Clinical trial NCT01443455: Adherence and Health Effects of Video Dance in Postmenopausal Women
Official title: Phase 2 Trial of Video Dance Versus Walking in Postmenopausal Sedentary Overweight Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Menopausal
Keywords: menopause
sedentary
overweight
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2011-09-29
Enrollment: 168
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?


Eligibility 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.

Primary outcomes:
measure: Adherence
timeFrame: six months after randomization
Secondary outcomes:
measure: Endurance
timeFrame: 3 and 6 months
measure: body composition
timeFrame: 6 months
measure: vascular health
timeFrame: 6 months
measure: balance
timeFrame: 3 and 6 months
measure: personality
timeFrame: baseline
measure: sleep quality
timeFrame: 3 and 6 monhts
measure: visuospatial/constructional function
timeFrame: 3 and 6 monhts
measure: attention domain
timeFrame: 3 and 6 monhts
measure: Useful Field of View
timeFrame: 3 and 6 monhts
measure: step reaction time
timeFrame: 3 and 6 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Stephanie A Studenski, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.