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Status unknownNCT03262714Updated Aug 25, 2017

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

An interventional study of Dance and Walking in Aging, Cardiovascular Risk Factor and Physical Activity, sponsored by Federal University of Rio Grande do Sul. Status unknown at 1 site in Brazil. Open to female participants aged 60 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-25.

Sponsored by Federal University of Rio Grande do Sul · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
60 Years to 80 Years
Sex
Female
01

Study 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.

Read the 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).

02

Conditions studied

  • Aging
  • Cardiovascular Risk Factor
  • Physical Activity

Keywords

  • Dance, walking, cardiovascular risk, functional capacity.
03

Who can participate

Ages eligible
60 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Dancing

    Elderly women randomized to the dance intervention programme.

    Other: Dance

  • Experimental
    Walking

    Elderly women randomized to the walking intervention programme.

    Other: Walking

  • Active comparator
    Stretching

    Elderly women randomized to the stretching intervention programme.

    Other: Stretching

Interventions

  • OtherDance

    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).

  • OtherWalking

    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).

  • OtherStretching

    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.

05

What researchers measure

Primary outcomes

  1. Change in Peak Oxygen Consumption (VO2peak)

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

    Time frame: Baseline and 8 weeks

Secondary outcomes

  1. Change in C-reactive protein (CRP)

    Cardiovascular risk marker. It will be analyzed in plasma, using ELISA specific kits.

    Time frame: Baseline and 8 weeks

  2. Change in Tumor necrosis factor alpha (TNF-alpha)

    Inflammatory marker. It will be analyzed in plasma, using ELISA specific kits.

    Time frame: Baseline and 8 weeks

  3. Change in Triglycerides

    Lipid profile marker. It will be analyzed in plasma, by enzymatic colorimetric method, using an automatic analyzer (ROCHE, Cobas C111, Switzerland).

    Time frame: Baseline and 8 weeks

  4. Change in Total Cholesterol

    Lipid profile marker. It will be analyzed in plasma, by enzymatic colorimetric method, using an automatic analyzer (ROCHE, Cobas C111, Switzerland).

    Time frame: Baseline and 8 weeks

  5. Change in LDL-Cholesterol

    Lipid profile marker. Estimation of the LDL concentration will be calculate using the formula of Friedewald.

    Time frame: Baseline and 8 weeks

  6. Change in HDL-Cholesterol

    Lipid profile marker. It will be analyzed in plasma, by enzymatic colorimetric method, using an automatic analyzer (ROCHE, Cobas C111, Switzerland).

    Time frame: Baseline and 8 weeks

  7. Change in Fasting Glycemia

    Glycaemic profile marker. It will be analyzed in plasma, by enzymatic colorimetric method, using an automatic analyzer (ROCHE, Cobas C111, Switzerland).

    Time frame: Baseline and 8 weeks

  8. Change in Fasting Insulin

    Glycaemic profile marker. It will be measured in plasma, usin a high sensitivity enzyme-linked immunosorbent assay.

    Time frame: Baseline and 8 weeks

  9. Change in HOMA-IR

    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.

    Time frame: Baseline and 8 weeks

  10. Change in Muscle Strength

    Isometric peak torque of the knee extensors will be measured using an isokinetic dynamometer (Cybex Norm, EUA).

    Time frame: Baseline and 8 weeks

  11. Change in Muscle Power

    Lower body muscle power will be measured by the performance of the counter movement jump in a force platform.

    Time frame: Baseline and 8 weeks

  12. Change in Muscle Quality

    Echo intensity of the quadriceps will be analyzed by ultrasound images.

    Time frame: Baseline and 8 weeks

  13. Change in Static Balance

    Static balance will be measured by a single leg support balance test, performed with both legs, with the eyes open and closed.

    Time frame: Baseline and 8 weeks

  14. Change in Dynamic Balance

    Dynamic balance will be measured by the Time to Up ang Go (TUG) test.

    Time frame: Baseline and 8 weeks

  15. Change in Gate ability

    Gate ability will be measured in a 10m track, picking up objects and passing over obstacles.

    Time frame: Baseline and 8 weeks

  16. Change in Body Weight

    Measurements of body weight will be measured in a digital scale.

    Time frame: Baseline and 8 weeks

  17. Change in Waist Circumference

    Measurements of waist circumference will be performed with a measuring tape.

    Time frame: Baseline and 8 weeks

  18. Change in Percentage of Body Fat

    Measurements of skinfolds will be taken to calculate the percentage of body fat.

    Time frame: Baseline and 8 weeks

  19. Change in Sit and Stand ability

    The ability to sit and stand in a chair 5 times, as fast as possible.

    Time frame: Baseline and 8 weeks

  20. Changes in Fall Risk

    The risk of fall will be measured by the performance in the TUG test.

    Time frame: Baseline and 8 weeks

  21. Changes in the Fear of Falling

    The fear of falling will be analyzed by the Falls Efficacy Scale-International Brazil (FES-I-Brazil).

    Time frame: Baseline and 8 weeks

  22. Changes in Quality of Life

    Quality of life will be analyzed by the questionary WHOQOL (World Health Organization Quality of Life.

    Time frame: Baseline and 8 weeks

06

Study locations

1 of 1 sites recruiting
  • Universidade Federal do Rio Grande do Sul
    Porto Alegre, Rio Grande do Sul, Brazil
    Recruiting
07

References and documents

Publications

  • 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. PubMed 30389581 ↗
08

Registry details

Key details

Study ID
NCT03262714
Lead sponsor
Federal University of Rio Grande do Sul
Responsible party
Alvaro Reischak-Oliveira (Professor Alvaro Reischak-Oliveira, Federal University of Rio Grande do Sul) — Principal investigator
First posted
Aug 25, 2017
Start date
Aug 1, 2017
Primary completion
Dec 2017 (estimated)
Completion
Aug 2018 (estimated)
Last update
Aug 25, 2017

Study contacts

Josianne Rodrigues-Krause, MSc.
Contact
rodrigues.krause@ufrgs.br
5551 999101821
Alvaro Reischak-Oliveira, PhD.
Contact
alvaro.oliveira@ufrgs.br
55-51-3308-5862
Alvaro Reischak-Oliveira, PhD.
principal investigator · Federal University of Rio Grande do Sul

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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