Comparative Effectiveness of Customary Fit and Strong! vs. Fit and Strong Plus!
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 413
- 试验地点
- 1
- 主要终点
- Dietary Intake
研究概览
简要总结
This randomized controlled trial is comparing outcomes of customary Fit and Strong!, to Fit and Strong! Plus, an enhanced version of the program that incorporates weight management. We hypothesize that Fit and Strong! Plus participants will show improved diet behaviors at 2, 6, 12, and 18 months that will be accompanied by a significant 5% weight loss at 6 months and maintained to 18 months, compared to participants in customary Fit and Strong!.
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
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Presence of symptoms of lower extremity osteoarthritis
- •Age 60 or older
- •Not currently participating in a regular physical activity program
- •BMI 25-50
- •Able to attend Fit and Strong! classes
排除标准
- •Score of 3 or greater on Mental Status Questionnaire
- •Recent hip or knee surgery
- •Recent steroid injection into hip or knee
- •Diagnosis of rheumatoid arthritis
- •Uncontrolled diabetes
- •Unspecified health conditions that may interfere with exercise
研究组 & 干预措施
Fit and Strong!
Fit & Strong! is evidence-based group exercise and self-management program. Classes meet for 90 minutes and include 60 minutes of physical activity (stretching/flexibility, low impact aerobics, and lower-extremity strength training) and 30 minutes of health education that follows a structured, scripted curriculum that centers on physical activity and osteoarthritis and incorporates self-efficacy, social support, and self-regulation. Classes are held 3 days per week for 8 weeks (24 sessions total).
干预措施: Fit and Strong! (Behavioral)
Fit and Strong! Plus
Fit & Strong! Plus differs from Fit & Strong! only in that the 30 minutes of health education, while retaining the core physical activity and osteoarthritis components, has weight and diet-related topics added to the curriculum.
干预措施: Fit and Strong! Plus (Behavioral)
结局指标
主要结局
Dietary Intake
时间窗: 2, 6, 12, and 18 months
The Healthy Eating Index 2010 (HEI-2010) measures diet quality based on the Dietary Guidelines for Americans. HEI-2010 total scores range from 0 to 100 points, with a higher score signifying superior diet quality.
Body Weight
时间窗: 2, 6, 12, and 18 months
A change in body weight (kilograms) measured using a calibrated digital scale (Tanita).
次要结局
- Physical Activity Engagement(2, 6, 12, and 18 months)
- Lower Extremity Stiffness(Baseline, 2, 6, 12, and 18 months)
- Lower Extremity Physical Function(Baseline, 2, 6, 12, and 18 months)
- Lower Extremity Muscle Strength(Baseline, 2, 6, 12, and 18 months)
- Lower Extremity Pain(Baseline, 2, 6, 12, and 18 months)
- Physical Endurance(Baseline, 2, 6, 12, and 18 months)
研究者
Susan Hughes
Professor, Director
University of Illinois at Chicago