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Adherence and Health Effects of Video Dance in Postmenopausal Women

27. september 2017 opdateret af: 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:

  1. Is exercise adherence at 6 months better with video dance games compared to brisk walking?
  2. Does video dance game exercise compared to wait list controls, induce beneficial changes in physical and mental health?
  3. Does video dance game exercise compared to brisk walking better promote balance, attention and visual spatial skills, without loss of benefit to cardiovascular fitness?
  4. Is video dance preferred to brisk walking for exercise among postmenopausal women? If so, who and why?

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

168

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
        • University of Pittsburgh

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

50 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: VideoDance
Adfærdsmæssigt: videodance
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.
Andre navne:
  • Konami
Aktiv komparator: Brisk Walking
Adfærdsmæssigt: Brisk Walking
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.
Andet: 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.
Adfærdsmæssigt: 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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Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Adherence
Tidsramme: six months after randomization
minutes per week of moderate or greater physical exercise activity assessed using accelerometers and activity diaries
six months after randomization

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Endurance
Tidsramme: 3 and 6 months
timed 2 km walk
3 and 6 months
body composition
Tidsramme: 6 months
Lunar Prodigy DXA scanner for lean body mass and total fat mass
6 months
vascular health
Tidsramme: 6 months
blood pressure, pulse, lipid levels, fasting glucose, fasting insulin and C reactive protein
6 months
balance
Tidsramme: 3 and 6 months
timed one foot stand and timed narrow walk
3 and 6 months
personality
Tidsramme: baseline
NEO Personality Inventory
baseline
sleep quality
Tidsramme: 3 and 6 monhts
Pittsburgh Sleep Quality Index
3 and 6 monhts
visuospatial/constructional function
Tidsramme: 3 and 6 monhts
domain of the Repeatable Battery for the Assessment of Neuropsychological Status
3 and 6 monhts
attention domain
Tidsramme: 3 and 6 monhts
subtests of the Repeatable Battery for the Assessment of Neuropsychological Status
3 and 6 monhts
Useful Field of View
Tidsramme: 3 and 6 monhts
Useful Field of View test
3 and 6 monhts
step reaction time
Tidsramme: 3 and 6 months
Step Reaction Tasks
3 and 6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Pittsburgh

Samarbejdspartnere

National Institute on Aging (NIA)

Efterforskere

  • Ledende efterforsker: Stephanie A Studenski, MD MPH, University of Pittsburgh

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2010

Primær færdiggørelse (Faktiske)

31. juli 2012

Studieafslutning (Faktiske)

30. september 2012

Datoer for studieregistrering

Først indsendt

27. september 2011

Først indsendt, der opfyldte QC-kriterier

28. september 2011

Først opslået (Skøn)

29. september 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. oktober 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. september 2017

Sidst verificeret

1. september 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • PRO08080012
  • P30AG024827 (U.S. NIH-bevilling/kontrakt)
  • T32AG021885 (U.S. NIH-bevilling/kontrakt)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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