Phase 2 Trial of Video Dance Versus Walking in Postmenopausal Sedentary Overweight Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 2
- 主要终点
- Adherence
研究概览
简要总结
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?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Participants must be female
- •age 50-65
- •not currently exercising at least 20 minutes
- •three times per week
- •a BMI of 25 or higher
排除标准
- •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.
研究组 & 干预措施
VideoDance
干预措施: videodance (Behavioral)
Brisk Walking
干预措施: Brisk Walking (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.
干预措施: delayed entry control (Behavioral)
结局指标
主要结局
Adherence
时间窗: six months after randomization
minutes per week of moderate or greater physical exercise activity assessed using accelerometers and activity diaries
次要结局
- attention domain(3 and 6 monhts)
- Useful Field of View(3 and 6 monhts)
- personality(baseline)
- step reaction time(3 and 6 months)
- Endurance(3 and 6 months)
- body composition(6 months)
- vascular health(6 months)
- balance(3 and 6 months)
- sleep quality(3 and 6 monhts)
- visuospatial/constructional function(3 and 6 monhts)
研究者
Stephanie Studenski
Professor
University of Pittsburgh