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临床试验/NCT03262714
NCT03262714Unknown不适用

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

Federal University of Rio Grande do Sul1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
1
主要终点
Change in Peak Oxygen Consumption (VO2peak)

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
60 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

研究组 & 干预措施

Dancing

Experimental

Elderly women randomized to the dance intervention programme.

干预措施: Dance (Other)

Walking

Experimental

Elderly women randomized to the walking intervention programme.

干预措施: Walking (Other)

Stretching

Active Comparator

Elderly women randomized to the stretching intervention programme.

干预措施: Stretching (Other)

结局指标

主要结局

Change in Peak Oxygen Consumption (VO2peak)

时间窗: Baseline and 8 weeks

The maximum capacity of oxygen consumption measured during an incremental exercise test.

次要结局

  • Change in Static Balance(Baseline and 8 weeks)
  • Change in Tumor necrosis factor alpha (TNF-alpha)(Baseline and 8 weeks)
  • Change in Muscle Quality(Baseline and 8 weeks)
  • Change in HDL-Cholesterol(Baseline and 8 weeks)
  • Change in Fasting Insulin(Baseline and 8 weeks)
  • Change in HOMA-IR(Baseline and 8 weeks)
  • Change in Dynamic Balance(Baseline and 8 weeks)
  • Change in Body Weight(Baseline and 8 weeks)
  • Changes in the Fear of Falling(Baseline and 8 weeks)
  • Changes in Quality of Life(Baseline and 8 weeks)
  • Change in LDL-Cholesterol(Baseline and 8 weeks)
  • Change in Muscle Strength(Baseline and 8 weeks)
  • Change in Muscle Power(Baseline and 8 weeks)
  • Change in Waist Circumference(Baseline and 8 weeks)
  • Changes in Fall Risk(Baseline and 8 weeks)
  • Change in Gate ability(Baseline and 8 weeks)
  • Change in Percentage of Body Fat(Baseline and 8 weeks)
  • Change in Sit and Stand ability(Baseline and 8 weeks)
  • Change in C-reactive protein (CRP)(Baseline and 8 weeks)
  • Change in Triglycerides(Baseline and 8 weeks)
  • Change in Total Cholesterol(Baseline and 8 weeks)
  • Change in Fasting Glycemia(Baseline and 8 weeks)

研究者

发起方
Federal University of Rio Grande do Sul
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alvaro Reischak-Oliveira

Professor Alvaro Reischak-Oliveira

Federal University of Rio Grande do Sul

研究点 (1)

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