Sarcopenia and Physical Performance in Hemodialysis Patients

Assessment of Sarcopenia, Physical Performance and Cognitive Function in Hemodialysis Patients

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.

Study Overview

• Status: Unknown
• Conditions: End Stage Kidney Disease

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 Type: Observational
• Enrollment (Anticipated): 26

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peripheral muscle strength	Knee extensor and hand grip strength will be evaluated using dynamometer.	5 minutes
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.	10 minutes
Physical activity level	Physical activity level will be evaluated using International Physical Activity Questionnaire-Short Form	5 minutes
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	5 minutes
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.	10 minutes

Collaborators and Investigators

• Sponsor: Hacettepe University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2021
• Primary Completion (ANTICIPATED): December 1, 2021
• Study Completion (ANTICIPATED): March 1, 2022

Study Registration Dates

• First Submitted: July 3, 2020
• First Submitted That Met QC Criteria: December 14, 2020
• First Posted (ACTUAL): December 16, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 16, 2020
• Last Update Submitted That Met QC Criteria: December 14, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: pain; physical performance; sarcopenia
• Additional Relevant MeSH Terms: Nervous System Diseases; Urologic Diseases; Neurologic Manifestations; Renal Insufficiency; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Renal Insufficiency, Chronic; Muscular Atrophy; Atrophy; Kidney Diseases; Kidney Failure, Chronic; Sarcopenia
• Other Study ID Numbers: GO 20/338

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No