Adherence and Health Effects of Video Dance in Postmenopausal Women

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by University of Pittsburgh.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stephanie Studenski, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01443455
First received: September 27, 2011
Last updated: September 28, 2011
Last verified: September 2011
  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 Phase
Post Menopausal
Behavioral: videodance
Behavioral: Brisk Walking
Behavioral: delayed entry control
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 2 Trial of Video Dance Versus Walking in Postmenopausal Sedentary Overweight Women

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Adherence [ Time Frame: six months after randomization ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    timed 2 km walk

  • body composition [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Lunar Prodigy DXA scanner for lean body mass and total fat mass

  • vascular health [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    blood pressure, pulse, lipid levels, fasting glucose, fasting insulin and C reactive protein

  • balance [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
    timed one foot stand and timed narrow walk

  • personality [ Time Frame: baseline ] [ Designated as safety issue: No ]
    NEO Personality Inventory

  • sleep quality [ Time Frame: 3 and 6 monhts ] [ Designated as safety issue: No ]
    Pittsburgh Sleep Quality Index

  • visuospatial/constructional function [ Time Frame: 3 and 6 monhts ] [ Designated as safety issue: No ]
    domain of the Repeatable Battery for the Assessment of Neuropsychological Status

  • attention domain [ Time Frame: 3 and 6 monhts ] [ Designated as safety issue: No ]
    subtests of the Repeatable Battery for the Assessment of Neuropsychological Status

  • Useful Field of View [ Time Frame: 3 and 6 monhts ] [ Designated as safety issue: No ]
    Useful Field of View test

  • step reaction time [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
    Step Reaction Tasks


Estimated Enrollment: 168
Study Start Date: January 2010
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: July 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.
No Intervention: 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.

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  Eligibility

Ages Eligible for Study:   50 Years to 65 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01443455

Contacts
Contact: Courtney Inge, BS 412 692 2361 cow8@PITT.EDU

Locations
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Courtney Inge, BS    412-692-2361    cow8@pitt.edu   
Principal Investigator: Stephanie Studenski, MD MPH         
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Stephanie A Studenski, MD MPH University of Pittsburgh
  More Information

No publications provided by University of Pittsburgh

Additional 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, P30AG024827
Study First Received: September 27, 2011
Last Updated: September 28, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
menopause
sedentary
overweight

ClinicalTrials.gov processed this record on August 26, 2014