NCT06277193

Brief Summary

This study (study type: cross-sectional) aims to investigate the relationship of sarcopenia level with balance, fear of falling and risk of falling in the elderly female population. In the first stage, 166 participants were divided into two groups: sarcopenia and non-sarcopenia. Afterwards, they were categorized according to sarcopenia level (probable sarcopenia group, sarcopenia group, severe sarcopenia group, group without sarcopenia) and comparisons were made between these subgroups. Then, they were evaluated with various scales and tests (in terms of balance, fear of falling and risk of falling).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
166

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2020

Typical duration 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

Study Start

First participant enrolled

November 3, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 26, 2024

Completed
Last Updated

February 26, 2024

Status Verified

February 1, 2024

Enrollment Period

2.1 years

First QC Date

February 10, 2024

Last Update Submit

February 17, 2024

Conditions

Keywords

SarcopeniaOldBalanceFear of fallingFalling risk

Outcome Measures

Primary Outcomes (4)

  • Sociodemographic data

    A form was created to determine the sociodemographic characteristics of the patients. In addition, data on the number of falls and fractures in the last year was also obtained in this form.

    During the initial evaluation of the patients, their information was recorded in approximately 1 hour.

  • Berg Balance Scale(BBS)

    The Berg balance scale was initially developed to evaluate postural control and is now widely used in many fields. Scoring is done on a 5-point scale that evaluates whether the patient can perform the task safely and independently within a certain period of time. 0 points are given for unrealizable performances and 4 points are given for normal performances. The points given are added together to obtain the maximum score. 0-20 points indicate high fall risk, 21-40 points indicate medium fall risk, 41-56 points indicate low fall risk.

    During the initial evaluation of the patients, their information was recorded in approximately 1 hour.

  • Falls Efficacy Scale (FES)

    Developed based on low perceived self-efficacy, FES is a reliable and valid method to measure fear of falling. Such as taking a bath, taking a shower, reaching shelves, walking around the house, preparing meals without carrying heavy or hot objects, getting in and out of bed, answering the door or telephone ring, sitting on a chair and getting up, dressing and undressing, going to the toilet and leaving the toilet, personal care. Patients are asked to rate their daily living activities. The points given are evaluated between "1 point I trust very much" and "10 points I do not trust at all", the scores between 0 and 10 are summed and the resulting score is recorded.

    During the initial evaluation of the patients, their information was recorded in approximately 1 hour.

  • Balance and Gait Assessment Scale

    This scale is an important tool to evaluate the individual's functional status and daily living activities. The scale consists of a maximum of 16 points for balance and a maximum of 12 points for walking, for a total of 28 points. Individuals who score 26 or below on the scale are thought to have a problem; For those with scores of 19 or below, it is observed that the risk of self-falling increases fivefold compared to normal individuals.

    During the initial evaluation of the patients, their information was recorded in approximately 1 hour.

Secondary Outcomes (12)

  • Biochemical data

    During the initial evaluation of the patients, their information was recorded in approximately 1 hour.

  • Co-morbidities

    During the initial evaluation of the patients, their information was recorded in approximately 1 hour.

  • Number of drugs

    During the initial evaluation of the patients, their information was recorded in approximately 1 hour.

  • Basic activities of daily living (Katz)

    During the initial evaluation of the patients, their information was recorded in approximately 1 hour.

  • Instrumental activities of living (Lawton-Brody; IADL)

    During the initial evaluation of the patients, their information was recorded in approximately 1 hour.

  • +7 more secondary outcomes

Study Arms (4)

Non-sarcopenia group

The diagnosis of sarcopenia was determined using EWGSOP2(The European Working Group on Sarcopenia in Older People) criteria. To evaluate walking speed, muscle strength and muscle mass, hand grip test, bioimpedance and 4-meter walking test were performed on each patient, respectively. Those who had results above the critical values determined in muscle strength measurement according to criteria were defined as the group without sarcopenia.

Diagnostic Test: valuation of balance status, fear of falling and risk of falling in patients non-sarcopenia.

Probable sarcopenia group

Individuals with results below the critical values determined in muscle strength measurement were defined as the probable sarcopenia group if their muscle mass and physical performance values were normal.

