Clinical trial NCT04840368: Cardiovascular Risk and Functional Responses From Dancing at Home in the Elderly With and Without Type 2 Diabetes
Official title: Cardiovascular Risk and Functional Responses From Dancing at Home Compared With Walking in Elderly Individuals With and Without Type 2 Diabetes Mellitus: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aging
Type2 Diabetes
Keywords: Aging
Type 2 diabetes
Aerobic Exercise
Dance
Cardiovascular risk
Functionality
Lead sponsor: Federal University of Rio Grande do Sul
Sponsor class: OTHER
First posted: 2021-04-12
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: 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 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.

Detailed description: The aging process is characterized by a loss of lean mass simultaneously to an increase in visceral adipose tissue (Bruseghini P. et al. 2015). This may result in reduced glucose uptake and increased levels of pro inflammatory cytokines, which leads to a chronic low grade inflammation state, insulin resistance, type 2 diabetes mellitus (T2DM) and elevated cardiovascular risk (CVR) (Krause, M.S. et al. 2013). Reductions in lean mass are also associated with reductions in muscle strength and power, inducing functional declines that result in difficulties to perform daily activities, and eventual loss of physical independence (Cadore, E.L. and Izquierdo, M. 2013) Costs with the treatment of aging-associated comorbidities are elevated for the health systems (Bielemann, R.M.K. et al. 2010). Searching for low cost strategies of prevention, with long term results, is essential then, especially the ones which may prevent dependence in a large spectrum (at the physical, social and cognitive levels), such as dancing (Laddu, D.R. et al 2020). Particularly, due to the pandemic of Corona Virus Disease-19 (COVID-19), long periods of self-isolation and social distancing have resulted in dramatic changes in the lifestyle of this population, beyond the risk of viral infection (Laddu, D.R. et al 2020). In this context, regular physical activity is considered to be a preventive strategy against chronic diseases due to its beneficial effects on global health (physical, mental, and social domains) (Fletcher, G.F. et.al. 2018). Particularly, dancing has been suggested as a strategy to increase levels of physical activity during quarantine periods (Jiménez-Pavón, D. et al. 2020), considering they can be adjusted for different ages, physical limitations, and levels of previous experience (Rodrigues-Krause, J.C. et al. 2019).

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 people, with and without type 2 diabetes mellitus (T2DM), comparing dancing to an active control group of walking exercise. The participants will include men and women between 65 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 cardiovascular complications, mobility limitations and neurodegenerative diseases.

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) Control Period: 4 weeks for the follow up of the maintenance or changes in the primary and secondary outcomes responses of the participants. Primary and secondary outcomes will be evaluated before and after the control period. 3) Period of interventions: patients will be randomized in blocks (randomization.com), in accordance to their VO2peak, gender, and the presence of T2DM, to one of the two groups: dance or walking. The duration of the dance and walking interventions will be 12 weeks, including 3 sessions per week, each lasting 60 min. performed at home, guided by an expertise instructor, as live online sessions. Session will include several styles (salsa, jazz, aerobics), basic technical elements, no partner required. Walking: performed as a continuous aerobic exercise, outside, at a self-selected intensity, with no simultaneous supervision. Both interventions will include a warm-up (10 min), main part (40 min) and cool-down (10 min). All participants will complete an exercise diary after each exercise session (reporting perception of subjective effort, affective responses, and others). 3) Post-intervention assessments: the same protocols of testing of the pre-interventions assessments will be repeated. 4) Follow-up assessments: participants will be evaluated in 12 weeks times, for primary and secondary outcomes, after the end of the exercise intervention period.

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. (3) Cognitive function: executive function (random number generation and trial making test). In the following outcomes description of this Clinical Trials record, protocols of assessment for outcomes 1 to 20 are based on Rodrigues-Krause, J.C. et al. 2018. For outcomes 21 and 22 the reference is Forte, R. et al. 2013.

Results will be expressed in mean and confidence interval. All the assessments will be held at the Laboratory of Research in Exercise (LAPEX-UFRGS). Statistics: Generalized estimating equations, followed by the post hoc of least significant difference (LSD) (p\<0.05). Comparisons before and after the interventions will be made among groups 1=dancing, 2=dancing T2DM, 3=walking, 4=walking T2DM.

Considering the well known benefits of the exercise, it is expected that our interventions will result in improvements on CVR (increases in cardiorespiratory fitness, reductions in adiposity, lipemia, insulin resistance and systemic inflammation), functionality (muscle strength and power, balance, gate and flexibility), and cognitive function (executive function). Our results will add on knowledge regarding the magnitude of possible gains from dancing at home, when compared to other forms of traditional aerobic exercise, a lack in the literature so far. Finally, the application of a purpose for an intervention of low cost and high levels of adherence, which stimulates multiple factors that decline with aging, may be a step forward in terms of strategies of prevention of aging-associated diseases on the public health context.

Eligibility criteria: Inclusion Criteria:

* 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%.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Changes in Peak Oxygen Consumption (VO2peak), expressed in mL/Kg/min
timeFrame: before intervention (week 0), after control period (week 5), and after intervention (week 13)
Secondary outcomes:
measure: Changes in Triglycerides, expressed in milligrams per deciliter (mg/dL)
timeFrame: before intervention (week 0), after control period (week 5), and after intervention (week 13)
measure: Changes in Total Cholesterol, expressed in mg/dL
timeFrame: before intervention (week 0), after control period (week 5), and after intervention (week 13)
measure: Changes in Low Density Lipoprotein Cholesterol (LDL-Cholesterol), expressed in mg/dL
timeFrame: before intervention (week 0), after control period (week 5), and after intervention (week 13)
measure: Changes in High Density Lipoprotein Cholesterol (HDL-Cholesterol), expressed in mg/dL
timeFrame: before intervention (week 0), after control period (week 5), and after intervention (week 13)
measure: Changes in Fasting Glycemia, expressed in mg/dL
timeFrame: before intervention (week 0), after control period (week 5), and after intervention (week 13)
measure: Changes in Fasting Insulin, expressed in milli-international units per litre (mlU/L)
timeFrame: before intervention (week 0), after control period (week 5), and after intervention (week 13)
measure: Changes in HOMA-IR, expressed in u.a
timeFrame: before intervention (week 0), after control period (week 5), and after intervention (week 13)
measure: Changes in Glycemic Responses to Oral Glucose Tolerance Test, expressed in mg/dL
timeFrame: before intervention (week 0), after control period (week 5), and after intervention (week 13)
measure: Changes in C-reactive protein (CRP), expressed in mg/L
timeFrame: before intervention (week 0), after control period (week 5), and after intervention (week 13)
measure: Changes in Tumor necrosis factor alpha (TNF-alpha), expressed in pg/mL
timeFrame: before intervention (week 0), after control period (week 5), and after intervention (week 13)
measure: Changes in Muscle Strength, expressed in (N・m)
timeFrame: before intervention (week 0), after control period (week 5), and after intervention (week 13)
measure: Changes in Muscle Power, expressed by the height (in cm) of the counter movement jump (CMJ)
timeFrame: before intervention (week 0), after control period (week 5), and after intervention (week 13)
measure: Changes in Muscle Thickness, expressed in mm
timeFrame: before intervention (week 0), after control period (week 5), and after intervention (week 13)
measure: Changes in Static Balance, expressed by the time (in seconds) spent at an unipedal stance leg position
timeFrame: before intervention (week 0), after control period (week 5), and after intervention (week 13)
measure: Changes in Gait ability, measured by the Time to Up and Go (TUG) test
timeFrame: before intervention (week 0), after control period (week 5), and after intervention (week 13)
measure: Changes in Sit and Stand ability, expressed in seconds
timeFrame: before intervention (week 0), after control period (week 5), and after intervention (week 13)
measure: Changes in the Fear of Falling, analyzed by the Falls Efficacy Scale- International Brazil (FES-I-Brazil).
timeFrame: before intervention (week 0), after control period (week 5), and after intervention (week 13)
measure: Changes in Quality of Life, assessed by how the person feels in the physical, psychological, social and environmental domains of the World Health Organization Quality of Life (WHOQOL) questionnaire
timeFrame: before intervention (week 0), after control period (week 5), and after intervention (week 13)
measure: Changes in Leisure Time Physical Activity
timeFrame: before intervention (week 0), after control period (week 5), and after intervention (week 13)
measure: Change in Executive function, assessed by the Random number generation task
timeFrame: before intervention (week 0), after control period (week 5), and after intervention (week 13)
measure: Change in Executive function, assessed by the Trail making test
timeFrame: [Time Frame: before intervention (week 0), after control period (week 5), and after intervention (week 13)]
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: School of Physical Education, Physiotherapy and Dance (Universidade Feferal 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
affiliation: Federal University of Rio Grande do Sul
name: Josianne Rodrigues-Krause, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
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.
citation: 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.