AgingNCT04840368
Cardiovascular Risk and Functional Responses From Dancing at Home in the Elderly With and Without Type 2 Diabetes
A study testing Dancing in people with Aging and Type2 Diabetes, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Type2 Diabetes
- What is being tested?
- Dancing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 3 May 2021to 23 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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%.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Alvaro Reischak, PhD contact
Brazil1 site
School of Physical Education, Physiotherapy and Dance (Universidade Feferal do Rio Grande do Sul)
Porto Alegre, Rio Grande do Sul, 90690-200
Exercise Research Laboratory, 55513308-5817, receplapex@ufrgs.br
Josianne Rodrigues-Krause, PhD, 5551999101821, rodrigues.krause@ufrgs.br
About this study
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.
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.
Read the 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.
- Conditions
- Aging, Type2 Diabetes
- Being tested
- Dancing
- Keywords
- Aging, Type 2 diabetes, Aerobic Exercise, Dance, Cardiovascular risk, Functionality
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DancingOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Other: Dancing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Triglycerides, a lipid profile marker, will be analyzed in plasma (after 8h fasting), and measured by enzymatic colorimetric method, using an automated analyzer (Cobas C111, Roche Diagnostics, Basel, Switzerland). Lower triglycerides values correspond to better metabolic health, as follows: Desirable levels: less than 150 (mg/dL). Borderline high: 150 to 199 mg/dL. High: 200 to 499 mg/dL.
Measured: before intervention (week 0), after control period (week 5), and after intervention (week 13)
Changes in Total Cholesterol, expressed in mg/dL
Total cholesterol, a lipid profile marker, will be analyzed in plasma (after 8h fasting), and measured by enzymatic colorimetric method, using an automated analyzer (Cobas C111, Roche Diagnostics, Basel, Switzerland). Lower LDL-Cholesterol values correspond to better metabolic health, as follows: Desirable: less than 200 mg/dL. Borderline high: 200-239 mg/dL. High: 240 mg/dL and above.
Measured: 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
LDL-Cholesterol levels, a lipid profile marker, will be estimated by Friedewald (1972). Lower LDL-Cholesterol values correspond to better metabolic health, as follows: Desirable: less than 100 mg/dL. Near-desirable: 100-129 mg/dL. Borderline High: 130-159 mg/dL. High: 160-189 mg/dL.
Measured: 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
HDL-Cholesterol, a lipid profile marker, will be analyzed in plasma (after 8h fasting), and measured by enzymatic colorimetric method, using an automated analyzer (Cobas C111, Roche Diagnostics, Basel, Switzerland). Higher HDL-Cholesterol values correspond to better metabolic health, as follows: Desirable HDL-Cholesterol values: 45 to 70 mg/dL for men, 50 to 90 mg/dL for women.
Measured: before intervention (week 0), after control period (week 5), and after intervention (week 13)
Changes in Fasting Glycemia, expressed in mg/dL
Blood fasting glucose levels, a glycemic profile marker, will be analyzed in plasma (after 8h fasting), and measured by enzymatic colorimetric method, using an automated analyzer (Cobas C111, Roche Diagnostics, Basel, Switzerland). Normal values of fasting glycaemia is between 70 and 100 mg/dL for people who do not have diabetes. Fasting blood glucose levels greater than or equal to 126 mg/dL is considered for diagnosis of diabetes.
Measured: before intervention (week 0), after control period (week 5), and after intervention (week 13)
Changes in Fasting Insulin, expressed in milli-international units per litre (mlU/L)
Fasting insulin, a glycemic profile marker, will be analyzed in plasma (after 8h fasting), and determined by enzyme-linked immunosorbent assay (ELISA), according to manufacturer's instructions. Normal insulin levels are considered superior to 25 mlU/L, or < 174 pmol/L (SI Units: Conversional units x 6.945).
Measured: before intervention (week 0), after control period (week 5), and after intervention (week 13)
Changes in HOMA-IR, expressed in u.a
Glycemic profile marker. Homeostatic model of insulin resistance, calculated using fasting values of insulin and glycemia, in accordance with the following formula: fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5.
Measured: before intervention (week 0), after control period (week 5), and after intervention (week 13)
Changes in Glycemic Responses to Oral Glucose Tolerance Test, expressed in mg/dL
Changes in Glycemic Responses to Oral Glucose Tolerance Test, used to test glucose tolerance, will be analyzed in plasma (after 8h fasting), by enzymatic colorimetric method, using an automatic analyzer (ROCHE, Cobas C111, Switzerland). Blood glucose will be measured at fasting, 30 min, one hour and two hours, after the ingestion of a drink with 75g of glucose dissolved in water. After two hours, plasma glucose levels (mg/dL) of 139 and below are considered normal. Values in between 140 and 199 correspond to pre-diabetes (impaired glucose tolerance). Values of 200 and above correspond to diabetes mellitus.
Measured: before intervention (week 0), after control period (week 5), and after intervention (week 13)
Changes in C-reactive protein (CRP), expressed in mg/L
CRP, a cardiovascular risk and inflammatory marker, will be analyzed in plasma (after 8h fasting), and determined by enzyme-linked immunosorbent assay (ELISA), according to manufacturer's instructions. High levels of CRP occur when some type of inflammatory or infectious processes is occurring in the bod. High CRP levels may predict a higher risk for cardiovascular disease. Values in between 3.0 to 10.0 mg/L indicate slight inflammation, but origin is unspecific.
Measured: before intervention (week 0), after control period (week 5), and after intervention (week 13)
Changes in Tumor necrosis factor alpha (TNF-alpha), expressed in pg/mL
TNF-alpha, an inflammatory marker, will be analyzed in serum (after 8h fasting), and determined by enzyme-linked immunosorbent assay (ELISA), according to manufacturer's instructions. Chronically elevated levels of TNF-alpha are linked with an increased risk of autoimmune diseases, obesity, and diabetes, among other diseases characterized by a chronic low-grade inflammation state. The recommended reference range of serum TNF-α vary from non detectable to 8.1 pg/mL.
Measured: before intervention (week 0), after control period (week 5), and after intervention (week 13)
Changes in Muscle Strength, expressed in (N・m)
The maximal isometric and isokinetic knee extension capacity will be measured using an Isokinetic Dynamometer (Cybex Norm, Cybex Norm,Ronkonkoma, New York, USA). The participants will perform 3 sets of 5 s and will be instructed to isometrically produce the maximal knee extension force as fast as possible at 60° of knee flexion (0° represents full extension). After a pre-test of 3 submaximal repetitions for angular velocity familiarization, maximal isokinetic knee extension peak torque will be measured during one set of 4 repetitions at the angular velocity of 60・s-1. The test will be performed in a 90° range of motion Both maximal isometric and isokinetic sets will be performed with 3 min of rest between them.
Measured: before intervention (week 0), after control period (week 5), and after intervention (week 13)
Changes in Muscle Power, expressed by the height (in cm) of the counter movement jump (CMJ)
Participants will perform a jump test using an electronic contact mat system. Jump height will be determined using an acknowledged flight-time calculation. Each participant will be instructed to use maximum effort to perform the double-leg CMJ test. They will be given 3 attempts to obtain their maximum jump height in each test, with 10 s of rest between attempts, with the highest value utilized for subsequent analysis.
Measured: before intervention (week 0), after control period (week 5), and after intervention (week 13)
Changes in Muscle Thickness, expressed in mm
For muscle thickness, transversal images of the right vastus lateralis, rectus femoris, vastus intermedius, and vastus medialis muscles will be obtained using a 38-mm, 9.0 megahertz linear-array transducer, with a Nemio XG ultrasound (Toshiba, Japan). The ultrasound muscular images were analysed via ImageJ software (National Institute of Health, USA, version 1.37). The subcutaneous adipose tissue and bone tissue will be identified, and the distance between them will be defined as muscle thickness. Quadriceps femoris muscle thickness will be considered as the sum of the four lower-body muscles muscle thickness. Increases in muscle thickness indicate gains in lean mass, improved body composition, and health and function related factors.
