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SarcopeniaNCT06122818

Evaluation of Sarcopenia in Patients Receiving Home Health Care

An observational study of Sarcopenia and Home Health Care, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Sarcopenia, Home Health Care
What is being tested?
Immobile patients receiving home health care
How many people
120 participants
Where
1 siteTurkey (Türkiye)
Study dates
6 Nov 2023to 5 Oct 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Immobile patients receiving home health care

Who may be able to join

  • 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

Who cannot join

  • 1) Patients who cannot cooperate

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Istanbul Physical Medicine Rehabilitation Training and Research Hospital

    Istanbul, 34192

Other trials in Turkey (Türkiye)

About this study

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.

Read the detailed description

Home Health Service is the provision of health services needed by immobile and chronic disease patients in the home environment. The purpose of this service is not to diagnose the patient, but rather to follow up, implement and educate the treatment of the diagnosed patient.

The aim of 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.

Being tested
Immobile patients receiving home health care
Keywords
Sarcopenia, home health care
Medical subject headings
Sarcopenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Immobile patients receiving home health careOther

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: three months

  2. 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

    Measured: three months

  3. 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

    Measured: three months

  4. 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

    Measured: three months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2023
  2. Study start6 Nov 2023
  3. Primary completion1 Oct 2024
  4. Study completion5 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06122818
Sponsor's protocol ID
IstanbulPMRTRHomecare-srcpn
Status last verified
Nov 2024
First submitted
3 Nov 2023
Last updated
20 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36554892

  • 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.

    PubMed 34379741

  • 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.

    PubMed 35029041

  • 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.

    PubMed 29555099

  • 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.

    PubMed 33183542

Questions about this trial

What is this clinical trial studying?

An observational study of Sarcopenia and Home Health Care, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

handgrip strength (time frame: three months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06122818, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.

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