NCT06394648

Brief Summary

To examine the sarcopenia and physical fitness levels of geriatric individuals living in nursing homes and at home. Considering these aims, our working hypotheses are; H1: There is a difference in sarcopenia level between geriatric individuals living in a nursing home and at home. H2: There is a difference in dynapenia levels between geriatric individuals living in a nursing home and at home. H3: There is a difference in physical fitness between geriatric individuals living in a nursing home and at home.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

April 28, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2024

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2024

Completed
Last Updated

August 19, 2024

Status Verified

August 1, 2024

Enrollment Period

2 months

First QC Date

April 28, 2024

Last Update Submit

August 16, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Ultrasonography Evaluation:

    Anterior thigh muscle thickness will be measured to evaluate sarcopenia. The obtained value will be divided by Body Mass Index (BMI). This evaluation method is referred to in the literature as the Sonographic T-high Adjustment Rate (STAR) method. Ultrasonographic measurements will be made by a physician with at least 10 years of experience in this field using linear probes.

    Baseline

  • Senior Fitness Test

    This test evaluates the level of functional fitness at which activities of daily living can be performed safely and independently without fatigue. In daily life, physiological parameters are related to performance. Senior Fitness Test evaluates physiological parameters such as muscle strength, flexibility, aerobic endurance, balance and body composition. Senior Fitness Test consists of seven subtests and determination of body composition: Chair sit-to-stand test, weight lifting test, six-minute walk or two-minute step test, chair sit-and-reach test, back scratching test, eight-step up-to-walk test and determination of body mass index.

    Baseline

Study Arms (2)

Geriatric individuals living in nursing homes

Geriatric individuals living in nursing homes will be included.

Geriatric individuals living at home

Geriatric individuals living at home will be included.

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Geriatric individuals

You may qualify if:

  • Getting a score between 24 and 30 on the Mini Mental State Exam
  • Living in a nursing home for at least six months (for nursing home residents)
  • Ability to stand without assistance for at least 90 seconds

You may not qualify if:

  • Inability to communicate verbally
  • Using a walking aid
  • Elderly people with severe visual impairment, neurological disorders and/or congestive heart failure
  • Older adults for whom exercise is not recommended

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atılım University

Ankara, Turkey (Türkiye)

Location

Related Publications (3)

  • Kara M, Kaymak B, Ata AM, Ozkal O, Kara O, Baki A, Sengul Aycicek G, Topuz S, Karahan S, Soylu AR, Cakir B, Halil M, Ozcakar L. STAR-Sonographic Thigh Adjustment Ratio: A Golden Formula for the Diagnosis of Sarcopenia. Am J Phys Med Rehabil. 2020 Oct;99(10):902-908. doi: 10.1097/PHM.0000000000001439.

    PMID: 32941253BACKGROUND
  • Wang JC, Wu WT, Chang KV, Chen LR, Chi SY, Kara M, Ozcakar L. Ultrasound Imaging for the Diagnosis and Evaluation of Sarcopenia: An Umbrella Review. Life (Basel). 2021 Dec 22;12(1):9. doi: 10.3390/life12010009.

    PMID: 35054402BACKGROUND
  • Kazoglu M, Yuruk ZO. Comparison of the physical fitness levels in nursing home residents and community-dwelling older adults. Arch Gerontol Geriatr. 2020 Jul-Aug;89:104106. doi: 10.1016/j.archger.2020.104106. Epub 2020 May 15.

    PMID: 32447125BACKGROUND

Study Officials

  • Süleyman Korkusuz, PhD

    Atılım University

    PRINCIPAL INVESTIGATOR
  • Özlem Yürük, Prof.Dr

    Baskent University

    STUDY CHAIR
  • Büşra Seçkinoğulları Korkusuz, MSc

    Hacettepe University

    STUDY CHAIR
  • Ferdi Yavuz, Assoc.Prof.

    European University of Lefke

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 28, 2024

First Posted

May 1, 2024

Study Start

April 28, 2024

Primary Completion

June 20, 2024

Study Completion

July 15, 2024

Last Updated

August 19, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations