End Stage Renal DiseaseNCT03120611
Virtual Reality Versus Conventional Exercise Intradialysis
A study testing Virtual Reality Exercise and Conventional exercise intradialysis in people with End Stage Renal Disease, run by Cardenal Herrera University at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Virtual Reality Exercise and Conventional exercise intradialysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2017to 31 Aug 2017
- 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
- Patients in HD therapy at least 3 months
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Exercise Programs Intradialysis: Virtual Reality Exercise Versus Conventional Exercise
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.
Read the detailed description
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.
- Conditions
- End Stage Renal Disease
- Being tested
- Virtual Reality Exercise, Conventional exercise intradialysis
- Keywords
- Exercise, Hemodialysis, Virtual Reality
- 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 ExerciseOther
Game developed by the Kinect, adapted to the lying position of participants.
Conventional exercise intradialysisOther
Aerobic exercise (cycling) and strengthening exercise for lower limbs using elastic bands and gravity
| Study group | Role | What they receive |
|---|---|---|
| Virtural reality exercise | Experimental | Virtual reality exercise performed during the hemodialysis session, using the Kinect, specially adapted for patients undertaking hemodialysis Receives: Other: Virtual Reality Exercise |
| Conventional exercise intradialysis | Active comparator | Exercise combining both aerobic (cycling) and strengthening exercise of lower limbs for patients during the hemodialysis session Receives: Other: Conventional exercise intradialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sit to Stand to Sit test 10
Time required to stand up from a chair and sit down 10 consecutive times
Measured: 20 weeks
Secondary outcomes (17)
Short Physical Performance Battery
Balance, gait speed and sit to stand to sit 5 times
Measured: 20 weeks
Timed Up and Go
Time to stand up, walk a short distance, turn, walk back and sit down to the chair again
Measured: 20 weeks
One leg stand test
Time to keep balance on one leg
Measured: 20 weeks
Sit to Stand to Sit test 60 seconds
Number of repetitions achieved of standing up from a chair during 60 seconds
Measured: 20 weeks
Handgrip
Handgrip strength right and left hands
Measured: 20 weeks
One leg heel rise test
Number of repetitions of standing on toes in both legs
Measured: 20 weeks
6 minutes walk test
Number of meters covered during 6 minutes of walking
Measured: 20 weeks
Adherence
Sessions performed/offered
Measured: 20 weeks
Physical Activity
Human activity profile, adjusted and maximal activity score
Measured: 16 weeks
Physical Activity
Physical activity score for the elderly
Measured: 16 weeks
Inflammatory markers
Interleukin 6 (IL6)
Measured: 16 weeks
Inflammatory markers
Monocyte chemoattractant protein-1 (MCP-1)
Measured: 16 weeks
Inflammatory markers
C-Reactive Protein (CRP)
Measured: 16 weeks
Inflammatory markers
Human Tumor Necrosis Factor α (TNF-α)
Measured: 16 weeks
Health-related quality of life
SF-36 subscales and components
Measured: 16 weeks
Oxidative stress markers
Malondialdehyde (MDA)
Measured: 16 weeks
Oxidative stress markers
Carbonylated proteins
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study start1 Jun 2017
- Primary completion30 Jul 2017
- Study completion31 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardenal Herrera University
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital de Manises, Valencia
- Responsible party
- Principal investigator, Eva Segura Ortí, Cardenal Herrera University
- Investigators
- Rafael García Maset, MD, Study chair, Hospital de Manises
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03120611
- Sponsor's protocol ID
- 2015/0193
- Status last verified
- May 2018
- First submitted
- 10 Apr 2017
- Last updated
- 23 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Exercise Programs Intradialysis: Virtual Reality Exercise Versus Conventional Exercise
- ClinicalTrials.gov ID
- NCT03120611
- Acronym / sponsor ID
- 2015/0193
- Conditions
- End Stage Renal Disease
- Keywords
- Exercise, Hemodialysis, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Collaborators
- Hospital de Manises, Valencia
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 30 Jul 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 19 Apr 2017 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtural reality exercise | Experimental | Other: Virtual Reality ExerciseVirtual reality exercise performed during the hemodialysis session, using the Kinect, specially adapted for patients undertaking hemodialysis |
| Conventional exercise intradialysis | Active comparator | Other: Conventional exercise intradialysisExercise combining both aerobic (cycling) and strengthening exercise of lower limbs for patients during the hemodialysis session |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients in HD therapy at least 3 months
Key exclusion criteria (7 listed)
- recent myocardial infarction (within 6 weeks)
- unstable angina
- malignant arrhythmias
- above the knee amputation without replacement
- cerebral vascular disease (ictus, transient ischemia)
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 ExerciseGame developed by the Kinect, adapted to the lying position of participants. | Other | Virtural reality exercise |
| Conventional exercise intradialysisAerobic exercise (cycling) and strengthening exercise for lower limbs using elastic bands and gravity | Other | Conventional exercise intradialysis |
Primary outcome
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
17 secondary outcomes
Short Physical Performance Battery
Time frame: 20 weeks
Timed Up and Go
Time frame: 20 weeks
One leg stand test
Time frame: 20 weeks
Sit to Stand to Sit test 60 seconds
Time frame: 20 weeks
Handgrip
Time frame: 20 weeks
One leg heel rise test
Time frame: 20 weeks
6 minutes walk test
Time frame: 20 weeks
Adherence
Time frame: 20 weeks
Physical Activity
Time frame: 16 weeks
Physical Activity
Time frame: 16 weeks
Inflammatory markers
Time frame: 16 weeks
Inflammatory markers
Time frame: 16 weeks
Inflammatory markers
Time frame: 16 weeks
Inflammatory markers
Time frame: 16 weeks
Health-related quality of life
Time frame: 16 weeks
Oxidative stress markers
Time frame: 16 weeks
Oxidative stress markers
Time frame: 16 weeks
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 23 May 2018.
- Individual participant dataSharing planned: No
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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.
Rafael García Maset, MD study chair
Hospital de Manises
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 and Conventional exercise intradialysis in people with End Stage Renal Disease, 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 1 inclusion and 7 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 23 May 2018. 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?
Sit to Stand to Sit test 10 (time frame: 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 May 2018.