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

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03262714
• Other study ID #: 53834516.0.0000.5347
• Status: Recruiting
• Phase: N/A
• First received: August 8, 2017
• Last updated: August 23, 2017
• Start date: August 1, 2017
• Est. completion date: August 2018

Study information

• Verified date: August 2017
• Source: Federal University of Rio Grande do Sul
• Contact: Josianne Rodrigues-Krause, MSc.
• Phone: 5551 999101821
• Email: rodrigues.krause[@]ufrgs.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 60 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aging
• Cardiovascular Risk Factor
• Physical Activity

Intervention

Other:
• Dance
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).
• Walking
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).
• Stretching
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.

Locations

Country	Name	City	State
Brazil	Universidade Federal do Rio Grande do Sul	Porto Alegre	Rio Grande do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Peak Oxygen Consumption (VO2peak)	The maximum capacity of oxygen consumption measured during an incremental exercise test.	Baseline and 8 weeks
Secondary	Change in C-reactive protein (CRP)	Cardiovascular risk marker. It will be analyzed in plasma, using ELISA specific kits.	Baseline and 8 weeks
Secondary	Change in Tumor necrosis factor alpha (TNF-alpha)	Inflammatory marker. It will be analyzed in plasma, using ELISA specific kits.	Baseline and 8 weeks
Secondary	Change in Triglycerides	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
Secondary	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).	Baseline and 8 weeks
Secondary	Change in LDL-Cholesterol	Lipid profile marker. Estimation of the LDL concentration will be calculate using the formula of Friedewald.	Baseline and 8 weeks
Secondary	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).	Baseline and 8 weeks
Secondary	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).	Baseline and 8 weeks
Secondary	Change in Fasting Insulin	Glycaemic profile marker. It will be measured in plasma, usin a high sensitivity enzyme-linked immunosorbent assay.	Baseline and 8 weeks
Secondary	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.	Baseline and 8 weeks
Secondary	Change in Muscle Strength	Isometric peak torque of the knee extensors will be measured using an isokinetic dynamometer (Cybex Norm, EUA).	Baseline and 8 weeks
Secondary	Change in Muscle Power	Lower body muscle power will be measured by the performance of the counter movement jump in a force platform.	Baseline and 8 weeks
Secondary	Change in Muscle Quality	Echo intensity of the quadriceps will be analyzed by ultrasound images.	Baseline and 8 weeks
Secondary	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.	Baseline and 8 weeks
Secondary	Change in Dynamic Balance	Dynamic balance will be measured by the Time to Up ang Go (TUG) test.	Baseline and 8 weeks
Secondary	Change in Gate ability	Gate ability will be measured in a 10m track, picking up objects and passing over obstacles.	Baseline and 8 weeks
Secondary	Change in Body Weight	Measurements of body weight will be measured in a digital scale.	Baseline and 8 weeks
Secondary	Change in Waist Circumference	Measurements of waist circumference will be performed with a measuring tape.	Baseline and 8 weeks
Secondary	Change in Percentage of Body Fat	Measurements of skinfolds will be taken to calculate the percentage of body fat.	Baseline and 8 weeks
Secondary	Change in Sit and Stand ability	The ability to sit and stand in a chair 5 times, as fast as possible.	Baseline and 8 weeks
Secondary	Changes in Fall Risk	The risk of fall will be measured by the performance in the TUG test.	Baseline and 8 weeks
Secondary	Changes in the Fear of Falling	The fear of falling will be analyzed by the Falls Efficacy Scale-International Brazil (FES-I-Brazil).	Baseline and 8 weeks
Secondary	Changes in Quality of Life	Quality of life will be analyzed by the questionary WHOQOL (World Health Organization Quality of Life.	Baseline and 8 weeks