Sarcopenia and Physical Performance in Hemodialysis Patients

End Stage Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04669184
• Other study ID #: GO 20/338
• Status: Not yet recruiting
• Start date: January 1, 2021
• Est. completion date: March 1, 2022

Study information

• Verified date: December 2020
• Source: Hacettepe University
• Contact: Merve Firat
• Phone: +903123051576
• Email: mervefirat[@]hacettepe.edu.tr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 26
• Est. completion date: March 1, 2022
• Est. primary completion date: December 1, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End Stage Kidney Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Sarcopenia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sarcopenia	Sarcopenia will be evaluated using SARC-F questionnaire. For SARC-F, a total score of = 4 indicates sarcopenia.	5 minutes
Primary	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
Primary	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
Primary	Pain level	Pain will be evaluated using Short-form McGill Pain questionnaire	5 minutes
Secondary	Peripheral muscle strength	Knee extensor and hand grip strength will be evaluated using dynamometer.	5 minutes
Secondary	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
Secondary	Physical activity level	Physical activity level will be evaluated using International Physical Activity Questionnaire-Short Form	5 minutes
Secondary	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
Secondary	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