Duchenne Muscular DystrophyNCT04607824
Heart Rate Variability in Duchenne Muscular Dystrophy During Computer Task
An observational study of Duchenne Muscular Dystrophy, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
HRV is attained using a Polar RS800CX. Then, evaluated through linear, non-linear and chaotic global techniques (CGT). Forty-five male subjects were included in the DMD group and age-matched with forty-five in the healthy Typical Development (TD) control group. Read more about this study
- Who is it for?
- Ages 9 to 21 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Duchenne Muscular Dystrophy
- What is being tested?
- Duchenne Muscular Dystrophy group and Typical Development group
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 90 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2014to Jun 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 9 to 21 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Study population: 45 individuals with DMD (convenience sample) and 45 age-matched healthy TD individuals participated in the trial.
Who may be able to join
- DMD diagnoses was based on molecular methods and/or muscular protein expression.
- TD age-matched with DMD.
Who cannot join
- subjects with severely dilated myocardium.
- subjects with other associated diseases.
- individuals with inability to understand task instructions.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Comitê de ética da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, 01246903
About this study
Official title: Computational Task in Duchenne Muscular Dystrophy: Involvement of Cardiac Autonomic Regulation.
HRV is attained using a Polar RS800CX. Then, evaluated through linear, non-linear and chaotic global techniques (CGT). Forty-five male subjects were included in the DMD group and age-matched with forty-five in the healthy Typical Development (TD) control group. They were assessed for twenty minutes at rest sitting, and then five minutes whilst performing the maze task on a computer.
Read the detailed description
This is a cross-sectional study, where HR was recorded beat-to-beat (RR intervals) using the portable Polar RS800CX HR monitor (Polar Electro, Finland). HR was recorded before the onset and at the end of the five minutes of the computer maze paradigm task.
The subjects were seated in a standard chair (walkers, TD group and DMD) or in their own wheelchair (non-walkers, DMD group), the Polar watch was positioned on the wrist. The analysis of HRV was possible through the recording of RR interval in two periods: the period of twenty minutes at seated rest, and then during the computer task for five minutes.
The computer task used a maze paradigm with one correct pathway that could be negotiated and ultimately solved. All participants were positioned comfortably and an evaluator responsible for instruction and annotation of data.
Each individual was instructed to walk the correct path with the digital character pawn (pointed on the screen by the evaluator) to the exit of the maze identified by an "x" (pointed on the screen by the evaluator). It was provided for the subjects, who used the arrow buttons on the keyboard, identified by up, down, right and left, using the dominant hand, with the arrows moving through a 20 x 20 cm maze. Participants were requested to complete the maze as fast as possible.
HRV analysis followed the guidelines published by the Task Force of the European Society of Cardiology and North American Society of Pacing and Electrophysiology. The RR intervals were recorded, and then were downloaded to the Polar Precision Performance program (v.3.0). This software enabled the visualization of HR and the extraction of a cardiac period (RR intervals series; the variation of beat-to-beat interval in milliseconds) file in ".txt" format. For analysis of HRV data at rest, we analyzed 1000 consecutive RR intervals, and for HRV analysis for the computational task, the number of consecutive RR intervals obtained was exactly 256 RR intervals. Digital filtering complemented by manual filtering was performed to eliminate artifacts and only series with greater than 95% of sinus beats were included in the study. HRV analysis was undertaken through linear, non-linear and chaotic global techniques (CGT).
- Conditions
- Duchenne Muscular Dystrophy
- Being tested
- Duchenne Muscular Dystrophy group, Typical Development group
- Keywords
- Heart rate variability, Duchenne muscular dystrophy, Typically developed, Autonomic nervous system, Chaotic global techniques
- Medical subject headings
- Muscular Dystrophy, Duchenne
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duchenne Muscular Dystrophy groupBehavioural
Assessment of heart rate variability at rest and during computational task in people with Duchenne muscular dystrophy
Typical Development groupBehavioural
Assessment of heart rate variability at rest and during computational task in people with typical Development
| Study group | Role | What they receive |
|---|---|---|
| Duchenne Muscular Dystrophy group | Forty-five male subjects were included in the Duchenne Muscular Dystrophy (DMD) group and they were assessed for twenty minutes at rest sitting, and then five minutes whilst performing the maze task on a computer. Receives: Behavioral: Duchenne Muscular Dystrophy group | |
| Typical Development group | Forty-five male subjects were included in the healthy Typical Development (TD) control group and they were assessed for twenty minutes at rest sitting, and then five minutes whilst performing the maze task on a computer Receives: Behavioral: Typical Development group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate Variability behavior during computational task
Linear, non-linear and complexity indices of heart rate variability will be assessed at rest and during computational task, in order to analyse it's behavior.
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 posted29 Oct 2020
- Study startMar 2014
- Primary completionDec 2014
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Duchenne Muscular DystrophyStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Bandeira de Mello Monteiro, University of Sao Paulo
- Investigators
- Carlos BM Monteiro, Ph.D., Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04607824
- Sponsor's protocol ID
- 14508213.4.0000.0065
- Status last verified
- Oct 2020
- First submitted
- 22 Oct 2020
- Last updated
- 29 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computational Task in Duchenne Muscular Dystrophy: Involvement of Cardiac Autonomic Regulation.
- ClinicalTrials.gov ID
- NCT04607824
- Acronym / sponsor ID
- 14508213.4.0000.0065
- Conditions
- Duchenne Muscular Dystrophy
- Keywords
- Heart rate variability, Duchenne muscular dystrophy, Typically developed, Autonomic nervous system, Chaotic global techniques
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Mar 2014 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 29 Oct 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.
HRV is attained using a Polar RS800CX. Then, evaluated through linear, non-linear and chaotic global techniques (CGT). Forty-five male subjects were included in the DMD group and age-matched with forty-five in the healthy Typical Development (TD) control group. They were assessed for twenty minutes at rest sitting, and then five minutes whilst performing the maze task on a computer.
Detailed description
This is a cross-sectional study, where HR was recorded beat-to-beat (RR intervals) using the portable Polar RS800CX HR monitor (Polar Electro, Finland). HR was recorded before the onset and at the end of the five minutes of the computer maze paradigm task.
The subjects were seated in a standard chair (walkers, TD group and DMD) or in their own wheelchair (non-walkers, DMD group), the Polar watch was positioned on the wrist. The analysis of HRV was possible through the recording of RR interval in two periods: the period of twenty minutes at seated rest, and then during the computer task for five minutes.
The computer task used a maze paradigm with one correct pathway that could be negotiated and ultimately solved. All participants were positioned comfortably and an evaluator responsible for instruction and annotation of data.
Each individual was instructed to walk the correct path with the digital character pawn (pointed on the screen by the evaluator) to the exit of the maze identified by an "x" (pointed on the screen by the evaluator). It was provided for the subjects, who used the arrow buttons on the keyboard, identified by up, down, right and left, using the dominant hand, with the arrows moving through a 20 x 20 cm maze. Participants were requested to complete the maze as fast as possible.
HRV analysis followed the guidelines published by the Task Force of the European Society of Cardiology and North American Society of Pacing and Electrophysiology. The RR intervals were recorded, and then were downloaded to the Polar Precision Performance program (v.3.0). This software enabled the visualization of HR and the extraction of a cardiac period (RR intervals series; the variation of beat-to-beat interval in milliseconds) file in ".txt" format. For analysis of HRV data at rest, we analyzed 1000 consecutive RR intervals, and for HRV analysis for the computational task, the number of consecutive RR intervals obtained was exactly 256 RR intervals. Digital filtering complemented by manual filtering was performed to eliminate artifacts and only series with greater than 95% of sinus beats were included in the study. HRV analysis was undertaken through linear, non-linear and chaotic global techniques (CGT).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Duchenne Muscular Dystrophy group | – | Behavioral: Duchenne Muscular Dystrophy groupForty-five male subjects were included in the Duchenne Muscular Dystrophy (DMD) group and they were assessed for twenty minutes at rest sitting, and then five minutes whilst performing the maze task on a computer. |
| Typical Development group | – | Behavioral: Typical Development groupForty-five male subjects were included in the healthy Typical Development (TD) control group and they were assessed for twenty minutes at rest sitting, and then five minutes whilst performing the maze task on a computer |
Who may qualify
- Ages
- 9 to 21 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 45 individuals with DMD (convenience sample) and 45 age-matched healthy TD individuals participated in the trial.
Key inclusion criteria (2 listed)
- DMD diagnoses was based on molecular methods and/or muscular protein expression.
- TD age-matched with DMD.
Key exclusion criteria (3 listed)
- subjects with severely dilated myocardium.
- subjects with other associated diseases.
- individuals with inability to understand task instructions.
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 |
|---|---|---|
| Duchenne Muscular Dystrophy groupAssessment of heart rate variability at rest and during computational task in people with Duchenne muscular dystrophy | Behavioural | Duchenne Muscular Dystrophy group |
| Typical Development groupAssessment of heart rate variability at rest and during computational task in people with typical Development | Behavioural | Typical Development group |
Primary outcome
Heart Rate Variability behavior during computational task
Time frame: 1 day
Linear, non-linear and complexity indices of heart rate variability will be assessed at rest and during computational task, in order to analyse it's behavior.
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 29 Oct 2020.
- 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.
Carlos BM Monteiro, 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 Duchenne Muscular Dystrophy, 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 3 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 29 Oct 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?
Heart Rate Variability behavior during computational task (time frame: 1 day). 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 29 Oct 2020.