NCT06122818

Brief Summary

The aim in the study is to evaluate the presence of sarcopenia in patients receiving home health care; To evaluate the relationship between sarcopenia and age, disease duration, and cause of immobility. In the literature review, a limited number of studies evaluating sarcopenia in home health patients were found.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2023

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

November 3, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

November 6, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 8, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2024

Completed
Last Updated

November 20, 2024

Status Verified

November 1, 2024

Enrollment Period

11 months

First QC Date

November 3, 2023

Last Update Submit

November 18, 2024

Conditions

Keywords

Sarcopeniahome health care

Outcome Measures

Primary Outcomes (4)

  • handgrip strength

    Handgrip strength will be measured using a hand grip dynamometer. Measurements will be taken 3 times in a sitting position with the elbow flexed to 90° and the wrist in neutral position. The measured maximal grip strength will be recorded as hand grip strength. The measurement will be repeated 3 months after the first measurement

    three months

  • calf circumference

    Calf circumference is an anthropometric measurement that indicates fat free muscle mass and has been considered by the World Health Organization (WHO) the most sensitive index for evaluating the decrease in muscle mass. Calf circumference will be measured with an elastic band over the subject's right leg, both sitting and standing. The measurement will be repeated 3 months after the first measurement

    three months

  • Body Mass Index (BMI)

    BMI will be calculated as weight (kg) divided by height2 (m2). The measurement will be repeated 3 months after the first measurement

    three months

  • Skeletal muscle mass

    Skeletal muscle mass will be evaluated using a multi-frequency body composition analysis device. The measurement will be repeated 3 months after the first measurement

    three months

Interventions

Demographic characteristics, duration of immobility, sarcopenia presence, thigh circumference , Hand grip strength , bioelectrical impedance analysis

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Immobile patients receiving home health care

You may qualify if:

  • Receiving home health care
  • Being at the mental and physical activity level to be able to perform and complete the tests
  • Being 18-85 years old

You may not qualify if:

  • \) Patients who cannot cooperate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Istanbul, 34192, Turkey (Türkiye)

Location

Related Publications (5)

  • Hua N, Zhang Y, Tan X, Liu L, Mo Y, Yao X, Wang X, Wiley J, Wang X. Nutritional Status and Sarcopenia in Nursing Home Residents: A Cross-Sectional Study. Int J Environ Res Public Health. 2022 Dec 18;19(24):17013. doi: 10.3390/ijerph192417013.

    PMID: 36554892BACKGROUND
  • De Spiegeleer A, Kahya H, Sanchez-Rodriguez D, Piotrowicz K, Surquin M, Marco E, Detremerie C, Hussein D, Hope S, Dallmeier D, Decker G, Hrnciarikova D, Czesak J, Toscano-Rico M, Meza-Valderrama D, Bahat G, Descamps A, Wynendaele E, Elewaut D, Vankova H, Landi F, Benoit F, Gasowski J, Van Den Noortgate N. Acute sarcopenia changes following hospitalization: influence of pre-admission care dependency level. Age Ageing. 2021 Nov 10;50(6):2140-2146. doi: 10.1093/ageing/afab163.

    PMID: 34379741BACKGROUND
  • Thompson MQ, Jadczak AD, Yu S, Tucker GR, Visvanathan R. Sarcopenia risk in nursing home residents using SARC-F: FIRST study findings. Geriatr Gerontol Int. 2022 Mar;22(3):206-212. doi: 10.1111/ggi.14327. Epub 2022 Jan 13.

    PMID: 35029041BACKGROUND
  • Kamo T, Ishii H, Suzuki K, Nishida Y. Prevalence of sarcopenia and its association with activities of daily living among japanese nursing home residents. Geriatr Nurs. 2018 Sep-Oct;39(5):528-533. doi: 10.1016/j.gerinurse.2018.02.011. Epub 2018 Mar 16.

    PMID: 29555099BACKGROUND
  • Fashho E, Ahmed T, Garden G, Readman D, Storey L, Wilkinson L, Wilson G, Slee A. Investigating the prevalence of malnutrition, frailty and physical disability and the association between them amongst older care home residents. Clin Nutr ESPEN. 2020 Dec;40:231-236. doi: 10.1016/j.clnesp.2020.09.014. Epub 2020 Sep 22.

    PMID: 33183542BACKGROUND

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

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

Study Officials

  • Tugba aydın

    Istanbul Physical Medicine Rehabilitation Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 3, 2023

First Posted

November 8, 2023

Study Start

November 6, 2023

Primary Completion

October 1, 2024

Study Completion

October 5, 2024

Last Updated

November 20, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations