- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03262714
Effects of Dancing on Cardiovascular and Functional Risk Factors in Older Women.
23 août 2017 mis à jour par: 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.
Aperçu de l'étude
Statut
Inconnue
Les conditions
Intervention / Traitement
Description détaillée
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).
Type d'étude
Interventionnel
Inscription (Anticipé)
30
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Josianne Rodrigues-Krause, MSc.
- Numéro de téléphone: 5551 999101821
- E-mail: rodrigues.krause@ufrgs.br
Sauvegarde des contacts de l'étude
- Nom: Alvaro Reischak-Oliveira, PhD.
- Numéro de téléphone: 55-51-3308-5862
- E-mail: alvaro.oliveira@ufrgs.br
Lieux d'étude
-
-
Rio Grande do Sul
-
Porto Alegre, Rio Grande do Sul, Brésil
- Recrutement
- Universidade Federal do Rio Grande do Sul
-
Contact:
- Josianne Rodrigues-Krause, MSc
- Numéro de téléphone: 55-51-999101821
- E-mail: rodrigues.krause@ufrgs.br
-
Contact:
- Alvaro Reischak-Oliveira, PhD
- Numéro de téléphone: 55-51-3308-5862
- E-mail: alvaro.oliveira@ufrgs.br
-
Sous-enquêteur:
- Josianne Rodrigues-Krause, MSc
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
60 ans à 80 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Femelle
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: 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).
|
Expérimental: 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).
|
Comparateur actif: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Change in Peak Oxygen Consumption (VO2peak)
Délai: Baseline and 8 weeks
|
The maximum capacity of oxygen consumption measured during an incremental exercise test.
|
Baseline and 8 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Change in C-reactive protein (CRP)
Délai: 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)
Délai: Baseline and 8 weeks
|
Inflammatory marker.
It will be analyzed in plasma, using ELISA specific kits.
|
Baseline and 8 weeks
|
Change in Triglycerides
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Baseline and 8 weeks
|
Echo intensity of the quadriceps will be analyzed by ultrasound images.
|
Baseline and 8 weeks
|
Change in Static Balance
Délai: 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
Délai: 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
Délai: 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
Délai: Baseline and 8 weeks
|
Measurements of body weight will be measured in a digital scale.
|
Baseline and 8 weeks
|
Change in Waist Circumference
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Baseline and 8 weeks
|
Quality of life will be analyzed by the questionary WHOQOL (World Health Organization Quality of Life.
|
Baseline and 8 weeks
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Alvaro Reischak-Oliveira, PhD., Federal University of Rio Grande do Sul
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 août 2017
Achèvement primaire (Anticipé)
1 décembre 2017
Achèvement de l'étude (Anticipé)
1 août 2018
Dates d'inscription aux études
Première soumission
8 août 2017
Première soumission répondant aux critères de contrôle qualité
23 août 2017
Première publication (Réel)
25 août 2017
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
25 août 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
23 août 2017
Dernière vérification
1 août 2017
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 53834516.0.0000.5347
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .