Adherence and Health Effects of Video Dance in Postmenopausal Women
27 september 2017 bijgewerkt door: Stephanie Studenski, University of Pittsburgh
Phase 2 Trial of Video Dance Versus Walking in Postmenopausal Sedentary Overweight Women
This is a 6 month randomized clinical trial comparing video dance, brisk walking and delayed entry controls. The interventions have two phases; a 12 week initiation phase with substantial structure and supervision, followed by a 12 week transition phase, with reduced structure and supervision. Participants are 168 overweight or obese, sedentary postmenopausal women aged 50 to 65; 60 in each exercise arm and 48 in the wait list control group.
The following research questions will be assessed:
- Is exercise adherence at 6 months better with video dance games compared to brisk walking?
- Does video dance game exercise compared to wait list controls, induce beneficial changes in physical and mental health?
- Does video dance game exercise compared to brisk walking better promote balance, attention and visual spatial skills, without loss of benefit to cardiovascular fitness?
- Is video dance preferred to brisk walking for exercise among postmenopausal women? If so, who and why?
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
168
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Pennsylvania
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Pittsburgh, Pennsylvania, Verenigde Staten, 15213
- University of Pittsburgh
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
50 jaar tot 65 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Vrouw
Beschrijving
Inclusion Criteria:
- Participants must be female
- age 50-65
- not currently exercising at least 20 minutes
- three times per week
- a BMI of 25 or higher
Exclusion Criteria:
- Exclusions are largely related to medical safety and include history of osteoporosis, osteoporotic fractures, active cardiovascular disease, uncontrolled hypertension, weight bearing pain that would limit exercise, seizure disorder or any medical condition or medication that would limit the safety of the study.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: VideoDance
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Using a commercially available product called Dance Dance Revolution (DDR) this video-game based dancing system uses a game player, force sensing pad and software.
The step sequences are set to a wide range of music and become more complex and frequent as the dancer gains skill.
Participants are oriented over 2 weeks.
For the rest of the first 3 months, the participant attends at least one supervised session per week.
Participants may use the center for additional, unsupervised sessions and/or they can take a dance system home.
They also receive brief behavioral intervention sessions for safety orientation, exercise education and adherence promotion.
For the following 3 months, the participant enters the transition phase in which she is encouraged to continue to exercise but no formal supervision is provided.
Andere namen:
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Actieve vergelijker: Brisk Walking
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The overall goal is to increase the duration and speed of walking, using structure and supervision for the first three months, followed by reduced support in the second three months.
For the first two weeks, each participant comes to the center at least twice a week to walk.They are encouraged to gradually increase effort and duration to a target of 150 minutes per week of brisk walking.Participants are taught to use Borg's ratings of perceived exertion and self-monitored heart rate to target their level of activity.
The next 10 weeks include once weekly supervised sessions and additional sessions either at the center or in preferred community settings.
The recommended goal is a minimum of 150 minutes per week of exercise in sessions of at least 10 -15 minutes duration.Participants are given pedometers in order to help them monitor their progress.
After 12 weeks, the participant enters a transition phase for a further 3 months.
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Ander: Delayed entry control
Participants who are randomized to the delayed entry non-exercise control group receive the American Heart Association pamphlet, but no direct support for exercise implementation.
After they have completed six months of follow up, they are invited to select any combination of dancing and walking that they prefer and then receive support and instruction according to the protocols described above.
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Participants who are randomized to the delayed entry non-exercise control group receive the American Heart Association pamphlet, but no direct support for exercise implementation. After they have completed six months of follow up, they are invited to select any combination of dancing and walking that they prefer and then receive support and instruction according to the protocols described above. -------------------------------------------------------------------------------- |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Adherence
Tijdsspanne: six months after randomization
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minutes per week of moderate or greater physical exercise activity assessed using accelerometers and activity diaries
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six months after randomization
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Endurance
Tijdsspanne: 3 and 6 months
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timed 2 km walk
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3 and 6 months
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body composition
Tijdsspanne: 6 months
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Lunar Prodigy DXA scanner for lean body mass and total fat mass
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6 months
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vascular health
Tijdsspanne: 6 months
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blood pressure, pulse, lipid levels, fasting glucose, fasting insulin and C reactive protein
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6 months
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balance
Tijdsspanne: 3 and 6 months
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timed one foot stand and timed narrow walk
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3 and 6 months
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personality
Tijdsspanne: baseline
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NEO Personality Inventory
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baseline
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sleep quality
Tijdsspanne: 3 and 6 monhts
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Pittsburgh Sleep Quality Index
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3 and 6 monhts
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visuospatial/constructional function
Tijdsspanne: 3 and 6 monhts
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domain of the Repeatable Battery for the Assessment of Neuropsychological Status
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3 and 6 monhts
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attention domain
Tijdsspanne: 3 and 6 monhts
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subtests of the Repeatable Battery for the Assessment of Neuropsychological Status
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3 and 6 monhts
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Useful Field of View
Tijdsspanne: 3 and 6 monhts
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Useful Field of View test
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3 and 6 monhts
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step reaction time
Tijdsspanne: 3 and 6 months
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Step Reaction Tasks
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3 and 6 months
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Stephanie A Studenski, MD MPH, University of Pittsburgh
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 januari 2010
Primaire voltooiing (Werkelijk)
31 juli 2012
Studie voltooiing (Werkelijk)
30 september 2012
Studieregistratiedata
Eerst ingediend
27 september 2011
Eerst ingediend dat voldeed aan de QC-criteria
28 september 2011
Eerst geplaatst (Schatting)
29 september 2011
Updates van studierecords
Laatste update geplaatst (Werkelijk)
2 oktober 2017
Laatste update ingediend die voldeed aan QC-criteria
27 september 2017
Laatst geverifieerd
1 september 2017
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- PRO08080012
- P30AG024827 (Subsidie/contract van de Amerikaanse NIH)
- T32AG021885 (Subsidie/contract van de Amerikaanse NIH)
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