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Completed

NCT Number: NCT03120611

Virtual Reality Versus Conventional Exercise Intradialysis

All participants exercised during 16 weeks following a conventional intradialysis exercise program. The last 4 weeks of the study participants were randomized into two different exercise programs intradialysis. One group exercised through a virtual reality exercise adapted specially for patients while receiving hemodialysis treatment. The other group exercised with a conventional exercise program, combining aerobic cycling and strengthening exercises.

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Key information

About this study

The first 16 weeks all participants followed an intradialysis exercise program. The exercise program consisted of strengthening exercises for lower limbs and for the upper limb free of fistula. The exercise program included isotonic exercises for quadriceps, triceps surae, psoas, glutei, and brachial biceps; and isometric exercises for hip adductors and hamstrings. Elastic bands were used to apply resistance. Progression was achieved from increasing from 1 set of 10 repetitions until 3 sets of 15 repetitions. This first part lasted no more than 30 minutes. The program also included aerobic exercise (cycling) for up to 30 minutes. Intensity was adapted through the duration of the study so that the participant felt the exercise from hard to somewhat hard (13 to 15 at the rate of perceived exertion 6 to 20). Time and resistance were adapted progressively.

The last four weeks of the program participants were randomized into virtual reality exercise or conventional exercise group. The virtual reality exercise group undertook 30 minutes of exercise. After warming up, participants had to play to an adapted 'treasure hunt' game. Their legs movements were the players projected into an individual tv that gave them feedback regarding their achievements. The aim of the game was to achieve the higher possible score.They moved to pick up coins and to avoid bombs. An adapted Kinect technology was used for the game development.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients in HD therapy at least 3 months

Exclusion criteria

  • recent myocardial infarction (within 6 weeks)
  • unstable angina
  • malignant arrhythmias
  • above the knee amputation without replacement
  • cerebral vascular disease (ictus, transient ischemia)
  • musculoskeletal and respiratory disorders that can get worse with exercise
  • impossibility to achieve functional testing

Treatment and study plan

Virtual Reality Exercise

Other

Game developed by the Kinect, adapted to the lying position of participants.

Conventional exercise intradialysis

Other

Aerobic exercise (cycling) and strengthening exercise for lower limbs using elastic bands and gravity

Primary outcomes

  1. Sit to Stand to Sit test 10

    Time frame: 20 weeks

    Time required to stand up from a chair and sit down 10 consecutive times

Secondary outcomes

  1. Short Physical Performance Battery

    Time frame: 20 weeks

    Balance, gait speed and sit to stand to sit 5 times

  2. Timed Up and Go

    Time frame: 20 weeks

    Time to stand up, walk a short distance, turn, walk back and sit down to the chair again

  3. One leg stand test

    Time frame: 20 weeks

    Time to keep balance on one leg

  4. Sit to Stand to Sit test 60 seconds

    Time frame: 20 weeks

    Number of repetitions achieved of standing up from a chair during 60 seconds

  5. Handgrip

    Time frame: 20 weeks

    Handgrip strength right and left hands

  6. One leg heel rise test

    Time frame: 20 weeks

    Number of repetitions of standing on toes in both legs

  7. 6 minutes walk test

    Time frame: 20 weeks

    Number of meters covered during 6 minutes of walking

  8. Adherence

    Time frame: 20 weeks

    Sessions performed/offered

  9. Physical Activity

    Time frame: 16 weeks

    Human activity profile, adjusted and maximal activity score

  10. Physical Activity

    Time frame: 16 weeks

    Physical activity score for the elderly

  11. Inflammatory markers

    Time frame: 16 weeks

    Interleukin 6 (IL6)

  12. Inflammatory markers

    Time frame: 16 weeks

    Monocyte chemoattractant protein-1 (MCP-1)

  13. Inflammatory markers

    Time frame: 16 weeks

    C-Reactive Protein (CRP)

  14. Inflammatory markers

    Time frame: 16 weeks

    Human Tumor Necrosis Factor α (TNF-α)

  15. Health-related quality of life

    Time frame: 16 weeks

    SF-36 subscales and components

  16. Oxidative stress markers

    Time frame: 16 weeks

    Malondialdehyde (MDA)

  17. Oxidative stress markers

    Time frame: 16 weeks

    Carbonylated proteins

Sponsors and collaborators

Lead sponsor

Cardenal Herrera University

Other

Collaborators

  • Hospital de Manises, Valencia

Registry information

Official study title

Comparison of Two Exercise Programs Intradialysis: Virtual Reality Exercise Versus Conventional Exercise

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 19, 2017
Registry last updated
May 23, 2018

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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