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Effect of Exercise With Virtual Reality in Hemodialysis Patients

80 participantsStarted 2023-06-09

Plain-language summary

Background. An increase in inflammatory biomarkers is associated with impaired kidney function and increased cardiovascular risk and mortality. Physical exercise has been shown to improve the functional capacity and inflammatory status of patients undergoing hemodialysis (HD) treatment, increasing their health-related quality of life. Virtual reality (VR) is an effective and safe tool to increase patient adherence to the exercise program, however, there are very few studies that analyze its effect on the functional capacity of patients with chronic kidney disease (CKD) in HD and none analyze its effect on the inflammatory state of these patients, which justifies the performance of this study. Methods. Eighty patients with CKD on HD treatment will be randomly assigned into two groups, one of them will perform an intradialysis exercise program with non-immersive VR (intervention group; n=40), and the other will exercise with a static pedal (control group; n). =40). The functional capacity of the patients and their inflammatory and psychological status, as well as their exercise adherende, will be analyzed before and after exercise programs.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria: \- Patients with CKF in a stable clinical situation who have been on HD treatment for at least 3 months. Exclusion criteria: * Had a myocardial infarction in the 6 months before the start of the study * Suffered unstable angina at rest or during exercise * Have cerebrovascular diseases (such as transient ischemia or stroke) * Present amputation of lower limbs above the knee without prothesis * Present a musculoskeletal or respiratory pathology likely to worsen with exercise * Present an inability to carry out functional assessment tests * Present visual or cognitive impairments that affect the ability to use the VR equipment or understand the VR exercise

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change of Interleuquine 6 (IL-6) (pg/ml)

Timeframe: Change from Baseline IL-6 at 12 weeks

Change of Tumoral Necrosis Factor-alpha (TNF-alpha) (pg/ml)

Timeframe: Change from Baseline TNF-a at 12 weeks

Change of C Reactive Protein (CRP) (mg/L)

Timeframe: Change from Baseline CRP at 12 weeks

Change of Intercellular Adhesion Molecule 1 (ICAM 1) (ng/ml)

Timeframe: Change from Baseline ICAM 1 at 12 weeks

Change of Vascular cell adhesion protein 1 (VCAM 1) (ng/ml)

Timeframe: Change from Baseline VCAM 1 at 12 weeks

Trial details

NCT IDNCT05606484

SponsorUniversidad Miguel Hernandez de Elche

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-01

View on ClinicalTrials.gov More Kidney Failure, Chronic trials