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Completed

NCT Number: NCT03456414

Virtual Reality 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.

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Key information

Conditions

End Stage Renal Disease Behavior Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hemodialysis-Induced Symptom Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Manises

Manises, Valencia, 46940, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least 3 months in hemodialysis treatment
  • Clinically stable

Exclusion criteria

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

Treatment and study plan

Virtual reality exercise during hemodialysis

Other

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

Primary outcomes

  1. Change from baseline gait speed at 12 weeks

    Time frame: Baseline, 12 weeks

    Speed to cover 4 meters at normal speed

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Cardenal Herrera University

Other

Collaborators

  • Hospital de Manises
  • Universitat Politècnica de València

Registry information

Official study title

Virtual Reality Exercise During Hemodialysis

Acronym: VRHD

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 7, 2018
Registry last updated
Jul 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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