Dance Therapy as an Alternative for Cardiac Rehabilitation in Women Population

Study Overview
=================
Brief 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. Also, as a secondary outcome, to compare the cardiovascular and autonomic responses of the dance-based session to a conventional exercise-based session.

Official Title
-----------------
Dance Therapy as an Alternative for Cardiac Rehabilitation in Women Population: Autonomic and Hemodynamic Acute Responses - A Crossover Clinical Trial

Conditions
-----------------
Cardiac Risk Factors, Cardiovascular Diseases

Intervention / Treatment
-----------------
* Other: Conventional Exercise-based Cardiac Rehabilitation Session
* Other: Dance-based Cardiac Rehabilitation Session


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 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 Exclusion Criteria: Volunteers who present errors superior to 5% in the RR intervals time series Volunteers who do not attend all study phases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional Exercise-based Cardiac Rehabilitation<br>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. | Other: Conventional Exercise-based Cardiac Rehabilitation Session<br>* 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.<br>|
| Experimental: Dance-Based Cardiac Rehabilitation<br>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. | Other: Dance-based Cardiac Rehabilitation Session<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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 | 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. | 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. | 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. | 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Acute evaluation during interventions | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Acute evaluation during interventions | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac Rehabilitation, Dance Therapy, Cardiac Risk Factors, Autonomic Nervous System, Heart Rate