Virtual Reality During Hemodialysis

NCT ID: NCT03456414

Last Updated: 2020-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-11

Study Completion Date

2018-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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End Stage Renal Disease Hemodialysis-Induced Symptom

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

All participants will receive during hemodialysis the conditions 'virtual reality exercise' for 12 weeks and 'control period-no exercise' for 12 more weeks
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
A team of assessors, different to the researchers implementing the exercise, will record all dependent variables

Study Groups

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Virtual reality during hemodialysis

During 12 weeks subjects will exercise during hemodialysis. The intervention will be virtual reality exercise during hemodialysis.

Group Type EXPERIMENTAL

Virtual reality exercise during hemodialysis

Intervention Type OTHER

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

Control period - no exercise

During 12 weeks subjects will not exercise during hemodialysis

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Virtual reality exercise during hemodialysis

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* At least 3 months in hemodialysis treatment
* Clinically stable

Exclusion Criteria

* Recent cardiac events (less than 3 months)
* Unable to exercise
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital de Manises

OTHER

Sponsor Role collaborator

Universitat Politècnica de València

OTHER

Sponsor Role collaborator

Cardenal Herrera University

OTHER

Sponsor Role lead

Responsible Party

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Eva Segura Ortí

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eva SEGURA-ORTÍ, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad CEU Cardenal Herrera, UCH CEU

Locations

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Hospital de Manises

Manises, Valencia, Spain

Site Status

Countries

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Spain

References

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Segura-Orti E, Gordon PL, Doyle JW, Johansen KL. Correlates of Physical Functioning and Performance Across the Spectrum of Kidney Function. Clin Nurs Res. 2018 Jun;27(5):579-596. doi: 10.1177/1054773816689282. Epub 2017 Jan 23.

Reference Type BACKGROUND
PMID: 28114792 (View on PubMed)

Segura-Orti E, Martinez-Olmos FJ. Test-retest reliability and minimal detectable change scores for sit-to-stand-to-sit tests, the six-minute walk test, the one-leg heel-rise test, and handgrip strength in people undergoing hemodialysis. Phys Ther. 2011 Aug;91(8):1244-52. doi: 10.2522/ptj.20100141. Epub 2011 Jun 30.

Reference Type BACKGROUND
PMID: 21719637 (View on PubMed)

Segura-Orti E, Johansen KL. Exercise in end-stage renal disease. Semin Dial. 2010 Jul-Aug;23(4):422-30. doi: 10.1111/j.1525-139X.2010.00766.x.

Reference Type BACKGROUND
PMID: 20701722 (View on PubMed)

Segura-Orti E. [Exercise in haemodyalisis patients: a literature systematic review]. Nefrologia. 2010;30(2):236-46. doi: 10.3265/Nefrologia.pre2010.Jan.10229. Epub 2010 Jan 21. Spanish.

Reference Type BACKGROUND
PMID: 20098466 (View on PubMed)

Segura-Orti E, Kouidi E, Lison JF. Effect of resistance exercise during hemodialysis on physical function and quality of life: randomized controlled trial. Clin Nephrol. 2009 May;71(5):527-37. doi: 10.5414/cnp71527.

Reference Type BACKGROUND
PMID: 19473613 (View on PubMed)

Segura-Orti E, Rodilla-Alama V, Lison JF. [Physiotherapy during hemodialysis: results of a progressive resistance-training programme]. Nefrologia. 2008;28(1):67-72. Spanish.

Reference Type BACKGROUND
PMID: 18336134 (View on PubMed)

Other Identifiers

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2017/0638

Identifier Type: -

Identifier Source: org_study_id

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