SarcopeniaNCT04122638
Prevalence of Sarcopenia and Sarcopenic Obesity in Older Adults
An observational study of Sarcopenia and Sarcopenic Obesity, run by Goztepe Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Syndromes such as sarcopenia, sarcopenic obesity and osteosarcopenic obesity are commonly seen in older adults. They result from the impairment of muscle, bone and adipose tissue. Thus, they lead to a decrease in quality of life and increase morbidity and mortality. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Sarcopenic Obesity, Osteopenia, Osteoporosis
- How many people
- 572 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Oct 2019to 1 Jan 2020
- Phase
- Observational
- 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
Study population: Community-dwelling older adults
Who may be able to join
- Being at the age of 65 or older
- Being able to complete 4-m walk test
Who cannot join
- <24 points on Mini-Mental State Examination
- 12 points or higher on Geriatric Depression Scale
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Goztepe Training and Research Hospital
Istanbul, 34722
About this study
Official title: Prevalence of Sarcopenia and Sarcopenic Obesity in Community-dwelling Outpatient Older Adults
Syndromes such as sarcopenia, sarcopenic obesity and osteosarcopenic obesity are commonly seen in older adults. They result from the impairment of muscle, bone and adipose tissue. Thus, they lead to a decrease in quality of life and increase morbidity and mortality. The aim of this study is to report the prevalence of sarcopenia, sarcopenic obesity and osteosarcopenic obesity in community-dwelling outpatient older adults and to investigate the related factors.
- Conditions
- Sarcopenia, Sarcopenic Obesity, Osteopenia, Osteoporosis
- Keywords
- Older adults
- Medical subject headings
- Sarcopenia, Bone Diseases, Metabolic
What is being measured
The primary outcome is the main question the study is designed to answer.
Handgrip Strength
Handgrip strength measured by Takei© Hand Dynamometer
Measured: 10 minutes
Muscle mass
Using Bioimpedance analysis (BİA) technique with TANITA© TBF 300
Measured: 5 minutes
Bone density
T score evaluation using Dual-energy X-ray absorptiometry (DEXA)
Measured: 30 minutes
Percentage of body fat
Using Bioimpedance analysis (BİA) technique with TANITA© TBF 300
Measured: 5 minutes
Secondary outcomes (9)
Gait speed
4-m usual walking speed test
Measured: 3 minutes
Physical Activity
Using Rapid Assessment of Physical Activity (RAPA)
Measured: 5-10 minutes
Nutritional Status
Assessed with Mini-Nutritional Assessment (MNA)
Measured: 10 minutes
Activities of Daily Living
Activities of daily living assessed with Katz Index of Independence in Activities of Daily Living
Measured: 10 minutes
Instrumental Activities of Daily Living
Instrumental activities of daily living assessed with Lawton -Brody Instrumental Activities of Daily Living Scale
Measured: 10 minutes
Depression
Assessed with The Geriatric Depression Scale- Short Form
Measured: 10 minutes
Mini-Mental State Examination
Mini-Mental State Examination
Measured: 10-15 minutes
Blood Sample Analysis
A blood sample analysis including parameters such as: wbc, hgb, htc, mcv ,plt, fasting blood sugar, urea, uric acid, creatin, AST, ALP, ALT, GGT, LDH, total colesterol, trigylicerid, LDL, HDL, NA, K, Mg, Ca, P, Albumin, protrombin time, CRP, B12, folate, iron, ferritin, PTH, vitamin-D, sedimentation, TSH, T4, insukin, HGBA1C, IHOMA-IR.
