- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01443455
Adherence and Health Effects of Video Dance in Postmenopausal Women
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?
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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:
|
Active Comparator: 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.
|
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. -------------------------------------------------------------------------------- |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adherence
Time Frame: six months after randomization
|
minutes per week of moderate or greater physical exercise activity assessed using accelerometers and activity diaries
|
six months after randomization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Endurance
Time Frame: 3 and 6 months
|
timed 2 km walk
|
3 and 6 months
|
body composition
Time Frame: 6 months
|
Lunar Prodigy DXA scanner for lean body mass and total fat mass
|
6 months
|
vascular health
Time Frame: 6 months
|
blood pressure, pulse, lipid levels, fasting glucose, fasting insulin and C reactive protein
|
6 months
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balance
Time Frame: 3 and 6 months
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timed one foot stand and timed narrow walk
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3 and 6 months
|
personality
Time Frame: baseline
|
NEO Personality Inventory
|
baseline
|
sleep quality
Time Frame: 3 and 6 monhts
|
Pittsburgh Sleep Quality Index
|
3 and 6 monhts
|
visuospatial/constructional function
Time Frame: 3 and 6 monhts
|
domain of the Repeatable Battery for the Assessment of Neuropsychological Status
|
3 and 6 monhts
|
attention domain
Time Frame: 3 and 6 monhts
|
subtests of the Repeatable Battery for the Assessment of Neuropsychological Status
|
3 and 6 monhts
|
Useful Field of View
Time Frame: 3 and 6 monhts
|
Useful Field of View test
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3 and 6 monhts
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step reaction time
Time Frame: 3 and 6 months
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Step Reaction Tasks
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3 and 6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Stephanie A Studenski, MD MPH, University of Pittsburgh
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PRO08080012
- P30AG024827 (U.S. NIH Grant/Contract)
- T32AG021885 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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