Spinal Cord InjuriesNCT04618003
Autonomic Modulation in Athletes and Non-Athletes With Spinal Cord Injury During Task in Virtual Reality Environment
An observational study of Spinal Cord Injuries, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The study consisted in the analysis of the autonomic modulation of the heart rate by the Heart Rate Variability of the participants at rest for 5 minutes, and during physical activity of 8 minutes, through a virtual reality game. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Adaptation of autonomic nervous system to activity in virtual reality
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 145 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2017to 1 Aug 2020
- Phase
- Observational
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study included athletes and non-athletes with a confirmed medical diagnosis of SCI, with voluntary extension of elbows and wrist, active trunk control, and who had already completed rehabilitation. For the athlete group, participants had to fulfill the minimum criteria for defining an active athlete, described in the next section. Also, a control group of able-bodied subjects, approximately paired by age and sex wit the and non-athlete groups were recruited.
Who may be able to join
- Confirmed medical diagnosis of SCI
- Preserved motor activity for extension of the upper limbs and active trunk control, which had already finished their process of adaptation to injury.
Who cannot join
- Functional incapacities of the upper limbs to perform the game,
- Diagnosis of heart disease or other neurological disorders not due to SCI,
- Consumption of drugs that are not part of their usual treatment routine and that influence the cardiac and nervous systems,
- Error greater than 5% in the analysis of HRV.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Comitê de Ética e Pesquisa da Universidade Federal de São Paulo
São Paulo, São Paulo, 04023-900
About this study
Official title: Analysis of Autonomic Modulation in Athletes and Non-Athletes With Spinal Cord Injury During Task in Virtual Reality Environment
The study consisted in the analysis of the autonomic modulation of the heart rate by the Heart Rate Variability of the participants at rest for 5 minutes, and during physical activity of 8 minutes, through a virtual reality game. The data capture was performed using a cardio-frequency meter with belt placed on the volunteer's trunk and, in addition, questionnaires, functional classification scales and personal data collection were applied.
Read the detailed description
This is a cross-sectional study, approved by the Ethics and Research Committee of the Medical School of the Federal University of São Paulo (UNIFESP) registered under CAAE 793517.1.0000.5505. The recruitment of non-athletes was carried out at the Acreditando Rehabilitation Center and the athletes were recruited at the Faca na Cadeira Institute, ICEL and Clube Espéria. Participants were enrolled in the study after signing the Free and Informed Consent Term. Convenience sampling technique was used with data collected from March 2017 to October 2018 Participants The study included athletes and non-athletes with a confirmed medical diagnosis of SCI, with voluntary extension of elbows and wrist, active trunk control, and who had already completed rehabilitation. For the athlete group, participants had to fulfill the minimum criteria for defining an active athlete, described in the next section. Also, a control group of able-bodied subjects, approximately paired by age and sex wit the AG and non-athlete groups were recruited. Participants were excluded if they presented with impairments to the upper limbs that interfered with the performance during the game, were diagnosed with heart disease or other neurological disorders , were using medication that were not part of their usual routine or that influenced the cardiac and nervous systems, and presented an error greater than 5% in the analysis of HRV.
Assessment of function The Funtional Independence Measure (FIM) and the Spinal Cord Independence Measure Version III (SCIM III) were used to classify functional independence. The International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) was employed to assess the level and severity of injury. To classify the physical activity levels of the participants, the the Physical Activity in Athlete Questionnaire and the Leisure Time Physical Activity Questionnaire for Non-Athletes with Spinal Cord Injury (LTPAQ-SCI) were employed.
Assessment of Heart Rate Variability For the HRV assessment, participants were instructed not to consume alcohol, caffeine or smoke 24 hours before the test. The procedures to measure HRV were conducted according to the guidelines from the Task Force of the European Society of Cardiology and the North American Society of Stimulation and Electrophysiology and were recorded using the Polar V800 electrocardiographic measuring device (Polar Electro, Finland), with a sampling rate of 1000 Hz.
The determination of the linear indexes of HRV for time and frequency was carried out using the software Kubios HRV (v. 3.3.0). The HRV data for time was analyzed using linear methods, using SDNN indices (standard deviation of the mean of all normal RR intervals) in milliseconds (ms); PNN50 (percentage of successive differences of the RR intervals with an absolute value greater than 50ms); RMSSD (square root of the mean square of the differences between adjacent normal RR intervals). Moreover, geometric methods such as, the RRTri (triangular index) and TINN (histogram interpolation of NN intervals), the indexes of the Poincaré graph with the SD1 (standard deviation of the instantaneous variability of the beat-to beat heart rate), SD2 (standard deviation of the long-term, continuous, RR interval variability), and the SD1/SD2 ratio-the ratio between the short- and long-term variations among the RR intervals and Parassympathetic Nervous System index (PNS index), Sympathetic Nervous System index (SNS index) and Stress index given by HRV Kubios, were employed. LF indices (low frequency spectral components, between 0.04 and 0.15 Hertz) were recorded in ms2 and in standard units (nu); while HF (high frequency spectral components, between 0.15 and 0.4 Hertz) was recorded in ms2 and nu; and the ratio of LF/HF in ms2.
PROTOCOL For the three groups the HRV measures were captured in 2 instances: 1. For 5 minutes at rest in the seated position; and 2. During the VR activity, in which the individual executed movements according to a game in front of a computer for 8 minutes. The VR activity was performed using the game MoveHero, developed at the School of Arts Sciences and Humanities of the University of São Paulo (EACH-USP). The game consists of virtual balls that fall in pre-determined time intervals and spacial distribution in four imaginary columns on a computer screen. The participant must move in the direction of the balls to touch them as they reach four pre-determined targets placed to the sides of the player's avatar. The targets are numbered (1 to 4) and are placed in parallel at two different heights, two to the left and two to the right of the player's avatar.
The game captures the participant's movements with a webcam, not requiring physical contact to perform the task. The participant must move his arms at 80% of their maximum lateral range. Before starting the task, the experimenter positioned the participant in a distance from the screen that allowed him/her to achieve the maximum lateral reach range for each side (left and right) when reaching towards the two farthest balls (1 and 4). From that position, the distance between the computer's table and the participant's feet was measured and the participant was asked to move his/her wheelchair to 80% of this distance. During the task, the participant had to wait for the balls to drop until they reached the pre-determined targets. When the balls reached the targets, the color of the balls changed to green, which prompted the participant to reach for them. Therefore, the game requires the participant to have a strategy of planning their movement to reach the targets at the same time as the balls.
- Conditions
- Spinal Cord Injuries
- Being tested
- Adaptation of autonomic nervous system to activity in virtual reality
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptation of autonomic nervous system to activity in virtual realityBehavioural
heart rate variability assessed at rest and during a physical activity in virtual reality.
| Study group | Role | What they receive |
|---|---|---|
| Athletes with Spinal Cord Injury | Group of athletes with spinal cord injury that was assessed at rest and during a physical activity in virtual reality. Receives: Behavioral: Adaptation of autonomic nervous system to activity in virtual reality | |
| Non-athletes with spinal cord injury | Group of non-athletes with spinal cord injury that was assessed at rest and during a physical activity in virtual reality. Receives: Behavioral: Adaptation of autonomic nervous system to activity in virtual reality | |
| Able-bodied control group | Group of non-athletes able-bodied control subjects that was assessed at rest and during a physical activity in virtual reality. Receives: Behavioral: Adaptation of autonomic nervous system to activity in virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac autonomic modulation is different between athletes and non athletes with spinal cord injury (SCI), bu no differences between athletes with SCI and able-bodied controls.
Athletes with SCI present a better cardiac autonomic modulation then non-athletes with SCI, assessed through linear and non-linear heart rate variability indices at rest and during VR activity
Measured: 1 day
Athletes and able-bodied subjects present a good adaptation of autonomic nervous system than non-athletes with spinal cord injury.
Athletes and able-bodied controls present a good adaptation of autonomic nervous system assessed through indices of heart rate variability. i.e. parasympathetic withdraw during physical activity in Virtual Reality, but with no significant difference for non-athletes with spinal cord injury.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start1 Mar 2017
- Primary completion1 Aug 2018
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Talita Dias da Silva, University of Sao Paulo
- Investigators
- Talita D Silva, Ph.D., Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04618003
- Sponsor's protocol ID
- 79346017.8.0000.5505
- Status last verified
- Oct 2020
- First submitted
- 30 Oct 2020
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dias ED, de Menezes LDC, da Silva TD, da Silva NM, Vidal PR, Brondane BR, Padula N, Gaspar RC, Santos S, Auricchio JR, de Mello Monteiro CB, Domingo A, de Oliveira CQ, de Macedo JC, Romanholo BMS, Barnabe V. Comparison of cardiac autonomic modulation of athletes and non-athletes individuals with spinal cord injury at rest and during a non-immersive virtual reality task. Spinal Cord. 2021 Dec;59(12):1294-1300. doi: 10.1038/s41393-021-00722-5. Epub 2021 Nov 2.
PubMed 34728783
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Autonomic Modulation in Athletes and Non-Athletes With Spinal Cord Injury During Task in Virtual Reality Environment
- ClinicalTrials.gov ID
- NCT04618003
- Acronym / sponsor ID
- 79346017.8.0000.5505
- Conditions
- Spinal Cord Injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 5 Nov 2020 (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 study consisted in the analysis of the autonomic modulation of the heart rate by the Heart Rate Variability of the participants at rest for 5 minutes, and during physical activity of 8 minutes, through a virtual reality game. The data capture was performed using a cardio-frequency meter with belt placed on the volunteer's trunk and, in addition, questionnaires, functional classification scales and personal data collection were applied.
Detailed description
This is a cross-sectional study, approved by the Ethics and Research Committee of the Medical School of the Federal University of São Paulo (UNIFESP) registered under CAAE 793517.1.0000.5505. The recruitment of non-athletes was carried out at the Acreditando Rehabilitation Center and the athletes were recruited at the Faca na Cadeira Institute, ICEL and Clube Espéria. Participants were enrolled in the study after signing the Free and Informed Consent Term. Convenience sampling technique was used with data collected from March 2017 to October 2018 Participants The study included athletes and non-athletes with a confirmed medical diagnosis of SCI, with voluntary extension of elbows and wrist, active trunk control, and who had already completed rehabilitation. For the athlete group, participants had to fulfill the minimum criteria for defining an active athlete, described in the next section. Also, a control group of able-bodied subjects, approximately paired by age and sex wit the AG and non-athlete groups were recruited. Participants were excluded if they presented with impairments to the upper limbs that interfered with the performance during the game, were diagnosed with heart disease or other neurological disorders , were using medication that were not part of their usual routine or that influenced the cardiac and nervous systems, and presented an error greater than 5% in the analysis of HRV.
Assessment of function The Funtional Independence Measure (FIM) and the Spinal Cord Independence Measure Version III (SCIM III) were used to classify functional independence. The International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) was employed to assess the level and severity of injury. To classify the physical activity levels of the participants, the the Physical Activity in Athlete Questionnaire and the Leisure Time Physical Activity Questionnaire for Non-Athletes with Spinal Cord Injury (LTPAQ-SCI) were employed.
Assessment of Heart Rate Variability For the HRV assessment, participants were instructed not to consume alcohol, caffeine or smoke 24 hours before the test. The procedures to measure HRV were conducted according to the guidelines from the Task Force of the European Society of Cardiology and the North American Society of Stimulation and Electrophysiology and were recorded using the Polar V800 electrocardiographic measuring device (Polar Electro, Finland), with a sampling rate of 1000 Hz.
The determination of the linear indexes of HRV for time and frequency was carried out using the software Kubios HRV (v. 3.3.0). The HRV data for time was analyzed using linear methods, using SDNN indices (standard deviation of the mean of all normal RR intervals) in milliseconds (ms); PNN50 (percentage of successive differences of the RR intervals with an absolute value greater than 50ms); RMSSD (square root of the mean square of the differences between adjacent normal RR intervals). Moreover, geometric methods such as, the RRTri (triangular index) and TINN (histogram interpolation of NN intervals), the indexes of the Poincaré graph with the SD1 (standard deviation of the instantaneous variability of the beat-to beat heart rate), SD2 (standard deviation of the long-term, continuous, RR interval variability), and the SD1/SD2 ratio-the ratio between the short- and long-term variations among the RR intervals and Parassympathetic Nervous System index (PNS index), Sympathetic Nervous System index (SNS index) and Stress index given by HRV Kubios, were employed. LF indices (low frequency spectral components, between 0.04 and 0.15 Hertz) were recorded in ms2 and in standard units (nu); while HF (high frequency spectral components, between 0.15 and 0.4 Hertz) was recorded in ms2 and nu; and the ratio of LF/HF in ms2.
PROTOCOL For the three groups the HRV measures were captured in 2 instances: 1. For 5 minutes at rest in the seated position; and 2. During the VR activity, in which the individual executed movements according to a game in front of a computer for 8 minutes. The VR activity was performed using the game MoveHero, developed at the School of Arts Sciences and Humanities of the University of São Paulo (EACH-USP). The game consists of virtual balls that fall in pre-determined time intervals and spacial distribution in four imaginary columns on a computer screen. The participant must move in the direction of the balls to touch them as they reach four pre-determined targets placed to the sides of the player's avatar. The targets are numbered (1 to 4) and are placed in parallel at two different heights, two to the left and two to the right of the player's avatar.
