End Stage Renal DiseaseVRHDNCT03456414
Virtual Reality During Hemodialysis
A study testing Virtual reality exercise during hemodialysis in people with End Stage Renal Disease and Hemodialysis-Induced Symptom, run by Cardenal Herrera University at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease, Hemodialysis-Induced Symptom
- What is being tested?
- Virtual reality exercise during hemodialysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 11 Apr 2018to 30 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 3 months in hemodialysis treatment
- Clinically stable
Who cannot join
- Recent cardiac events (less than 3 months)
- Unable to exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Virtual Reality Exercise 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.
Read the 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.
- Being tested
- Virtual reality exercise during hemodialysis
- Keywords
- exercise, physical function, health related quality of life
- Medical subject headings
- Kidney Failure, Chronic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality exercise during hemodialysisOther
Subjects will play a virtual reality game specially adapted for subjects undertaking hemodialysis treatment
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality during hemodialysis | Experimental | During 12 weeks subjects will exercise during hemodialysis. The intervention will be virtual reality exercise during hemodialysis. Receives: Other: Virtual reality exercise during hemodialysis |
| Control period - no exercise | No intervention | During 12 weeks subjects will not exercise during hemodialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline gait speed at 12 weeks
Speed to cover 4 meters at normal speed
Measured: Baseline, 12 weeks
Secondary outcomes (13)
Change from baseline sit to stand 10 at 12 weeks
Time to perform 10 sit to stand repetitions,
Measured: Baseline, 12 weeks
Change from baseline sit to stand 60 at 12 weeks
Sit to stand repetitions performed in 60 seconds
Measured: Baseline, 12 weeks
Change from baseline timed up and go at 12 weeks
Time to stand up, walk 3 meters, come back and sit down again
Measured: Baseline, 12 weeks
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
Measured: Baseline, 12 weeks
Change from baseline handgrip at 12 weeks
Bilateral handgrip strength
Measured: Baseline, 12 weeks
Change from baseline one-leg standing test at 12 weeks
Time achieved while standing on one leg
Measured: Baseline, 12 weeks
Change from baseline one-leg heel rise test at 12 weeks
Number of heel rise repetitions achieved
Measured: Baseline, 12 weeks
Change from baseline 6 minutes walk test at 12 weeks
Number of meters walked in 6 minutes
Measured: Baseline, 12 weeks
Change from baseline Physical activity level at 12 weeks
Physical activity questionnaires
Measured: Baseline, 12 weeks
Change from baseline Health related quality of life at 12 weeks
Short Form 36 questionnaire to measure health-related quality of life
Measured: Baseline, 12 weeks
Change from baseline Cognitive function at 12 weeks
Mini-mental State Examination questionnaire
Measured: Baseline, 12 weeks
Adherence
Sessions performed/sessions offered
Measured: 12 weeks
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.
Measured: 12 months before starting the exercise program- 12 months after the starting date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start11 Apr 2018
- Primary completion1 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardenal Herrera University
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital de Manises, Universitat Politècnica de València
- Responsible party
- Principal investigator, Eva Segura Ortí, Cardenal Herrera University
- Investigators
- Eva SEGURA-ORTÍ, PhD, Principal investigator, Universidad CEU Cardenal Herrera, UCH CEU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03456414
- Sponsor's protocol ID
- 2017/0638
- Acronym
- VRHD
- Status last verified
- Jul 2020
- First submitted
- 22 Feb 2018
- Last updated
- 17 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28114792Segura-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.
PubMed 21719637Segura-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.
PubMed 20701722Segura-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.
PubMed 20098466Segura-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.
PubMed 19473613Segura-Orti E, Rodilla-Alama V, Lison JF. [Physiotherapy during hemodialysis: results of a progressive resistance-training programme]. Nefrologia. 2008;28(1):67-72. Spanish.
PubMed 18336134
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Exercise During Hemodialysis
- ClinicalTrials.gov ID
- NCT03456414
- Acronym / sponsor ID
- VRHD / 2017/0638
- Keywords
- exercise, physical function, health related quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Collaborators
- Hospital de Manises, Universitat Politècnica de València
- Study start
- 11 Apr 2018 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 7 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Virtual reality during hemodialysis | Experimental | Other: Virtual reality exercise during hemodialysisDuring 12 weeks subjects will exercise during hemodialysis. The intervention will be virtual reality exercise during hemodialysis. |
| Control period - no exercise | No intervention | –During 12 weeks subjects will not exercise during hemodialysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- At least 3 months in hemodialysis treatment
- Clinically stable
Key exclusion criteria (2 listed)
- Recent cardiac events (less than 3 months)
- Unable to exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality exercise during hemodialysisSubjects will play a virtual reality game specially adapted for subjects undertaking hemodialysis treatment | Other | Virtual reality during hemodialysis |
Primary outcome
Change from baseline gait speed at 12 weeks
Time frame: Baseline, 12 weeks
Speed to cover 4 meters at normal speed
13 secondary outcomes
Change from baseline sit to stand 10 at 12 weeks
Time frame: Baseline, 12 weeks
Change from baseline sit to stand 60 at 12 weeks
Time frame: Baseline, 12 weeks
Change from baseline timed up and go at 12 weeks
Time frame: Baseline, 12 weeks
Change from baseline short physical performance battery at 12 weeks
Time frame: Baseline, 12 weeks
Change from baseline handgrip at 12 weeks
Time frame: Baseline, 12 weeks
Change from baseline one-leg standing test at 12 weeks
Time frame: Baseline, 12 weeks
Change from baseline one-leg heel rise test at 12 weeks
Time frame: Baseline, 12 weeks
Change from baseline 6 minutes walk test at 12 weeks
Time frame: Baseline, 12 weeks
Change from baseline Physical activity level at 12 weeks
Time frame: Baseline, 12 weeks
Change from baseline Health related quality of life at 12 weeks
Time frame: Baseline, 12 weeks
Change from baseline Cognitive function at 12 weeks
Time frame: Baseline, 12 weeks
Adherence
Time frame: 12 weeks
Healthcare resources expenditure and costs
Time frame: 12 months before starting the exercise program- 12 months after the starting date
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2020.
- Background: PubMed 28114792Segura-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.
- Background: PubMed 21719637Segura-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.
- Background: PubMed 20701722Segura-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.
- Background: PubMed 20098466Segura-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.
- Background: PubMed 19473613Segura-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.
- Background: PubMed 18336134Segura-Orti E, Rodilla-Alama V, Lison JF. [Physiotherapy during hemodialysis: results of a progressive resistance-training programme]. Nefrologia. 2008;28(1):67-72. Spanish.
- Individual participant dataSharing planned: Undecided
Related trials for End Stage Renal Disease
Recruiting
Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula
End Stage Renal Disease
Not yet recruitingObservational study
Unmasking Diabetes in Dialysis With Continuous Glucose Monitoring
End Stage Kidney Disease (ESKD), Hyperglycaemia
Not yet recruitingObservational study
Microbiota Changes Related to Outcomes in Kidney Transplantation
End-stage Renal Disease (ESRD), Kidney Transplantation
Recruiting
Laser Acupuncture for Fatigue in Hemodialysis Patients
ESRD (End Stage Renal Disease), Dialysis
Active, not recruitingObservational study
Central Blood Pressure and Pulse Wave Velocity in Kidney Transplant Recipients
End Stage Renal Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva SEGURA-ORTÍ, PhD principal investigator
Universidad CEU Cardenal Herrera, UCH CEU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality exercise during hemodialysis in people with End Stage Renal Disease and Hemodialysis-Induced Symptom, run by Cardenal Herrera University at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline gait speed at 12 weeks (time frame: Baseline, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03456414, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2020.