Adherence and Health Effects of Video Dance in Postmenopausal Women

Sponsor
University of Pittsburgh (Other)
Overall Status
Completed
CT.gov ID
NCT01443455
Collaborator
National Institute on Aging (NIA) (NIH)
168
1
3
33
5.1

Study Details

Study Description

Brief Summary

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?

Condition or Disease Intervention/Treatment Phase
  • Behavioral: videodance
  • Behavioral: Brisk Walking
  • Behavioral: delayed entry control
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
168 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Phase 2 Trial of Video Dance Versus Walking in Postmenopausal Sedentary Overweight Women
Actual Study Start Date :
Jan 1, 2010
Actual Primary Completion Date :
Jul 31, 2012
Actual Study Completion Date :
Sep 30, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: VideoDance

Behavioral: 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.
Other Names:
  • Konami
  • Active Comparator: Brisk Walking

    Behavioral: 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.

    Other: 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.

    Behavioral: 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. --------------------------------------------------------------------------------

    Outcome Measures

    Primary Outcome Measures

    1. Adherence [six months after randomization]

      minutes per week of moderate or greater physical exercise activity assessed using accelerometers and activity diaries

    Secondary Outcome Measures

    1. Endurance [3 and 6 months]

      timed 2 km walk

    2. body composition [6 months]

      Lunar Prodigy DXA scanner for lean body mass and total fat mass

    3. vascular health [6 months]

      blood pressure, pulse, lipid levels, fasting glucose, fasting insulin and C reactive protein

    4. balance [3 and 6 months]

      timed one foot stand and timed narrow walk

    5. personality [baseline]

      NEO Personality Inventory

    6. sleep quality [3 and 6 monhts]

      Pittsburgh Sleep Quality Index

    7. visuospatial/constructional function [3 and 6 monhts]

      domain of the Repeatable Battery for the Assessment of Neuropsychological Status

    8. attention domain [3 and 6 monhts]

      subtests of the Repeatable Battery for the Assessment of Neuropsychological Status

    9. Useful Field of View [3 and 6 monhts]

      Useful Field of View test

    10. step reaction time [3 and 6 months]

      Step Reaction Tasks

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 65 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Pittsburgh Pittsburgh Pennsylvania United States 15213

    Sponsors and Collaborators

    • University of Pittsburgh
    • National Institute on Aging (NIA)

    Investigators

    • Principal Investigator: Stephanie A Studenski, MD MPH, University of Pittsburgh

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Stephanie Studenski, Professor, University of Pittsburgh
    ClinicalTrials.gov Identifier:
    NCT01443455
    Other Study ID Numbers:
    • PRO08080012
    • T32AG021885
    • P30AG024827
    First Posted:
    Sep 29, 2011
    Last Update Posted:
    Oct 2, 2017
    Last Verified:
    Sep 1, 2017
    Keywords provided by Stephanie Studenski, Professor, University of Pittsburgh

    Study Results

    No Results Posted as of Oct 2, 2017