Physical Activity Program for Asthma
(ACTION E2I Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Chicago
Disqualifiers: COPD, Current smoker, Unstable heart disease, others
No Placebo Group
Trial Summary
What is the purpose of this trial?Physical inactivity is associated with poor asthma control and quality of life, and greater health care utilization. Rates of physical inactivity, asthma, and asthma mortality among Black women are higher than those of their White counterparts. Our formative work identified barriers to PA among Black women with asthma including a lack of social support, self-efficacy, unsafe neighborhood and fear related to experiences with life-threatening asthma exacerbations. Given the unique barriers to PA and high rates of physical inactivity that are associated with poor asthma outcomes in Black women, there is an urgent need to optimize PA interventions for this population. The proposed study uses our theory-driven intervention (ACTION: A lifestyle physiCal acTivity Intervention for minOrity womeN with asthma) to deliver a 24-week lifestyle physical activity intervention designed for and by urban Black women with asthma. Participants will be recruited through two urban health care systems that care for a diverse urban Black populations. Participants will be randomized to one of two groups: 1) ACTION intervention (group sessions, physical activity self-monitoring and text-based support for goal-setting), or 2) education control (an individual asthma education session and text messages related to asthma education). Participants will be followed for an additional 24-weeks after the intervention to assess for the maintenance of intervention effects on asthma health outcomes. We are proposing an efficacy study that focuses on asthma outcomes (Aim 1A/B), explores behavioral mechanisms of the intervention (Aim 2) and assesses factors that influence its reach and implementation potential (Aim 3). This trial will provide the first ever evidence of the efficacy of a lifestyle physical activity intervention among urban Black women with asthma, a population that is understudied yet plagued by low levels of PA and poor health outcomes. Our study has high potential to advance clinical treatment of asthma, and further the mechanistic understanding of physical activity interventions in minority populations living in low-resourced urban environments.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the ACTION Intervention treatment for asthma?
Research shows that educational interventions, like the ACTION Intervention, can improve asthma management by increasing knowledge, self-efficacy (confidence in managing one's own health), and adherence to treatment. These programs have been effective in reducing symptoms and improving activity levels in urban communities, particularly among minority groups.
12345Is the Physical Activity Program for Asthma safe for humans?
The research does not provide specific safety data for the Physical Activity Program for Asthma, but physical activity interventions are generally considered safe for people with asthma, as they are often used to improve health outcomes.
678910How is the ACTION Intervention treatment for asthma different from other treatments?
The ACTION Intervention is unique because it focuses on increasing physical activity specifically for minority women with asthma, using lifestyle changes and possibly mobile health technology, rather than relying on medication alone.
610111213Eligibility Criteria
This trial is for Black or African-American women over 18 with persistent asthma that isn't well-controlled. They should be physically able to walk, not smoke tobacco, and engage in less than 150 minutes of moderate exercise weekly. Participants must not have severe medical/psychiatric conditions, plans to move from the Chicagoland area during the study, recent severe asthma issues, current pregnancy or intention to become pregnant soon.Inclusion Criteria
I am 18 years old or older.
Willing to enroll and provide written-informed consent
I am a Black or African-American woman.
+3 more
Exclusion Criteria
I have had a severe asthma attack or needed steroids for asthma in the last month.
Investigator discretion for safety or protocol adherence reasons
I need a wheelchair or scooter to move around.
+9 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Orientation
Orientation session including individual asthma education or group session
1 week
1 visit (in-person)
Induction
Participants engage in weekly goal setting and group sessions to initiate physical activity
12 weeks
8 visits (virtual), 2 visits (in-person)
Adoptive
Participants continue with bi-weekly and monthly goal setting and group sessions
12 weeks
2 visits (virtual), 3 visits (in-person)
Maintenance
Participants are monitored for maintenance of intervention effects on asthma health outcomes
24 weeks
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
24 weeks
Participant Groups
The ACTION Intervention aims to increase physical activity among urban Black women with asthma through group sessions, self-monitoring and text support for goal-setting over a period of 24 weeks. The control group receives individual education on asthma management. The study will measure how these approaches affect asthma health outcomes.
2Treatment groups
Experimental Treatment
Group I: Education ControlExperimental Treatment1 Intervention
Orientation (week 0): 1 individual asthma education session Education texts: weekly (weeks 1-8), then bi-weekly (week 9-12), then monthly (weeks 13-24) Outcome assessments (12-, 24-, 48-weeks)
Group II: ACTION InterventionExperimental Treatment1 Intervention
Orientation (week 0): 1 group session Induction phase (weeks 1-12): 8 weekly then 2 bi-weekly goal setting via text with health coach + 2 group sessions (week 5, 9) Adoptive phase (weeks 13-24): 2 monthly goal setting with remote health coach + 3 group sessions (week 13, 17, 21) Maintenance phase (weeks 25-48): 1 group session Outcome assessment (12-, 24-, and 48-weeks)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Illinois ChicagoChicago, IL
University of ChicagoChicago, IL
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Who Is Running the Clinical Trial?
