Dance Therapy as an Alternative for Cardiac Rehabilitation in Women Population

NCT04967235 | Completed

• 1 other identifier: 79786017.5.0000.5402
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Risk Factors; Cardiovascular Diseases

Keywords

Cardiac Rehabilitation; Dance Therapy; Cardiac Risk Factors; Autonomic Nervous System; Heart Rate

Outcome Measures

Primary Outcomes (18)

• 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 Outcomes (2)

• Heart rate recovery of 1 minute

  Acute evaluation during interventions

• 30-seconds rMSSD

  Acute evaluation during interventions

Study Arms (2)

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.

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.

Other: Dance-based Cardiac Rehabilitation Session

Interventions

Conventional Exercise-based Cardiac Rehabilitation Session OTHER

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.

Conventional Exercise-based Cardiac Rehabilitation

Dance-based Cardiac Rehabilitation Session OTHER

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.

Dance-Based Cardiac Rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Volunteers who present errors superior to 5% in the RR intervals time series
• Volunteers who do not attend all study phases

Sponsors & Collaborators

• Universidade Estadual Paulista Júlio de Mesquita Filho: lead

Study Sites (1)

Universidade Estadual Paulista Júlio de Mesquita Filho

Presidente Prudente, São Paulo, 19060900, Brazil

Location

Related Publications (1)

• 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. 2025 Feb 19:1089313X251316672. doi: 10.1177/1089313X251316672. Online ahead of print.

  PMID: 39968942 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Luiz Carlos M Vanderlei, PhD

  Universidade Estadual Paulista "Julho de Mesquita Filho" (UNESP)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The researcher performing the heart rate variability and heart rate recovery data filtering will be blinded, and the researcher performing the data analysis will also be blinded. All data will be handled in a coded datasheet and all volunteer's names will be replaced by a confidential ID.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: 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

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: July 19, 2021
• Study Start: September 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: December 31, 2022
• Last Updated: January 13, 2023

Record last verified: 2023-01

Locations

BR (1)