Hemodialysis ComplicationNCT05534542
Comparison of the Effectiveness of Intradialytic Core Stabilization and Aerobic Exercise in Hemodialysis Patients
A study testing exercıse in people with Hemodialysis Complication, run by Muş Alparslan University at 1 site in Turkey (Türkiye).
Trial summary
Purpose: To examine the effects of core stabilization and aerobic exercises on dialysis adequacy, functionality level, and quality of life in hemodialysis (HD) patients. The secondary aim of the study is to compare the effectiveness of intradialytic core stabilization and aerobic exercises in HD patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemodialysis Complication
- What is being tested?
- exercıse
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2022to 7 Oct 2022
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To receive HD treatment for a minimum of 6 months, for 4 hours per day, three days per week
- Being 18 years or older
- A score of 3 and/or below in the Sarcopenia Screening Test (SARC-F)
Who cannot join
- Having a history of myocardial infarction in the last 3 months
- Having angina pectoris, arrhythmia, or uncontrolled hypertension
- Having communication and/or cognitive issues that prevent them from meeting the requirements of the tests
- Becoming pregnant or going through infertility treatment
- Having a psychiatric diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
Purpose: To examine the effects of core stabilization and aerobic exercises on dialysis adequacy, functionality level, and quality of life in hemodialysis (HD) patients. The secondary aim of the study is to compare the effectiveness of intradialytic core stabilization and aerobic exercises in HD patients.
Materials and Methods: Patients who received hemodialysis treatment for 4 hours, 3 days a week were planned to be included in this randomized controlled study. Patients participating in the study will be randomly divided into 2 groups. Grup 1 was planned to be given core stabilization exercises during hemodialysis three times a week for eight weeks; Group 2 was planned to be given aerobic exercise during hemodialysis three times a week for eight weeks. It aimed to evaluate the patients in the weeks before the start of the treatment and the week after the end of the treatment. Personal information form for evaluation, dialysis adequacy, quality of life questionnaire-kidney disease quality of life-36, piper fatigue scale, hospital anxiety and depression scale (hads), Pittsburgh sleep scale, five times sit and stand test, 10 m walking test , tinetti balance and walking test, and 2-minute step test were planned to be used.
- Conditions
- Hemodialysis Complication
- Being tested
- exercıse
- Keywords
- hemodialysis, dialysis efficiency, fatigue, quality of life, sleep, functionality
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercıseOther
ıntradıalıtıc core stabılızatıon
| Study group | Role | What they receive |
|---|---|---|
| core stabılızatıon | Active comparator | use of ıntradıalıtıc core stabılızatıon ın hemodıalysıs patıents Receives: Other: exercıse |
| aerobıc exercıse | Active comparator | use of ıntradıalıtıc aerobıc exercıse ın hemodıalysıs patıents Receives: Other: exercıse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dialysis adequacy
Dialysis adequacy is determined as the urea reduction rate (URR) and unitless Kt/V value. In calculating the Kt/V value; K-is the urea clearance coefficient of the dialyzer (ml/min), t refers to dialysis time (min), and V signifies the urea distribution volume (ml).
Measured: one month
Kidney Disease Quality of Life-36 (KDQOL-36)
The KDQOL-36 is a measure of kidney disease-related quality of life that comprises four subscales: generic core [Physical Component Summary (PCS, 12 items) and Mental Component Summary (MCS, 12 items)]; Symptoms/Problems (12 items); Burden of Kidney Disease (4 items), and Effects of Kidney Disease (8 items).
Measured: Two months
Five times sit-to-stand test
The Five-Times Sit to Stand Test measures one aspect of transfer skill. The test provides a method to quantify functional lower extremity strength and/or identify movement strategies a patient uses to complete transitional movements.
Measured: Two months
2 Minute Step Test
The test, known as the 2-minute step test (TMST), simply requires that tested individuals march in place as fast as possible for 2 minutes while lifting their knees to a height midway between their patella and iliac crest when standing.
Measured: Two months
10 Metre Walk Test
The 10 meter walk test is a performance measure used to assess walking speed in meters per second over a short distance. It can be employed to determine functional mobility, gait, and vestibular function.
Measured: Two months
Secondary outcomes (4)
Piper Fatigue Scale
The Piper Fatigue Scale (PFS) is one of the commonly used multidimensional fatigue measures and includes subdomains of behavioral, affective, sensory, and cognitive/mood attributes of fatigue.
Measured: Two months
Hospital Anxiety and Depression Scale (HADS)
The HADS was developed to detect states of anxiety and depression in hospitalized patients. The measure was designed to exclude items that might conflate anxiety or depression with physical health problems.
Measured: Two months
Pittsburgh Sleep Quality Index (PSQI)
PSQI is a self-rated questionnaire that assesses sleep quality and disturbances over a 1-month time interval.
