NCT06398704

Brief Summary

The aim of our study is to examine the effects of sarcopenia and dynapenia on inspiratory muscle strength and cardiorespiratory fitness in geriatric individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

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
2 days until next milestone

Study Start

First participant enrolled

April 30, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 3, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2024

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

September 27, 2024

Status Verified

September 1, 2024

Enrollment Period

2 months

First QC Date

April 28, 2024

Last Update Submit

September 25, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Ultrasonography Evaluation

    Anterior thigh muscle thickness will be measured to evaluate sarcopenia. The obtained value will be divided by the Body Mass Index. 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

  • Evaluation of Inspiratory Muscle Strength

    Powerbreathe K5 device was used to evaluate inspiratory muscle strength. This device is a portable, easy-to-use, accessible and reliable device used for both education and treatment purposes and evaluation purposes.

    Baseline

  • 2 Minute Step Test:

    The purpose of this test is to elevate the knees to the midpoint between the patella and the anterior-superior iliac crest. The 2 Minute Step Test is valid and reliable for assessing cardiorespiratory fitness in older adults.

    Baseline

Study Arms (3)

Sarcopenia Group

Individuals with sarcopenia according to the ISarcoPRM algorithm using the STAR method and Hand-grip

Other: Standart of care

Dinapenia Group

Individuals with dynapenia according to the ISarcoPRM algorithm using the STAR method and Hand-grip

Other: Standart of care

Non-sarcopenia Group

Individuals with non-sarcopenia according to the ISarcoPRM algorithm using the STAR method and Hand-grip

Other: Standart of care

Interventions

No additional intervention was made. An evaluation was made.

Dinapenia GroupNon-sarcopenia GroupSarcopenia Group

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersNo
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 Assessment
  • Ability to stand without assistance for at least 90 seconds

You may not qualify if:

  • Inability to communicate verbally
  • Using a walking aid
  • Older adults 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 (4)

  • Ohara DG, Pegorari MS, Oliveira Dos Santos NL, de Fatima Ribeiro Silva C, Monteiro RL, Matos AP, Jamami M. Respiratory Muscle Strength as a Discriminator of Sarcopenia in Community-Dwelling Elderly: A Cross-Sectional Study. J Nutr Health Aging. 2018;22(8):952-958. doi: 10.1007/s12603-018-1079-4.

    PMID: 30272099BACKGROUND
  • Sawaya Y, Shiba T, Ishizaka M, Hirose T, Sato R, Kubo A, Urano T. Sarcopenia is not associated with inspiratory muscle strength but with expiratory muscle strength among older adults requiring long-term care/support. PeerJ. 2022 Feb 17;10:e12958. doi: 10.7717/peerj.12958. eCollection 2022.

    PMID: 35194529BACKGROUND
  • Kara M, Kaymak B, Frontera W, Ata AM, Ricci V, Ekiz T, Chang KV, Han DS, Michail X, Quittan M, Lim JY, Bean JF, Franchignoni F, Ozcakar L. Diagnosing sarcopenia: Functional perspectives and a new algorithm from the ISarcoPRM. J Rehabil Med. 2021 Jun 21;53(6):jrm00209. doi: 10.2340/16501977-2851.

    PMID: 34121127BACKGROUND
  • 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

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
  • Hülya Arıkan, Prof.Dr.

    Atılım University

    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 3, 2024

Study Start

April 30, 2024

Primary Completion

June 20, 2024

Study Completion

June 30, 2024

Last Updated

September 27, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations