Virtual Reality During Hemodialysis (VRHD)

July 15, 2020 updated by: Eva Segura Ortí, Cardenal Herrera University

Virtual Reality Exercise During Hemodialysis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Valencia
      • Manises, Valencia, Spain, 46940
        • Hospital de Manises

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • At least 3 months in hemodialysis treatment
  • Clinically stable

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline gait speed at 12 weeks
Time Frame: Baseline, 12 weeks
Speed to cover 4 meters at normal speed
Baseline, 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline sit to stand 10 at 12 weeks
Time Frame: Baseline, 12 weeks
Time to perform 10 sit to stand repetitions,
Baseline, 12 weeks
Change from baseline sit to stand 60 at 12 weeks
Time Frame: Baseline, 12 weeks
Sit to stand repetitions performed in 60 seconds
Baseline, 12 weeks
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
Baseline, 12 weeks
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
Baseline, 12 weeks
Change from baseline handgrip at 12 weeks
Time Frame: Baseline, 12 weeks
Bilateral handgrip strength
Baseline, 12 weeks
Change from baseline one-leg standing test at 12 weeks
Time Frame: Baseline, 12 weeks
Time achieved while standing on one leg
Baseline, 12 weeks
Change from baseline one-leg heel rise test at 12 weeks
Time Frame: Baseline, 12 weeks
Number of heel rise repetitions achieved
Baseline, 12 weeks
Change from baseline 6 minutes walk test at 12 weeks
Time Frame: Baseline, 12 weeks
Number of meters walked in 6 minutes
Baseline, 12 weeks
Change from baseline Physical activity level at 12 weeks
Time Frame: Baseline, 12 weeks
Physical activity questionnaires
Baseline, 12 weeks
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
Baseline, 12 weeks
Change from baseline Cognitive function at 12 weeks
Time Frame: Baseline, 12 weeks
Mini-mental State Examination questionnaire
Baseline, 12 weeks
Adherence
Time Frame: 12 weeks
Sessions performed/sessions offered
12 weeks
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.
12 months before starting the exercise program- 12 months after the starting date

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardenal Herrera University

Collaborators

Hospital de Manises
Universitat Politècnica de València

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 11, 2018

Primary Completion (ACTUAL)

September 1, 2018

Study Completion (ACTUAL)

September 30, 2018

Study Registration Dates

First Submitted

February 22, 2018

First Submitted That Met QC Criteria

February 28, 2018

First Posted (ACTUAL)

March 7, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 17, 2020

Last Update Submitted That Met QC Criteria

July 15, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017/0638

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on End Stage Renal Disease

Clinical Trials on Virtual reality exercise during hemodialysis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Suriname

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe