NCT03262714

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

August 8, 2017

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 25, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

August 25, 2017

Status Verified

August 1, 2017

Enrollment Period

4 months

First QC Date

August 8, 2017

Last Update Submit

August 23, 2017

Conditions

Keywords

Dance, walking, cardiovascular risk, functional capacity.

Outcome Measures

Primary Outcomes (1)

  • Change in Peak Oxygen Consumption (VO2peak)

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

    Baseline and 8 weeks

Secondary Outcomes (22)

  • Change in C-reactive protein (CRP)

    Baseline and 8 weeks

  • Change in Tumor necrosis factor alpha (TNF-alpha)

    Baseline and 8 weeks

  • Change in Triglycerides

    Baseline and 8 weeks

  • Change in Total Cholesterol

    Baseline and 8 weeks

  • Change in LDL-Cholesterol

    Baseline and 8 weeks

  • +17 more secondary outcomes

Study Arms (3)

Dancing

EXPERIMENTAL

Elderly women randomized to the dance intervention programme.

Other: Dance

Walking

EXPERIMENTAL

Elderly women randomized to the walking intervention programme.

Other: Walking

Stretching

ACTIVE COMPARATOR

Elderly women randomized to the stretching intervention programme.

Other: Stretching

Interventions

DanceOTHER

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).

Dancing
WalkingOTHER

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).

Walking

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.

Stretching

Eligibility Criteria

Age60 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Motor Activity

Interventions

Walking

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

LocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Officials

  • Alvaro Reischak-Oliveira, PhD.

    Federal University of Rio Grande do Sul

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Josianne Rodrigues-Krause, MSc.

CONTACT

Alvaro Reischak-Oliveira, PhD.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Alvaro Reischak-Oliveira

Study Record Dates

First Submitted

August 8, 2017

First Posted

August 25, 2017

Study Start

August 1, 2017

Primary Completion

December 1, 2017

Study Completion

August 1, 2018

Last Updated

August 25, 2017

Record last verified: 2017-08

Locations