Renal DiseaseNCT05246956
Investigation of the Effect of Intradialytic Exercise on Functional Capacity,Quality of Life in Hemodialysis Patients
A study testing Intradialytic exercise in people with Renal Disease, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Chronic renal failure (CKD) is defined as a chronic, progressive degeneration in the kidney's fluid-electrolyte balance and metabolic-endocrine functions as a result of the glomerular filtration rate (GFR) falling below 60 ml/min/1.73 m², regardless of the etiology of the kidney disease. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Renal Disease
- What is being tested?
- Intradialytic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2021to 1 Dec 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having stage 5 (ESRD) CRF according to GFR
- Being between 20-80 years old
- Ability to read and write
- Being cooperative
- Dialysis treatment for at least three months
- Willingness to participate in the research
Who cannot join
- History of myocardial ischemia in the last 6 months
- Uncontrolled diabetes mellitus and hypertension
- heart failure
- Having a malignant disease,
- Having mental retardation,
- illiteracy,
- Not being cooperative
- Having neurological or orthopedic disability.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Medipol University
Istanbul
Ozal Keles, okeles@biruni.edu.tr
About this study
Official title: Investigation of the Effect of Intradialytic Exercise on Functional Capacity and Quality of Life in Hemodialysis Patients
Chronic renal failure (CKD) is defined as a chronic, progressive degeneration in the kidney's fluid-electrolyte balance and metabolic-endocrine functions as a result of the glomerular filtration rate (GFR) falling below 60 ml/min/1.73 m², regardless of the etiology of the kidney disease. CRF is divided into five stages according to the glomerular filtration rate. Stage V is end-stage renal disease (ESRD), a life-threatening condition in which GFR falls below 15 ml/min/1.73 m2. ESRD patients have to receive dialysis [hemodialysis (HD), peritoneal dialysis (PD)] or kidney transplantation (Tx) under the name of renal replacement therapies (RRT) in order to survive and to support the metabolic hemostatic function of the kidney. Although the majority of ESRD patients survive on dialysis, their quality of life and functional capacity are reduced due to uremic cardiomyopathy, cardiovascular diseases, anemia, diabetes mellitus, bone diseases, deconditioning, fatigue, weakness, inactivity and accompanying psychological problems. In addition, due to the burden of chronic disease and the necessity of being dependent on machinery, patients are also faced with the risk of losing their job, addiction in daily life activities, depression, anxiety, changes in body image, financial problems, sexual problems, social isolation, mortality and hospitalization.
Intradialytic exercise (IDE) is defined as exercise training performed during the hemodialysis session to increase the patient's strength and endurance and thus target various physiological and psychosocial parameters. Patients' choice of exercise depends on individual factors such as medical history, physical capacity, and transportation options, which are associated with cost and overall preferences. In this context, exercise programs during dialysis and at home are more preferred by patients due to the lack of transfer problems and loss of time. The exercise rehabilitation program to be chosen should also have features such as being practical, low cost and sustainable for patients receiving dialysis. Intradialytic exercise is a common recommendation to encourage patients to be physically active. Previous studies have shown that intradialytic exercise can reduce the severity of fatigue, improve sleep quality, increase exercise tolerance, improve life He claimed that it was effective in improving the quality of life and even improving the psychological state. Patients typically undergo two or three hemodialysis sessions per week, with each session lasting approximately 4 hours. As many patients maintain bed rest during hemodialysis sessions, intradialytic exercise can be a potentially useful approach to improve their health without spending extra time in the interdialytic period. Although exercise variety is limited during hemodialysis sessions, intradialytic exercise maximizes the use of HD time. In addition, intradialytic exercise has been reported to increase patient compliance. However, conflicting data on the effects of intradialytic exercise have been reported. Intradialytic exercise (IDE) is not yet a routine practice for hemodialysis patients, an important reason is the lack of guidelines to support it. Intradialytic exercise is rarely given as standard of care, although numerous small studies have demonstrated the multiple benefits and safe practice of intradialytic exercise training for patients with end-stage renal disease.
The aim of our study is to investigate the effect of intradialytic exercises on functional capacity and quality of life, although it is known that it can be done without spending extra time and is more preferred by patients, which is not routinely applied and needs more studies on its effects.
- Conditions
- Renal Disease
- Being tested
- Intradialytic exercise
- Keywords
- intradialytic exercise, chronic kidney disease, quality of life, depression, functional capacity
- Medical subject headings
- Kidney Diseases, Renal Insufficiency, Chronic, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intradialytic exerciseOther
Intradialytic exercise group
| Study group | Role | What they receive |
|---|---|---|
| Intradialytic exercise in hemodialysis patients ( Experimental Group) | Experimental | Intradialytic exercise group Receives: Other: Intradialytic exercise |
| Control Group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 min walking test
Measured: 6 minute
Kidney Disease Quality of Life-36 Scale
Measured: 10 minute
Secondary outcomes (2)
Beck Depression Inventory
Measured: 5 minute
Visual Analog Scale
Fatigue
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start1 Jun 2021
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal DiseaseStudies 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
- Model description
- experimental group control group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Medipol University
- Responsible party
- Sponsor
- Investigators
- Özal Keleş, Principal investigator, Student
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05246956
- Sponsor's protocol ID
- Intradialytic Exercise
- Status last verified
- Jun 2021
- First submitted
- 9 Feb 2022
- Last updated
- 18 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Keles O, Algun ZC, Civi Karaaslan T, Harmankaya Kaptanogullari NO, Kaptanogullari H. Effects of Intradialytic Exercise on Functional Capacity and Health-Related Quality of Life in Hemodialysis Patients. Ther Apher Dial. 2026 Aug;30(4):602-612. doi: 10.1002/1744-9987.70153. Epub 2026 May 13.
