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Virtual Reality During Hemodialysis (VRHD)

Primary Purpose

End Stage Renal Disease, Hemodialysis-Induced Symptom

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Virtual reality exercise during hemodialysis
Sponsored by
Cardenal Herrera University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease focused on measuring exercise, physical function, health related quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • At least 3 months in hemodialysis treatment
  • Clinically stable

Exclusion Criteria:

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

Sites / Locations

  • Hospital de Manises

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Virtual reality during hemodialysis

Control period - no exercise

Arm Description

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

During 12 weeks subjects will not exercise during hemodialysis

Outcomes

Primary Outcome Measures

Change from baseline gait speed at 12 weeks
Speed to cover 4 meters at normal speed

Secondary Outcome Measures

Change from baseline sit to stand 10 at 12 weeks
Time to perform 10 sit to stand repetitions,
Change from baseline sit to stand 60 at 12 weeks
Sit to stand repetitions performed in 60 seconds
Change from baseline timed up and go at 12 weeks
Time to stand up, walk 3 meters, come back and sit down again
Change from baseline short physical performance battery at 12 weeks
Score achieved at the battery that includes balance tests, sit to stand to sit 5 and and gait speed
Change from baseline handgrip at 12 weeks
Bilateral handgrip strength
Change from baseline one-leg standing test at 12 weeks
Time achieved while standing on one leg
Change from baseline one-leg heel rise test at 12 weeks
Number of heel rise repetitions achieved
Change from baseline 6 minutes walk test at 12 weeks
Number of meters walked in 6 minutes
Change from baseline Physical activity level at 12 weeks
Physical activity questionnaires
Change from baseline Health related quality of life at 12 weeks
Short Form 36 questionnaire to measure health-related quality of life
Change from baseline Cognitive function at 12 weeks
Mini-mental State Examination questionnaire
Adherence
Sessions performed/sessions offered
Healthcare resources expenditure and costs
Total amount in euros spent on external consultations, laboratory tests, radiology tests, hospital pharmacy, emergency department healthcare provision, and hospitalisation.

Full Information

First Posted
February 22, 2018
Last Updated
July 15, 2020
Sponsor
Cardenal Herrera University
Collaborators
Hospital de Manises, Universitat Politècnica de València
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1. Study Identification

Unique Protocol Identification Number
NCT03456414
Brief Title
Virtual Reality During Hemodialysis
Acronym
VRHD
Official Title
Virtual Reality Exercise During Hemodialysis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
April 11, 2018 (Actual)
Primary Completion Date
September 1, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cardenal Herrera University
Collaborators
Hospital de Manises, Universitat Politècnica de València

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease, Hemodialysis-Induced Symptom
Keywords
exercise, physical function, health related quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
All participants will receive during hemodialysis the conditions 'virtual reality exercise' for 12 weeks and 'control period-no exercise' for 12 more weeks
Masking
InvestigatorOutcomes Assessor
Masking Description
A team of assessors, different to the researchers implementing the exercise, will record all dependent variables
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual reality during hemodialysis
Arm Type
Experimental
Arm Description
During 12 weeks subjects will exercise during hemodialysis. The intervention will be virtual reality exercise during hemodialysis.
Arm Title
Control period - no exercise
Arm Type
No Intervention
Arm Description
During 12 weeks subjects will not exercise during hemodialysis
Intervention Type
Other
Intervention Name(s)
Virtual reality exercise during hemodialysis
Intervention Description
Subjects will play a virtual reality game specially adapted for subjects undertaking hemodialysis treatment
Primary Outcome Measure Information:
Title
Change from baseline gait speed at 12 weeks
Description
Speed to cover 4 meters at normal speed
Time Frame
Baseline, 12 weeks
Secondary Outcome Measure Information:
Title
Change from baseline sit to stand 10 at 12 weeks
Description
Time to perform 10 sit to stand repetitions,
Time Frame
Baseline, 12 weeks
Title
Change from baseline sit to stand 60 at 12 weeks
Description
Sit to stand repetitions performed in 60 seconds
Time Frame
Baseline, 12 weeks
Title
Change from baseline timed up and go at 12 weeks
Description
Time to stand up, walk 3 meters, come back and sit down again
Time Frame
Baseline, 12 weeks
Title
Change from baseline short physical performance battery at 12 weeks
Description
Score achieved at the battery that includes balance tests, sit to stand to sit 5 and and gait speed
Time Frame
Baseline, 12 weeks
Title
Change from baseline handgrip at 12 weeks
Description
Bilateral handgrip strength
Time Frame
Baseline, 12 weeks
Title
Change from baseline one-leg standing test at 12 weeks
Description
Time achieved while standing on one leg
Time Frame
Baseline, 12 weeks
Title
Change from baseline one-leg heel rise test at 12 weeks
Description
Number of heel rise repetitions achieved
Time Frame
Baseline, 12 weeks
Title
Change from baseline 6 minutes walk test at 12 weeks
Description
Number of meters walked in 6 minutes
Time Frame
Baseline, 12 weeks
Title
Change from baseline Physical activity level at 12 weeks
Description
Physical activity questionnaires
Time Frame
Baseline, 12 weeks
Title
Change from baseline Health related quality of life at 12 weeks
Description
Short Form 36 questionnaire to measure health-related quality of life
Time Frame
Baseline, 12 weeks
Title
Change from baseline Cognitive function at 12 weeks
Description
Mini-mental State Examination questionnaire
Time Frame
Baseline, 12 weeks
Title
Adherence
Description
Sessions performed/sessions offered
Time Frame
12 weeks
Title
Healthcare resources expenditure and costs
Description
Total amount in euros spent on external consultations, laboratory tests, radiology tests, hospital pharmacy, emergency department healthcare provision, and hospitalisation.
Time Frame
12 months before starting the exercise program- 12 months after the starting date

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least 3 months in hemodialysis treatment Clinically stable Exclusion Criteria: Recent cardiac events (less than 3 months) Unable to exercise
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva SEGURA-ORTÍ, PhD
Organizational Affiliation
Universidad CEU Cardenal Herrera, UCH CEU
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Manises
City
Manises
State/Province
Valencia
ZIP/Postal Code
46940
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28114792
Citation
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.
Results Reference
background
PubMed Identifier
21719637
Citation
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.
Results Reference
background
PubMed Identifier
20701722
Citation
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.
Results Reference
background
PubMed Identifier
20098466
Citation
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.
Results Reference
background
PubMed Identifier
19473613
Citation
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.
Results Reference
background
PubMed Identifier
18336134
Citation
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.
Results Reference
background

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Virtual Reality During Hemodialysis

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