Clinical trial NCT03265665: physicAl aCtiviTy In minOrity womeN With Asthma Intervention
Official title: ACTION: physicAl aCtiviTy In minOrity womeN With Asthma Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: walking
African American women
lifestyle
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2017-08-29
Enrollment: 53
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria: • 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

Primary outcomes:
measure: Feasibility of Intervention-Recruitment
timeFrame: 24 weeks
measure: Feasibility of Intervention-Withdrawals
timeFrame: 24 weeks
measure: Feasibility of Lifestyle PA Intervention
timeFrame: 24 weeks
measure: Acceptability of Lifestyle PA Intervention
timeFrame: 24-weeks
measure: Acceptability of Lifestyle PA Intervention-Qualitative Data
timeFrame: 24-weeks
Secondary outcomes:
measure: Light Physical Activity Levels
timeFrame: 24 weeks
measure: Asthma Quality of Life Questionnaire (AQLQ)
timeFrame: 24 weeks
measure: Asthma Control Questionnaire (ACQ-6)
timeFrame: 24 weeks
measure: Daily Step Counts
timeFrame: 24 weeks
measure: Moderate Physical Activity Levels
timeFrame: 24 weeks
measure: Vigorous Physical Activity Levels
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois Hospital and Health Sciences System
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Sharmilee M Nyenhuis, MD
role: PRINCIPAL_INVESTIGATOR
References: