Sarcopenia and Physical Performance in Hemodialysis Patients

NCT04669184 | Unknown

• 1 other identifier: GO 20/338
• Study Type: observational
• Target: 26
• Locations: 0 countries
• Sites: N/A

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.

Conditions

End Stage Kidney Disease

Keywords

sarcopenia; pain; physical performance

Outcome Measures

Primary Outcomes (4)

• Sarcopenia

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

  5 minutes

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

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

  10 minutes

• 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

  5 minutes

• Pain level

  Pain will be evaluated using Short-form McGill Pain questionnaire

  5 minutes

Secondary Outcomes (5)

• Peripheral muscle strength

  5 minutes

• Cognitive function

  10 minutes

• Physical activity level

  5 minutes

• Fragility

  5 minutes

• Activities of daily living

  10 minutes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hacettepe University: lead

MeSH Terms

Conditions

Kidney Failure, Chronic; Sarcopenia; Pain

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Study Officials

• Merve Firat, MSc

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Naciye Vardar-Yagli, PhD

  Hacettepe University

  STUDY DIRECTOR

• 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 CHAIR

Central Study Contacts

Merve Firat

CONTACT

+903123051576; mervefirat@hacettepe.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 3, 2020
• First Posted: December 16, 2020
• Study Start: January 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: March 1, 2022
• Last Updated: December 16, 2020

Record last verified: 2020-12