NCT05345041进行中（未招募）不适用
Keep it Movin': A Church-based Intervention to Improve Physical Function
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Change in Physical Function
研究概览
简要总结
This is a 12-month multi-level behavioral cluster randomized trial testing a church-based intervention to improve physical function (PF) in Americans with PF limitations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Churches (Community-level):
- •Membership of 300 or more adults
- •Located in Cook, Lake, Dupage, Will, McHenry, Kane, or Kendall counties
- •Participants (Individual-level):
- •Age 40 or older
- •Have mobility limitations (defined as SPPB score of ≤9)
- •Ambulatory, defined as able to get out of a chair and walk without assistance without using a straight cane
- •Able to speak and read English
- •Attend recruitment church; and
- •Safe to begin an exercise program, which will be determined using the Exercise Assessment and Screening for You (EASY) Tool.
排除标准
- •Participants (Individual-level):
- •Severe cognitive impairment, defined as five or more errors on the Short-Portable Mental Status Questionnaire
- •Unable to consistently attend group classes at a scheduled time due to lack of reliable transportation, schedule conflicts, travel, plans to relocate, upcoming surgery, etc.
- •Participating in a medically supervised rehabilitation program such as cardiac rehab
- •Inpatient treatment for a psychiatric condition within the past 6 months, or currently receiving treatment for schizophrenia or other serious psychiatric illness
- •Contraindications to exercise determined using the EASY/healthcare follow-up
- •Congestive heart failure New York Health Association (NYHA) Class I or higher; unstable angina; heart attack or stroke within past 6 months
- •Visual or hearing impairment.
研究组 & 干预措施
Keep it Movin'
Experimental
干预措施: Keep it Movin' (Behavioral)
Go 4 Life Self Guided Education
Active Comparator
干预措施: Go 4 Life Self Guided Education (Behavioral)
结局指标
主要结局
Change in Physical Function
时间窗: Measured at baseline and 6 months and 12 months after start of the intervention
Objective physical function will be measured using the Short Physical Performance Battery (SPPB) an instrument commonly used to measure physical performance within the aging population.
次要结局
- Change in Self-Reported Physical Function(Measured at baseline and 6 months and 12 months after start of the intervention)
- Change in Self-Reported Physical Activity(Measured at baseline and 6 months and 12 months after start of the intervention)
- Change in Quality of Life(Measured at baseline and 6 months and 12 months after start of the intervention)
- Change in Physical Activity(Measured at baseline and 6 months and 12 months after start of the intervention)
- Change in Social Support(Measured at baseline and 6 months and 12 months after start of the intervention)
- Change in Self-efficacy(Measured at baseline and 6 months and 12 months after start of the intervention)
研究者
Elizabeth Lynch
Principal Investigator
Rush University Medical Center
研究点 (1)
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