PubMed 42128622
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Intradialytic Exercise on Functional Capacity and Quality of Life in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT05246956
- Acronym / sponsor ID
- Intradialytic Exercise
- Conditions
- Renal Disease
- Keywords
- intradialytic exercise, chronic kidney disease, quality of life, depression, functional capacity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Collaborators
- Medipol University
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 18 Feb 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.
Chronic renal failure (CKD) is defined as a chronic, progressive degeneration in the kidney's fluid-electrolyte balance and metabolic-endocrine functions as a result of the glomerular filtration rate (GFR) falling below 60 ml/min/1.73 m², regardless of the etiology of the kidney disease. CRF is divided into five stages according to the glomerular filtration rate. Stage V is end-stage renal disease (ESRD), a life-threatening condition in which GFR falls below 15 ml/min/1.73 m2. ESRD patients have to receive dialysis [hemodialysis (HD), peritoneal dialysis (PD)] or kidney transplantation (Tx) under the name of renal replacement therapies (RRT) in order to survive and to support the metabolic hemostatic function of the kidney. Although the majority of ESRD patients survive on dialysis, their quality of life and functional capacity are reduced due to uremic cardiomyopathy, cardiovascular diseases, anemia, diabetes mellitus, bone diseases, deconditioning, fatigue, weakness, inactivity and accompanying psychological problems. In addition, due to the burden of chronic disease and the necessity of being dependent on machinery, patients are also faced with the risk of losing their job, addiction in daily life activities, depression, anxiety, changes in body image, financial problems, sexual problems, social isolation, mortality and hospitalization.
Intradialytic exercise (IDE) is defined as exercise training performed during the hemodialysis session to increase the patient's strength and endurance and thus target various physiological and psychosocial parameters. Patients' choice of exercise depends on individual factors such as medical history, physical capacity, and transportation options, which are associated with cost and overall preferences. In this context, exercise programs during dialysis and at home are more preferred by patients due to the lack of transfer problems and loss of time. The exercise rehabilitation program to be chosen should also have features such as being practical, low cost and sustainable for patients receiving dialysis. Intradialytic exercise is a common recommendation to encourage patients to be physically active. Previous studies have shown that intradialytic exercise can reduce the severity of fatigue, improve sleep quality, increase exercise tolerance, improve life He claimed that it was effective in improving the quality of life and even improving the psychological state. Patients typically undergo two or three hemodialysis sessions per week, with each session lasting approximately 4 hours. As many patients maintain bed rest during hemodialysis sessions, intradialytic exercise can be a potentially useful approach to improve their health without spending extra time in the interdialytic period. Although exercise variety is limited during hemodialysis sessions, intradialytic exercise maximizes the use of HD time. In addition, intradialytic exercise has been reported to increase patient compliance. However, conflicting data on the effects of intradialytic exercise have been reported. Intradialytic exercise (IDE) is not yet a routine practice for hemodialysis patients, an important reason is the lack of guidelines to support it. Intradialytic exercise is rarely given as standard of care, although numerous small studies have demonstrated the multiple benefits and safe practice of intradialytic exercise training for patients with end-stage renal disease.
The aim of our study is to investigate the effect of intradialytic exercises on functional capacity and quality of life, although it is known that it can be done without spending extra time and is more preferred by patients, which is not routinely applied and needs more studies on its effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- experimental group control group
| Arm | Type | Receives |
|---|---|---|
| Intradialytic exercise in hemodialysis patients ( Experimental Group) | Experimental | Other: Intradialytic exerciseIntradialytic exercise group |
| Control Group | No intervention | –No intervention |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Having stage 5 (ESRD) CRF according to GFR
- Being between 20-80 years old
- Ability to read and write
- Being cooperative
- Dialysis treatment for at least three months
Key exclusion criteria (8 listed)
- History of myocardial ischemia in the last 6 months
- Uncontrolled diabetes mellitus and hypertension
- heart failure
- Having a malignant disease,
- Having mental retardation,
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 |
|---|---|---|
| Intradialytic exerciseIntradialytic exercise group | Other | Intradialytic exercise in hemodialysis patients ( Experimental Group) |
Primary outcome
6 min walking test
Time frame: 6 minute
Kidney Disease Quality of Life-36 Scale
Time frame: 10 minute
2 secondary outcomes
Beck Depression Inventory
Time frame: 5 minute
Visual Analog Scale
Time frame: 1 minute
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
- Derived from this study: PubMed 42128622Keles O, Algun ZC, Civi Karaaslan T, Harmankaya Kaptanogullari NO, Kaptanogullari H. Effects of Intradialytic Exercise on Functional Capacity and Health-Related Quality of Life in Hemodialysis Patients. Ther Apher Dial. 2026 Aug;30(4):602-612. doi: 10.1002/1744-9987.70153. Epub 2026 May 13.
- Individual participant dataSharing planned: No
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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.
Özal Keleş principal investigator
Student
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intradialytic exercise in people with Renal Disease, run by Istanbul Medipol University Hospital 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 6 inclusion and 8 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 18 Feb 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ozal Keles, Master (+90 5539602252, okeles@biruni.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 min walking test (time frame: 6 minute). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05246956, which also lists 1 linked publication.
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 18 Feb 2022.