Cardiovascular Risk and Functional Responses From Dancing at Home in the Elderly With and Without Type 2 Diabetes

NCT04840368 | Unknown

• 1 other identifier: 27116919.5.0000.5347
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized controlled trial is to investigate the effects of a dance intervention performed at home, on cardiovascular risk factors and functional capacity of elderly individuals with and without type 2 diabetes mellitus. Comparison will be performed with a walking exercise intervention, performed outside. Dance sessions will be guided online by an expertise instructor, and walking sessions will be performed at a self-selected intensity, with no simultaneous supervision. All participants will complete an exercise diary after each exercise session (reporting perception of subjective effort, affective responses, and others).The participants will include men and women between 65 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). Cognitive skills (executive function and memory) will be also assessed. The experimental design will include a control period of four weeks, two sessions of assessments before and after the interventions, and twelve weeks of dancing or walking interventions, performed three times a week, in non-consecutive days, with 60 min duration.

Conditions

Aging; Type2 Diabetes

Keywords

Aging; Type 2 diabetes; Aerobic Exercise; Dance; Cardiovascular risk; Functionality

Outcome Measures

Primary Outcomes (1)

• Changes in Peak Oxygen Consumption (VO2peak), expressed in mL/Kg/min

  Participants' VO2peak will be determined through an incremental exercise test on a treadmill. The test will start with a 5 min warm-up (from 3 to 5 km/h, increasing 0.5 km/h each min, until 5 min), followed by 2% increases in slope every min, while maintaining a constant speed of 5 km/h throughout the entire test. In order to be considered a maximum effort test, participants must attain at least two of the following criteria: (1) age-predicted HRmax, (2) respiratory exchange ratio (RER) ≥1.1, (3) subjective perception of effort ≥17 (Borg scale 6-20), (4) signals of muscle fatigue, such as loss of motor coordination. Ventilatory parameters will be measured continuously, breath-by breath, using an open-circuit spirometry system (Quark Cardio Pulmonary Exercise Test, Cosmed Italy). VO2peak was identified as the highest VO2 value in a line of tendency plotted against the time. Higher VO2peak values indicate better cardiorespiratory fitness and cardiovascular health.

  before intervention (week 0), after control period (week 5), and after intervention (week 13)

Secondary Outcomes (21)

• Changes in Triglycerides, expressed in milligrams per deciliter (mg/dL)

  before intervention (week 0), after control period (week 5), and after intervention (week 13)

• Changes in Total Cholesterol, expressed in mg/dL

  before intervention (week 0), after control period (week 5), and after intervention (week 13)

• Changes in Low Density Lipoprotein Cholesterol (LDL-Cholesterol), expressed in mg/dL

  before intervention (week 0), after control period (week 5), and after intervention (week 13)

• Changes in High Density Lipoprotein Cholesterol (HDL-Cholesterol), expressed in mg/dL

  before intervention (week 0), after control period (week 5), and after intervention (week 13)

• Changes in Fasting Glycemia, expressed in mg/dL

  before intervention (week 0), after control period (week 5), and after intervention (week 13)

Study Arms (2)

Dancing

EXPERIMENTAL

Participants randomized to the dance group will take part in a dance intervention programme for 12 weeks, including 3 sessions per week (non-consecutive days), each lasting 60 min. Dance classes will be performed individually at home, guided by an expertise instructor, as live sessions online. They will include a variety of rhythms such as salsa, merengue, jazz dance, aerobics, etc. The dance sessions will include a warm up of approximately 10 min (posture, join mobility and dance technique), a main part of 40 min (practicing isolated dance moves and learning of specific choreographic routines), and a cool down of 10 min (muscle stretching and relaxation).

Other: Dancing

Walking

ACTIVE COMPARATOR

Participants randomized to the walking group will take part in a walking intervention programme for 12 weeks, including 3 sessions per week (non-consecutive days), 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, and a cool down of 10 min (muscle stretching and relaxation). They will be performed individually, outside, at a self-selected intensity, with no supervision.

Other: Dancing

Interventions

Dancing OTHER

Participants randomized to the dance group will take part in a dance intervention programme for 12 weeks, including 3 sessions per week (non-consecutive days), each lasting 60 min. Dance classes will be performed individually at home, guided by an expertise instructor, as live sessions online. They will include a variety of rhythms such as salsa, merengue, jazz dance, aerobics, etc. The dance sessions will include a warm up of approximately 10 min (posture, join mobility and dance technique), a main part of 40 min (practicing isolated dance moves and learning of specific choreographic routines), and a cool down of 10 min (muscle stretching and relaxation).

Dancing; Walking

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Women and Men between 65 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
• Participants with T2DM should be previously diagnosed, with basal glycaemia superior to 126 mg/dL, and/or HbA1C superior to 6.5%.

