End Stage Kidney DiseaseNCT04669184
Sarcopenia and Physical Performance in Hemodialysis Patients
An observational study of End Stage Kidney Disease, run by Hacettepe University.
Trial summary
Many systems such as the cardiovascular, pulmonary, musculoskeletal, hematological, immunological, gastrointestinal, central nervous system are affected due to decreased kidney function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Kidney Disease
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2021to 1 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- Having been diagnosed with end stage kidney disease
- Receiving hemodialysis for more than 3 months
- Being clinically stable
- Volunteering to participate in the research
Who cannot join
- Having an orthopedic disease that may affect functional capacity
- Having cardiac event in the past 3 months
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- End Stage Kidney Disease
- Keywords
- sarcopenia, pain, physical performance
- Medical subject headings
- Kidney Failure, Chronic, Sarcopenia, Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Sarcopenia
Sarcopenia will be evaluated using SARC-F questionnaire. For SARC-F, a total score of ≥ 4 indicates sarcopenia.
Measured: 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.
Measured: 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
Measured: 5 minutes
Pain level
Pain will be evaluated using Short-form McGill Pain questionnaire
Measured: 5 minutes
Secondary outcomes (5)
Peripheral muscle strength
Knee extensor and hand grip strength will be evaluated using dynamometer.
Measured: 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.
Measured: 10 minutes
Physical activity level
Physical activity level will be evaluated using International Physical Activity Questionnaire-Short Form
Measured: 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
Measured: 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.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start1 Jan 2021 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Firat, Hacettepe University
- Investigators
- Merve Firat, MSc, Principal investigator, Hacettepe UniversityNaciye Vardar-Yagli, PhD, Study director, Hacettepe UniversityDeniz İnal-İnce, Professor, Study chair, Hacettepe UniversityTolga Yildirim, MD, Study chair, Hacettepe UniversityMelda Saglam, PhD, Study chair, Hacettepe UniversityEbru Calik-Kütükcü, PhD, Study chair, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04669184
- Sponsor's protocol ID
- GO 20/338
- Status last verified
- Dec 2020
- First submitted
- 3 Jul 2020
- Last updated
- 16 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Sarcopenia, Physical Performance and Cognitive Function in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT04669184
- Acronym / sponsor ID
- GO 20/338
- Conditions
- End Stage Kidney Disease
- Keywords
- sarcopenia, pain, physical performance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 16 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- Having been diagnosed with end stage kidney disease
- Receiving hemodialysis for more than 3 months
- Being clinically stable
- Volunteering to participate in the research
Key exclusion criteria (2 listed)
- Having an orthopedic disease that may affect functional capacity
- Having cardiac event in the past 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sarcopenia
Time frame: 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.
Time frame: 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.
Time frame: 5 minutes
1 minute sit to stand test, the maximum number of repetitions within the established time was recorded
Pain level
Time frame: 5 minutes
Pain will be evaluated using Short-form McGill Pain questionnaire
5 secondary outcomes
Peripheral muscle strength
Time frame: 5 minutes
Cognitive function
Time frame: 10 minutes
Physical activity level
Time frame: 5 minutes
Fragility
Time frame: 5 minutes
Activities of daily living
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merve Firat, MSc principal investigator
Hacettepe University
Naciye Vardar-Yagli, PhD study director
Hacettepe University
Deniz İnal-İnce, Professor study chair
Hacettepe University
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Kidney Disease, run by Hacettepe University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Merve Firat (+903123051576, mervefirat@hacettepe.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sarcopenia (time frame: 5 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2020.