Measured: before intervention (week 0), after control period (week 5), and after intervention (week 13)
Changes in Static Balance, expressed by the time (in seconds) spent at an unipedal stance leg position
Static balance will be evaluated with the participant in unipedal stance of the dominant leg, with eyes closed. The opposite leg remained in the air, with hip and knee flexed at a 90° angle. The longest duration keeping the position (30s maximum) in three attempts will be recorded (stopwatch), with 2 min break.
Measured: before intervention (week 0), after control period (week 5), and after intervention (week 13)
Changes in Gait ability, measured by the Time to Up and Go (TUG) test
The TUG test consist in measuring the time (s) that the participant need to get up from a standard arm chair (43 cm), walk for 3m at usual walking speed, turn, and walk back to sit down. The fastest time in three attempts was recorded, with 2 min break in between them. Times were recorded to the nearest millisecond and transformed in m/s. A TUG score of 13.5 seconds or longer is predictive of reduced dynamic balance and fall risk.
Measured: before intervention (week 0), after control period (week 5), and after intervention (week 13)
Changes in Sit and Stand ability, expressed in seconds
The ability to seat and stand (chair raise test) will be assessed by the time required to rise from sitting five times as fast as possible from a standard chair (43 cm) with the participants folding arms across their chest. Recordings will be made using a stopwatch starting at the initiation of the movement and stopping when subjects stood upright for the 5th time.
Measured: before intervention (week 0), after control period (week 5), and after intervention (week 13)
Changes in the Fear of Falling, analyzed by the Falls Efficacy Scale- International Brazil (FES-I-Brazil).
The fear of falling will be analyzed by the Falls Efficacy Scale- International Brazil (FES-I-Brazil). This scale evaluates how confident the participant is in performing daily activities. The total score varies from 16 points (not worried at all) to 64 (extremely worried). The cut-off point to discriminate fallers and non fallers is 31 points.
Measured: before intervention (week 0), after control period (week 5), and after intervention (week 13)
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
Quality of life will be assessed by the abbreviated version of the World Health Organization Quality of Life (WHOQOL) questionnaire, which is specific for the elderly population. It contains 26 questions in total (2 for general quality of life assessment), and 24 including four domains (physical, psychological, social and environmental). The scores for each question are from 1 (very bad) to 5 (very good) quality of life for each specific domain. Scores 2, 3 and 4 mean bad, neutral and good, respectively. The final score is expressed in percentage (from 0 to 100%). As closer the score is to 100%, higher is the general quality of life of that individual.
Measured: before intervention (week 0), after control period (week 5), and after intervention (week 13)
Changes in Leisure Time Physical Activity
The Godin-Shephard leisure-time physical activity questionnaire will be used in its validated version and translated into Brazilian Portuguese. Light, moderate or vigorous physical activities, performed for at least 15 min during leisure time, will be registered by the participants. The frequency is multiplied by the metabolic equivalent (MET). High scores indicate a higher level of physical activity during leisure. For example, in the reference to the score in units using only moderate and strenuous physical activities, 24 units or more means "Active", indicating substantial benefits; from 14 to 23 units means "Moderately active", indicating some benefits; and less than 14 units means "Insufficiently active", indicating low benefits.
Measured: before intervention (week 0), after control period (week 5), and after intervention (week 13)
Change in Executive function, assessed by the Random number generation task
The random number generation task evaluates executive functions, particularly inhibition. Briefly, participants verbally generated a random sequence of 100 numbers chosen between one and nine, at a frequency of 40 bpm, paced by a metronome. The randomness of the sequence is elaborated to obtain three indices that were theoreti¬cally related to the inhibitory function: the Turning Point Index, the Adjacency, and the Runs. High levels on the Turning Point Index, but low levels of Adjacency and Runs correspond to a high ability to inhibit the production of stereotyped strings, therefore contributing to the optimal control of complex activities.
