- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT03262714
Effects of Dancing on Cardiovascular and Functional Risk Factors in Older Women.
23. srpna 2017 aktualizováno: Alvaro Reischak-Oliveira, Federal University of Rio Grande do Sul
Effects of Dancing and Walking on Cardiovascular Risk Factors and Functional Capacity in Older Women: a Randomized Controlled Trial.
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.
Přehled studie
Postavení
Neznámý
Intervence / Léčba
Detailní popis
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).
Typ studie
Intervenční
Zápis (Očekávaný)
30
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brazílie
- Nábor
- Universidade Federal do Rio Grande do Sul
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Kontakt:
- Josianne Rodrigues-Krause, MSc
- Telefonní číslo: 55-51-999101821
- E-mail: rodrigues.krause@ufrgs.br
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Kontakt:
- Alvaro Reischak-Oliveira, PhD
- Telefonní číslo: 55-51-3308-5862
- E-mail: alvaro.oliveira@ufrgs.br
-
Dílčí vyšetřovatel:
- Josianne Rodrigues-Krause, MSc
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-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
60 let až 80 let (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ano
Pohlaví způsobilá ke studiu
Ženský
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Dancing
Elderly women randomized to the dance intervention programme.
|
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).
|
|
Experimentální: Walking
Elderly women randomized to the walking intervention programme.
|
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).
|
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Aktivní komparátor: Stretching
Elderly women randomized to the stretching intervention programme.
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Peak Oxygen Consumption (VO2peak)
Časové okno: Baseline and 8 weeks
|
The maximum capacity of oxygen consumption measured during an incremental exercise test.
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Baseline and 8 weeks
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in C-reactive protein (CRP)
Časové okno: Baseline and 8 weeks
|
Cardiovascular risk marker.
It will be analyzed in plasma, using ELISA specific kits.
|
Baseline and 8 weeks
|
|
Change in Tumor necrosis factor alpha (TNF-alpha)
Časové okno: Baseline and 8 weeks
|
Inflammatory marker.
It will be analyzed in plasma, using ELISA specific kits.
|
Baseline and 8 weeks
|
|
Change in Triglycerides
Časové okno: Baseline and 8 weeks
|
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
|
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Change in Total Cholesterol
Časové okno: Baseline and 8 weeks
|
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
|
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Change in LDL-Cholesterol
Časové okno: Baseline and 8 weeks
|
Lipid profile marker.
Estimation of the LDL concentration will be calculate using the formula of Friedewald.
|
Baseline and 8 weeks
|
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Change in HDL-Cholesterol
Časové okno: Baseline and 8 weeks
|
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
|
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Change in Fasting Glycemia
Časové okno: Baseline and 8 weeks
|
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
|
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Change in Fasting Insulin
Časové okno: Baseline and 8 weeks
|
Glycaemic profile marker.
It will be measured in plasma, usin a high sensitivity enzyme-linked immunosorbent assay.
|
Baseline and 8 weeks
|
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Change in HOMA-IR
Časové okno: Baseline and 8 weeks
|
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.
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Baseline and 8 weeks
|
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Change in Muscle Strength
Časové okno: Baseline and 8 weeks
|
Isometric peak torque of the knee extensors will be measured using an isokinetic dynamometer (Cybex Norm, EUA).
|
Baseline and 8 weeks
|
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Change in Muscle Power
Časové okno: Baseline and 8 weeks
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Lower body muscle power will be measured by the performance of the counter movement jump in a force platform.
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Baseline and 8 weeks
|
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Change in Muscle Quality
Časové okno: Baseline and 8 weeks
|
Echo intensity of the quadriceps will be analyzed by ultrasound images.
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Baseline and 8 weeks
|
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Change in Static Balance
Časové okno: Baseline and 8 weeks
|
Static balance will be measured by a single leg support balance test, performed with both legs, with the eyes open and closed.
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Baseline and 8 weeks
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Change in Dynamic Balance
Časové okno: Baseline and 8 weeks
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Dynamic balance will be measured by the Time to Up ang Go (TUG) test.
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Baseline and 8 weeks
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Change in Gate ability
Časové okno: Baseline and 8 weeks
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Gate ability will be measured in a 10m track, picking up objects and passing over obstacles.
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Baseline and 8 weeks
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Change in Body Weight
Časové okno: Baseline and 8 weeks
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Measurements of body weight will be measured in a digital scale.
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Baseline and 8 weeks
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Change in Waist Circumference
Časové okno: Baseline and 8 weeks
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Measurements of waist circumference will be performed with a measuring tape.
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Baseline and 8 weeks
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Change in Percentage of Body Fat
Časové okno: Baseline and 8 weeks
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Measurements of skinfolds will be taken to calculate the percentage of body fat.
|
Baseline and 8 weeks
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Change in Sit and Stand ability
Časové okno: Baseline and 8 weeks
|
The ability to sit and stand in a chair 5 times, as fast as possible.
|
Baseline and 8 weeks
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Changes in Fall Risk
Časové okno: Baseline and 8 weeks
|
The risk of fall will be measured by the performance in the TUG test.
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Baseline and 8 weeks
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Changes in the Fear of Falling
Časové okno: Baseline and 8 weeks
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The fear of falling will be analyzed by the Falls Efficacy Scale-International Brazil (FES-I-Brazil).
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Baseline and 8 weeks
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Changes in Quality of Life
Časové okno: Baseline and 8 weeks
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Quality of life will be analyzed by the questionary WHOQOL (World Health Organization Quality of Life.
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Baseline and 8 weeks
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Vyšetřovatelé
- Vrchní vyšetřovatel: Alvaro Reischak-Oliveira, PhD., Federal University of Rio Grande do Sul
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
1. srpna 2017
Primární dokončení (Očekávaný)
1. prosince 2017
Dokončení studie (Očekávaný)
1. srpna 2018
Termíny zápisu do studia
První předloženo
8. srpna 2017
První předloženo, které splnilo kritéria kontroly kvality
23. srpna 2017
První zveřejněno (Aktuální)
25. srpna 2017
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
25. srpna 2017
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
23. srpna 2017
Naposledy ověřeno
1. srpna 2017
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- 53834516.0.0000.5347
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