Cardiac Risk FactorsNCT04967235
Dance Therapy as an Alternative for Cardiac Rehabilitation in Women Population
A study testing Conventional Exercise-based Cardiac Rehabilitation Session and Dance-based Cardiac Rehabilitation Session in people with Cardiac Risk Factors and Cardiovascular Diseases, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.
Trial summary
This research project aims to investigate the acute effects of a dance-based cardiac rehabilitation session in the cardiovascular system and autonomic modulation of women with cardiac risk factors. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cardiac Risk Factors, Cardiovascular Diseases
- What is being tested?
- Conventional Exercise-based Cardiac Rehabilitation Session and Dance-based Cardiac Rehabilitation Session
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Sep 2021to 31 Dec 2022
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hemodynamically stable
- Previously attending exercise-based cardiac rehabilitation and dance classes for at least 3 months
- Do not present orthopedics or neurologic impairments that could preclude the execution of dance movements
- To be previously diagnosed with at least one of the following cardiac risk factors:
- Age ≥ 55 years
- Family history: Known myocardial infarction, coronary revascularization, or sudden death in the first-degree relatives before 55 years in male or 65 years in female relatives
Show all 13Show fewer
- Hypertension: values of systolic blood pressure (SBP) equal to or higher than 140 mmHg and/or values of diastolic blood pressure (DBP) equal to or higher than 90 mmHg, or daily use of antihypertensive drugs
- Dyslipidemia: values of low-density lipoprotein (LDL) ≥ 130 mg.dL-1, or values of high-density lipoprotein (HDL) < 40 mg.dL-1, or daily use of lipid-lowering drugs
- Obesity: body mass index ≥ 30 Kg.m-2
- Cigarette smoking: former smokers for more than six months
- Diabetes Mellitus: fasting blood glucose level ≥ 100 mg.dL-1
- Physically inactivity: the volunteer will be considered physically inactivity when classified as "sedentary" or "irregularly active A or B" by the International Physical Activity Questionnaire (IPAQ)
- Stress: the presence of stress will be evaluated by the Lipp's Stress Symptoms Inventory (LSSI), and the classifications "alert", "resistance", and "exhaustion" will be considered
Who cannot join
- Volunteers who present errors superior to 5% in the RR intervals time series
- Volunteers who do not attend all study phases
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Estadual Paulista Júlio de Mesquita Filho
Presidente Prudente, São Paulo, 19060900
About this study
Official title: Dance Therapy as an Alternative for Cardiac Rehabilitation in Women Population: Autonomic and Hemodynamic Acute Responses - A Crossover Clinical Trial
This research project aims to investigate the acute effects of a dance-based cardiac rehabilitation session in the cardiovascular system and autonomic modulation of women with cardiac risk factors. Also, as a secondary outcome, to compare the cardiovascular and autonomic responses of the dance-based session to a conventional exercise-based session.
- Conditions
- Cardiac Risk Factors, Cardiovascular Diseases
- Being tested
- Conventional Exercise-based Cardiac Rehabilitation Session, Dance-based Cardiac Rehabilitation Session
- Keywords
- Cardiac Rehabilitation, Dance Therapy, Cardiac Risk Factors, Autonomic Nervous System, Heart Rate
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Exercise-based Cardiac Rehabilitation SessionOther
This session will be composed of:
I.10 minutes of initial rest in the supine position; II. 15 minutes of warm-up through stretching and global exercises; III. 30 minutes of treadmill aerobic exercise at an intensity of 60-80% of the heart rate reserve for those without diabetes Mellitus and 40-70% of the heart rate reserve for those diagnosed with diabetes mellitus; IV. 1 minute passive recovery in orthostatic position; V. 30 minutes of passive recovery in the supine position.
