CClinicalTrials.gg
Status unknownNCT04669184Updated Dec 16, 2020

Sarcopenia and Physical Performance in Hemodialysis Patients

An observational study in End Stage Kidney Disease, sponsored by Hacettepe University. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-16.

Sponsored by Hacettepe University · Observational

The sponsor has not verified this record recently (last verified Dec 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
26
Ages
18 Years and older
Sex
All
01

Study summary

Many systems such as the cardiovascular, pulmonary, musculoskeletal, hematological, immunological, gastrointestinal, central nervous system are affected due to decreased kidney function. The aim of this study was to investigate the relationship between physical performance and sarcopenia, peripheral muscle strength, activities of daily living, cognitive functions, physical activity level, fragility, pain in hemodialysis patients.

Read the detailed description

A high prevalence of sarcopenia has been reported in end stage kidney disease. The incidence of sarcopenia increases with age. Muscle atrophy is caused by an imbalance between the anabolic and catabolic processes in chronic kidney disease. Sarcopenia and physical inactivity progress synergistically. Decreased physical performance is associated with sarcopenia. In hemodialysis patients, daily physical activity level and physical performance decrease. Cognitive impairment is common in chronic kidney disease. Uremic toxins can cause a decrease in cognitive function. One of the most important problems associated with hemodialysis is pain and pain negatively affects functional capacity and quality of life.

02

Conditions studied

  • End Stage Kidney Disease

Keywords

  • sarcopenia
  • pain
  • physical performance
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In context

Sarcopenia

1,208 studies on the registry are indexed under Sarcopenia; 402 are open to participants now.

This study's planned enrollment of 26 is below the median of 120 across 419 observational studies indexed under Sarcopenia.

Browse Sarcopenia studies →

Lead sponsor

Hacettepe University is the lead sponsor of 983 studies on the registry; 212 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Probability sample

Study population

Patients aged 18 years and older, who are diagnosed with end stage kidney disease at the Hacettepe University, Faculty of Medicine, Department of Internal Diseases, Nephrology Subdivision

Inclusion criteria

  • Having been diagnosed with end stage kidney disease
  • Receiving hemodialysis for more than 3 months
  • Being clinically stable
  • Volunteering to participate in the research

Exclusion criteria

Exclusion Criteria:

  • Having an orthopedic disease that may affect functional capacity
  • Having cardiac event in the past 3 months
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
26 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Sarcopenia

    Sarcopenia will be evaluated using SARC-F questionnaire. For SARC-F, a total score of ≥ 4 indicates sarcopenia.

    Time frame: 5 minutes

  2. Physical performance will be evaluated using Short physical performance battery.

    The total score of Short physical performance battery ranges from 0 to 12.

    Time frame: 10 minutes

  3. Physical performance will be evaluated using 1 minute sit to stand test.

    1 minute sit to stand test, the maximum number of repetitions within the established time was recorded

    Time frame: 5 minutes

  4. Pain level

    Pain will be evaluated using Short-form McGill Pain questionnaire

    Time frame: 5 minutes

Secondary outcomes

  1. Peripheral muscle strength

    Knee extensor and hand grip strength will be evaluated using dynamometer.

    Time frame: 5 minutes

  2. Cognitive function

    Cognitive function will be evaluated using Standardized Mini-Mental State Examination. The test is a 30-point screening tool. Higher scores mean a better outcome.

    Time frame: 10 minutes

  3. Physical activity level

    Physical activity level will be evaluated using International Physical Activity Questionnaire-Short Form

    Time frame: 5 minutes

  4. Fragility

    Fragility will be evaluated using the five Fried frailty criteria (unintentional weight loss, exhaustion, weakness, slowness, low physical activity). The total score is interpreted as follows: 0 non-frail, 1-2 pre-frail and 3-5 frail

    Time frame: 5 minutes

  5. Activities of daily living

    Activities of daily living will be evaluated using Barthel Index for Activities of Daily Living.The total score is100 and higher scores mean a better outcome.

    Time frame: 10 minutes

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04669184
Lead sponsor
Hacettepe University
Responsible party
Merve Firat (Principal Investigator, Hacettepe University) — Principal investigator
First posted
Dec 16, 2020
Start date
Jan 1, 2021 (estimated)
Primary completion
Dec 1, 2021 (estimated)
Completion
Mar 1, 2022 (estimated)
Last update
Dec 16, 2020

Study contacts

Merve Firat
Contact
mervefirat@hacettepe.edu.tr
+903123051576
Merve Firat, MSc
principal investigator · Hacettepe University
Naciye Vardar-Yagli, PhD
study director · Hacettepe University
Deniz İnal-İnce, Professor
study chair · Hacettepe University
Tolga Yildirim, MD
study chair · Hacettepe University
Melda Saglam, PhD
study chair · Hacettepe University
Ebru Calik-Kütükcü, PhD
study chair · Hacettepe University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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