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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).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Ozal Keles, Master contact

+90 5539602252

okeles@biruni.edu.tr

Turkey (Türkiye)1 site, 1 recruiting
  • Istanbul Medipol University

    Istanbul

    Ozal Keles, okeles@biruni.edu.tr

    Recruiting

Other trials in Turkey (Türkiye)

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 groups in NCT05246956
Study groupRoleWhat they receive
Intradialytic exercise in hemodialysis patients ( Experimental Group)ExperimentalIntradialytic exercise group
Receives: Other: Intradialytic exercise
Control GroupNo interventionNo intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 6 min walking test

    Measured: 6 minute

  2. Kidney Disease Quality of Life-36 Scale

    Measured: 10 minute

Secondary outcomes (2)
  1. Beck Depression Inventory

    Measured: 5 minute

  2. 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.

  1. First posted18 Feb 2022
  2. Study start1 Jun 2021
  3. Primary completion1 Dec 2022 (estimated)
  4. Study completion1 Dec 2022 (estimated)

Resources

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)
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

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.

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