Virtual Reality Intradialysis: Last vs. First Part of the Session (VRI)
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| ClinicalTrials.gov Identifier: NCT04046042 |
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Recruitment Status :
Recruiting
First Posted : August 6, 2019
Last Update Posted : September 7, 2022
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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 |
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'.
| 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 : | August 30, 2023 |
| Estimated Study Completion Date : | December 30, 2023 |
| Arm | Intervention/treatment |
|---|---|
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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
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Other: Conventional exercise
Virtual reality exercise performed during the first two hours of the hemodialysis session |
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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
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Other: Exercise during the last two hours of the hemodialysis session
Virtual reality exercise performed during the last two hours of the hemodialysis session |
- Number of hypotension episodes [ Time Frame: 3 Months ]Number of hypotension episodes, including hypotension that requires treatment, hypertensive crisis and acute arrhythmias
- Number of hypotension episodes [ Time Frame: 6 Months ]Number of hypotension episodes, including hypotension that requires treatment, hypertensive crisis and acute arrhythmias
- Number of hypotension episodes [ Time Frame: 12 Months ]Number of hypotension episodes, including hypotension that requires treatment, hypertensive crisis and acute arrhythmias
- 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.
- 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
- Adherence, as number of sessions performed /number of sessions offered [ Time Frame: Baseline, 3 Months, 6 months and 12 months ]Sessions performed/sessions offered
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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.
- 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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- At least 3 months in hemodialysis treatment
- Clinically stable
Exclusion Criteria:
- Recent cardiac events (less than 3 months)
- Unable to exercise
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
| Contact: Eva Segura-Ortí, PhD | 00 34 671580094 | eva.segura@gmail.com | |
| Contact: Alicia García-Testal, PhD | 00 34 637519626 | Agtestal@gmail.com |
| Spain | |
| Hospital de Manises | Recruiting |
| Manises, Valencia, Spain, 46940 | |
| Contact: EVA SEGURA-ORTÍ, PhD 00 34 671580094 eva.segura@gmail.com | |
| Principal Investigator: | Eva Segura-Ortí, PhD | Universidad CEU Cardenal Herrera, UCH CEU |
| 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: | September 7, 2022 |
| Last Verified: | September 2022 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Exercise Virtual reality physical function health-related quality of life hemodynamic instability |
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