Dance-based Cardiac Rehabilitation SessionOther
I.10 minutes of initial rest in the supine position; II. 15 minutes of warm-up through stretching and global exercises; III. 30 minutes of dance therapy. The intensity of the choreography will be set at the same range as the conventional exercise-based session. (60-80% of the heart rate reserve for those without diabetes Mellitus and 40-70% of the heart rate reserve for those diagnosed with diabetes mellitus); IV. 1 minute passive recovery in orthostatic position; V. 30 minutes of passive recovery in the supine position.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Exercise-based Cardiac Rehabilitation | Active comparator | This interventional arm consists of a conventional exercise-based cardiac rehabilitation, composed of initial rest, warm-up, treadmill aerobic exercise, orthostatic passive recovery, and supine passive recovery. Receives: Other: Conventional Exercise-based Cardiac Rehabilitation Session |
| Dance-Based Cardiac Rehabilitation | Experimental | This interventional arm consists of a new dance-based cardiac rehabilitation, composed of initial rest, warm-up, dance therapy, orthostatic passive recovery and supine passive recovery. Receives: Other: Dance-based Cardiac Rehabilitation Session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate
The heart rate will be collected using a heart rate monitor (Polar RS800CX - Polar Electro, Kempele, Finland). The data will be assessed at the 5th minute of initial rest, and at the 1st, 2nd, 3rd, 5th, 10th, 20th, and 30th minutes of passive recovery in supine position.
Measured: Acute evaluation during interventions
Blood Pressure
Evaluated indirectly by an experienced physiotherapist using a stethoscope and a sphygmomanometer. This data will be assessed at he 5th minute of initial rest, and at the 1st, 2nd, 3rd, 5th, 10th, 20th, and 30th minutes of passive recovery in supine position.
Measured: Acute evaluation during interventions
Peripheral oxygen saturation
Evaluated through a pulse oximeter (Mindray PM-50 Pulse Oximeter, China). This data will be assessed at he 5th minute of initial rest, and at the 1st, 2nd, 3rd, 5th, 10th, 20th, and 30th minutes of passive recovery in supine position.
Measured: Acute evaluation during interventions
Respiratory Rate
Evaluated by an experienced and independent researcher that will count the number of respiratory incursions within one minute, without the volunteer noticing this procedure. This data will be assessed at he 5th minute of initial rest, and at the 1st, 2nd, 3rd, 5th, 10th, 20th, and 30th minutes of passive recovery in supine position.
Measured: Acute evaluation during interventions
Autonomic Modulation - rMSSD index
The data for this evaluation will be collected using a heart rate monitor that registers the heart rate beat by beat and provides information regarding the RR intervals. This data will be analyzed in the following time sections: 5th to 10th min of initial rest, from the 5th to the 25th minute of resistance phase (treadmill exercise and dance therapy), and from the beginning to the end of the supine recovery phase. The rMSSD index corresponds to the root-mean square of differences between adjacent normal RR intervals in a time interval, expressed in milliseconds.
Measured: Acute evaluation during interventions
Autonomic Modulation - SDNN index
The data for this evaluation will be collected using a heart rate monitor that registers the heart rate beat by beat and provides information regarding the RR intervals. This data will be analyzed in the following time sections: 5th to 10th min of initial rest, from the 5th to the 25th minute of resistance phase (treadmill exercise and dance therapy), and from the beginning to the end of the supine recovery phase. The SDNN index corresponds to the standard deviation of all normal RR intervals recorded in a time interval, expressed in milliseconds
Measured: Acute evaluation during interventions
Autonomic Modulation - LF index
The data for this evaluation will be collected using a heart rate monitor that registers the heart rate beat by beat and provides information regarding the RR intervals. This data will be analyzed in the following time sections: 5th to 10th min of initial rest, from the 5th to the 25th minute of resistance phase (treadmill exercise and dance therapy), and from the beginning to the end of the supine recovery phase.The LF index is the low-frequency component of the oscillatory components of heart rate variability, and ranges from 0.04 to 0.15 Hz.