Measured: before intervention (week 0), after control period (week 5), and after intervention (week 13)
Change in Executive function, assessed by the Trail making test
The trail making test assesses attention, speed, and cognitive flexibility. The standard protocol used requires participants to draw lines connecting in ascending order and as quickly as possible 25 circles distributed over a sheet of paper. The test has a part A with numbers only and a part B with numbers and letters joined in alternation (i.e, 1-A-2-B-3-C, and so on). A summary score will be calculated by subtracting the time taken in seconds to complete part A from the time at part B (ΔTrail Making) and used for analysis.
Measured: [Time Frame: before intervention (week 0), after control period (week 5), and after intervention (week 13)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start3 May 2021 (estimated)
- Primary completion3 May 2023 (estimated)
- Study completion23 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alvaro Reischak-Oliveira, Federal University of Rio Grande do Sul
- Investigators
- Alvaro Reischak-Oliveira, PhD, Principal investigator, Federal University of Rio Grande do SulJosianne Rodrigues-Krause, PhD, Study director, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04840368
- Sponsor's protocol ID
- 27116919.5.0000.5347
- Status last verified
- Apr 2021
- First submitted
- 25 Mar 2021
- Last updated
- 12 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We intend that the data to be collected in this trial may contribute beyond our actions to the knowledge on dance, exercise, aging and T2DM. Ethical consent from participants, and Institutional Review Boards approval to share data will be obtained. Data sets, variables' dictionary and statistical analysis description will be available online upon registration and acceptance of the study team's data sharing terms and policy. Data usage will be under the PI's auspices, but restrictions or screenings will not be imposed upon data requests. VO2peak (main outcome) data and relevant support information (sociodemographic, clinical history and allocated groups) will be shared. Data on other outcomes may be requested by contacting the PI.
Publications
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.
PubMed 26046575Krause 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.
PubMed 24233244Cadore 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.
PubMed 23288690Bielemann, 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.
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.
PubMed 32278694Fletcher 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.
PubMed 30261965Jimenez-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.
PubMed 32220590Rodrigues-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.
PubMed 29428927Rodrigues-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 30389581Forte 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.
PubMed 23341738
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04840368
- Acronym / sponsor ID
- 27116919.5.0000.5347
- Conditions
- Aging, Type2 Diabetes
- Keywords
- Aging, Type 2 diabetes, Aerobic Exercise, Dance, Cardiovascular risk, Functionality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Study start
- 3 May 2021 (estimated)
- Primary completion
- 3 May 2023 (estimated)
- Study completion
- 23 Dec 2023 (estimated)
- First posted
- 12 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dancing | Experimental | Other: DancingParticipants 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). |
| Walking | Active comparator | Other: DancingParticipants 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. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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%.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DancingParticipants 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 |
Primary outcome
Changes in Peak Oxygen Consumption (VO2peak), expressed in mL/Kg/min
Time frame: before intervention (week 0), after control period (week 5), and after intervention (week 13)
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.
21 secondary outcomes
Changes in Triglycerides, expressed in milligrams per deciliter (mg/dL)
Time frame: before intervention (week 0), after control period (week 5), and after intervention (week 13)
Changes in Total Cholesterol, expressed in mg/dL
Time frame: 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
Time frame: 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
Time frame: before intervention (week 0), after control period (week 5), and after intervention (week 13)
Changes in Fasting Glycemia, expressed in mg/dL
Time frame: before intervention (week 0), after control period (week 5), and after intervention (week 13)
Changes in Fasting Insulin, expressed in milli-international units per litre (mlU/L)
Time frame: before intervention (week 0), after control period (week 5), and after intervention (week 13)
Changes in HOMA-IR, expressed in u.a
Time frame: before intervention (week 0), after control period (week 5), and after intervention (week 13)
Changes in Glycemic Responses to Oral Glucose Tolerance Test, expressed in mg/dL
Time frame: before intervention (week 0), after control period (week 5), and after intervention (week 13)
Changes in C-reactive protein (CRP), expressed in mg/L
Time frame: before intervention (week 0), after control period (week 5), and after intervention (week 13)
Changes in Tumor necrosis factor alpha (TNF-alpha), expressed in pg/mL
Time frame: before intervention (week 0), after control period (week 5), and after intervention (week 13)
Changes in Muscle Strength, expressed in (N・m)
Time frame: before intervention (week 0), after control period (week 5), and after intervention (week 13)
Changes in Muscle Power, expressed by the height (in cm) of the counter movement jump (CMJ)
Time frame: before intervention (week 0), after control period (week 5), and after intervention (week 13)
Changes in Muscle Thickness, expressed in mm
Time frame: before intervention (week 0), after control period (week 5), and after intervention (week 13)
Changes in Static Balance, expressed by the time (in seconds) spent at an unipedal stance leg position
Time frame: before intervention (week 0), after control period (week 5), and after intervention (week 13)
Changes in Gait ability, measured by the Time to Up and Go (TUG) test
Time frame: before intervention (week 0), after control period (week 5), and after intervention (week 13)
Changes in Sit and Stand ability, expressed in seconds
Time frame: before intervention (week 0), after control period (week 5), and after intervention (week 13)
Changes in the Fear of Falling, analyzed by the Falls Efficacy Scale- International Brazil (FES-I-Brazil).
Time frame: before intervention (week 0), after control period (week 5), and after intervention (week 13)
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
Time frame: before intervention (week 0), after control period (week 5), and after intervention (week 13)
Changes in Leisure Time Physical Activity
Time frame: before intervention (week 0), after control period (week 5), and after intervention (week 13)
Change in Executive function, assessed by the Random number generation task
Time frame: before intervention (week 0), after control period (week 5), and after intervention (week 13)
Change in Executive function, assessed by the Trail making test
Time frame: [Time Frame: before intervention (week 0), after control period (week 5), and after intervention (week 13)]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2021.
- Background: PubMed 26046575Bruseghini 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.
- Background: PubMed 24233244Krause 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.
- Background: PubMed 23288690Cadore 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.
- BackgroundBielemann, 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: PubMed 32278694Laddu 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.
- Background: PubMed 30261965Fletcher 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.
- Background: PubMed 32220590Jimenez-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.
- Background: PubMed 29428927Rodrigues-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.
- Background: PubMed 30389581Rodrigues-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.
- Background: PubMed 23341738Forte 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.
- Individual participant dataSharing planned: Yes. We intend that the data to be collected in this trial may contribute beyond our actions to the knowledge on dance, exercise, aging and T2DM. Ethical consent from participants, and Institutional Review Boards approval to share data will be obtained. Data sets, variables' dictionary and statistical analysis description will be available online upon registration and acceptance of the study team's data sharing terms and policy. Data usage will be under the PI's auspices, but restrictions or screenings will not be imposed upon data requests. VO2peak (main outcome) data and relevant support information (sociodemographic, clinical history and allocated groups) will be shared. Data on other outcomes may be requested by contacting the PI.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alvaro Reischak, PhD contact
Alvaro Reischak-Oliveira, PhD principal investigator
Federal University of Rio Grande do Sul
Josianne Rodrigues-Krause, PhD study director
Federal University of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dancing in people with Aging and Type2 Diabetes, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Josianne R Rodrigues-Krause, PhD (+5551999101821, rodrigues.krause@ufrgs.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Peak Oxygen Consumption (VO2peak), expressed in mL/Kg/min (time frame: before intervention (week 0), after control period (week 5), and after intervention (week 13)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04840368, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2021.