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Effects of Dancing on Cardiovascular and Functional Risk Factors in Older Women.

23 de agosto de 2017 actualizado por: Alvaro Reischak-Oliveira, Federal University of Rio Grande do Sul

Effects of Dancing and Walking on Cardiovascular Risk Factors and Functional Capacity in Older Women: a Randomized Controlled Trial.

The goal of this randomized controlled trial is to investigate the effects of a dance intervention on cardiovascular risk factors and functional capacity of older women, comparing dancing to a walking exercise intervention and to an active control condition (stretching). The participants will include women between 60 and 80 years old, with body mass index inferior to 35 Kg /m2. The main outcome of this study is the peak oxygen consumption (VO2peak). The secondary outcomes are cardiovascular risk associated factors (C-reactive protein, TNF-alpha, lipid profile, etc) and functional performance (muscle strength and power, balance, gate ability, etc). The experimental design will include 3 parts: 1) Pre-intervention assessments: medical evaluation, fasting blood exams, maximum exercise test, assessments of body composition, balance, gate ability, muscular strength and power. 2) Period of interventions: patients will be randomized to one of the three following groups: dance, walking or stretching. The duration of the interventions will be 8 weeks, including 3 sessions per week for dance and walking, and once a week for the stretching group. Each session will last 60 min. 3) Post-intervention assessments: the same protocols of testing as pre-intervention.

Descripción general del estudio

Descripción detallada

The aging process is characterized by reductions of lean mass simultaneously to increases in visceral adipose tissue. Metabolically, this is related to insulin resistance and higher risk to develop cardiovascular diseases. Functionally, loss of strength and cardiorespiratory fitness may lead to early muscle fatigue onset, which may limit the performance of daily activities, and eventually lead to loss of independence with aging. Dancing has been used as a form of exercise to improve functional and metabolic outcomes during aging. However, the field lacks of randomized controlled trials (RCT) evaluating metabolic outcomes related to dance interventions, as well as comparisons of dancing with other types of exercise on functional performance and metabolic health of older adults. Therefore, the goal of this randomized controlled trial is to investigate the effects of a dance intervention on cardiovascular risk factors and functional capacity of older women, comparing dancing to a walking exercise intervention and to an active control condition (stretching). Additionally, we aim to investigate the acute cardiorespiratory responses of a dance session. The participants will include women between 60 and 80 years old, with body mass index inferior to 35 Kg /m2 and independent for performing daily activities. They should not be engaged in any type of regular physical activity in the past 6 months. Exclusion criteria will include type 2 diabetes mellitus, cardiovascular complications and neurodegenerative diseases. The main outcome of this study is the peak oxygen consumption (VO2peak), as it has been associated with both, cardiovascular risk and functional performance in aging individuals. The secondary outcomes are: (1) cardiovascular risk associated factors: C-reactive protein, TNF-alpha, triglycerides, total cholesterol, LDL-cholesterol, HDL-cholesterol, fasting glucose and insulin, and homeostatic model assessment of insulin resistance (HOMA-IR). (2) Functional performance: muscle strength and power, balance, gate ability and muscle quality. The experimental design will include 3 parts: 1) Pre-intervention assessments: medical evaluation, fasting blood exams, maximum exercise test, assessments of body composition, balance, gate ability, muscular strength and power. 2) Period of interventions: patients will be randomized in blocks (randomization.com), in accordance to their VO2peak , to one of the three following groups: dance, walking or control. The duration of the dance and walking interventions will be 8 weeks, including 3 sessions per week, each lasting 60 min. Dance classes will be performed in group in a dance studio, including a variety of rhythms such as salsa, jazz and aerobics. Walking sessions will be performed individually or in groups of two people, in a treadmill, at the gym. The control group will have 60min stretching classes once a week, also for 8 weeks. 3) Post-intervention assessments: the same protocols of testing of the pre-interventions assessments will be repeated. All the assessments and interventions will be held at the Laboratory of Research in Exercise (LAPEX-UFRGS).

