- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT03262714
Effects of Dancing on Cardiovascular and Functional Risk Factors in Older Women.
23 sierpnia 2017 zaktualizowane przez: 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.
Przegląd badań
Status
Nieznany
Interwencja / Leczenie
Szczegółowy opis
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 studiów
Interwencyjne
Zapisy (Oczekiwany)
30
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Josianne Rodrigues-Krause, MSc.
- Numer telefonu: 5551 999101821
- E-mail: rodrigues.krause@ufrgs.br
Kopia zapasowa kontaktu do badania
- Nazwa: Alvaro Reischak-Oliveira, PhD.
- Numer telefonu: 55-51-3308-5862
- E-mail: alvaro.oliveira@ufrgs.br
Lokalizacje studiów
-
-
Rio Grande do Sul
-
Porto Alegre, Rio Grande do Sul, Brazylia
- Rekrutacyjny
- Universidade Federal do Rio Grande do Sul
-
Kontakt:
- Josianne Rodrigues-Krause, MSc
- Numer telefonu: 55-51-999101821
- E-mail: rodrigues.krause@ufrgs.br
-
Kontakt:
- Alvaro Reischak-Oliveira, PhD
- Numer telefonu: 55-51-3308-5862
- E-mail: alvaro.oliveira@ufrgs.br
-
Pod-śledczy:
- Josianne Rodrigues-Krause, MSc
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
60 lat do 80 lat (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Tak
Płeć kwalifikująca się do nauki
Kobieta
Opis
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.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
---|---|
Eksperymentalny: 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).
|
Eksperymentalny: 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).
|
Aktywny komparator: Stretching
Elderly women randomized to the stretching intervention programme.
|
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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Change in Peak Oxygen Consumption (VO2peak)
Ramy czasowe: Baseline and 8 weeks
|
The maximum capacity of oxygen consumption measured during an incremental exercise test.
|
Baseline and 8 weeks
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Change in C-reactive protein (CRP)
Ramy czasowe: 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)
Ramy czasowe: Baseline and 8 weeks
|
Inflammatory marker.
It will be analyzed in plasma, using ELISA specific kits.
|
Baseline and 8 weeks
|
Change in Triglycerides
Ramy czasowe: 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
|
Change in Total Cholesterol
Ramy czasowe: 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
|
Change in LDL-Cholesterol
Ramy czasowe: Baseline and 8 weeks
|
Lipid profile marker.
Estimation of the LDL concentration will be calculate using the formula of Friedewald.
|
Baseline and 8 weeks
|
Change in HDL-Cholesterol
Ramy czasowe: 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
|
Change in Fasting Glycemia
Ramy czasowe: 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
|
Change in Fasting Insulin
Ramy czasowe: 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
|
Change in HOMA-IR
Ramy czasowe: 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.
|
Baseline and 8 weeks
|
Change in Muscle Strength
Ramy czasowe: 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
|
Change in Muscle Power
Ramy czasowe: Baseline and 8 weeks
|
Lower body muscle power will be measured by the performance of the counter movement jump in a force platform.
|
Baseline and 8 weeks
|
Change in Muscle Quality
Ramy czasowe: Baseline and 8 weeks
|
Echo intensity of the quadriceps will be analyzed by ultrasound images.
|
Baseline and 8 weeks
|
Change in Static Balance
Ramy czasowe: 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.
|
Baseline and 8 weeks
|
Change in Dynamic Balance
Ramy czasowe: Baseline and 8 weeks
|
Dynamic balance will be measured by the Time to Up ang Go (TUG) test.
|
Baseline and 8 weeks
|
Change in Gate ability
Ramy czasowe: Baseline and 8 weeks
|
Gate ability will be measured in a 10m track, picking up objects and passing over obstacles.
|
Baseline and 8 weeks
|
Change in Body Weight
Ramy czasowe: Baseline and 8 weeks
|
Measurements of body weight will be measured in a digital scale.
|
Baseline and 8 weeks
|
Change in Waist Circumference
Ramy czasowe: Baseline and 8 weeks
|
Measurements of waist circumference will be performed with a measuring tape.
|
Baseline and 8 weeks
|
Change in Percentage of Body Fat
Ramy czasowe: Baseline and 8 weeks
|
Measurements of skinfolds will be taken to calculate the percentage of body fat.
|
Baseline and 8 weeks
|
Change in Sit and Stand ability
Ramy czasowe: Baseline and 8 weeks
|
The ability to sit and stand in a chair 5 times, as fast as possible.
|
Baseline and 8 weeks
|
Changes in Fall Risk
Ramy czasowe: Baseline and 8 weeks
|
The risk of fall will be measured by the performance in the TUG test.
|
Baseline and 8 weeks
|
Changes in the Fear of Falling
Ramy czasowe: Baseline and 8 weeks
|
The fear of falling will be analyzed by the Falls Efficacy Scale-International Brazil (FES-I-Brazil).
|
Baseline and 8 weeks
|
Changes in Quality of Life
Ramy czasowe: Baseline and 8 weeks
|
Quality of life will be analyzed by the questionary WHOQOL (World Health Organization Quality of Life.
|
Baseline and 8 weeks
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Śledczy
- Główny śledczy: Alvaro Reischak-Oliveira, PhD., Federal University of Rio Grande do Sul
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
1 sierpnia 2017
Zakończenie podstawowe (Oczekiwany)
1 grudnia 2017
Ukończenie studiów (Oczekiwany)
1 sierpnia 2018
Daty rejestracji na studia
Pierwszy przesłany
8 sierpnia 2017
Pierwszy przesłany, który spełnia kryteria kontroli jakości
23 sierpnia 2017
Pierwszy wysłany (Rzeczywisty)
25 sierpnia 2017
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
25 sierpnia 2017
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
23 sierpnia 2017
Ostatnia weryfikacja
1 sierpnia 2017
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- 53834516.0.0000.5347
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
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