NCT05758792

Brief Summary

The aim of the study was to investigate the effects of muscle quality on fear of fall, and lower extremity functionality in older women. The differences between muscle quality, fear of falling and lower extremity functionality in the elderly male and female participating in the study were investigated. Older women had worse muscle quality, higher fall concern and less lower extremity functionality than older men.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
168

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

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

Study Start

First participant enrolled

January 20, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 26, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 7, 2023

Completed
Last Updated

March 7, 2023

Status Verified

March 1, 2023

Enrollment Period

7 months

First QC Date

November 25, 2022

Last Update Submit

March 6, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Muscle Quality Index

    Muscle Quality Index scored is calculated through anthropometric measurements of older adults. The muscle quality depends on the formula as follows: MQI (Watts) = ((Leg length×0.4)×Body mass×gravity ×10)/ Five Times Sit To Stand.

    6 months

  • Lower Extremity Functional Scale

    LEFS presents 20 questions about daily living activities. The questionnaire was developed to assess lower extremity functionality and can be used in older adults.The minimum and maximum total score ranges from 0 to 80. High scores show high functional status.

    6 months

  • International Fall Efficiency Scale

    The scale consist of items about fall concern during daily living activities. The minimum and maximum total score ranges from 16 to 64. High scores represents high fall concern.

    6 months

Interventions

Evaluations are applied to older adults to compare the results of muscle quality.

Also known as: Lower Extremity Functional Scale, International Fall Efficiency Scale

Eligibility Criteria

Age65 Years - 85 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsThis study was planned to investigate the effects of muscle quality on older women comparing to older men.
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Age-matched older men and women were included in the study.

You may qualify if:

  • Being 65 years old or older
  • Having no neurological, orthopedic, communicational,
  • Mental disability that affects the evaluations.

You may not qualify if:

  • Incomplete data and older adults not agreeing to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, Pamukkale, 20160, Turkey (Türkiye)

Location

Related Publications (3)

  • Binkley JM, Stratford PW, Lott SA, Riddle DL. The Lower Extremity Functional Scale (LEFS): scale development, measurement properties, and clinical application. North American Orthopaedic Rehabilitation Research Network. Phys Ther. 1999 Apr;79(4):371-83.

  • Fragala MS, Fukuda DH, Stout JR, Townsend JR, Emerson NS, Boone CH, Beyer KS, Oliveira LP, Hoffman JR. Muscle quality index improves with resistance exercise training in older adults. Exp Gerontol. 2014 May;53:1-6. doi: 10.1016/j.exger.2014.01.027. Epub 2014 Feb 6.

  • Gadelha AB, Neri SGR, Nobrega OT, Pereira JC, Bottaro M, Fonseca A, Lima RM. Muscle quality is associated with dynamic balance, fear of falling, and falls in older women. Exp Gerontol. 2018 Apr;104:1-6. doi: 10.1016/j.exger.2018.01.003. Epub 2018 Jan 9. No abstract available.

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Güzin Kara Çakıcı, PhD

    Pamukkale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT., PhD.

Study Record Dates

First Submitted

November 25, 2022

First Posted

March 7, 2023

Study Start

January 20, 2021

Primary Completion

August 30, 2021

Study Completion

August 26, 2022

Last Updated

March 7, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

There is no plan to make individual participant data.

Locations