Measured: Acute evaluation during interventions
Autonomic Modulation - HF index
The data for this evaluation will be collected using a heart rate monitor that registers the heart rate beat by beat and provides information regarding the RR intervals. This data will be analyzed in the following time sections: 5th to 10th min of initial rest, from the 5th to the 25th minute of resistance phase (treadmill exercise and dance therapy), and from the beginning to the end of the supine recovery phase. The HF index is the high-frequency component of the oscillatory components of heart rate variability, and ranges from 0.15 to 0.4 Hz.
Measured: Acute evaluation during interventions
Autonomic Modulation - TINN index
The data for this evaluation will be collected using a heart rate monitor that registers the heart rate beat by beat and provides information regarding the RR intervals. This data will be analyzed in the following time sections: 5th to 10th min of initial rest, from the 5th to the 25th minute of resistance phase (treadmill exercise and dance therapy), and from the beginning to the end of the supine recovery phase. extracted from the density histogram constructed with all normal RR intervals, where the x-axis contains the RR intervals length, and the y-axis contains the frequency of occurrence of the RR intervals. The measure of the histogram base corresponds to the TINN index.
Measured: Acute evaluation during interventions
Autonomic Modulation - RRtri index
The data for this evaluation will be collected using a heart rate monitor that registers the heart rate beat by beat and provides information regarding the RR intervals. This data will be analyzed in the following time sections: 5th to 10th min of initial rest, from the 5th to the 25th minute of resistance phase (treadmill exercise and dance therapy), and from the beginning to the end of the supine recovery phase. Extracted from the density histogram constructed with all normal RR intervals, where the x-axis contains the RR intervals length, and the y-axis contains the frequency of occurrence of the RR intervals. The ratio between the histogram area and the modal frequency corresponds to the RRtri index
Measured: Acute evaluation during interventions
Autonomic Modulation - SD1 index
The data for this evaluation will be collected using a heart rate monitor that registers the heart rate beat by beat and provides information regarding the RR intervals. This data will be analyzed in the following time sections: 5th to 10th min of initial rest, from the 5th to the 25th minute of resistance phase (treadmill exercise and dance therapy), and from the beginning to the end of the supine recovery phase. The SD1 index corresponds to the dispersion of points perpendicular to the line of identity of the ellipse obtained from the Poincaré plot. Expressed in milliseconds.
Measured: Acute evaluation during interventions
Autonomic Modulation - SD2 index
The data for this evaluation will be collected using a heart rate monitor that registers the heart rate beat by beat and provides information regarding the RR intervals. This data will be analyzed in the following time sections: 5th to 10th min of initial rest, from the 5th to the 25th minute of resistance phase (treadmill exercise and dance therapy), and from the beginning to the end of the supine recovery phase. The SD2 index corresponds to the dispersion of points along the line of identity of the ellipse obtained from the Poincaré plot. Expressed in milliseconds.
Measured: Acute evaluation during interventions
Autonomic Modulation - Recurrence rate
The data for this evaluation will be collected using a heart rate monitor that registers the heart rate beat by beat and provides information regarding the RR intervals. This data will be analyzed in the following time sections: 5th to 10th min of initial rest, from the 5th to the 25th minute of resistance phase (treadmill exercise and dance therapy), and from the beginning to the end of the supine recovery phase. Extracted from the graph reconstruction of the spatial trajectory of the RR interval time series, the recurrence rate corresponds to the ratio of all recurrence states to all possible states.
Measured: Acute evaluation during interventions
Autonomic Modulation - Determinism
The data for this evaluation will be collected using a heart rate monitor that registers the heart rate beat by beat and provides information regarding the RR intervals. This data will be analyzed in the following time sections: 5th to 10th min of initial rest, from the 5th to the 25th minute of resistance phase (treadmill exercise and dance therapy), and from the beginning to the end of the supine recovery phase. Extracted from the graph reconstruction of the spatial trajectory of the RR interval time series, the determinism corresponds to the ratio of recurrence points forming diagonal to all recurrence points.
Measured: Acute evaluation during interventions
Autonomic Modulation - Sample Entropy
The data for this evaluation will be collected using a heart rate monitor that registers the heart rate beat by beat and provides information regarding the RR intervals. This data will be analyzed in the following time sections: 5th to 10th min of initial rest, from the 5th to the 25th minute of resistance phase (treadmill exercise and dance therapy), and from the beginning to the end of the supine recovery phase. Defined as the conditional probability that two sequences similar for n points remain similar at the next point, which indicates the series complexity.
Measured: Acute evaluation during interventions
Autonomic Modulation - Approximate Entropy
The data for this evaluation will be collected using a heart rate monitor that registers the heart rate beat by beat and provides information regarding the RR intervals. This data will be analyzed in the following time sections: 5th to 10th min of initial rest, from the 5th to the 25th minute of resistance phase (treadmill exercise and dance therapy), and from the beginning to the end of the supine recovery phase. Measure the complexity of the series by examining the frequency in which similar epochs occurs.
Measured: Acute evaluation during interventions
Autonomic Modulation - Detrended fluctuation analysis (DFA)
The data for this evaluation will be collected using a heart rate monitor that registers the heart rate beat by beat and provides information regarding the RR intervals. This data will be analyzed in the following time sections: 5th to 10th min of initial rest, from the 5th to the 25th minute of resistance phase (treadmill exercise and dance therapy), and from the beginning to the end of the supine recovery phase. Will be considered the DFA-total, the short-term alpha correlations - considering correlations from 4 to 11 RR intervals, and the long-term alpha correlations - considering 11 to 64 RR intervals.
Measured: Acute evaluation during interventions
Autonomic Modulation - Symbolic Analysis
The data for this evaluation will be collected using a heart rate monitor that registers the heart rate beat by beat and provides information regarding the RR intervals. This data will be analyzed in the following time sections: 5th to 10th min of initial rest, from the 5th to the 25th minute of resistance phase (treadmill exercise and dance therapy), and from the beginning to the end of the supine recovery phase. This analysis indicates the quantity and type of variation between 3 consecutive RR intervals, classifying them in the following families: 0V (no variation), 1V (one variation), 2LV (two equal variations), and 2LV (two different variations. Also, will be analyzed the Shannon Entropy that is calculated by quantifying the frequency in which each family appears and summing the relative frequencies weighted by the logarithm of the inverse of the relative frequencies.
Measured: Acute evaluation during interventions
Secondary outcomes (2)
Heart rate recovery of 1 minute
The heart rate will be collected using a heart rate monitor (Polar RS800CX - Polar Electro, Kempele, Finland). The heart rate recovery of 1 minute (HRR1) will be calculated considering the following formula: HRR1 = HRpeak - HR1, where HRpeak will be determined by the mean of the last five beats registered at the resistance phase, and HR1 will be determined by the mean of the four beats around the heart rate registered exactly after one minute of recovery, two beats before and two beats after this value. This data will be extracted from the 1 minute orthostatic recovery.
Measured: Acute evaluation during interventions
30-seconds rMSSD
The data for this evaluation will be collected using a heart rate monitor that registers the heart rate beat by beat and provides information regarding the RR intervals. This index will be calculated in the last 30 seconds of the resistance phase (treadmill exercise and dance therapy), and during the one minute of orthostatic passive recovery after the resistance phase.
Measured: Acute evaluation during interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start1 Sep 2021
- Primary completion1 Sep 2022
- Study completion31 Dec 2022
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 Cardiac Risk FactorsStudies 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
- Non-randomised
- Intervention model
- Crossover
- Model description
- The study consists of one group of women who will be submitted to one dance-based cardiac rehabilitation session and after that will be submitted to one conventional exercise-based cardiac rehabilitation session
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita Filho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luiz Carlos Marques Vanderlei, Universidade Estadual Paulista Júlio de Mesquita Filho
- Investigators
- Luiz Carlos M Vanderlei, PhD, Principal investigator, Universidade Estadual Paulista "Julho de Mesquita Filho" (UNESP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04967235
- Sponsor's protocol ID
- 79786017.5.0000.5402
- Status last verified
- Jan 2023
- First submitted
- 13 Jul 2021
- Last updated
- 13 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lucas Neves Silva JP, de Avila Soares JC, Lopez Laurino MJ, Ribeiro F, de Lima Gervazoni N, Spinardi Alves BI, Carvalho Novaes Moreira E, Marques Vanderlei LC, Modolo Regueiro Lorenconi R. Comparison of Nonlinear Dynamics of Heart Rate Variability Between Conventional Cardiac Rehabilitation and Dance-Based Therapy: A Non-Randomized Crossover Clinical Trial. J Dance Med Sci. 2026 Mar;30(1):3-13. doi: 10.1177/1089313X251316672. Epub 2025 Feb 19.
PubMed 39968942
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dance Therapy as an Alternative for Cardiac Rehabilitation in Women Population: Autonomic and Hemodynamic Acute Responses - A Crossover Clinical Trial
- ClinicalTrials.gov ID
- NCT04967235
- Acronym / sponsor ID
- 79786017.5.0000.5402
- Conditions
- Cardiac Risk Factors, Cardiovascular Diseases
- Keywords
- Cardiac Rehabilitation, Dance Therapy, Cardiac Risk Factors, Autonomic Nervous System, Heart Rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita FilhoUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 19 Jul 2021 (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.
This research project aims to investigate the acute effects of a dance-based cardiac rehabilitation session in the cardiovascular system and autonomic modulation of women with cardiac risk factors. Also, as a secondary outcome, to compare the cardiovascular and autonomic responses of the dance-based session to a conventional exercise-based session.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study consists of one group of women who will be submitted to one dance-based cardiac rehabilitation session and after that will be submitted to one conventional exercise-based cardiac rehabilitation session
| Arm | Type | Receives |
|---|---|---|
| Conventional Exercise-based Cardiac Rehabilitation | Active comparator | Other: Conventional Exercise-based Cardiac Rehabilitation SessionThis interventional arm consists of a conventional exercise-based cardiac rehabilitation, composed of initial rest, warm-up, treadmill aerobic exercise, orthostatic passive recovery, and supine passive recovery. |
| Dance-Based Cardiac Rehabilitation | Experimental | Other: Dance-based Cardiac Rehabilitation SessionThis interventional arm consists of a new dance-based cardiac rehabilitation, composed of initial rest, warm-up, dance therapy, orthostatic passive recovery and supine passive recovery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Hemodynamically stable
- Previously attending exercise-based cardiac rehabilitation and dance classes for at least 3 months
- Do not present orthopedics or neurologic impairments that could preclude the execution of dance movements
- To be previously diagnosed with at least one of the following cardiac risk factors:
Key exclusion criteria (2 listed)
- Volunteers who present errors superior to 5% in the RR intervals time series
- Volunteers who do not attend all study phases
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 |
|---|---|---|
| Conventional Exercise-based Cardiac Rehabilitation SessionThis session will be composed of: I.10 minutes of initial rest in the supine position; II. 15 minutes of warm-up through stretching and global exercises; III. 30 minutes of treadmill aerobic exercise at an intensity of 60-80% of the heart rate reserve for those without diabetes Mellitus and 40-70% of the heart rate reserve for those diagnosed with diabetes mellitus; IV. 1 minute passive recovery in orthostatic position; V. 30 minutes of passive recovery in the supine position. | Other | Conventional Exercise-based Cardiac Rehabilitation |
| Dance-based Cardiac Rehabilitation SessionI.10 minutes of initial rest in the supine position; II. 15 minutes of warm-up through stretching and global exercises; III. 30 minutes of dance therapy. The intensity of the choreography will be set at the same range as the conventional exercise-based session. (60-80% of the heart rate reserve for those without diabetes Mellitus and 40-70% of the heart rate reserve for those diagnosed with diabetes mellitus); IV. 1 minute passive recovery in orthostatic position; V. 30 minutes of passive recovery in the supine position. | Other | Dance-Based Cardiac Rehabilitation |
Primary outcome
Heart Rate
Time frame: Acute evaluation during interventions
The heart rate will be collected using a heart rate monitor (Polar RS800CX - Polar Electro, Kempele, Finland). The data will be assessed at the 5th minute of initial rest, and at the 1st, 2nd, 3rd, 5th, 10th, 20th, and 30th minutes of passive recovery in supine position.
