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Completed

NCT Number: NCT03265665

physicAl aCtiviTy In minOrity womeN With Asthma Intervention

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois Hospital and Health Sciences System

Chicago, Illinois, 60612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ACTION Intervention

Behavioral

The intervention is based on the Women's Lifestyle Physical Activity Program, a culturally sensitive lifestyle physical activity intervention for African American (AA) women. There are 2 phases to the intervention: Adoptive (24 weeks) and Maintenance (12 weeks). 3 motivational/reminder texts will be made each week during the adoption phase. 5 Group sessions(adoptive): Participants will be given individualized step goals, watch a short DVD featuring AA women demonstrating skills and sharing experiences of engaging in walking. 1 Group session (maintenance): watch a short DVD featuring AA women demonstrating skills and sharing experiences of engaging in walking, reinforce barriers and facilitators to walking. An interventionist will lead a discussion on role-modeling and encouraging problem solving. Each intervention group will have 10 women with 1 interventionist. Data will be collected at 3 time points: baseline, 24-weeks and 36-weeks.

Other names: Group sessions

Enhanced usual care

Other

Participants will attend 1 two hour asthma education/physical activity session at community location near them. Participants will review basic asthma topics in a didactic session and will include exercising with asthma and exercise-induced asthma. Participants will be given Fitbit and provided instructions on how to use it. Participants may receive 2 newsletters with information on asthma and reminder texts regarding data collection visits.

Data will be collected at 3 time points: baseline, 24-weeks and 36-weeks.

Primary outcomes

  1. Feasibility of Intervention-Recruitment

    Time frame: 24 weeks

    The total number of participants recruited and consented in the study.

  2. Feasibility of Intervention-Withdrawals

    Time frame: 24 weeks

    Number of participants that withdrew from the study

  3. Feasibility of Lifestyle PA Intervention

    Time frame: 24 weeks

    Number of participants that completed 24-week outcomes assessment

  4. Acceptability of Lifestyle PA Intervention

    Time frame: 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.

  5. Acceptability of Lifestyle PA Intervention-Qualitative Data

    Time frame: 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.

Secondary outcomes

  1. Light Physical Activity Levels

    Time frame: 24 weeks

    as measured by accelerometer and using proprietary Actilife software

  2. Asthma Quality of Life Questionnaire (AQLQ)

    Time frame: 24 weeks

    The Asthma Quality of Life Questionnaire (AQLQ) is a 32-item questionnaire. It has 4 domains: symptoms (12 items), activity limitation (6 generic and 5 patient-specific items), emotional function (5 items), and environmental stimuli (4 items). The AQLQ items are each scored on a 7-point Likert scale, with 1 representing maximal impairment and 7 representing no impairment. Scores range 1-7, with higher scores indicating better quality of life. A total score was calculated by summing all responses for each question and then dividing by the number of items in the questionnaire (n=32). Subdomains were not reported/used.

  3. Asthma Control Questionnaire (ACQ-6)

    Time frame: 24 weeks

    Unabbreviated scale title: Asthma control questionnaire (ACQ) The ACQ score correlates with a measure of asthma control based on the GINA/NIH criteria. ACQ includes 6 questions on symptoms, activity limitation and beta2-agonist use. Each question is scored from 0 to 6 with the total score being the average of the questions. The ACQ score ranges between 0 (well controlled) and 6 (extremely poorly controlled). Recent studies show that a score of 1.5 or more on the 6-item Asthma Control Questionnaire (ACQ) indicates that a patient has inadequate asthma control.Higher scores mean poorer asthma control.

  4. Daily Step Counts

    Time frame: 24 weeks

    as measured by accelerometer

  5. Moderate Physical Activity Levels

    Time frame: 24 weeks

    as measured by accelerometer and using proprietary Actilife software

  6. Vigorous Physical Activity Levels

    Time frame: 24 weeks

    as measured by accelerometer and using proprietary Actilife software

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

ACTION: physicAl aCtiviTy In minOrity womeN With Asthma Intervention

Acronym: ACTION

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 29, 2017
Registry last updated
Feb 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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