Sarcopenia and Physical Performance in Hemodialysis Patients

• Conditions: End Stage Kidney Disease

• Registration Number: NCT04669184
• Lead Sponsor: Hacettepe University

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2020-07-03
• Status Verified: 2020-12
• Study First Submitted QC: 2020-12-14
• Last Update Submitted: 2020-12-14
• Study First Posted: 2020-12-16
• Last Update Posted: 2020-12-16
• Study Start: 2021-01-01
• Primary Completion: 2021-12-01
• Study Completion: 2022-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 26

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

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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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sarcopenia	5 minutes	Sarcopenia will be evaluated using SARC-F questionnaire. For SARC-F, a total score of ≥ 4 indicates sarcopenia.
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.
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
Pain level	5 minutes	Pain will be evaluated using Short-form McGill Pain questionnaire

Secondary Outcome Measures

Name	Time	Method
Peripheral muscle strength	5 minutes	Knee extensor and hand grip strength will be evaluated using dynamometer.
Physical activity level	5 minutes	Physical activity level will be evaluated using International Physical Activity Questionnaire-Short Form
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.
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.
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