- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03262714
Effects of Dancing on Cardiovascular and Functional Risk Factors in Older Women.
23 agosto 2017 aggiornato da: 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.
Panoramica dello studio
Stato
Sconosciuto
Intervento / Trattamento
Descrizione dettagliata
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).
Tipo di studio
Interventistico
Iscrizione (Anticipato)
30
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
Rio Grande do Sul
-
Porto Alegre, Rio Grande do Sul, Brasile
- Reclutamento
- Universidade Federal do Rio Grande do Sul
-
Contatto:
- Josianne Rodrigues-Krause, MSc
- Numero di telefono: 55-51-999101821
- Email: rodrigues.krause@ufrgs.br
-
Contatto:
- Alvaro Reischak-Oliveira, PhD
- Numero di telefono: 55-51-3308-5862
- Email: alvaro.oliveira@ufrgs.br
-
Sub-investigatore:
- Josianne Rodrigues-Krause, MSc
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 60 anni a 80 anni (Adulto, Adulto più anziano)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Femmina
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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).
|
|
Sperimentale: 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).
|
|
Comparatore attivo: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Peak Oxygen Consumption (VO2peak)
Lasso di tempo: Baseline and 8 weeks
|
The maximum capacity of oxygen consumption measured during an incremental exercise test.
|
Baseline and 8 weeks
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in C-reactive protein (CRP)
Lasso di tempo: 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)
Lasso di tempo: Baseline and 8 weeks
|
Inflammatory marker.
It will be analyzed in plasma, using ELISA specific kits.
|
Baseline and 8 weeks
|
|
Change in Triglycerides
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline and 8 weeks
|
Echo intensity of the quadriceps will be analyzed by ultrasound images.
|
Baseline and 8 weeks
|
|
Change in Static Balance
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline and 8 weeks
|
Measurements of body weight will be measured in a digital scale.
|
Baseline and 8 weeks
|
|
Change in Waist Circumference
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline and 8 weeks
|
Quality of life will be analyzed by the questionary WHOQOL (World Health Organization Quality of Life.
|
Baseline and 8 weeks
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Investigatore principale: Alvaro Reischak-Oliveira, PhD., Federal University of Rio Grande do Sul
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 agosto 2017
Completamento primario (Anticipato)
1 dicembre 2017
Completamento dello studio (Anticipato)
1 agosto 2018
Date di iscrizione allo studio
Primo inviato
8 agosto 2017
Primo inviato che soddisfa i criteri di controllo qualità
23 agosto 2017
Primo Inserito (Effettivo)
25 agosto 2017
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
25 agosto 2017
Ultimo aggiornamento inviato che soddisfa i criteri QC
23 agosto 2017
Ultimo verificato
1 agosto 2017
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- 53834516.0.0000.5347
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Dance
-
National Taiwan University HospitalCompletato
-
Vilnius UniversityCompletatoSano | Fatica | Ansia | Disagio psicologico | Benessere | Salute mentale | Disturbi della depressione | Consapevolezza del corpo | VitalitàLituania
-
Anne KloosCompletatoMalattia di HuntingtonStati Uniti
-
Virginia Polytechnic Institute and State UniversityCompletato
-
Universidad Catolica Silva HenriquezUniversidad Arturo PratIscrizione su invitoMalattie sovrappeso, obesità e non comunibiliChile
-
McMaster UniversityReclutamentoFragilità | Sindrome da fragilità | Anziani fragili | Fragilità nell'invecchiamentoCanada
-
University of Erlangen-Nürnberg Medical SchoolCompletatoCavalatori di cancro e attività fisicaGermania
-
University of Illinois at Urbana-ChampaignUniversity of Illinois at ChicagoNon ancora reclutamentoAttività fisica | Cognizione | Anziani (50-90 anni)
-
The University of The West IndiesCompletato
-
Casa di Cura Villa Margherita FrescoCompletato