Adherence and Health Effects of Video Dance in Postmenopausal Women

Post Menopausal Clinical Trial

Official title:

Phase 2 Trial of Video Dance Versus Walking in Postmenopausal Sedentary Overweight Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01443455
• Other study ID #: PRO08080012
• Secondary ID: T32AG021885P30AG
• Status: Completed
• Phase: N/A
• First received: September 27, 2011
• Last updated: September 27, 2017
• Start date: January 2010
• Est. completion date: September 30, 2012

Study information

• Verified date: September 2017
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: September 30, 2012
• Est. primary completion date: July 31, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Post Menopausal

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence	minutes per week of moderate or greater physical exercise activity assessed using accelerometers and activity diaries	six months after randomization
Secondary	Endurance	timed 2 km walk	3 and 6 months
Secondary	body composition	Lunar Prodigy DXA scanner for lean body mass and total fat mass	6 months
Secondary	vascular health	blood pressure, pulse, lipid levels, fasting glucose, fasting insulin and C reactive protein	6 months
Secondary	balance	timed one foot stand and timed narrow walk	3 and 6 months
Secondary	personality	NEO Personality Inventory	baseline
Secondary	sleep quality	Pittsburgh Sleep Quality Index	3 and 6 monhts
Secondary	visuospatial/constructional function	domain of the Repeatable Battery for the Assessment of Neuropsychological Status	3 and 6 monhts
Secondary	attention domain	subtests of the Repeatable Battery for the Assessment of Neuropsychological Status	3 and 6 monhts
Secondary	Useful Field of View	Useful Field of View test	3 and 6 monhts
Secondary	step reaction time	Step Reaction Tasks	3 and 6 months