You may not qualify if:

• Chronic diseases such as fibromyalgia, labyrinthitis, cancer or neurodegenerative disorders
• Compromised cognitive skills: Mini Mental State Examination (MMSE) scores inferior to 24/30.
• 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.

Sponsors & Collaborators

• Federal University of Rio Grande do Sul: lead

Study Sites (1)

School of Physical Education, Physiotherapy and Dance (Universidade Feferal do Rio Grande do Sul)

Porto Alegre, Rio Grande do Sul, 90690-200, Brazil

Location

Related Publications (10)

• Bruseghini P, Calabria E, Tam E, Milanese C, Oliboni E, Pezzato A, Pogliaghi S, Salvagno GL, Schena F, Mucelli RP, Capelli C. Effects of eight weeks of aerobic interval training and of isoinertial resistance training on risk factors of cardiometabolic diseases and exercise capacity in healthy elderly subjects. Oncotarget. 2015 Jul 10;6(19):16998-7015. doi: 10.18632/oncotarget.4031.

  PMID: 26046575 BACKGROUND

• Krause M, Rodrigues-Krause J, O'Hagan C, Medlow P, Davison G, Susta D, Boreham C, Newsholme P, O'Donnell M, Murphy C, De Vito G. The effects of aerobic exercise training at two different intensities in obesity and type 2 diabetes: implications for oxidative stress, low-grade inflammation and nitric oxide production. Eur J Appl Physiol. 2014 Feb;114(2):251-60. doi: 10.1007/s00421-013-2769-6.

  PMID: 24233244 BACKGROUND

• Cadore EL, Izquierdo M. How to simultaneously optimize muscle strength, power, functional capacity, and cardiovascular gains in the elderly: an update. Age (Dordr). 2013 Dec;35(6):2329-44. doi: 10.1007/s11357-012-9503-x. Epub 2013 Jan 4.

  PMID: 23288690 BACKGROUND

• Bielemann, R.M.K., A. G; Hallal, P.C. R, Physical activity and cost savings for chronic diseases to the sistema Único de saúde. Revista Brasileira de Atividade Física e Saúde, 2010. 15(1): p. 9-14.

  BACKGROUND

• Laddu DR, Lavie CJ, Phillips SA, Arena R. Physical activity for immunity protection: Inoculating populations with healthy living medicine in preparation for the next pandemic. Prog Cardiovasc Dis. 2021 Jan-Feb;64:102-104. doi: 10.1016/j.pcad.2020.04.006. Epub 2020 Apr 9. No abstract available.

  PMID: 32278694 BACKGROUND

• Fletcher GF, Landolfo C, Niebauer J, Ozemek C, Arena R, Lavie CJ. Promoting Physical Activity and Exercise: JACC Health Promotion Series. J Am Coll Cardiol. 2018 Oct 2;72(14):1622-1639. doi: 10.1016/j.jacc.2018.08.2141.

  PMID: 30261965 BACKGROUND

• Jimenez-Pavon D, Carbonell-Baeza A, Lavie CJ. Physical exercise as therapy to fight against the mental and physical consequences of COVID-19 quarantine: Special focus in older people. Prog Cardiovasc Dis. 2020 May-Jun;63(3):386-388. doi: 10.1016/j.pcad.2020.03.009. Epub 2020 Mar 24. No abstract available.

  PMID: 32220590 BACKGROUND

• Rodrigues-Krause J, Krause M, Reischak-Oliveira A. Dancing for Healthy Aging: Functional and Metabolic Perspectives. Altern Ther Health Med. 2019 Jan;25(1):44-63.

  PMID: 29428927 BACKGROUND

• 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.

  PMID: 30389581 BACKGROUND

• Forte R, Boreham CA, Leite JC, De Vito G, Brennan L, Gibney ER, Pesce C. Enhancing cognitive functioning in the elderly: multicomponent vs resistance training. Clin Interv Aging. 2013;8:19-27. doi: 10.2147/CIA.S36514. Epub 2013 Jan 10.

  PMID: 23341738 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Alvaro Reischak-Oliveira, PhD

  Federal University of Rio Grande do Sul

  PRINCIPAL INVESTIGATOR

• Josianne Rodrigues-Krause, PhD

  Federal University of Rio Grande do Sul

  STUDY DIRECTOR

Central Study Contacts

Josianne R Rodrigues-Krause, PhD

CONTACT

+5551999101821; rodrigues.krause@ufrgs.br

Alvaro Reischak, PhD

CONTACT

alvaro.oliveira@ufrgs.br

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

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: April 12, 2021
• Study Start: May 3, 2021
• Primary Completion: May 3, 2023
• Study Completion: December 23, 2023
• Last Updated: April 12, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be shared through a public repository no later than six months after the first study publication (data access available as long as deemed necessary by the study coordination).
• Access Criteria: The public repository for data sharing is not yet defined (it will be presented in the study website and scientific publications).

Locations

BR (1)