Measured: 5 minutes
Comorbidities
Assessed with Charlson Comorbidity Index
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start7 Oct 2019
- Primary completion1 Jan 2020
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 572 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goztepe Training and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul Medeniyet University, Istanbul University
- Responsible party
- Principal investigator, Filiz Demirdağ, Goztepe Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04122638
- Sponsor's protocol ID
- GoztepeTRH
- Status last verified
- Feb 2020
- First submitted
- 7 Oct 2019
- Last updated
- 28 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Publications
Demirdag F, Kolbasi EN, Aykut GB, Guler KY, Murat S, Ozturk GB, Oguz A. Nutritional status as a mediator between the age-related muscle loss and frailty in community-dwelling older adults. Arch Gerontol Geriatr. 2022 Jan-Feb;98:104569. doi: 10.1016/j.archger.2021.104569. Epub 2021 Nov 3.
PubMed 34768160
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Sarcopenia and Sarcopenic Obesity in Community-dwelling Outpatient Older Adults
- ClinicalTrials.gov ID
- NCT04122638
- Acronym / sponsor ID
- GoztepeTRH
- Conditions
- Sarcopenia, Sarcopenic Obesity, Osteopenia, Osteoporosis
- Keywords
- Older adults
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 572 participants (actual)
- Lead sponsor
- Goztepe Training and Research HospitalUniversity, hospital or other
- Collaborators
- Istanbul Medeniyet University, Istanbul University
- Study start
- 7 Oct 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 10 Oct 2019 (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.
Syndromes such as sarcopenia, sarcopenic obesity and osteosarcopenic obesity are commonly seen in older adults. They result from the impairment of muscle, bone and adipose tissue. Thus, they lead to a decrease in quality of life and increase morbidity and mortality. The aim of this study is to report the prevalence of sarcopenia, sarcopenic obesity and osteosarcopenic obesity in community-dwelling outpatient older adults and to investigate the related factors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Community-dwelling older adults
Key inclusion criteria (2 listed)
- Being at the age of 65 or older
- Being able to complete 4-m walk test
Key exclusion criteria (2 listed)
- <24 points on Mini-Mental State Examination
- 12 points or higher on Geriatric Depression Scale
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Handgrip Strength
Time frame: 10 minutes
Handgrip strength measured by Takei© Hand Dynamometer
Muscle mass
Time frame: 5 minutes
Using Bioimpedance analysis (BİA) technique with TANITA© TBF 300
Bone density
Time frame: 30 minutes
T score evaluation using Dual-energy X-ray absorptiometry (DEXA)
Percentage of body fat
Time frame: 5 minutes
Using Bioimpedance analysis (BİA) technique with TANITA© TBF 300
9 secondary outcomes
Gait speed
Time frame: 3 minutes
Physical Activity
Time frame: 5-10 minutes
Nutritional Status
Time frame: 10 minutes
Activities of Daily Living
Time frame: 10 minutes
Instrumental Activities of Daily Living
Time frame: 10 minutes
Depression
Time frame: 10 minutes
Mini-Mental State Examination
Time frame: 10-15 minutes
Blood Sample Analysis
Time frame: 5 minutes
Comorbidities
Time frame: 5 minutes
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 28 Feb 2020.
- Derived from this study: PubMed 34768160Demirdag F, Kolbasi EN, Aykut GB, Guler KY, Murat S, Ozturk GB, Oguz A. Nutritional status as a mediator between the age-related muscle loss and frailty in community-dwelling older adults. Arch Gerontol Geriatr. 2022 Jan-Feb;98:104569. doi: 10.1016/j.archger.2021.104569. Epub 2021 Nov 3.
- Individual participant dataSharing planned: No
Related trials for Sarcopenia
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Not yet recruitingPhase 2
MF-300 for Treatment of Age-Related Sarcopenia
Sarcopenia in Elderly
Not yet recruitingObservational study
Validation of Uzbek SARC-F and IPAQ-SF Questionnaires in Adults With and Without Hypothyroidism
Hypothyroidism, Psychometrics
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia and Sarcopenic Obesity, run by Goztepe Training and Research Hospital 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 2 inclusion and 2 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 28 Feb 2020. 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. 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?
Handgrip Strength (time frame: 10 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04122638, which also lists 1 linked publication.
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 28 Feb 2020; AzTrials last refreshed its copy on 8 Nov 2026.