Clinical trial NCT04967235: Dance Therapy as an Alternative for Cardiac Rehabilitation in Women Population
Official title: Dance Therapy as an Alternative for Cardiac Rehabilitation in Women Population: Autonomic and Hemodynamic Acute Responses - A Crossover Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Risk Factors
Cardiovascular Diseases
Keywords: Cardiac Rehabilitation
Dance Therapy
Cardiac Risk Factors
Autonomic Nervous System
Heart Rate
Lead sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho
Sponsor class: OTHER
First posted: 2021-07-19
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention 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
Primary purpose: TREATMENT

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.


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:

  1. Age ≥ 55 years
  2. 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
  3. 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
  4. 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
  5. Obesity: body mass index ≥ 30 Kg.m-2
  6. Cigarette smoking: former smokers for more than six months
  7. Diabetes Mellitus: fasting blood glucose level ≥ 100 mg.dL-1
  8. 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)
  9. 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

Primary outcomes:
measure: Heart Rate
timeFrame: Acute evaluation during interventions
measure: Blood Pressure
timeFrame: Acute evaluation during interventions
measure: Peripheral oxygen saturation
timeFrame: Acute evaluation during interventions
measure: Respiratory Rate
timeFrame: Acute evaluation during interventions
measure: Autonomic Modulation - rMSSD index
timeFrame: Acute evaluation during interventions
measure: Autonomic Modulation - SDNN index
timeFrame: Acute evaluation during interventions
measure: Autonomic Modulation - LF index
timeFrame: Acute evaluation during interventions
measure: Autonomic Modulation - HF index
timeFrame: Acute evaluation during interventions
measure: Autonomic Modulation - TINN index
timeFrame: Acute evaluation during interventions
measure: Autonomic Modulation - RRtri index
timeFrame: Acute evaluation during interventions
measure: Autonomic Modulation - SD1 index
timeFrame: Acute evaluation during interventions
measure: Autonomic Modulation - SD2 index
timeFrame: Acute evaluation during interventions
measure: Autonomic Modulation - Recurrence rate
timeFrame: Acute evaluation during interventions
measure: Autonomic Modulation - Determinism
timeFrame: Acute evaluation during interventions
measure: Autonomic Modulation - Sample Entropy
timeFrame: Acute evaluation during interventions
measure: Autonomic Modulation - Approximate Entropy
timeFrame: Acute evaluation during interventions
measure: Autonomic Modulation - Detrended fluctuation analysis (DFA)
timeFrame: Acute evaluation during interventions
measure: Autonomic Modulation - Symbolic Analysis
timeFrame: Acute evaluation during interventions
Secondary outcomes:
measure: Heart rate recovery of 1 minute
timeFrame: Acute evaluation during interventions
measure: 30-seconds rMSSD
timeFrame: Acute evaluation during interventions
Other outcomes:
Locations:
city: Presidente Prudente
country: Brazil
facility: Universidade Estadual Paulista Júlio de Mesquita Filho
state: São Paulo
Study officials:
affiliation: Universidade Estadual Paulista "Julho de Mesquita Filho" (UNESP)
name: Luiz Carlos M Vanderlei, PhD
role: PRINCIPAL_INVESTIGATOR
References: