Kidney Failure, ChronicNCT05606484
Effect of Exercise With Virtual Reality in Hemodialysis Patients
A study testing Exercise with non-immersive virtual reality and Exercise with a static pedal in people with Kidney Failure, Chronic, run by Universidad Miguel Hernandez de Elche.
Trial summary
Background. An increase in inflammatory biomarkers is associated with impaired kidney function and increased cardiovascular risk and mortality. Physical exercise has been shown to improve the functional capacity and inflammatory status of patients undergoing hemodialysis (HD) treatment, increasing their health-related… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Kidney Failure, Chronic
- What is being tested?
- Exercise with non-immersive virtual reality and Exercise with a static pedal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 9 Jun 2023to 1 Dec 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with CKF in a stable clinical situation who have been on HD treatment for at least 3 months.
Who cannot join
- Had a myocardial infarction in the 6 months before the start of the study
- Suffered unstable angina at rest or during exercise
- Have cerebrovascular diseases (such as transient ischemia or stroke)
- Present amputation of lower limbs above the knee without prothesis
- Present a musculoskeletal or respiratory pathology likely to worsen with exercise
- Present an inability to carry out functional assessment tests
- Present visual or cognitive impairments that affect the ability to use the VR equipment or understand the VR exercise
About this study
Official title: Effect of Virtual Reality Exercise on Hemodialysis Patients: A Randomized Controlled Clinical Trial Research Protocol
Background. An increase in inflammatory biomarkers is associated with impaired kidney function and increased cardiovascular risk and mortality. Physical exercise has been shown to improve the functional capacity and inflammatory status of patients undergoing hemodialysis (HD) treatment, increasing their health-related quality of life. Virtual reality (VR) is an effective and safe tool to increase patient adherence to the exercise program, however, there are very few studies that analyze its effect on the functional capacity of patients with chronic kidney disease (CKD) in HD and none analyze its effect on the inflammatory state of these patients, which justifies the performance of this study.
Methods. Eighty patients with CKD on HD treatment will be randomly assigned into two groups, one of them will perform an intradialysis exercise program with non-immersive VR (intervention group; n=40), and the other will exercise with a static pedal (control group; n). =40). The functional capacity of the patients and their inflammatory and psychological status, as well as their exercise adherende, will be analyzed before and after exercise programs.
Read the detailed description
Description of the intervention The exercise program will last for 12 weeks. Randomly, half of the patients will be instructed to - Control Group (CG): They will be instructed to exercise with a static pedal (control group) and the other half will be instructed to carry out the intradialysis non-immersive virtual reality exercise program.
- Intervention Group (IG): Will perform an intradialysis physical exercise program with non-immersive virtual reality during the first two hours of hemodialysis treatment (n = 40).
- Control Group (CG): They will exercise with a static pedal (n = 40). Exercise program The direction and supervision of the exercise programs will be the responsibility of the nursing staff of the Hemodialysis Unit and several physiotherapists of the Rehabilitation Unit of the General University Hospital of Alicante Doctor Balmis, the nursing staff being in charge of directing and supervising the intradialysis exercise program.
Prior to the beginning of the intervention, said personnel will receive exhaustive training on the characteristics of the exercise program and on how to carry it out in an optimal way. In this training they will be instructed on how to execute each of the exercises in the program with virtual reality.
During the two weeks prior to the intervention, a "first contact" period will be carried out, during which the nursing staff will implement the virtual reality intradialis exercise program as a test, so that they can familiarize themselves with the material necessary to exercise, as well as resolve any doubts that may arise. This trial period will be supervised by the physiotherapist in charge of giving them the training.
On the other hand, to improve adherence to exercise by patients and avoid losses throughout the program, all the staff in charge of directing and supervising the exercise will receive a training session by a psychologist specialized in managing barriers in special populations during exercise, with the aim of developing strategies to address these barriers during the intervention period.
The exercise program will have a duration of 12 weeks, with a frequency of 3 exercise sessions per week, these being of a progressive duration according to the patient's capacity (EEP 13-15), until reaching 30 minutes per session, and performed during the first two hours of HD treatment.
Before and after each exercise session, heart rate and blood pressure will be recorded.
Patients will be instructed to perform the exercise independently or with minimal assistance.
The non-immersive virtual reality exercise program is described below:
- Intervention Group (IG): Participants assigned to this group will start with a 5-minute warm-up session and then perform a virtual reality exercise session for up to a maximum of 30 minutes, depending on the rate of perceived exertion that should be felt between "somewhat hard" and "hard" (13-15 out of 20 in EEP). The intensity will progress by increasing the number of exercise series (each lasting 3 minutes) and may vary between 1 and 10 series, depending on the patient's capacity, taking a 1-minute break between each series.
The hemodialysis session may be carried out simultaneously with the exercise, since the work will focus on the lower limbs.
An adapted version of ACT (Treasure Hunt) will be used for the VR program. ACT is a non-immersive virtual reality system designed with a playful scheme. For the participants, the system is an intradialysis virtual reality game, which makes dialysis sessions more enjoyable. In ACT, the subject tries to hit a series of targets (avoiding obstacles) by moving the leg.
The difficulty in ACT is graduated according to the characteristics of the participants, who will be able to change the leg during the game when they feel tired.
The general hardware setup consists of a standard computer, a television (commonly found in HD units), and a Ms Kinect® motion tracking system.
At the beginning of the session, the therapists define the VR intervention for the session using a management tool, adding different rest periods and configuring their duration. The difficulty level of the exercise will also be set at startup, and therapists will be able to program the system to automatically increase or decrease the difficulty level depending on the participant's performance.
Before their first session, each participant will receive instructions on the general use of the system and a test session will take place.
At the end of the program, participants will end the session with another 5 minutes of gentle stretching.
Control group (CG): The participants in this group will exercise with a static pedal, exercising the same muscle groups as the VR group. They will perform the exercise at the same time as the VR group, during the first two hours of hemodialysis, with a duration of 30 minutes each session, performing 3 weekly sessions at a perceived exertion intensity of 12-15 (something hard-hard) in the Borg scale.
The patients will be blind, being distributed in the hemodialysis room so that in one area there are the patients who exercise with VR and in the other the patients who exercise with a static pedal.
- Conditions
- Kidney Failure, Chronic
- Being tested
- Exercise with non-immersive virtual reality, Exercise with a static pedal
- Keywords
- Kidney Failure, Chronic, Inflammation, Functional capacity, Psychological state, Renal Dialysis
- Medical subject headings
- Kidney Failure, Chronic, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise with non-immersive virtual realityOther
Patients will exercise for 30 minutes with non-immersive virtual reality (VR) with a perceived exertion between 12-15 (somewhat hard-hard) on the Borg scale. Patients will perform 3 weekly sessions during the second hour of hemodialysis, on simultaneous days.
Exercise with a static pedalOther
Patients will exercise with a stationary pedal for 30 minutes at an intensity of 12-15 (somewhat hard-hard) on the Borg scale of perceived exertion. The patients will carry out an exercise session 3 times a week on alternate days, coinciding with the patients of the exercise with VR.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (IG) | Experimental | They will perform an intradialysis physical exercise program with non-immersive virtual reality during the first two hours of hemodialysis treatment (n = 40). Receives: Other: Exercise with non-immersive virtual reality; Other: Exercise with a static pedal |
| Control Group (CG) | Active comparator | They will exercise with a static pedal during the first two hour of hemodialysis treatment (n = 40). Receives: Other: Exercise with non-immersive virtual reality; Other: Exercise with a static pedal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Interleuquine 6 (IL-6) (pg/ml)
Inflammatoy marker
Measured: Change from Baseline IL-6 at 12 weeks
Change of Tumoral Necrosis Factor-alpha (TNF-alpha) (pg/ml)
Inflammatoy marker
Measured: Change from Baseline TNF-a at 12 weeks
Change of C Reactive Protein (CRP) (mg/L)
Inflammatoy marker
Measured: Change from Baseline CRP at 12 weeks
Change of Intercellular Adhesion Molecule 1 (ICAM 1) (ng/ml)
Inflammatoy marker
Measured: Change from Baseline ICAM 1 at 12 weeks
Change of Vascular cell adhesion protein 1 (VCAM 1) (ng/ml)
Inflammatoy marker
Measured: Change from Baseline VCAM 1 at 12 weeks
Secondary outcomes (5)
Assessment of the functional capacity of patients: Short Physical Performance Battery (SPPB)
Mesure dependency, institutionalization, hospitalization and mortality. Score ranges from 1 to 12 points
Measured: baseline and up to 12 weeks
Assessment of the functional capacity of patients: 10 Sit To Stand Test (10 STS).
Seconds it takes for the patient to get up and sit down 10 times
Measured: baseline and up to 12 weeks
Assessment of the functional capacity of patients: 60 Sit To Stand Test (60 STS).
Number of times the patient gets up and sits down during 60 seconds
Measured: baseline and up to 12 weeks
Assessment of the functional capacity of patients: 6 minute walk test (6MWT)
Meters that a patient is able to walk for 6 minutes
Measured: baseline and up to 12 weeks
Psychological assessment of patients: Multidimensional Questionnaire of Adaptation to the Disease for Renal Patients on Dialysis
It consists of two phases: Phase A and Phase B. The Phase A, which includes 12 items, collects all the information from the clinical history of the patient. This phase includes two areas "Data Doctors" and "Previous Psychopathological History". Phase B, which includes 51 items, it is made up of nine areas that make up the evaluation of the patient. This phase includes the following areas: "Sociodemographic data" (6 items), "Information",(9 items), "Medication and diet" (3 items), "Social support" (4 items), "State of encouragement" (2 items), "Personal resources, coping and resilience" (8 items), "Learning and perceived changes" (5 items), "Spirituality" (2 items) and "Care planning" (2 items). The questions have four formats of response; three of them closed in nature (dichotomous responses, nominal categorical, and 10-point Likert-type scales), and one open and qualitative. An increase in the scale score is positive. A change α < 0.05 is considered statistically significant.
Measured: baseline and up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start9 Jun 2023 (estimated)
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Failure, ChronicStudies 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
- Parallel groups
- Model description
- Experimental, controlled and randomized study, whose methodology complies with the CONSORT standards for clinical trials
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Miguel Hernandez de Elche
- Sponsor type
- University, hospital or other
- Collaborators
- European University of Madrid
- Responsible party
- Principal investigator, Érika Meléndez Oliva, Universidad Miguel Hernandez de Elche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05606484
- Sponsor's protocol ID
- TFM.MMC.EJPP.EMO.220221
- Status last verified
- Feb 2023
- First submitted
- 25 Sep 2022
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality Exercise on Hemodialysis Patients: A Randomized Controlled Clinical Trial Research Protocol
- ClinicalTrials.gov ID
- NCT05606484
- Acronym / sponsor ID
- TFM.MMC.EJPP.EMO.220221
- Conditions
- Kidney Failure, Chronic
- Keywords
- Kidney Failure, Chronic, Inflammation, Functional capacity, Psychological state, Renal Dialysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Universidad Miguel Hernandez de ElcheUniversity, hospital or other
- Collaborators
- European University of Madrid
- Study start
- 9 Jun 2023 (estimated)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 4 Nov 2022 (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.
Background. An increase in inflammatory biomarkers is associated with impaired kidney function and increased cardiovascular risk and mortality. Physical exercise has been shown to improve the functional capacity and inflammatory status of patients undergoing hemodialysis (HD) treatment, increasing their health-related quality of life. Virtual reality (VR) is an effective and safe tool to increase patient adherence to the exercise program, however, there are very few studies that analyze its effect on the functional capacity of patients with chronic kidney disease (CKD) in HD and none analyze its effect on the inflammatory state of these patients, which justifies the performance of this study.
Methods. Eighty patients with CKD on HD treatment will be randomly assigned into two groups, one of them will perform an intradialysis exercise program with non-immersive VR (intervention group; n=40), and the other will exercise with a static pedal (control group; n). =40). The functional capacity of the patients and their inflammatory and psychological status, as well as their exercise adherende, will be analyzed before and after exercise programs.
Detailed description
Description of the intervention The exercise program will last for 12 weeks. Randomly, half of the patients will be instructed to - Control Group (CG): They will be instructed to exercise with a static pedal (control group) and the other half will be instructed to carry out the intradialysis non-immersive virtual reality exercise program.
- Intervention Group (IG): Will perform an intradialysis physical exercise program with non-immersive virtual reality during the first two hours of hemodialysis treatment (n = 40).
- Control Group (CG): They will exercise with a static pedal (n = 40). Exercise program The direction and supervision of the exercise programs will be the responsibility of the nursing staff of the Hemodialysis Unit and several physiotherapists of the Rehabilitation Unit of the General University Hospital of Alicante Doctor Balmis, the nursing staff being in charge of directing and supervising the intradialysis exercise program.
Prior to the beginning of the intervention, said personnel will receive exhaustive training on the characteristics of the exercise program and on how to carry it out in an optimal way. In this training they will be instructed on how to execute each of the exercises in the program with virtual reality.
During the two weeks prior to the intervention, a "first contact" period will be carried out, during which the nursing staff will implement the virtual reality intradialis exercise program as a test, so that they can familiarize themselves with the material necessary to exercise, as well as resolve any doubts that may arise. This trial period will be supervised by the physiotherapist in charge of giving them the training.
On the other hand, to improve adherence to exercise by patients and avoid losses throughout the program, all the staff in charge of directing and supervising the exercise will receive a training session by a psychologist specialized in managing barriers in special populations during exercise, with the aim of developing strategies to address these barriers during the intervention period.
The exercise program will have a duration of 12 weeks, with a frequency of 3 exercise sessions per week, these being of a progressive duration according to the patient's capacity (EEP 13-15), until reaching 30 minutes per session, and performed during the first two hours of HD treatment.
Before and after each exercise session, heart rate and blood pressure will be recorded.
Patients will be instructed to perform the exercise independently or with minimal assistance.
The non-immersive virtual reality exercise program is described below:
- Intervention Group (IG): Participants assigned to this group will start with a 5-minute warm-up session and then perform a virtual reality exercise session for up to a maximum of 30 minutes, depending on the rate of perceived exertion that should be felt between "somewhat hard" and "hard" (13-15 out of 20 in EEP). The intensity will progress by increasing the number of exercise series (each lasting 3 minutes) and may vary between 1 and 10 series, depending on the patient's capacity, taking a 1-minute break between each series.
The hemodialysis session may be carried out simultaneously with the exercise, since the work will focus on the lower limbs.
An adapted version of ACT (Treasure Hunt) will be used for the VR program. ACT is a non-immersive virtual reality system designed with a playful scheme. For the participants, the system is an intradialysis virtual reality game, which makes dialysis sessions more enjoyable. In ACT, the subject tries to hit a series of targets (avoiding obstacles) by moving the leg.
The difficulty in ACT is graduated according to the characteristics of the participants, who will be able to change the leg during the game when they feel tired.
The general hardware setup consists of a standard computer, a television (commonly found in HD units), and a Ms Kinect® motion tracking system.
At the beginning of the session, the therapists define the VR intervention for the session using a management tool, adding different rest periods and configuring their duration. The difficulty level of the exercise will also be set at startup, and therapists will be able to program the system to automatically increase or decrease the difficulty level depending on the participant's performance.
Before their first session, each participant will receive instructions on the general use of the system and a test session will take place.
At the end of the program, participants will end the session with another 5 minutes of gentle stretching.
Control group (CG): The participants in this group will exercise with a static pedal, exercising the same muscle groups as the VR group. They will perform the exercise at the same time as the VR group, during the first two hours of hemodialysis, with a duration of 30 minutes each session, performing 3 weekly sessions at a perceived exertion intensity of 12-15 (something hard-hard) in the Borg scale.
The patients will be blind, being distributed in the hemodialysis room so that in one area there are the patients who exercise with VR and in the other the patients who exercise with a static pedal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Experimental, controlled and randomized study, whose methodology complies with the CONSORT standards for clinical trials
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (IG) | Experimental | Other: Exercise with non-immersive virtual reality, Other: Exercise with a static pedalThey will perform an intradialysis physical exercise program with non-immersive virtual reality during the first two hours of hemodialysis treatment (n = 40). |
| Control Group (CG) | Active comparator | Other: Exercise with non-immersive virtual reality, Other: Exercise with a static pedalThey will exercise with a static pedal during the first two hour of hemodialysis treatment (n = 40). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with CKF in a stable clinical situation who have been on HD treatment for at least 3 months.
Key exclusion criteria (7 listed)
- Had a myocardial infarction in the 6 months before the start of the study
- Suffered unstable angina at rest or during exercise
- Have cerebrovascular diseases (such as transient ischemia or stroke)
- Present amputation of lower limbs above the knee without prothesis
- Present a musculoskeletal or respiratory pathology likely to worsen with 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 |
|---|---|---|
| Exercise with non-immersive virtual realityPatients will exercise for 30 minutes with non-immersive virtual reality (VR) with a perceived exertion between 12-15 (somewhat hard-hard) on the Borg scale. Patients will perform 3 weekly sessions during the second hour of hemodialysis, on simultaneous days. | Other | Control Group (CG), Intervention Group (IG) |
| Exercise with a static pedalPatients will exercise with a stationary pedal for 30 minutes at an intensity of 12-15 (somewhat hard-hard) on the Borg scale of perceived exertion. The patients will carry out an exercise session 3 times a week on alternate days, coinciding with the patients of the exercise with VR. | Other | Control Group (CG), Intervention Group (IG) |
Primary outcome
Change of Interleuquine 6 (IL-6) (pg/ml)
Time frame: Change from Baseline IL-6 at 12 weeks
Inflammatoy marker
Change of Tumoral Necrosis Factor-alpha (TNF-alpha) (pg/ml)
Time frame: Change from Baseline TNF-a at 12 weeks
Inflammatoy marker
Change of C Reactive Protein (CRP) (mg/L)
Time frame: Change from Baseline CRP at 12 weeks
Inflammatoy marker
Change of Intercellular Adhesion Molecule 1 (ICAM 1) (ng/ml)
Time frame: Change from Baseline ICAM 1 at 12 weeks
Inflammatoy marker
Change of Vascular cell adhesion protein 1 (VCAM 1) (ng/ml)
Time frame: Change from Baseline VCAM 1 at 12 weeks
Inflammatoy marker
5 secondary outcomes
Assessment of the functional capacity of patients: Short Physical Performance Battery (SPPB)
Time frame: baseline and up to 12 weeks
Assessment of the functional capacity of patients: 10 Sit To Stand Test (10 STS).
Time frame: baseline and up to 12 weeks
Assessment of the functional capacity of patients: 60 Sit To Stand Test (60 STS).
Time frame: baseline and up to 12 weeks
Assessment of the functional capacity of patients: 6 minute walk test (6MWT)
Time frame: baseline and up to 12 weeks
Psychological assessment of patients: Multidimensional Questionnaire of Adaptation to the Disease for Renal Patients on Dialysis
Time frame: baseline and up to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Kidney Failure, Chronic
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise with non-immersive virtual reality and Exercise with a static pedal in people with Kidney Failure, Chronic, run by Universidad Miguel Hernandez de Elche.
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: status not confirmed, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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 of Interleuquine 6 (IL-6) (pg/ml) (time frame: Change from Baseline IL-6 at 12 weeks). The study lists 5 primary outcomes in all. 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 21 Feb 2023.