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

NCT ID: NCT04046042

Last Updated: 2024-06-14

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

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-02

Study Completion Date

2024-08-30

Brief Summary

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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

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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'.

Conditions

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End Stage Renal Disease on Dialysis Hemodialysis Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
A team of assessors, different from the researchers implementing the exercise, will record all dependent variables. A blind researcher will randomize participants

Study Groups

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Conventional exercise time

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

Group Type ACTIVE_COMPARATOR

Conventional exercise

Intervention Type OTHER

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

Experimental group

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

Group Type EXPERIMENTAL

Exercise during the last two hours of the hemodialysis session

Intervention Type OTHER

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

Interventions

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Conventional exercise

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

Intervention Type OTHER

Exercise during the last two hours of the hemodialysis session

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

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 Valéncia

UNKNOWN

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 RECRUITING

Countries

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Spain

Central Contacts

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Eva Segura-Ortí, PhD

Role: CONTACT

00 34 671580094

Alicia García-Testal, PhD

Role: CONTACT

00 34 637519626

Facility Contacts

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EVA SEGURA-ORTÍ, PhD

Role: primary

00 34 671580094

References

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Segura-Orti E, Perez-Dominguez B, Ortega-Perez de Villar L, Melendez-Oliva E, Martinez-Gramage J, Garcia-Maset R, Gil-Gomez JA. Virtual reality exercise intradialysis to improve physical function: A feasibility randomized trial. Scand J Med Sci Sports. 2019 Jan;29(1):89-94. doi: 10.1111/sms.13304. Epub 2018 Oct 7.

Reference Type BACKGROUND
PMID: 30230041 (View on PubMed)

Segura-Orti E, Garcia-Testal A. Intradialytic virtual reality exercise: Increasing physical activity through technology. Semin Dial. 2019 Jul;32(4):331-335. doi: 10.1111/sdi.12788. Epub 2019 Mar 27.

Reference Type BACKGROUND
PMID: 30916415 (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)

Garcia Testal A, Garcia Maset R, Hervas Marin D, Perez-Dominguez B, Royo Maicas P, Rico Salvador IS, Melendez-Oliva E, Molina Aracil J, Murgui Chiva M, Del Pozo Blanco O, Olague Diaz P, Fernandez Najera JE, Torregrosa De Juan E, Benedito Carrera C, Segura-Orti E. Influence of Physical Exercise on the Dialytic Adequacy Parameters of Patients on Hemodialysis. Ther Apher Dial. 2019 Apr;23(2):160-166. doi: 10.1111/1744-9987.12762. Epub 2018 Oct 19.

Reference Type BACKGROUND
PMID: 30226299 (View on PubMed)

Ortega-Perez de Villar L, Martinez-Olmos FJ, Junque-Jimenez A, Amer-Cuenca JJ, Martinez-Gramage J, Mercer T, Segura-Orti E. Test-retest reliability and minimal detectable change scores for the short physical performance battery, one-legged standing test and timed up and go test in patients undergoing hemodialysis. PLoS One. 2018 Aug 22;13(8):e0201035. doi: 10.1371/journal.pone.0201035. eCollection 2018.

Reference Type BACKGROUND
PMID: 30133445 (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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ReVID

Identifier Type: -

Identifier Source: org_study_id

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