medical subject headings
- Sarcopenia, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
evaluation groupOther
Elderly individuals will be evaluated once, by face-to-face interview method.
| Study group | Role | What they receive |
|---|---|---|
| Individuals aged 65 and over who were screened for sarcopenia | Other | Persons aged 65 and over will be evaluated only once and the assessment will be made through a face-to-face interview. Receives: Other: evaluation group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioimpedance Analysis
used to measure muscle mass in epidemiological studies.A muscle mass index of less than 5.5 in women and less than 7 in men is associated with the risk of sarcopenia.
Measured: day 1
Secondary outcomes (8)
Muscle Strength Evaluation
Handgrip strength is more commonly used, and low handgrip strength correlates better with impaired mobility and undesirable clinical outcomes than low muscle mass. In practice, a linear relationship was also found between basal handshake strength and dependence on activities of daily living. Therefore, hand grip strength measurement is a good and simple method to evaluate muscle strength.
Measured: day 1
Short Physical Performance Test
The test measures parameters such as balance, sitting and standing from a chair and walking speed.All three physical performance measures (walking speed, balance, getting up from a chair) are scored between 0-4 according to the duration of the activity, the scores of the three tests are summed to give a total score between 0 (poor) and 12 (very good).
Measured: day 1
SARC-F
Used for rapid diagnosis of sarcopenia.In the SARC-F questionnaire, information such as strength, walking without support, getting up from a chair/stool, climbing stairs and the number of falls in the last year are questioned (66). According to the EWGSOP2 guideline, a score of 4 or higher on the SARC-F questionnaire is considered significant in terms of sarcopenia.
Measured: day 1
Mini Nutritional Assessment
The long MNA contains 18 items collected in 4 chapters. These four parts; anthropometric assessment (BMI, weight, arm and calf circumferences); overall assessment (lifestyle, medication, mobility, depression and dementia symptoms); short nutritional assessment (number of meals, food and fluid intake, autonomy in nutrition) and subjective assessment (self-perception of health and nutrition)
Measured: day 1
Physical Activity Scale for the Elderly
The questionnaire evaluates the physical activities of the bereaved individuals in the last week and includes the components of leisure time, housework and work-related physical activity. walking activity outside the home; mild, moderate and vigorous sports and recreational activities; Participation in leisure time activities, including muscle strengthening exercises, was recorded as never, rarely (1-2 days / week), sometimes (3-4 days / week), and often (5-7 days / week), while the duration of the activities was: 1 It is classified as less than 1 hour, 1-2 hours, 2-4 hours and more than 4 hours.
Measured: day 1
Tinetti balance and walking test
assesses balance and walking.In the test, the walking score is a maximum of 12 points, the balance score is a maximum of 16 points, and a total of 28 points. Those who score twenty-six and below are considered to have a problem. Studies have shown that the risk of falling increases as the score decreases.
Measured: day 1
Fall Risk Self-Assessment Scale
It is a scale that assesses the risk of falling in the elderly. It consists of 13 items assessing the risk of falling in the elderly. The answers are yes (1 point) and no (0 points), and individuals who get 4 points or more from the score are classified as having a high risk of falling.
Measured: day 1
Anthropometric Measurements
Anthropometric measurements of middle arm muscle circumference and calf circumference have been shown to predict functionality, general health status, nutritional adequacy, and survival in the elderly.
It has been reported that calf circumference of 31 cm or less, arm circumference of 23 cm or less in women, and 24 cm or less in men are associated with sarcopenia.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- There is no randomization in our study, all elderly individuals who meet the inclusion and exclusion criteria will be evaluated.
- Masking
- None (open label)
- Enrolment
- 843 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyma Akdagli, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06012422
- Sponsor's protocol ID
- KU-FTR-SA-01
- Status last verified
- Aug 2023
- First submitted
- 20 Aug 2023
- Last updated
- 25 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sarcopenia Screening in Elderly Individuals Living in Kirikkale Province
- ClinicalTrials.gov ID
- NCT06012422
- Acronym / sponsor ID
- KU-FTR-SA-01
- Conditions
- Sarcopenia
- Keywords
- rehabilitation, physical inactivity, fragility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 843 participants (estimated)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 25 Aug 2023 (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.
In this study, it is aimed to evaluate parameters such as sarcopenia screening, muscle mass measurement, loss of strength that may develop due to sarcopenia, loss of balance and related fall, decrease in functionality, fragility and decreased physical activity in individuals aged 65 years and older in Kırıkkale city center.
Detailed description
Although aging occurs in all periods in the human body, physical, mental and physical aging becomes visible as you get older. This situation is caused by physiological aging, environmental factors, existing chronic diseases and related symptoms. Today, increasing life expectancy and aging population must be taken into account. Since the age-related symptoms of elderly individuals are compatible with the consequences of aging, they can be ignored as a natural process, and therefore its progression cannot be prevented. With our project, it is aimed that screening for sarcopenia will be an exemplary study throughout Turkey and this type of screening will be widespread. In addition, it is aimed to divide elderly individuals into groups as presarcopenia, sarcopenia and severe sarcopenia, and to provide necessary guidance, protective and prevention approaches, strengthening and exercise training.
Demographic data of elderly individuals (age, gender, height, weight, BMI (Body mass index will be obtained by dividing body weight (kg), height (m) squared) occupation, etc.), chronic diseases (hypertension, diabetes, chronic obstructive pulmonary disease) (COPD), rheumatic diseases), drugs used, smoking, alcohol habits, and assistive device use, and the 'Clinical Vulnerability Scale' to evaluate the cognitive status of individuals through the 'Mini Nutritional Assessment form (MNA)'. 'Standardized Mini-Mental Test' to assess balance and walking, 'Tinetti balance and walking test' to evaluate balance and walking, 'Falling Risk Self-Assessment Scale' to assess falls, 'Functional Independence and Challenge Scale' to measure functional independence in activities of daily living. 'Short Physical Performance Test' (KFPT), Sarcopenia screening test (SA) to assess physical fitness RC-F), it is planned to use the Physical Activity Scale for the Elderly (PASE) to evaluate the level of physical activity, to use hand dynamometer, to evaluate muscle strength, and to measure the muscle mass of individuals with an inbody bioimpedance device.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- There is no randomization in our study, all elderly individuals who meet the inclusion and exclusion criteria will be evaluated.
| Arm | Type | Receives |
|---|---|---|
| Individuals aged 65 and over who were screened for sarcopenia | Other | Other: evaluation groupPersons aged 65 and over will be evaluated only once and the assessment will be made through a face-to-face interview. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Individuals aged 65 and over
- Their willingness to participate in the study
- A score of 24 or higher on the Mini Mental State Test (MMDT)
Key exclusion criteria (5 listed)
- Individuals under the age of 65
- Individuals who cannot communicate well
- Elderly individuals who cannot walk independently, have any orthopedic or neurological problems
- Individuals who do not want to participate in the study
- Individuals not eligible for bioimpedance analysis (pregnant individuals with pacemakers).
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 |
|---|---|---|
| evaluation groupElderly individuals will be evaluated once, by face-to-face interview method. | Other | Individuals aged 65 and over who were screened for sarcopenia |
Primary outcome
Bioimpedance Analysis
Time frame: day 1
used to measure muscle mass in epidemiological studies.A muscle mass index of less than 5.5 in women and less than 7 in men is associated with the risk of sarcopenia.
8 secondary outcomes
Muscle Strength Evaluation
Time frame: day 1
Short Physical Performance Test
Time frame: day 1
SARC-F
Time frame: day 1
Mini Nutritional Assessment
Time frame: day 1
Physical Activity Scale for the Elderly
Time frame: day 1
Tinetti balance and walking test
Time frame: day 1
Fall Risk Self-Assessment Scale
Time frame: day 1
Anthropometric Measurements
Time frame: day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing evaluation group in people with Sarcopenia, run by Kırıkkale University.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
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?
Bioimpedance Analysis (time frame: day 1). 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 25 Aug 2023.