Blood Pressure
Time frame: Acute evaluation during interventions
Evaluated indirectly by an experienced physiotherapist using a stethoscope and a sphygmomanometer. This data will be assessed at he 5th minute of initial rest, and at the 1st, 2nd, 3rd, 5th, 10th, 20th, and 30th minutes of passive recovery in supine position.
Peripheral oxygen saturation
Time frame: Acute evaluation during interventions
Evaluated through a pulse oximeter (Mindray PM-50 Pulse Oximeter, China). This data will be assessed at he 5th minute of initial rest, and at the 1st, 2nd, 3rd, 5th, 10th, 20th, and 30th minutes of passive recovery in supine position.
Respiratory Rate
Time frame: Acute evaluation during interventions
Evaluated by an experienced and independent researcher that will count the number of respiratory incursions within one minute, without the volunteer noticing this procedure. This data will be assessed at he 5th minute of initial rest, and at the 1st, 2nd, 3rd, 5th, 10th, 20th, and 30th minutes of passive recovery in supine position.
Autonomic Modulation - rMSSD index
Time frame: Acute evaluation during interventions
The data for this evaluation will be collected using a heart rate monitor that registers the heart rate beat by beat and provides information regarding the RR intervals. This data will be analyzed in the following time sections: 5th to 10th min of initial rest, from the 5th to the 25th minute of resistance phase (treadmill exercise and dance therapy), and from the beginning to the end of the supine recovery phase. The rMSSD index corresponds to the root-mean square of differences between adjacent normal RR intervals in a time interval, expressed in milliseconds.
Autonomic Modulation - SDNN index
Time frame: Acute evaluation during interventions
The data for this evaluation will be collected using a heart rate monitor that registers the heart rate beat by beat and provides information regarding the RR intervals. This data will be analyzed in the following time sections: 5th to 10th min of initial rest, from the 5th to the 25th minute of resistance phase (treadmill exercise and dance therapy), and from the beginning to the end of the supine recovery phase. The SDNN index corresponds to the standard deviation of all normal RR intervals recorded in a time interval, expressed in milliseconds
Autonomic Modulation - LF index
Time frame: Acute evaluation during interventions
The data for this evaluation will be collected using a heart rate monitor that registers the heart rate beat by beat and provides information regarding the RR intervals. This data will be analyzed in the following time sections: 5th to 10th min of initial rest, from the 5th to the 25th minute of resistance phase (treadmill exercise and dance therapy), and from the beginning to the end of the supine recovery phase.The LF index is the low-frequency component of the oscillatory components of heart rate variability, and ranges from 0.04 to 0.15 Hz.
Autonomic Modulation - HF index
Time frame: Acute evaluation during interventions
The data for this evaluation will be collected using a heart rate monitor that registers the heart rate beat by beat and provides information regarding the RR intervals. This data will be analyzed in the following time sections: 5th to 10th min of initial rest, from the 5th to the 25th minute of resistance phase (treadmill exercise and dance therapy), and from the beginning to the end of the supine recovery phase. The HF index is the high-frequency component of the oscillatory components of heart rate variability, and ranges from 0.15 to 0.4 Hz.
Autonomic Modulation - TINN index
Time frame: Acute evaluation during interventions
The data for this evaluation will be collected using a heart rate monitor that registers the heart rate beat by beat and provides information regarding the RR intervals. This data will be analyzed in the following time sections: 5th to 10th min of initial rest, from the 5th to the 25th minute of resistance phase (treadmill exercise and dance therapy), and from the beginning to the end of the supine recovery phase. extracted from the density histogram constructed with all normal RR intervals, where the x-axis contains the RR intervals length, and the y-axis contains the frequency of occurrence of the RR intervals. The measure of the histogram base corresponds to the TINN index.
Autonomic Modulation - RRtri index
Time frame: Acute evaluation during interventions
The data for this evaluation will be collected using a heart rate monitor that registers the heart rate beat by beat and provides information regarding the RR intervals. This data will be analyzed in the following time sections: 5th to 10th min of initial rest, from the 5th to the 25th minute of resistance phase (treadmill exercise and dance therapy), and from the beginning to the end of the supine recovery phase. Extracted from the density histogram constructed with all normal RR intervals, where the x-axis contains the RR intervals length, and the y-axis contains the frequency of occurrence of the RR intervals. The ratio between the histogram area and the modal frequency corresponds to the RRtri index
Autonomic Modulation - SD1 index
Time frame: Acute evaluation during interventions
The data for this evaluation will be collected using a heart rate monitor that registers the heart rate beat by beat and provides information regarding the RR intervals. This data will be analyzed in the following time sections: 5th to 10th min of initial rest, from the 5th to the 25th minute of resistance phase (treadmill exercise and dance therapy), and from the beginning to the end of the supine recovery phase. The SD1 index corresponds to the dispersion of points perpendicular to the line of identity of the ellipse obtained from the Poincaré plot. Expressed in milliseconds.
Autonomic Modulation - SD2 index
Time frame: Acute evaluation during interventions
The data for this evaluation will be collected using a heart rate monitor that registers the heart rate beat by beat and provides information regarding the RR intervals. This data will be analyzed in the following time sections: 5th to 10th min of initial rest, from the 5th to the 25th minute of resistance phase (treadmill exercise and dance therapy), and from the beginning to the end of the supine recovery phase. The SD2 index corresponds to the dispersion of points along the line of identity of the ellipse obtained from the Poincaré plot. Expressed in milliseconds.
Autonomic Modulation - Recurrence rate
Time frame: Acute evaluation during interventions
The data for this evaluation will be collected using a heart rate monitor that registers the heart rate beat by beat and provides information regarding the RR intervals. This data will be analyzed in the following time sections: 5th to 10th min of initial rest, from the 5th to the 25th minute of resistance phase (treadmill exercise and dance therapy), and from the beginning to the end of the supine recovery phase. Extracted from the graph reconstruction of the spatial trajectory of the RR interval time series, the recurrence rate corresponds to the ratio of all recurrence states to all possible states.
Autonomic Modulation - Determinism
Time frame: Acute evaluation during interventions
The data for this evaluation will be collected using a heart rate monitor that registers the heart rate beat by beat and provides information regarding the RR intervals. This data will be analyzed in the following time sections: 5th to 10th min of initial rest, from the 5th to the 25th minute of resistance phase (treadmill exercise and dance therapy), and from the beginning to the end of the supine recovery phase. Extracted from the graph reconstruction of the spatial trajectory of the RR interval time series, the determinism corresponds to the ratio of recurrence points forming diagonal to all recurrence points.
Autonomic Modulation - Sample Entropy
Time frame: Acute evaluation during interventions
The data for this evaluation will be collected using a heart rate monitor that registers the heart rate beat by beat and provides information regarding the RR intervals. This data will be analyzed in the following time sections: 5th to 10th min of initial rest, from the 5th to the 25th minute of resistance phase (treadmill exercise and dance therapy), and from the beginning to the end of the supine recovery phase. Defined as the conditional probability that two sequences similar for n points remain similar at the next point, which indicates the series complexity.
Autonomic Modulation - Approximate Entropy
Time frame: Acute evaluation during interventions
The data for this evaluation will be collected using a heart rate monitor that registers the heart rate beat by beat and provides information regarding the RR intervals. This data will be analyzed in the following time sections: 5th to 10th min of initial rest, from the 5th to the 25th minute of resistance phase (treadmill exercise and dance therapy), and from the beginning to the end of the supine recovery phase. Measure the complexity of the series by examining the frequency in which similar epochs occurs.
Autonomic Modulation - Detrended fluctuation analysis (DFA)
Time frame: Acute evaluation during interventions
The data for this evaluation will be collected using a heart rate monitor that registers the heart rate beat by beat and provides information regarding the RR intervals. This data will be analyzed in the following time sections: 5th to 10th min of initial rest, from the 5th to the 25th minute of resistance phase (treadmill exercise and dance therapy), and from the beginning to the end of the supine recovery phase. Will be considered the DFA-total, the short-term alpha correlations - considering correlations from 4 to 11 RR intervals, and the long-term alpha correlations - considering 11 to 64 RR intervals.
Autonomic Modulation - Symbolic Analysis
Time frame: Acute evaluation during interventions
The data for this evaluation will be collected using a heart rate monitor that registers the heart rate beat by beat and provides information regarding the RR intervals. This data will be analyzed in the following time sections: 5th to 10th min of initial rest, from the 5th to the 25th minute of resistance phase (treadmill exercise and dance therapy), and from the beginning to the end of the supine recovery phase. This analysis indicates the quantity and type of variation between 3 consecutive RR intervals, classifying them in the following families: 0V (no variation), 1V (one variation), 2LV (two equal variations), and 2LV (two different variations. Also, will be analyzed the Shannon Entropy that is calculated by quantifying the frequency in which each family appears and summing the relative frequencies weighted by the logarithm of the inverse of the relative frequencies.
2 secondary outcomes
Heart rate recovery of 1 minute
Time frame: Acute evaluation during interventions
30-seconds rMSSD
Time frame: Acute evaluation during interventions
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 13 Jan 2023.
- Derived from this study: PubMed 39968942Lucas Neves Silva JP, de Avila Soares JC, Lopez Laurino MJ, Ribeiro F, de Lima Gervazoni N, Spinardi Alves BI, Carvalho Novaes Moreira E, Marques Vanderlei LC, Modolo Regueiro Lorenconi R. Comparison of Nonlinear Dynamics of Heart Rate Variability Between Conventional Cardiac Rehabilitation and Dance-Based Therapy: A Non-Randomized Crossover Clinical Trial. J Dance Med Sci. 2026 Mar;30(1):3-13. doi: 10.1177/1089313X251316672. Epub 2025 Feb 19.
- Individual participant dataSharing planned: Undecided
Related trials for Cardiac Risk Factors
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
RecruitingObservational study
Imaging Techniques in MRI
Cardiac Risk Factors, Healthy
RecruitingObservational study
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
Metabolic Disease, Obesity
Recruiting
Determining Efficacy of an Artificial Intelligence-based System for Heart Failure Detection Through Interpretation of Electrocardiograms (DECISION)
Heart Failure, Cardiovascular Risk Factors
RecruitingObservational study
Reliability of Multiple-Repetition-Maximum Tests in Patients With Cardiovascular Disease or Risk Factors
Heart Failure, Coronary Heart Disease (CHD)
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.
Luiz Carlos M Vanderlei, PhD principal investigator
Universidade Estadual Paulista "Julho de Mesquita Filho" (UNESP)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Exercise-based Cardiac Rehabilitation Session and Dance-based Cardiac Rehabilitation Session in people with Cardiac Risk Factors and Cardiovascular Diseases, run by Universidade Estadual Paulista Júlio de Mesquita Filho 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 13 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 13 Jan 2023. 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 (time frame: Acute evaluation during interventions). The study lists 18 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 NCT04967235, 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 13 Jan 2023.