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Virtual Reality During Hemodialysis (VRHD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03456414
Recruitment Status : Completed
First Posted : March 7, 2018
Last Update Posted : July 17, 2020
Sponsor:
Collaborators:
Hospital de Manises
Universitat Politècnica de València
Information provided by (Responsible Party):
Eva Segura Ortí, Cardenal Herrera University

Brief 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.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Hemodialysis-Induced Symptom Other: Virtual reality exercise during hemodialysis Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: All participants will receive during hemodialysis the conditions 'virtual reality exercise' for 12 weeks and 'control period-no exercise' for 12 more weeks
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: A team of assessors, different to the researchers implementing the exercise, will record all dependent variables
Primary Purpose: Treatment
Official Title: Virtual Reality Exercise During Hemodialysis
Actual Study Start Date : April 11, 2018
Actual Primary Completion Date : September 1, 2018
Actual Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine


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

No Intervention: Control period - no exercise
During 12 weeks subjects will not exercise during hemodialysis



Primary Outcome Measures :
  1. Change from baseline gait speed at 12 weeks [ Time Frame: Baseline, 12 weeks ]
    Speed to cover 4 meters at normal speed


Secondary Outcome Measures :
  1. Change from baseline sit to stand 10 at 12 weeks [ Time Frame: Baseline, 12 weeks ]
    Time to perform 10 sit to stand repetitions,

  2. Change from baseline sit to stand 60 at 12 weeks [ Time Frame: Baseline, 12 weeks ]
    Sit to stand repetitions performed in 60 seconds

  3. Change from baseline timed up and go at 12 weeks [ Time Frame: Baseline, 12 weeks ]
    Time to stand up, walk 3 meters, come back and sit down again

  4. Change from baseline short physical performance battery at 12 weeks [ Time Frame: Baseline, 12 weeks ]
    Score achieved at the battery that includes balance tests, sit to stand to sit 5 and and gait speed

  5. Change from baseline handgrip at 12 weeks [ Time Frame: Baseline, 12 weeks ]
    Bilateral handgrip strength

  6. Change from baseline one-leg standing test at 12 weeks [ Time Frame: Baseline, 12 weeks ]
    Time achieved while standing on one leg

  7. Change from baseline one-leg heel rise test at 12 weeks [ Time Frame: Baseline, 12 weeks ]
    Number of heel rise repetitions achieved

  8. Change from baseline 6 minutes walk test at 12 weeks [ Time Frame: Baseline, 12 weeks ]
    Number of meters walked in 6 minutes

  9. Change from baseline Physical activity level at 12 weeks [ Time Frame: Baseline, 12 weeks ]
    Physical activity questionnaires

  10. Change from baseline Health related quality of life at 12 weeks [ Time Frame: Baseline, 12 weeks ]
    Short Form 36 questionnaire to measure health-related quality of life

  11. Change from baseline Cognitive function at 12 weeks [ Time Frame: Baseline, 12 weeks ]
    Mini-mental State Examination questionnaire

  12. Adherence [ Time Frame: 12 weeks ]
    Sessions performed/sessions offered

  13. Healthcare resources expenditure and costs [ Time Frame: 12 months before starting the exercise program- 12 months after the starting date ]
    Total amount in euros spent on external consultations, laboratory tests, radiology tests, hospital pharmacy, emergency department healthcare provision, and hospitalisation.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 3 months in hemodialysis treatment
  • Clinically stable

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03456414


Locations
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Spain
Hospital de Manises
Manises, Valencia, Spain, 46940
Sponsors and Collaborators
Cardenal Herrera University
Hospital de Manises
Universitat Politècnica de València
Investigators
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Principal Investigator: Eva SEGURA-ORTÍ, PhD Universidad CEU Cardenal Herrera, UCH CEU
Publications:
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Responsible Party: Eva Segura Ortí, Professor, Cardenal Herrera University
ClinicalTrials.gov Identifier: NCT03456414    
Other Study ID Numbers: 2017/0638
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: July 17, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eva Segura Ortí, Cardenal Herrera University:
exercise
physical function
health related quality of life
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency