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Adherence and Health Effects of Video Dance in Postmenopausal Women

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01443455
First Posted: September 29, 2011
Last Update Posted: October 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Stephanie Studenski, University of Pittsburgh
  Purpose

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 Intervention
Post Menopausal Behavioral: videodance Behavioral: Brisk Walking Behavioral: delayed entry control

Study Type: Interventional
Study Design: 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

Further study details as provided by Stephanie Studenski, University of Pittsburgh:

Primary Outcome Measures:
  • Adherence [ Time Frame: six months after randomization ]
    minutes per week of moderate or greater physical exercise activity assessed using accelerometers and activity diaries


Secondary Outcome Measures:
  • Endurance [ Time Frame: 3 and 6 months ]
    timed 2 km walk

  • body composition [ Time Frame: 6 months ]
    Lunar Prodigy DXA scanner for lean body mass and total fat mass

  • vascular health [ Time Frame: 6 months ]
    blood pressure, pulse, lipid levels, fasting glucose, fasting insulin and C reactive protein

  • balance [ Time Frame: 3 and 6 months ]
    timed one foot stand and timed narrow walk

  • personality [ Time Frame: baseline ]
    NEO Personality Inventory

  • sleep quality [ Time Frame: 3 and 6 monhts ]
    Pittsburgh Sleep Quality Index

  • visuospatial/constructional function [ Time Frame: 3 and 6 monhts ]
    domain of the Repeatable Battery for the Assessment of Neuropsychological Status

  • attention domain [ Time Frame: 3 and 6 monhts ]
    subtests of the Repeatable Battery for the Assessment of Neuropsychological Status

  • Useful Field of View [ Time Frame: 3 and 6 monhts ]
    Useful Field of View test

  • step reaction time [ Time Frame: 3 and 6 months ]
    Step Reaction Tasks


Enrollment: 168
Actual Study Start Date: January 2010
Study Completion Date: September 30, 2012
Primary Completion Date: July 31, 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.
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.


  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01443455


Locations
United States, Pennsylvania
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stephanie Studenski, Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01443455     History of Changes
Other Study ID Numbers: PRO08080012
T32AG021885 ( U.S. NIH Grant/Contract )
P30AG024827 ( U.S. NIH Grant/Contract )
First Submitted: September 27, 2011
First Posted: September 29, 2011
Last Update Posted: October 2, 2017
Last Verified: September 2017

Keywords provided by Stephanie Studenski, University of Pittsburgh:
menopause
sedentary
overweight