The game captures the participant's movements with a webcam, not requiring physical contact to perform the task. The participant must move his arms at 80% of their maximum lateral range. Before starting the task, the experimenter positioned the participant in a distance from the screen that allowed him/her to achieve the maximum lateral reach range for each side (left and right) when reaching towards the two farthest balls (1 and 4). From that position, the distance between the computer's table and the participant's feet was measured and the participant was asked to move his/her wheelchair to 80% of this distance. During the task, the participant had to wait for the balls to drop until they reached the pre-determined targets. When the balls reached the targets, the color of the balls changed to green, which prompted the participant to reach for them. Therefore, the game requires the participant to have a strategy of planning their movement to reach the targets at the same time as the balls.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Athletes with Spinal Cord Injury | – | Behavioral: Adaptation of autonomic nervous system to activity in virtual realityGroup of athletes with spinal cord injury that was assessed at rest and during a physical activity in virtual reality. |
| Non-athletes with spinal cord injury | – | Behavioral: Adaptation of autonomic nervous system to activity in virtual realityGroup of non-athletes with spinal cord injury that was assessed at rest and during a physical activity in virtual reality. |
| Able-bodied control group | – | Behavioral: Adaptation of autonomic nervous system to activity in virtual realityGroup of non-athletes able-bodied control subjects that was assessed at rest and during a physical activity in virtual reality. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study included athletes and non-athletes with a confirmed medical diagnosis of SCI, with voluntary extension of elbows and wrist, active trunk control, and who had already completed rehabilitation. For the athlete group, participants had to fulfill the minimum criteria for defining an active athlete, described in the next section. Also, a control group of able-bodied subjects, approximately paired by age and sex wit the and non-athlete groups were recruited.
Key inclusion criteria (2 listed)
- Confirmed medical diagnosis of SCI
- Preserved motor activity for extension of the upper limbs and active trunk control, which had already finished their process of adaptation to injury.
Key exclusion criteria (4 listed)
- Functional incapacities of the upper limbs to perform the game,
- Diagnosis of heart disease or other neurological disorders not due to SCI,
- Consumption of drugs that are not part of their usual treatment routine and that influence the cardiac and nervous systems,
- Error greater than 5% in the analysis of HRV.
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 |
|---|---|---|
| Adaptation of autonomic nervous system to activity in virtual realityheart rate variability assessed at rest and during a physical activity in virtual reality. | Behavioural | Able-bodied control group, Athletes with Spinal Cord Injury, Non-athletes with spinal cord injury |
Primary outcome
Cardiac autonomic modulation is different between athletes and non athletes with spinal cord injury (SCI), bu no differences between athletes with SCI and able-bodied controls.
Time frame: 1 day
Athletes with SCI present a better cardiac autonomic modulation then non-athletes with SCI, assessed through linear and non-linear heart rate variability indices at rest and during VR activity
Athletes and able-bodied subjects present a good adaptation of autonomic nervous system than non-athletes with spinal cord injury.
Time frame: 1 day
Athletes and able-bodied controls present a good adaptation of autonomic nervous system assessed through indices of heart rate variability. i.e. parasympathetic withdraw during physical activity in Virtual Reality, but with no significant difference for non-athletes with spinal cord injury.
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 5 Nov 2020.
- Derived from this study: PubMed 34728783Dias ED, de Menezes LDC, da Silva TD, da Silva NM, Vidal PR, Brondane BR, Padula N, Gaspar RC, Santos S, Auricchio JR, de Mello Monteiro CB, Domingo A, de Oliveira CQ, de Macedo JC, Romanholo BMS, Barnabe V. Comparison of cardiac autonomic modulation of athletes and non-athletes individuals with spinal cord injury at rest and during a non-immersive virtual reality task. Spinal Cord. 2021 Dec;59(12):1294-1300. doi: 10.1038/s41393-021-00722-5. Epub 2021 Nov 2.
- Individual participant dataSharing planned: Undecided
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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.
Talita D Silva, Ph.D. principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries, run by University of Sao Paulo at 1 site in Brazil.
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 4 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 5 Nov 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 Brazil. 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?
Cardiac autonomic modulation is different between athletes and non athletes with spinal cord injury (SCI), bu no differences between athletes with SCI and able-bodied controls. (time frame: 1 day). The study lists 2 primary outcomes in all. 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 NCT04618003, which also lists 1 linked publication.
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 5 Nov 2020.