Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Virtual Reality Intradialysis: Last vs. First Part of the Session (VRI)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04046042
Recruitment Status : Recruiting
First Posted : August 6, 2019
Last Update Posted : January 27, 2020
Sponsor:
Collaborators:
Hospital de Manises
Universitat Politècnica de Valéncia
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 program during the last two hours of the hemodialysis session results in greater hemodynamic stability than exercise performed during the first two hours of the hemodialysis session.

The secondary aims are to assess the impact of intradialysis virtual reality exercise during the last two hours of the hemodialysis session on dialysis efficacy, postdialysis molecules rebound, adherence to exercise, functional capacity, physical activity level, health-related quality of life, cognitive function, morbidity, frailty and dependency. We will also analyze the reliability of muscle strength assessment of lower limb muscles with a handheld dynamometer during hemodialysis.


Condition or disease Intervention/treatment Phase
End Stage Renal Disease on Dialysis Hemodialysis Complication Other: Conventional exercise Other: Exercise during the last two hours of the hemodialysis session Not Applicable

Detailed Description:

Participants will be randomized into one of two groups. The first group will perform a virtual reality exercise during the first two hours of the hemodialysis session. The second group will perform a virtual reality exercise during the last two hours of the hemodialysis session. The exercise program will last for 9 months.

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 game development. The exercise session will end-up with a cool-down period that will include simple lower limb stretching exercises. Two more games will be introduced progressively for patients not to get bored, 'Air Hockey' and 'Simon'.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized into one of two exercise groups, during the first two hours of hemodialysis or during the last two hours of hemodialysis
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: A team of assessors, different from the researchers implementing the exercise, will record all dependent variables. A blind researcher will randomize participants
Primary Purpose: Treatment
Official Title: Virtual Reality Exercise Intradialysis: Tolerance and Dialysis Dose Effects During the Last vs. First Part of the Hemodialysis Session
Actual Study Start Date : September 2, 2019
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Conventional exercise time
During 12 months subjects will exercise during the first two hours of the hemodialysis session. A virtual reality exercise program will be implemented
Other: Conventional exercise
Virtual reality exercise performed during the first two hours of the hemodialysis session

Experimental: Experimental group
During 12 months subjects will exercise during the last two hours of the hemodialysis session. A virtual reality exercise program will be implemented
Other: Exercise during the last two hours of the hemodialysis session
Virtual reality exercise performed during the last two hours of the hemodialysis session




Primary Outcome Measures :
  1. Number of hypotension episodes [ Time Frame: 3 Months ]
    Number of hypotension episodes, including hypotension that requires treatment, hypertensive crisis and acute arrhythmias

  2. Number of hypotension episodes [ Time Frame: 6 Months ]
    Number of hypotension episodes, including hypotension that requires treatment, hypertensive crisis and acute arrhythmias

  3. Number of hypotension episodes [ Time Frame: 12 Months ]
    Number of hypotension episodes, including hypotension that requires treatment, hypertensive crisis and acute arrhythmias


Secondary Outcome Measures :
  1. Change from baseline postdialysis rebound urea, creatinine, phosphorus and potassium at 3 months [ Time Frame: Baseline and 3 months ]
    Postdialysis rebound urea, creatinine, phosphorus and potassium. All measurements presented as a percentage.

  2. Change from baseline dialysis dose at 3 months, 6 months, and 12 months [ Time Frame: Baseline, 3 Months, 6 months and 12 months ]
    Dialysis dose, measured through Kt/V

  3. Adherence, as number of sessions performed /number of sessions offered [ Time Frame: Baseline, 3 Months, 6 months and 12 months ]
    Sessions performed/sessions offered

  4. Change from baseline short physical performance battery at 3 months, 6 months, and 12 months [ Time Frame: Baseline, 3 Months, 6 months and 12 months ]
    Score achieved at the battery that includes balance tests (4 points), sit to stand to sit 5 (4 points) and and gait speed (4 points). The total score is calculated , from 1 to 12, being 12 the highest functional score

  5. Change from baseline gait speed at 3 months, 6 months, and 12 months [ Time Frame: Baseline, 3 Months, 6 months and 12 months ]
    Speed to cover 4 meters, in meters/second

  6. Change from baseline handgrip at 3 months, 6 months, and 12 months [ Time Frame: Baseline, 3 Months, 6 months and 12 months ]
    Bilateral handgrip strength

  7. Change from baseline lower limb muscle strength at 3 months, 6 months, and 12 months [ Time Frame: Baseline, 3 Months, 6 months and 12 months ]
    Muscle strength measured with a handheld dynamometer on the main muscle groups during hemodialysis

  8. Change from baseline one-leg standing test at 3 months, 6 months, and 12 months [ Time Frame: Baseline, 3 Months, 6 months and 12 months ]
    Time achieved while standing on one leg

  9. Change from baseline sit to stand 10 test at 3 months, 6 months, and 12 months [ Time Frame: Baseline, 3 Months, 6 months and 12 months ]
    Time to perform 10 repetitions sit to stand

  10. Change from baseline sit to stand 60 at 3 months, 6 months, and 12 months [ Time Frame: Baseline, 3 Months, 6 months and 12 months ]
    Sit to stand repetitions performed in 60 seconds

  11. Change from baseline timed up and go at 3 months, 6 months, and 12 months [ Time Frame: Baseline, 3 Months, 6 months and 12 months ]
    Time to stand up, walk 3 meters, come back and sit down again

  12. Change from baseline one-leg heel rise test at 3 months, 6 months, and 12 months [ Time Frame: Baseline, 3 Months, 6 months and 12 months ]
    Number of heel rise repetitions achieved

  13. Change from baseline 6 minutes walk test at 3 months, 6 months, and 12 months [ Time Frame: Baseline, 3 Months, 6 months and 12 months ]
    Number of meters walked in 6 minutes

  14. Change from baseline Physical activity level at 3 months, 6 months, and 12 months [ Time Frame: Baseline, 3 Months, 6 months and 12 months ]
    Physical activity questionnaires

  15. Change from baseline Health related quality of life at 3 months, 6 months, and 12 months [ Time Frame: Baseline, 3 Months, 6 months and 12 months ]
    Medical outcomes survey Short Form 36 questionnaire to measure health-related quality of life, rated from 0 to 100, being the highest score the better the quality of life

  16. Change from baseline Cognitive function at 3 months, 6 months, and 12 months [ Time Frame: Baseline, 3 Months, 6 months and 12 months ]
    Mini-mental State Examination questionnaire, score ranges from 0 to 30, higher scores indicates higher cognitive function

  17. Change from baseline disability by Barthel Index at 3 months, 6 months, and 12 months [ Time Frame: Baseline, 3 Months, 6 months and 12 months ]
    Functional evaluation by Barthel Index, to evaluate capacity to perform daily tasks without assistance. Score ranges from 0 to 100. Higher scores indicates higher capacity to perform activities.

  18. Change from baseline frailty (slowness; weakness; weight loss/malnutrition;low physical activity; exhaustion) at 3 months, 6 months, and 12 months [ Time Frame: Baseline, 3 Months, 6 months and 12 months ]
    Frailty will be measured from 0 to 5, depending on how many of the 5 components are present in each subject, being 5 the highest frailty score



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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): NCT04046042


Contacts
Layout table for location contacts
Contact: Eva Segura-Ortí, PhD 00 34 671580094 eva.segura@gmail.com
Contact: Alicia García-Testal, PhD 00 34 637519626 Agtestal@gmail.com

Locations
Layout table for location information
Spain
Hospital de Manises Recruiting
Manises, Valencia, Spain, 46940
Contact: EVA SEGURA-ORTÍ, PhD    00 34 671580094    eva.segura@gmail.com   
Sponsors and Collaborators
Cardenal Herrera University
Hospital de Manises
Universitat Politècnica de Valéncia
Investigators
Layout table for investigator information
Principal Investigator: Eva Segura-Ortí, PhD Universidad CEU Cardenal Herrera, UCH CEU
Publications:

Layout table for additonal information
Responsible Party: Eva Segura Ortí, Professor, Cardenal Herrera University
ClinicalTrials.gov Identifier: NCT04046042    
Other Study ID Numbers: ReVID
First Posted: August 6, 2019    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020

Layout table for additional information
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
Virtual reality
physical function
health-related quality of life
hemodynamic instability
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency