ClinicalTrials.gg
CompletedNCT03456414VRHDUpdated Jul 17, 2020

Virtual Reality During Hemodialysis

An interventional study of Virtual reality exercise during hemodialysis in End Stage Renal Disease and Hemodialysis-Induced Symptom, sponsored by Cardenal Herrera University. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-17.

Sponsored by Cardenal Herrera University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 68 studies in Kidney Failure, Chronic with a site in Spain — 10 open to participants now, 17 under way, 5 of them phase 3. Kidney Failure, Chronic · Spain.

Enrollment
44th of 55
40 · median 120
Started
2018
with 4 others
No phase
20 of 68
1 open now
Registered
34th of 68
by date
Lead sponsor
9 of 68
Cardenal Herrera University

Among the 68 studies in Kidney Failure, Chronic with a site in Spain, this one is the 44th largest by enrollment of the 55 interventional ones that give a count, is one of 5 that started in 2018, is one of 20 with no phase, and was the 34th registered.

Kidney Failure, Chronic

2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.

Browse Kidney Failure, Chronic studies →

Open to participants now

10 of the 68 studies in Kidney Failure, Chronic with a site in Spain are open now. Recruiting first, the newest first:

5 more — sign in →

All 10 open studies →

A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →

Who these studies take

Of the 170 Kidney Failure, Chronic studies recruiting now, 109 (64%) set no upper age limit and 32 (19%) stop at 75 or younger; 18 take children under 18; 22 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study summary

The main objective of this investigation is to assess if an intradialysis virtual reality exercise-based program results in an improvement in physical function and if it results in high adherence rates to exercise. The secondary aim is to assess the effect of intradialysis VR in physical activity level, health related quality of life and in cognitive function.

Read the detailed description

Participants will be randomized into one of two groups. The first group will start with 12 weeks of virtual reality exercise during hemodialysis and will carry on with a control period of 12 weeks. The second group will start with a control period of 12 weeks (no exercise) and will carry on with a virtual reality exercise period of 12 weeks.

The virtual reality exercise will undertake up to 30 minutes of exercise. After warming up, participants will play to an adapted 'treasure hunt' game. Their legs movements will be the players projected into an individual tv that will give them feedback regarding their achievements. The aim of the game will be to achieve the higher possible score.They will move their legs to pick up coins and to avoid bombs. An adapted Kinect technology will be used for the game development. The exercise session will end-up with a cool-down period that will include simple lower limb stretching exercises.

03

Conditions studied

  • End Stage Renal Disease
  • Hemodialysis-Induced Symptom

Keywords

  • exercise
  • physical function
  • health related quality of life
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • At least 3 months in hemodialysis treatment
  • Clinically stable

Exclusion criteria

Exclusion Criteria:

  • Recent cardiac events (less than 3 months)
  • Unable to exercise
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Virtual reality during hemodialysis

    During 12 weeks subjects will exercise during hemodialysis. The intervention will be virtual reality exercise during hemodialysis.

    Other: Virtual reality exercise during hemodialysis

  • No intervention
    Control period - no exercise

    During 12 weeks subjects will not exercise during hemodialysis

Interventions

  • OtherVirtual reality exercise during hemodialysis

    Subjects will play a virtual reality game specially adapted for subjects undertaking hemodialysis treatment

06

What researchers measure

Primary outcomes

  1. Change from baseline gait speed at 12 weeks

    Speed to cover 4 meters at normal speed

    Time frame: Baseline, 12 weeks

Secondary outcomes

  1. Change from baseline sit to stand 10 at 12 weeks

    Time to perform 10 sit to stand repetitions,

    Time frame: Baseline, 12 weeks

  2. Change from baseline sit to stand 60 at 12 weeks

    Sit to stand repetitions performed in 60 seconds

    Time frame: Baseline, 12 weeks

  3. Change from baseline timed up and go at 12 weeks

    Time to stand up, walk 3 meters, come back and sit down again

    Time frame: Baseline, 12 weeks

  4. Change from baseline short physical performance battery at 12 weeks

    Score achieved at the battery that includes balance tests, sit to stand to sit 5 and and gait speed

    Time frame: Baseline, 12 weeks

  5. Change from baseline handgrip at 12 weeks

    Bilateral handgrip strength

    Time frame: Baseline, 12 weeks

  6. Change from baseline one-leg standing test at 12 weeks

    Time achieved while standing on one leg

    Time frame: Baseline, 12 weeks

  7. Change from baseline one-leg heel rise test at 12 weeks

    Number of heel rise repetitions achieved

    Time frame: Baseline, 12 weeks

  8. Change from baseline 6 minutes walk test at 12 weeks

    Number of meters walked in 6 minutes

    Time frame: Baseline, 12 weeks

  9. Change from baseline Physical activity level at 12 weeks

    Physical activity questionnaires

    Time frame: Baseline, 12 weeks

  10. Change from baseline Health related quality of life at 12 weeks

    Short Form 36 questionnaire to measure health-related quality of life

    Time frame: Baseline, 12 weeks

  11. Change from baseline Cognitive function at 12 weeks

    Mini-mental State Examination questionnaire

    Time frame: Baseline, 12 weeks

  12. Adherence

    Sessions performed/sessions offered

    Time frame: 12 weeks

  13. Healthcare resources expenditure and costs

    Total amount in euros spent on external consultations, laboratory tests, radiology tests, hospital pharmacy, emergency department healthcare provision, and hospitalisation.

    Time frame: 12 months before starting the exercise program- 12 months after the starting date

07

Study locations

1 site
  • Hospital de Manises
    Manises, Valencia 46940, Spain
08

References and documents

Publications

  • Segura-Orti E, Gordon PL, Doyle JW, Johansen KL. Correlates of Physical Functioning and Performance Across the Spectrum of Kidney Function. Clin Nurs Res. 2018 Jun;27(5):579-596. doi: 10.1177/1054773816689282. Epub 2017 Jan 23. PubMed 28114792 ↗
  • Segura-Orti E, Martinez-Olmos FJ. Test-retest reliability and minimal detectable change scores for sit-to-stand-to-sit tests, the six-minute walk test, the one-leg heel-rise test, and handgrip strength in people undergoing hemodialysis. Phys Ther. 2011 Aug;91(8):1244-52. doi: 10.2522/ptj.20100141. Epub 2011 Jun 30. PubMed 21719637 ↗
  • Segura-Orti E, Johansen KL. Exercise in end-stage renal disease. Semin Dial. 2010 Jul-Aug;23(4):422-30. doi: 10.1111/j.1525-139X.2010.00766.x. PubMed 20701722 ↗
  • Segura-Orti E. [Exercise in haemodyalisis patients: a literature systematic review]. Nefrologia. 2010;30(2):236-46. doi: 10.3265/Nefrologia.pre2010.Jan.10229. Epub 2010 Jan 21. Spanish. PubMed 20098466 ↗
  • Segura-Orti E, Kouidi E, Lison JF. Effect of resistance exercise during hemodialysis on physical function and quality of life: randomized controlled trial. Clin Nephrol. 2009 May;71(5):527-37. doi: 10.5414/cnp71527. PubMed 19473613 ↗
  • Segura-Orti E, Rodilla-Alama V, Lison JF. [Physiotherapy during hemodialysis: results of a progressive resistance-training programme]. Nefrologia. 2008;28(1):67-72. Spanish. PubMed 18336134 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2018 to primary completion in Sep 2018, 4 months.

Of 347 non-industry interventional studies with no phase under Kidney Failure, Chronic, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 47. This study's 4 months is below that.

Counting every sponsor, half of 425 studies reached it within 23 months; a quarter within 8 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 22, 2018
First posted
Mar 7, 2018
StartActual
Apr 11, 2018
Primary completionActual
Sep 1, 2018
CompletionActual
Sep 30, 2018
Last update
Jul 17, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03456414
Collaborators
Hospital de Manises, Universitat Politècnica de València
Responsible party
Eva Segura Ortí (Professor, Cardenal Herrera University) — Principal investigator
First posted
Mar 7, 2018
Start date
Apr 11, 2018
Primary completion
Sep 1, 2018
Completion
Sep 30, 2018
Last update
Jul 17, 2020

Study contacts

Eva SEGURA-ORTÍ, PhD
principal investigator · Universidad CEU Cardenal Herrera, UCH CEU

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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