Sarcopenia and Physical Performance in Hemodialysis Patients

Sponsor
Hacettepe University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04669184
Collaborator
(none)
26
13.9

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    26 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Assessment of Sarcopenia, Physical Performance and Cognitive Function in Hemodialysis Patients
    Anticipated Study Start Date :
    Jan 1, 2021
    Anticipated Primary Completion Date :
    Dec 1, 2021
    Anticipated Study Completion Date :
    Mar 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Sarcopenia [5 minutes]

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

    2. Physical performance will be evaluated using Short physical performance battery. [10 minutes]

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

    3. Physical performance will be evaluated using 1 minute sit to stand test. [5 minutes]

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

    4. Pain level [5 minutes]

      Pain will be evaluated using Short-form McGill Pain questionnaire

    Secondary Outcome Measures

    1. Peripheral muscle strength [5 minutes]

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

    2. Cognitive function [10 minutes]

      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.

    3. Physical activity level [5 minutes]

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

    4. Fragility [5 minutes]

      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

    5. Activities of daily living [10 minutes]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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:
    • Having an orthopedic disease that may affect functional capacity

    • Having cardiac event in the past 3 months

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Hacettepe University

    Investigators

    • Principal Investigator: Merve Firat, MSc, Hacettepe University
    • Study Director: Naciye Vardar-Yagli, PhD, Hacettepe University
    • Study Chair: Deniz İnal-İnce, Professor, Hacettepe University
    • Study Chair: Tolga Yildirim, MD, Hacettepe University
    • Study Chair: Melda Saglam, PhD, Hacettepe University
    • Study Chair: Ebru Calik-Kütükcü, PhD, Hacettepe University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Merve Firat, Principal Investigator, Hacettepe University
    ClinicalTrials.gov Identifier:
    NCT04669184
    Other Study ID Numbers:
    • GO 20/338
    First Posted:
    Dec 16, 2020
    Last Update Posted:
    Dec 16, 2020
    Last Verified:
    Dec 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Merve Firat, Principal Investigator, Hacettepe University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 16, 2020