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临床试验/NCT03180008
NCT03180008已完成不适用

Comparative Effectiveness of Customary Fit and Strong! vs. Fit and Strong Plus!

University of Illinois at Chicago2 个研究点 分布在 1 个国家目标入组 413 人开始时间: 2012年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
413
试验地点
2
主要终点
Body Weight

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

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

结局指标

主要结局

Body Weight

时间窗: 2, 6, 12, and 18 months

A change in body weight (kilograms) measured using a calibrated digital scale (Tanita).

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.

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Susan Hughes

Professor, Director

University of Illinois at Chicago

研究点 (2)

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