Post MenopausalNCT01443455
Adherence and Health Effects of Video Dance in Postmenopausal Women
A study testing videodance and Brisk Walking in people with Post Menopausal, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post Menopausal
- What is being tested?
- videodance and Brisk Walking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to 30 Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must be female
- age 50-65
- not currently exercising at least 20 minutes
- three times per week
- a BMI of 25 or higher
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: 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?
- Conditions
- Post Menopausal
- Being tested
- videodance, Brisk Walking, delayed entry control
- Keywords
- menopause, sedentary, overweight
- Medical subject headings
- Sedentary Behavior, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
videodanceBehavioural
Also called Konami
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.
Brisk WalkingBehavioural
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 controlBehavioural
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.
--------------------------------------------------------------------------------
| Study group | Role | What they receive |
|---|---|---|
| VideoDance | Experimental | Not described Receives: Behavioral: videodance |
| Brisk Walking | Active comparator | Not described Receives: Behavioral: Brisk Walking |
| Delayed entry control | Other | 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. Receives: Behavioral: delayed entry control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence
minutes per week of moderate or greater physical exercise activity assessed using accelerometers and activity diaries
Measured: six months after randomization
Secondary outcomes (10)
Endurance
timed 2 km walk
Measured: 3 and 6 months
body composition
Lunar Prodigy DXA scanner for lean body mass and total fat mass
Measured: 6 months
vascular health
blood pressure, pulse, lipid levels, fasting glucose, fasting insulin and C reactive protein
Measured: 6 months
balance
timed one foot stand and timed narrow walk
Measured: 3 and 6 months
personality
NEO Personality Inventory
Measured: baseline
sleep quality
Pittsburgh Sleep Quality Index
Measured: 3 and 6 monhts
visuospatial/constructional function
domain of the Repeatable Battery for the Assessment of Neuropsychological Status
Measured: 3 and 6 monhts
attention domain
subtests of the Repeatable Battery for the Assessment of Neuropsychological Status
Measured: 3 and 6 monhts
Useful Field of View
Useful Field of View test
Measured: 3 and 6 monhts
step reaction time
Step Reaction Tasks
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2011 (estimated)
- Study startJan 2010
- Primary completion31 Jul 2012
- Study completion30 Sep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post MenopausalStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Stephanie Studenski, University of Pittsburgh
- Investigators
- Stephanie A Studenski, MD MPH, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01443455
- Sponsor's protocol ID
- PRO08080012
- Other IDs
- T32AG021885, P30AG024827
- Status last verified
- Sep 2017
- First submitted
- 27 Sep 2011
- Last updated
- 2 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jovancevic J, Rosano C, Perera S, Erickson KI, Studenski S. A protocol for a randomized clinical trial of interactive video dance: potential for effects on cognitive function. BMC Geriatr. 2012 Jun 6;12:23. doi: 10.1186/1471-2318-12-23.
PubMed 22672287
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Trial of Video Dance Versus Walking in Postmenopausal Sedentary Overweight Women
- ClinicalTrials.gov ID
- NCT01443455
- Acronym / sponsor ID
- PRO08080012
- Conditions
- Post Menopausal
- Keywords
- menopause, sedentary, overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Jan 2010 (actual)
- Primary completion
- 31 Jul 2012 (actual)
- Study completion
- 30 Sep 2012 (actual)
- First posted
- 29 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VideoDance | Experimental | Behavioral: videodance |
| Brisk Walking | Active comparator | Behavioral: Brisk Walking |
| Delayed entry control | Other | Behavioral: delayed entry controlParticipants 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. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants must be female
- age 50-65
- not currently exercising at least 20 minutes
- three times per week
- a BMI of 25 or higher
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| videodanceAlso: KonamiUsing 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. | Behavioural | VideoDance |
| Brisk WalkingThe 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. | Behavioural | Brisk Walking |
| delayed entry controlParticipants 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. -------------------------------------------------------------------------------- | Behavioural | Delayed entry control |
Primary outcome
Adherence
Time frame: six months after randomization
minutes per week of moderate or greater physical exercise activity assessed using accelerometers and activity diaries
10 secondary outcomes
Endurance
Time frame: 3 and 6 months
body composition
Time frame: 6 months
vascular health
Time frame: 6 months
balance
Time frame: 3 and 6 months
personality
Time frame: baseline
sleep quality
Time frame: 3 and 6 monhts
visuospatial/constructional function
Time frame: 3 and 6 monhts
attention domain
Time frame: 3 and 6 monhts
Useful Field of View
Time frame: 3 and 6 monhts
step reaction time
Time frame: 3 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2017.
- Derived from this study: PubMed 22672287Jovancevic J, Rosano C, Perera S, Erickson KI, Studenski S. A protocol for a randomized clinical trial of interactive video dance: potential for effects on cognitive function. BMC Geriatr. 2012 Jun 6;12:23. doi: 10.1186/1471-2318-12-23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie A Studenski, MD MPH principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing videodance and Brisk Walking in people with Post Menopausal, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence (time frame: six months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01443455, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2017.