Function Improvement Exercises for Older Sedentary Community-dwelling Latino Residents (FE-SaLiR)
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Changes in Health-Related Quality of Life
研究概览
简要总结
As complementary and alternative medicines in both Chinese and Western populations, Wu Qin Xi (the Five Animal Play) and Ba Duan Jin (the Eight Pieces of Brocade) have demonstrated small to medium effects on the improvement of various physical, cognitive, and quality of life measures. The purpose of this proposed study is to develop a culturally tailored, low-cost exercise program, "Function Improvement Exercises for Older Sedentary Community-Dwelling Latino Residents (FE-SaLiR)", to improve physical and cognitive functions and quality of life in older Latino adults in a non-clinical community setting. This will be the first study to combine Wu Qin Xi and Ba Duan Jin in non-Chinese population.
The study has three specific aims:
- Following the community-based participatory research model (CBPR), the research team, community health advocates and senior program participants will co-adapt Wu Qin Xi and Ba Duan Jin and co-design the content and delivery form of FE-SaLiR (Phase 1).
- To conduct a three-arm pragmatic controlled trial to test the feasibility and acceptability of FE-SaLiR in older sedentary community-dwelling Latino residents (Phase 2).
- To generate the estimates of effect size and retention from the pilot study data that will be used to conduct the power estimation of a large RCT that will compare the effectiveness of FE-SaLiR with other types of exercises in an NIH RO1 grant application.
FE-SaLiR Phase 1 was delivered from August 2019 to November 2019. FE-SaLiR Phase 2 started recruiting participants by invitation in January 2020; the exercise program started in February 2020.
详细描述
Phase 1: Formative Study
A 3-month formative study with a community advisory group at the Modonna Center to co-design the study protocol (the content and delivery format of the exercise programs, recruitment and retention procedures and strategies, and procedures of study assessments).
The research team and the community advisory group (n=10) met weekly with the goal of making FE-SaLiR appealing to older Latino adults while maintaining the integrity of Chinese medicine exercises. Areas modified include the sequence of the exercises, difficulty level of the exercises, verbal instruction, background music, and visual aids (as compared to the official video published by the General Administration of Sport of China), etc. An English instruction video with the modified components was developed for phase 2 of the proposed study.
The group identified the barriers and enablers in health promotion programs for low-income, low-literacy, minority populations, and develop the strategies to engage and motivate the study participants.
The advisory group also guided the investigators in developing a process evaluation plan that provides insightful information on the acceptability of FE-SaLiR from the study participants in Phase 2 of the proposed study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 否
入选标准
- •participating in Senior programs at Ella Austin, Good Samaritan, and Palacio del sol
- •ages greater than 60
- •ability to exercise in a standing position
- •owning a cell phone or living with someone owning a cell phone
- •willingness to complete a 3-month study
排除标准
- •without permission to exercise from physicians
- •inability to complete the 3-month study due to external factors
结局指标
主要结局
Changes in Health-Related Quality of Life
时间窗: Baseline and 12-week posttest
The participants will complete SF-12 survey in self-administration or interview format. The SF-12 survey contains 12 items that focus on generic assessment on health-related quality of life.
Changes in Five-time Sit to Stand Test
时间窗: Baseline and 12-week posttest
The participants will to try stand up straight from the sitting position five times as quickly as they can for 5 times, without stopping between to assess their functional lower extremity strength, transitional movements, balance, and fall risk. Participants will be timed in seconds.
次要结局
- Changes in 6-minute Walking for Distance Test(Baseline and 12-week posttest)
- Changes in 50-feet Fast Walking Test(Baseline and 12-week posttest)
- Changes in Resting Blood Pressure(Baseline and 12-week posttest)
- Changes in Mindfulness Skills(Baseline and 12-week posttest)
- Changes in Symbol Digit Modalities Test(Baseline and 12-week posttest)
- Changes in Hand Grip Strength(Baseline and 12-week posttest)
- Changes in Lead Forward Balance Test(Baseline and 12-week posttest)
- Changes in Height and Weight(Baseline and 12-week posttest)
- Changes in Pain Severity and Pain Functioning(Baseline and 12-week posttest)