Diagnostic Test: Evaluation of balance status, fear of falling and risk of falling in patients with probable sarcopenia.

Sarcopenia group

If low muscle mass is present in addition to the decrease in muscle strength, this condition is classified as sarcopenia.

Diagnostic Test: Evaluation of balance status, fear of falling and risk of falling in patients with sarcopenia.

Severe sarcopenia group

If there is a decrease in muscle mass and physical performance along with muscle strength, this condition can be classified as severe sarcopenia.

Diagnostic Test: Evaluation of balance status, fear of falling and risk of falling in patients with severe sarcopenia.

Interventions

Daily living activities, frailty, physical performance, balance status, risk of falling, fear of falling, nutritional status, and mental status were evaluated with various scales.

Non-sarcopenia group

Daily living activities, frailty, physical performance, balance status, risk of falling, fear of falling, nutritional status, and mental status were evaluated with various scales.

Probable sarcopenia group

Daily living activities, frailty, physical performance, balance status, risk of falling, fear of falling, nutritional status, and mental status were evaluated with various scales.

Sarcopenia group

Daily living activities, frailty, physical performance, balance status, risk of falling, fear of falling, nutritional status, and mental status were evaluated with various scales.

Severe sarcopenia group

Eligibility Criteria

Age65 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

208 patients who applied to the outpatient clinic were examined for eligibility for the study. During the detailed evaluation process, patients who did not meet the exclusion criteria (communication problems, etc.) and did not want to participate in the study were excluded from the study. Detailed histories were taken from the remaining 166 participants and physical examinations were performed.

You may qualify if:

  • Being over 60 years old
  • Being a woman

You may not qualify if:

  • Those under 60 years of age
  • Male ones
  • Hand deformities
  • Advanced knee osteoarthritis
  • Advanced hand osteoarthritis
  • Advanced osteoarthritis in the waist and hip area
  • History of Carpal Tunnel Syndrome
  • Communication disorders
  • Muscle diseases
  • Root compressions
  • History of upper and lower extremity spine surgery, prostheses and previous fracture history
  • Those with advanced kyphosis and scoliosis
  • Those with serious neck problems
  • Lumbar spinal stenosis
  • Those with decompensated heart, liver and kidney failure
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konya Beyhekim Training and Research Hospital Physical Medicine and Rehabilitation Clinic

Selçuklu, Konya, Turkey (Türkiye)

Location

Related Publications (18)

  • Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13.

    PMID: 20392703BACKGROUND
  • Cruz-Jentoft AJ, Landi F, Schneider SM, Zuniga C, Arai H, Boirie Y, Chen LK, Fielding RA, Martin FC, Michel JP, Sieber C, Stout JR, Studenski SA, Vellas B, Woo J, Zamboni M, Cederholm T. Prevalence of and interventions for sarcopenia in ageing adults: a systematic review. Report of the International Sarcopenia Initiative (EWGSOP and IWGS). Age Ageing. 2014 Nov;43(6):748-59. doi: 10.1093/ageing/afu115. Epub 2014 Sep 21.

    PMID: 25241753BACKGROUND
  • Batsis JA, Buscemi S. Sarcopenia, sarcopenic obesity and insulin resistance. Medical Complications of Type 2 Diabetes: IntechOpen; 2011. p. 233-56

    BACKGROUND
  • Abellan van Kan G. Epidemiology and consequences of sarcopenia. J Nutr Health Aging. 2009 Oct;13(8):708-12. doi: 10.1007/s12603-009-0201-z.

    PMID: 19657554BACKGROUND
  • Metter EJ, Conwit R, Tobin J, Fozard JL. Age-associated loss of power and strength in the upper extremities in women and men. J Gerontol A Biol Sci Med Sci. 1997 Sep;52(5):B267-76. doi: 10.1093/gerona/52a.5.b267.

    PMID: 9310077BACKGROUND
  • Rolland Y, Lauwers-Cances V, Cournot M, Nourhashemi F, Reynish W, Riviere D, Vellas B, Grandjean H. Sarcopenia, calf circumference, and physical function of elderly women: a cross-sectional study. J Am Geriatr Soc. 2003 Aug;51(8):1120-4. doi: 10.1046/j.1532-5415.2003.51362.x.

    PMID: 12890076BACKGROUND
  • Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.

    PMID: 30312372BACKGROUND
  • ŞAHİN G, ŞEKER H, YEŞİLIRMAK M, ÇADIR A. Denge diski egzersizlerinin dinamik denge ve duruş kontrolü üzerindeki etkisinin incelenmesi. Spor ve performans araştırmaları dergisi. 2015;6(1):50-7.

    BACKGROUND
  • Alkan S. 65 yaş ve üstü bireylerde D vitamini düzeyi ile düşme riski arasındaki ilişki. 2009.

    BACKGROUND
  • Akman MN, Karataş M. Temel ve uygulanan kinezyoloji: Haberal Eğitim Vakfı; 2003.

    BACKGROUND
  • Stel VS, Smit JH, Pluijm SM, Lips P. Balance and mobility performance as treatable risk factors for recurrent falling in older persons. J Clin Epidemiol. 2003 Jul;56(7):659-68. doi: 10.1016/s0895-4356(03)00082-9.

    PMID: 12921935BACKGROUND
  • ÇINARLI T, Zeliha K. 65 Yaş Ve Üzeri Yaşlılarda Düşme Risk Ve Korkusunun Günlük Yaşam Aktiviteleri Ve Yaşam Kalitesi Üzerine Etkisi. Gümüşhane Üniversitesi Sağlık Bilimleri Dergisi. 2015;4(4):660-79.

    BACKGROUND
  • Tinetti ME, Williams TF, Mayewski R. Fall risk index for elderly patients based on number of chronic disabilities. Am J Med. 1986 Mar;80(3):429-34. doi: 10.1016/0002-9343(86)90717-5.

    PMID: 3953620BACKGROUND
  • Schepens S, Sen A, Painter JA, Murphy SL. Relationship between fall-related efficacy and activity engagement in community-dwelling older adults: a meta-analytic review. Am J Occup Ther. 2012 Mar-Apr;66(2):137-48. doi: 10.5014/ajot.2012.001156.

    PMID: 22394523BACKGROUND
  • Carpenter CR. Evidence-based emergency medicine/systematic review abstract. Preventing falls in community-dwelling older adults. Ann Emerg Med. 2010 Mar;55(3):296-8. doi: 10.1016/j.annemergmed.2009.06.014. Epub 2009 Jul 17. No abstract available.

    PMID: 19615786BACKGROUND
  • Oh-Park M, Xue X, Holtzer R, Verghese J. Transient versus persistent fear of falling in community-dwelling older adults: incidence and risk factors. J Am Geriatr Soc. 2011 Jul;59(7):1225-31. doi: 10.1111/j.1532-5415.2011.03475.x. Epub 2011 Jun 30.

    PMID: 21718266BACKGROUND
  • Cawthon PM, Marshall LM, Michael Y, Dam TT, Ensrud KE, Barrett-Connor E, Orwoll ES; Osteoporotic Fractures in Men Research Group. Frailty in older men: prevalence, progression, and relationship with mortality. J Am Geriatr Soc. 2007 Aug;55(8):1216-23. doi: 10.1111/j.1532-5415.2007.01259.x.

    PMID: 17661960BACKGROUND
  • Cawthon PM, Fox KM, Gandra SR, Delmonico MJ, Chiou CF, Anthony MS, Sewall A, Goodpaster B, Satterfield S, Cummings SR, Harris TB; Health, Aging and Body Composition Study. Do muscle mass, muscle density, strength, and physical function similarly influence risk of hospitalization in older adults? J Am Geriatr Soc. 2009 Aug;57(8):1411-9. doi: 10.1111/j.1532-5415.2009.02366.x.

    PMID: 19682143BACKGROUND

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Fatih güreş

    assistant doctor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Doctor

Study Record Dates

First Submitted

February 10, 2024

First Posted

February 26, 2024

Study Start

November 3, 2020

Primary Completion

December 1, 2022

Study Completion

September 28, 2023

Last Updated

February 26, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations