Clinical trial NCT03262714: Effects of Dancing on Cardiovascular and Functional Risk Factors in Older Women.
Official title: Effects of Dancing and Walking on Cardiovascular Risk Factors and Functional Capacity in Older Women: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aging
Cardiovascular Risk Factor
Physical Activity
Keywords: Dance, walking, cardiovascular risk, functional capacity.
Lead sponsor: Federal University of Rio Grande do Sul
Sponsor class: OTHER
First posted: 2017-08-25
Enrollment: 30
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Peak Oxygen Consumption (VO2peak)
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Change in C-reactive protein (CRP)
timeFrame: Baseline and 8 weeks
measure: Change in Tumor necrosis factor alpha (TNF-alpha)
timeFrame: Baseline and 8 weeks
measure: Change in Triglycerides
timeFrame: Baseline and 8 weeks
measure: Change in Total Cholesterol
timeFrame: Baseline and 8 weeks
measure: Change in LDL-Cholesterol
timeFrame: Baseline and 8 weeks
measure: Change in HDL-Cholesterol
timeFrame: Baseline and 8 weeks
measure: Change in Fasting Glycemia
timeFrame: Baseline and 8 weeks
measure: Change in Fasting Insulin
timeFrame: Baseline and 8 weeks
measure: Change in HOMA-IR
timeFrame: Baseline and 8 weeks
measure: Change in Muscle Strength
timeFrame: Baseline and 8 weeks
measure: Change in Muscle Power
timeFrame: Baseline and 8 weeks
measure: Change in Muscle Quality
timeFrame: Baseline and 8 weeks
measure: Change in Static Balance
timeFrame: Baseline and 8 weeks
measure: Change in Dynamic Balance
timeFrame: Baseline and 8 weeks
measure: Change in Gate ability
timeFrame: Baseline and 8 weeks
measure: Change in Body Weight
timeFrame: Baseline and 8 weeks
measure: Change in Waist Circumference
timeFrame: Baseline and 8 weeks
measure: Change in Percentage of Body Fat
timeFrame: Baseline and 8 weeks
measure: Change in Sit and Stand ability
timeFrame: Baseline and 8 weeks
measure: Changes in Fall Risk
timeFrame: Baseline and 8 weeks
measure: Changes in the Fear of Falling
timeFrame: Baseline and 8 weeks
measure: Changes in Quality of Life
timeFrame: Baseline and 8 weeks
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Universidade Federal do Rio Grande do Sul
state: Rio Grande do Sul
Study officials:
affiliation: Federal University of Rio Grande do Sul
name: Alvaro Reischak-Oliveira, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rodrigues-Krause J, Farinha JB, Ramis TR, Macedo RCO, Boeno FP, Dos Santos GC, Vargas J Jr, Lopez P, Grazioli R, Costa RR, Pinto RS, Krause M, Reischak-Oliveira A. Effects of dancing compared to walking on cardiovascular risk and functional capacity of older women: A randomized controlled trial. Exp Gerontol. 2018 Dec;114:67-77. doi: 10.1016/j.exger.2018.10.015. Epub 2018 Oct 31.