ACTION: physicAl aCtiviTy In minOrity womeN With Asthma Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Feasibility of Intervention-Recruitment
研究概览
简要总结
The ACTION intervention: physicAl aCtiviTy In minOrity womeN with asthma is a 3lifestyle physical activity intervention refined to be applicable for sedentary African American (AA) women with asthma. The main outcome of this study is to test the feasibility, acceptability and estimate the efficacy of the ACTION intervention in a randomized controlled pilot of 80 AA women with asthma within a pragmatic community setting at 24-weeks.
详细描述
Asthma is a highly prevalent chronic disease that disproportionately impacts African American (AA) women. AA women have poorer asthma-related quality of life and higher rates of asthma exacerbations, healthcare utilization and mortality compared to Caucasian women. Further, AA women are less physically active than any other subgroup of adults, which may help explain the asthma health disparities, found between AA and Caucasian women. Physical inactivity among individuals with asthma is associated with poor asthma control and respiratory function, greater health care utilization, and poorer quality of life. Given the connection between poor asthma outcomes and physical inactivity, addressing physical activity (PA) among sedentary AA women with asthma is imperative. Physical activity demonstrated improvement in asthma outcomes specifically asthma control, quality of life and healthcare utilization. Despite these benefits, fewer than 25% of AA women with asthma engage in regular physical activity. The ACTION intervention: physicAl aCtiviTy In minOrity womeN with asthma is a lifestyle PA intervention refined to be applicable for sedentary AA women with asthma.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Self-identify as female and black or AA
- •Age 18-70
- •Sub-optimally controlled persistent asthma based on Asthma Control Test (ACT <20)
- •Wiling to enroll and provide written-informed consent
- •Willing to be randomly assigned to treatment or control group
排除标准
- •Plans to relocate outside of the Chicagoland area during the study period.
- •Unable to ambulate without human assistance (ie. use of a wheelchair, scooter)
- •History of significant mental illness (e.g. uncontrolled bipolar disorder, psychoses)
- •Currently pregnant, planning to become pregnant over the next 3 months
- •Diagnosis of COPD (emphysema or chronic bronchitis) suggested by patient report of doctor diagnosis or smoking history (>20 pack years)
- •Poorly controlled high blood pressure (BP >180/100 at baseline visit)
- •Family/household member of another study participant or staff member
- •Inability to speak, read or understand English;
- •Investigator discretion for safety or protocol adherence reasons
- •Participation in ACTION focus groups (Aim 1) or pre-pilot (Aim 2) of the study
结局指标
主要结局
Feasibility of Intervention-Recruitment
时间窗: 24 weeks
The total number of participants recruited and consented in the study.
Feasibility of Intervention-Withdrawals
时间窗: 24 weeks
Number of participants that withdrew from the study
Feasibility of Lifestyle PA Intervention
时间窗: 24 weeks
Number of participants that completed 24-week outcomes assessment
Acceptability of Lifestyle PA Intervention
时间窗: 24-weeks
Unabbreviated scale title: ACTION Satisfaction Scale. Acceptability was measured using a 7-point Likert scale with 1 representing not satisfied and 7 representing very satisfied. Higher scores mean more satisfied with the intervention. The range is from 1-7.
Acceptability of Lifestyle PA Intervention-Qualitative Data
时间窗: 24-weeks
Intervention participants were asked open-ended questions about their satisfaction with the study. Responses were written down by the participant and data collector. It is not possible to summarize the data collected from the open-ended questions in tabular form as it is qualitative data.
次要结局
- Light Physical Activity Levels(24 weeks)
- Moderate Physical Activity Levels(24 weeks)
- Asthma Quality of Life Questionnaire (AQLQ)(24 weeks)
- Daily Step Counts(24 weeks)
- Asthma Control Questionnaire (ACQ-6)(24 weeks)
- Vigorous Physical Activity Levels(24 weeks)
研究者
Sharmilee Nyenhuis
Associate Professor of Medicine
University of Illinois at Chicago