Adherence and Health Effects of Video Dance in Postmenopausal Women

• ClinicalTrials.gov Identifier: NCT01443455
• Recruitment Status: Completed
• First Posted: September 29, 2011
• Last Update Posted: October 2, 2017
• Sponsor: University of Pittsburgh
• Collaborator: National Institute on Aging (NIA)
• Information provided by (Responsible Party): Stephanie Studenski, University of Pittsburgh

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
Post Menopausal	Behavioral: videodance; Behavioral: Brisk Walking; Behavioral: delayed entry control	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• 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: January 2010
• Actual Primary Completion Date: July 31, 2012
• Actual Study Completion Date: September 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 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. --------------------------------------------------------------------------------

Outcome Measures

Primary Outcome Measures :

1. 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 :

1. Endurance [ Time Frame: 3 and 6 months ]
   timed 2 km walk
2. body composition [ Time Frame: 6 months ]
   Lunar Prodigy DXA scanner for lean body mass and total fat mass
3. vascular health [ Time Frame: 6 months ]
   blood pressure, pulse, lipid levels, fasting glucose, fasting insulin and C reactive protein
4. balance [ Time Frame: 3 and 6 months ]
   timed one foot stand and timed narrow walk
5. personality [ Time Frame: baseline ]
   NEO Personality Inventory
6. sleep quality [ Time Frame: 3 and 6 monhts ]
   Pittsburgh Sleep Quality Index
7. visuospatial/constructional function [ Time Frame: 3 and 6 monhts ]
   domain of the Repeatable Battery for the Assessment of Neuropsychological Status
8. attention domain [ Time Frame: 3 and 6 monhts ]
   subtests of the Repeatable Battery for the Assessment of Neuropsychological Status
9. Useful Field of View [ Time Frame: 3 and 6 monhts ]
   Useful Field of View test
10. step reaction time [ Time Frame: 3 and 6 months ]
    Step Reaction Tasks

Eligibility Criteria

• Ages Eligible for Study: 50 Years to 65 Years (Adult, Older 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

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):

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.

• Responsible Party: Stephanie Studenski, Professor, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT01443455
• Other Study ID Numbers: PRO08080012; T32AG021885 ( U.S. NIH Grant/Contract ); P30AG024827 ( U.S. NIH Grant/Contract )
• 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