Measured: Two months
Tinetti Gait and Balance Test
The Tinetti assessment tool is an easily administered, task-oriented test that measures an adult's gait and balance abilities. To assess balance, the patient is seated in a firm, armless chair. stand next to the patient to evaluate the gait. The patient is asked to walk normally and then speed up.
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study start1 Aug 2022
- Primary completion5 Aug 2022
- Study completion7 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis ComplicationStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muş Alparslan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cengiz TAŞKAYA, Principal investigator, scholarBuket Büyükturan, Study director, scholar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05534542
- Sponsor's protocol ID
- cngztaskaya
- Status last verified
- Mar 2023
- First submitted
- 1 Sep 2022
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Intradialytic Core Stabilization and Aerobic Exercise in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT05534542
- Acronym / sponsor ID
- cngztaskaya
- Conditions
- Hemodialysis Complication
- Keywords
- hemodialysis, dialysis efficiency, fatigue, quality of life, sleep, functionality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Muş Alparslan UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 5 Aug 2022 (actual)
- Study completion
- 7 Oct 2022 (actual)
- First posted
- 9 Sep 2022 (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.
Purpose: To examine the effects of core stabilization and aerobic exercises on dialysis adequacy, functionality level, and quality of life in hemodialysis (HD) patients. The secondary aim of the study is to compare the effectiveness of intradialytic core stabilization and aerobic exercises in HD patients.
Materials and Methods: Patients who received hemodialysis treatment for 4 hours, 3 days a week were planned to be included in this randomized controlled study. Patients participating in the study will be randomly divided into 2 groups. Grup 1 was planned to be given core stabilization exercises during hemodialysis three times a week for eight weeks; Group 2 was planned to be given aerobic exercise during hemodialysis three times a week for eight weeks. It aimed to evaluate the patients in the weeks before the start of the treatment and the week after the end of the treatment. Personal information form for evaluation, dialysis adequacy, quality of life questionnaire-kidney disease quality of life-36, piper fatigue scale, hospital anxiety and depression scale (hads), Pittsburgh sleep scale, five times sit and stand test, 10 m walking test , tinetti balance and walking test, and 2-minute step test were planned to be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| core stabılızatıon | Active comparator | Other: exercıseuse of ıntradıalıtıc core stabılızatıon ın hemodıalysıs patıents |
| aerobıc exercıse | Active comparator | Other: exercıseuse of ıntradıalıtıc aerobıc exercıse ın hemodıalysıs patıents |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- To receive HD treatment for a minimum of 6 months, for 4 hours per day, three days per week
- Being 18 years or older
- A score of 3 and/or below in the Sarcopenia Screening Test (SARC-F)
Key exclusion criteria (5 listed)
- Having a history of myocardial infarction in the last 3 months
- Having angina pectoris, arrhythmia, or uncontrolled hypertension
- Having communication and/or cognitive issues that prevent them from meeting the requirements of the tests
- Becoming pregnant or going through infertility treatment
- Having a psychiatric diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercıseıntradıalıtıc core stabılızatıon | Other | aerobıc exercıse, core stabılızatıon |
Primary outcome
Dialysis adequacy
Time frame: one month
Dialysis adequacy is determined as the urea reduction rate (URR) and unitless Kt/V value. In calculating the Kt/V value; K-is the urea clearance coefficient of the dialyzer (ml/min), t refers to dialysis time (min), and V signifies the urea distribution volume (ml).
Kidney Disease Quality of Life-36 (KDQOL-36)
Time frame: Two months
The KDQOL-36 is a measure of kidney disease-related quality of life that comprises four subscales: generic core [Physical Component Summary (PCS, 12 items) and Mental Component Summary (MCS, 12 items)]; Symptoms/Problems (12 items); Burden of Kidney Disease (4 items), and Effects of Kidney Disease (8 items).
Five times sit-to-stand test
Time frame: Two months
The Five-Times Sit to Stand Test measures one aspect of transfer skill. The test provides a method to quantify functional lower extremity strength and/or identify movement strategies a patient uses to complete transitional movements.
2 Minute Step Test
Time frame: Two months
The test, known as the 2-minute step test (TMST), simply requires that tested individuals march in place as fast as possible for 2 minutes while lifting their knees to a height midway between their patella and iliac crest when standing.
10 Metre Walk Test
Time frame: Two months
The 10 meter walk test is a performance measure used to assess walking speed in meters per second over a short distance. It can be employed to determine functional mobility, gait, and vestibular function.
4 secondary outcomes
Piper Fatigue Scale
Time frame: Two months
Hospital Anxiety and Depression Scale (HADS)
Time frame: Two months
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Two months
Tinetti Gait and Balance Test
Time frame: Two months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
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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.
Cengiz TAŞKAYA principal investigator
scholar
Buket Büyükturan study director
scholar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercıse in people with Hemodialysis Complication, run by Muş Alparslan University at 1 site in Turkey (Türkiye).
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dialysis adequacy (time frame: one month). The study lists 5 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 4 Jun 2024; AzTrials last refreshed its copy on 8 Nov 2026.