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Effects of Dancing on Cardiovascular and Functional Risk Factors in Older Women.

23. August 2017 aktualisiert von: 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.

Studienübersicht

Detaillierte Beschreibung

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).

Studientyp

Interventionell

Einschreibung (Voraussichtlich)

30

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brasilien
        • Rekrutierung
        • Universidade Federal do Rio Grande do Sul
        • Kontakt:
        • Kontakt:
        • Unterermittler:
          • Josianne Rodrigues-Krause, MSc

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

60 Jahre bis 80 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Weiblich

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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).
Experimental: 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).
Aktiver 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Peak Oxygen Consumption (VO2peak)
Zeitfenster: Baseline and 8 weeks
The maximum capacity of oxygen consumption measured during an incremental exercise test.
Baseline and 8 weeks

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in C-reactive protein (CRP)
Zeitfenster: 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)
Zeitfenster: Baseline and 8 weeks
Inflammatory marker. It will be analyzed in plasma, using ELISA specific kits.
Baseline and 8 weeks
Change in Triglycerides
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Baseline and 8 weeks
Echo intensity of the quadriceps will be analyzed by ultrasound images.
Baseline and 8 weeks
Change in Static Balance
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Baseline and 8 weeks
Measurements of body weight will be measured in a digital scale.
Baseline and 8 weeks
Change in Waist Circumference
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Baseline and 8 weeks
Quality of life will be analyzed by the questionary WHOQOL (World Health Organization Quality of Life.
Baseline and 8 weeks

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Hauptermittler: Alvaro Reischak-Oliveira, PhD., Federal University of Rio Grande do Sul

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. August 2017

Primärer Abschluss (Voraussichtlich)

1. Dezember 2017

Studienabschluss (Voraussichtlich)

1. August 2018

Studienanmeldedaten

Zuerst eingereicht

8. August 2017

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

23. August 2017

Zuerst gepostet (Tatsächlich)

25. August 2017

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

25. August 2017

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

23. August 2017

Zuletzt verifiziert

1. August 2017

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • 53834516.0.0000.5347

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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