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

Primary Purpose

End Stage Renal Disease on Dialysis, Hemodialysis Complication

Status

Recruiting

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Conventional exercise

Exercise during the last two hours of the hemodialysis session

About this trial

This is an interventional treatment trial for End Stage Renal Disease on Dialysis focused on measuring Exercise, Virtual reality, physical function, health-related quality of life, hemodynamic instability

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

At least 3 months in hemodialysis treatment
Clinically stable

Exclusion Criteria:

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

Sites / Locations

Hospital de ManisesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional exercise time

Experimental group

Arm Description

During 12 months subjects will exercise during the first two hours of the hemodialysis session. A virtual reality exercise program will be implemented

During 12 months subjects will exercise during the last two hours of the hemodialysis session. A virtual reality exercise program will be implemented

Outcomes

Primary Outcome Measures

Number of hypotension episodes

Number of hypotension episodes, including hypotension that requires treatment, hypertensive crisis and acute arrhythmias

Number of hypotension episodes

Number of hypotension episodes, including hypotension that requires treatment, hypertensive crisis and acute arrhythmias

Number of hypotension episodes

Number of hypotension episodes, including hypotension that requires treatment, hypertensive crisis and acute arrhythmias

Secondary Outcome Measures

Change from baseline postdialysis rebound urea, creatinine, phosphorus and potassium at 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

Dialysis dose, measured through Kt/V

Adherence, as number of sessions performed /number of sessions offered

Sessions performed/sessions offered

Change from baseline short physical performance battery at 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

Speed to cover 4 meters, in meters/second

Change from baseline handgrip at 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

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 achieved while standing on one leg

Change from baseline sit to stand 10 test at 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

Sit to stand repetitions performed in 60 seconds

Change from baseline timed up and go at 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

Number of heel rise repetitions achieved

Change from baseline 6 minutes walk test at 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

Physical activity questionnaires

Change from baseline Health related quality of life at 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

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

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

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

Full Information

NCT ID

NCT04046042

First Posted

August 1, 2019

Last Updated

September 6, 2022

Sponsor

Cardenal Herrera University

Collaborators

Hospital de Manises, Universitat Politècnica de Valéncia

1. Study Identification

Unique Protocol Identification Number

NCT04046042

Brief Title

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

Acronym

VRI

Official Title

Virtual Reality Exercise Intradialysis: Tolerance and Dialysis Dose Effects During the Last vs. First Part of the Hemodialysis Session

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 2, 2019 (Actual)

Primary Completion Date

August 30, 2023 (Anticipated)

Study Completion Date

December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cardenal Herrera University

Collaborators

Hospital de Manises, Universitat Politècnica de Valéncia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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'.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

End Stage Renal Disease on Dialysis, Hemodialysis Complication

Keywords

Exercise, Virtual reality, physical function, health-related quality of life, hemodynamic instability

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

InvestigatorOutcomes 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

Allocation

Randomized

Enrollment

43 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Conventional exercise time

Arm Type

Active Comparator

Arm Description

During 12 months subjects will exercise during the first two hours of the hemodialysis session. A virtual reality exercise program will be implemented

Arm Title

Experimental group

Arm Type

Experimental

Arm Description

During 12 months subjects will exercise during the last two hours of the hemodialysis session. A virtual reality exercise program will be implemented

Intervention Type

Other

Intervention Name(s)

Conventional exercise

Intervention Description

Virtual reality exercise performed during the first two hours of the hemodialysis session

Intervention Type

Other

Intervention Name(s)

Exercise during the last two hours of the hemodialysis session

Intervention Description

Virtual reality exercise performed during the last two hours of the hemodialysis session

Primary Outcome Measure Information:

Title

Number of hypotension episodes

Description

Number of hypotension episodes, including hypotension that requires treatment, hypertensive crisis and acute arrhythmias

Time Frame

3 Months

Title

Number of hypotension episodes

Description

Number of hypotension episodes, including hypotension that requires treatment, hypertensive crisis and acute arrhythmias

Time Frame

6 Months

Title

Number of hypotension episodes

Description

Number of hypotension episodes, including hypotension that requires treatment, hypertensive crisis and acute arrhythmias

Time Frame

12 Months

Secondary Outcome Measure Information:

Title

Change from baseline postdialysis rebound urea, creatinine, phosphorus and potassium at 3 months

Description

Postdialysis rebound urea, creatinine, phosphorus and potassium. All measurements presented as a percentage.

Time Frame

Baseline and 3 months

Title

Change from baseline dialysis dose at 3 months, 6 months, and 12 months

Description

Dialysis dose, measured through Kt/V

Time Frame