Strong People Strength Training Program: A Community-Based Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 167
- 试验地点
- 12
- 主要终点
- Change from Baseline Hemoglobin A1c at 12 Weeks
研究概览
简要总结
The Strong People Strength Training study aims to assess whether a community-based progressive strength training program can improve risk factors for diabetes and heart disease in older rural adults.
详细描述
This study aims to evaluate the effects of a twice weekly, 12-week progressive strength training program, Strong People Strength Training, on cardiometabolic risk factors in a pragmatic, community-based randomized intervention trial among rural men and women 50 and older. We hypothesize that individuals randomized to the intervention group will demonstrate statistically significant and clinically meaningful improvements in cardiometabolic risk factors as well as physical function, quality of life, and physical activity compared to those randomized to the delayed intervention control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Randomization to arm follows the baseline assessment visit.
入排标准
- 年龄范围
- 50 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 50 or older
- •Willing and able to get health care provider (HCP) authorization if required (PAR-Q answered yes to any question or 70 and older)
排除标准
- •Strength trained in last 12 months
- •Previous enrollment in Strong People
- •Enrolled or planning to enroll in lifestyle program
- •Cognitive impairment
- •Unable to obtain physician authorization
结局指标
主要结局
Change from Baseline Hemoglobin A1c at 12 Weeks
时间窗: Baseline and outcome (after 12 weeks)
The hemoglobin A1c test tells you your average level of blood sugar over the past 2 to 3 months. It's also called HbA1c.
Change from Baseline BMI at 12 Weeks
时间窗: Baseline and outcome (after 12 weeks)
Body mass index (BMI) is a measure of body fat based on height and weight that applies to adult men and women.
Change from Baseline Weight at 12 Weeks
时间窗: Baseline and outcome (after 12 weeks)
body weight
Change from Baseline in American Heart Association's Life's Simple 7 score at 12 Weeks
时间窗: Baseline and outcome (after 12 weeks)
The American Heart Association's Life's Simple 7 score is comprised of seven cardiovascular disease (CVD) risk factors: physical activity, healthy diet score, blood glucose, BMI, blood cholesterol, blood pressure, and smoking; each risk factor is categorized as ideal, intermediate, or poor. Minimum value is 0, Maximum value is 14. Higher scores on the scale represent a better outcome.
次要结局
- Change from Baseline Fatigue at 12 Weeks(Baseline and outcome (after 12 weeks))
- Change from Baseline Depression using the Patient Health Questionnaire (PHQ-8) at 12 Weeks(Baseline and outcome (after 12 weeks))
- Change from Baseline Anxiety at 12 Weeks using the Beck Anxiety Inventory(Baseline and outcome (after 12 weeks))
- Change from Baseline Cholesterol at 12 Weeks(Baseline and outcome (after 12 weeks))
- Change from Baseline Resting Heart Rate at 12 Weeks(Baseline and outcome (after 12 weeks))
- Change from Baseline Blood Pressure at 12 Weeks(Baseline and outcome (after 12 weeks))
- Change from Baseline Functional Fitness Tests at 12 Weeks(Baseline and outcome (after 12 weeks))
- Change from Baseline Physical Activity at 12 Weeks measured using accelerometry(Baseline and outcome (after 12 weeks))
- Change from Baseline Physical Activity at 12 Weeks measured using self-report(Baseline and outcome (after 12 weeks))
- Change from Baseline Depression using the Center for Epidemiologic Studies Depression Scale (CES-D) at 12 Weeks(Baseline and outcome (after 12 weeks))
- Change from Baseline Anxiety at 12 Weeks using the the General Anxiety Disorder Scale (GAD-7)(Baseline and outcome (after 12 weeks))
- Change from Baseline Stress at 12 Weeks(Baseline and outcome (after 12 weeks))