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

30

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brasil
        • Reclutamiento
        • Universidade Federal do Rio Grande do Sul
        • Contacto:
        • Contacto:
        • Sub-Investigador:
          • Josianne Rodrigues-Krause, MSc

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

60 años a 80 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Femenino

Descripción

Inclusion Criteria:

  • Women between 60 and 80 years old
  • BMI inferior to 35 kg/m2
  • Independent for performing daily activities (OARS scale)
  • Not engaged in any type of regular exercise programme for the past 6 months

Exclusion Criteria:

  • Type 2 diabetes mellitus, dyslipidemia, cardiovascular diseases or other non-controlled metabolic disorders
  • Chronic diseases such as fibromyalgia, cancer or neurodegenerative disorders
  • Bone, joints or muscle problems that could impair exercise performance
  • Not being able to perform the effort test in the first assessment session, abnormal electrocardiogram, or any other condition identified by the physician of the study that limit the engagement in an exercise training programme.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Dancing
Elderly women randomized to the dance intervention programme.
Participants randomized to the dance group will take part in a dance intervention programme for 8 weeks, including 3 sessions per week, each lasting 60 min. Dance classes will be performed in group in a dance studio, including a variety of rhythms such as salsa, jazz and aerobics. The dance session wil include a warm up of 15 min (posture, join mobility and dance technique), a main part of 40 min (learning of specific choreographies and practice of moves across the floor), and a cool down of 5 min (muscle stretching and relaxation).
Experimental: Walking
Elderly women randomized to the walking intervention programme.
Participants randomized to the walking group will take part in a walking intervention programme for 8 weeks, including 3 sessions per week, each lasting 60 min. The walking session will include a warm up of 10 min (posture and join mobility), a main part of 40 min (walking on a treadmill with a heart rate corresponding to 60% of VO2peak), and a cool down of 10 min (muscle stretching and relaxation).
Comparador activo: Stretching
Elderly women randomized to the stretching intervention programme.
Participants randomized to the control group will take part in stretching classes, once a week, each lasting 60 min, also for 8 weeks. Stretching exercises for large muscle groups will be performed standing or in a match, holding the positions for a maximum of 10 s. There will be no music playing during the session.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Peak Oxygen Consumption (VO2peak)
Periodo de tiempo: Baseline and 8 weeks
The maximum capacity of oxygen consumption measured during an incremental exercise test.
Baseline and 8 weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in C-reactive protein (CRP)
Periodo de tiempo: Baseline and 8 weeks
Cardiovascular risk marker. It will be analyzed in plasma, using ELISA specific kits.
Baseline and 8 weeks
Change in Tumor necrosis factor alpha (TNF-alpha)
Periodo de tiempo: Baseline and 8 weeks
Inflammatory marker. It will be analyzed in plasma, using ELISA specific kits.
Baseline and 8 weeks
Change in Triglycerides
Periodo de tiempo: Baseline and 8 weeks
Lipid profile marker. It will be analyzed in plasma, by enzymatic colorimetric method, using an automatic analyzer (ROCHE, Cobas C111, Switzerland).
Baseline and 8 weeks
Change in Total Cholesterol
Periodo de tiempo: Baseline and 8 weeks
Lipid profile marker. It will be analyzed in plasma, by enzymatic colorimetric method, using an automatic analyzer (ROCHE, Cobas C111, Switzerland).
Baseline and 8 weeks
Change in LDL-Cholesterol
Periodo de tiempo: Baseline and 8 weeks
Lipid profile marker. Estimation of the LDL concentration will be calculate using the formula of Friedewald.
Baseline and 8 weeks
Change in HDL-Cholesterol
Periodo de tiempo: Baseline and 8 weeks
Lipid profile marker. It will be analyzed in plasma, by enzymatic colorimetric method, using an automatic analyzer (ROCHE, Cobas C111, Switzerland).
Baseline and 8 weeks
Change in Fasting Glycemia
Periodo de tiempo: Baseline and 8 weeks
Glycaemic profile marker. It will be analyzed in plasma, by enzymatic colorimetric method, using an automatic analyzer (ROCHE, Cobas C111, Switzerland).
Baseline and 8 weeks
Change in Fasting Insulin
Periodo de tiempo: Baseline and 8 weeks
Glycaemic profile marker. It will be measured in plasma, usin a high sensitivity enzyme-linked immunosorbent assay.
Baseline and 8 weeks
Change in HOMA-IR
Periodo de tiempo: Baseline and 8 weeks
Glycaemic profile marker. Homeostatic model of insulin resistance. It will be calculated according to the following formula: fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5.
Baseline and 8 weeks
Change in Muscle Strength
Periodo de tiempo: Baseline and 8 weeks
Isometric peak torque of the knee extensors will be measured using an isokinetic dynamometer (Cybex Norm, EUA).
Baseline and 8 weeks
Change in Muscle Power
Periodo de tiempo: Baseline and 8 weeks
Lower body muscle power will be measured by the performance of the counter movement jump in a force platform.
Baseline and 8 weeks
Change in Muscle Quality
Periodo de tiempo: Baseline and 8 weeks
Echo intensity of the quadriceps will be analyzed by ultrasound images.
Baseline and 8 weeks
Change in Static Balance
Periodo de tiempo: Baseline and 8 weeks
Static balance will be measured by a single leg support balance test, performed with both legs, with the eyes open and closed.
Baseline and 8 weeks
Change in Dynamic Balance
Periodo de tiempo: Baseline and 8 weeks
Dynamic balance will be measured by the Time to Up ang Go (TUG) test.
Baseline and 8 weeks
Change in Gate ability
Periodo de tiempo: Baseline and 8 weeks
Gate ability will be measured in a 10m track, picking up objects and passing over obstacles.
Baseline and 8 weeks
Change in Body Weight
Periodo de tiempo: Baseline and 8 weeks
Measurements of body weight will be measured in a digital scale.
Baseline and 8 weeks
Change in Waist Circumference
Periodo de tiempo: Baseline and 8 weeks
Measurements of waist circumference will be performed with a measuring tape.
Baseline and 8 weeks
Change in Percentage of Body Fat
Periodo de tiempo: Baseline and 8 weeks
Measurements of skinfolds will be taken to calculate the percentage of body fat.
Baseline and 8 weeks
Change in Sit and Stand ability
Periodo de tiempo: Baseline and 8 weeks
The ability to sit and stand in a chair 5 times, as fast as possible.
Baseline and 8 weeks
Changes in Fall Risk
Periodo de tiempo: Baseline and 8 weeks
The risk of fall will be measured by the performance in the TUG test.
Baseline and 8 weeks
Changes in the Fear of Falling
Periodo de tiempo: Baseline and 8 weeks
The fear of falling will be analyzed by the Falls Efficacy Scale-International Brazil (FES-I-Brazil).
Baseline and 8 weeks
Changes in Quality of Life
Periodo de tiempo: Baseline and 8 weeks
Quality of life will be analyzed by the questionary WHOQOL (World Health Organization Quality of Life.
Baseline and 8 weeks

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Alvaro Reischak-Oliveira, PhD., Federal University of Rio Grande do Sul

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de agosto de 2017

Finalización primaria (Anticipado)

1 de diciembre de 2017

Finalización del estudio (Anticipado)

1 de agosto de 2018

Fechas de registro del estudio

Enviado por primera vez

8 de agosto de 2017

Primero enviado que cumplió con los criterios de control de calidad

23 de agosto de 2017

Publicado por primera vez (Actual)

25 de agosto de 2017

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

25 de agosto de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

23 de agosto de 2017

Última verificación

1 de agosto de 2017

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 53834516.0.0000.5347

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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