University of ChicagoLead Sponsor
University of Illinois at ChicagoCollaborator
University of Texas at AustinCollaborator
References
Action plans in asthma. [2022]Action plans are recommended for most patients with persistent asthma to reduce the morbidity associated with this chronic disease. Unfortunately, despite these recommendations, this tool remains underused.
Best practices for pediatric asthma: improved clinical management for the inner-city patient. [2019]Asthma patients who live in urban areas face many challenges that contribute to and influence poor outcomes. Many inner-city asthma patients are burdened with significant barriers to care, which include difficulty in obtaining short- and long-term treatment and misperceptions about the chronic nature of the disease. Poor access to care, poor quality of care, or both have been shown to contribute to the high morbidity rate in this population. The objective of asthma therapy is to interrupt allergen/antigen exposures wherever possible and to control airway inflammation. The goal of an effective asthma program is to prevent exacerbations of the disease, achieve and maintain normal activity levels and normal or near-normal lung function, and achieve a personal best for each patient with an effective action plan. An effective action plan is often difficult to implement because it takes much effort from both physician and patient to incorporate complete treatment strategies. Nevertheless, over time these plans can be very effective. The 1997 NIH report provides specific guidelines to help accomplish these goals.
An individualized intervention to improve asthma management among urban Latino and African-American families. [2022]We hypothesized that an educational intervention based on a readiness model would lead to improved health outcomes among patients with asthma. Within a randomized control design in an urban Latino and African-American community we conducted an intensive three-month pediatric intervention. A Family Coordinator provided patient education based on a readiness-to-learn model, and facilitated improved interactions between the patient and the doctor. Family education addressed the most basic learning needs of patients with asthma by improving their perception of asthma symptom persistence using asthma diaries and peak flown measures. The physician intervention focused cliniciancs' attention on patients' diary records and peak flow measures, and encouraged physicians to use stepped action plans. Patients were also tested for allergic sensitization and provided strategies to reduce contact with allergens and other asthma triggers. The results showed significant improvements by intervention group families on measures of knowledge, health belief, self-efficacy, self-regulatory skill, and adherence; decreases in symptom persistence and activity restriction; and increased prescription of anti-inflammatory medication by the physicians of the intervention group families.
[The role of written action plans in the management of asthma]. [2021]The Written Action Plan is a tool designed to help people with asthma to manage their condition when they experience an exacerbation. Asthma guidelines are consistent in their recommendation that action plans are useful for all people with asthma, but implementation is not systematic. The evidence base for such plans is limited because of methodological biases, but does support their effectiveness. The recommended action plan involves different color-coded zones which advise patients to adjust their management, such as increasing the level of daily treatment, or introducing oral corticosteroids based on symptoms and peak expiratory flow measurements. Recommendations are much less clear as to how to encourage patients to adopt and take ownership of their plan, although they all recommend that written action plans be incorporated into therapeutic education programs. The published literature shows that those caring for people with asthma may not support action plans because they are uncomfortable with the necessary educational posture and as a consequence of this they are under-utilized by patients. Patient-centered therapeutic education principles help us understand both how to encourage the patient want to have a written action plan and how to co-create it with them so that it is useful and meaningful in their life in order to make it more than just a disconnected tool.
Assessment of an ambulatory care asthma program. [2019]In response to rising asthma morbidity and mortality, numerous comprehensive asthma programs have been developed. However, few studies have examined critically the effectiveness of such programs or the means by which treatment or outcome is altered. To assess the role of a specialized ambulatory asthma care program, we reviewed the interventions recommended to 344 patients referred for the assessment of asthma. A subset of 127 made return visits 6-12 months following their initial assessment, thereby allowing assessment of behavioral and physiological outcomes. At the initial consultation, the recommended medication changes were: inhaled beta-agonists +6% (p
The Feasibility of a Lifestyle Physical Activity Intervention for Black Women with Asthma. [2022]Black women are disproportionately affected by both physical inactivity and asthma. Lifestyle physical activity (PA) interventions targeted for Black women with asthma are lacking.
Identifying Barriers to Physical Activity Among African American Women with Asthma. [2023]African American Women (AAW) are disproportionately impacted by both physical inactivity and asthma. The aims of this study were to: 1) understand barriers to physical activity among AAW with asthma; 2) obtain feedback from AAW on an evidence-based walking intervention; and 3) modify the intervention using input from AAW with asthma.
Encouraging physical activity in pediatric asthma: a case-control study of the wonders of walking (WOW) program. [2021]The complex overlap between asthma and obesity may be explained in part by activity avoidance in asthma. We compared responses to a walking intervention between matched groups of children with and without asthma. We expected youth with asthma to have lower baseline and post-intervention activity levels. Psychosocial, demographic, and physiologic correlates of activity were also examined.
Moderating effect of gender on the prospective relation of physical activity with psychosocial outcomes and asthma control in adolescents: a longitudinal study. [2015]Adolescents with asthma experience more psychosocial and physiological problems compared to their healthy peers. Physical activity (PA) might decrease these problems. This study was the first observational longitudinal study to examine whether habitual PA could predict changes in psychosocial outcomes (i.e., symptoms of anxiety and depression, quality of life [QOL] and stress) and asthma control over time in adolescents with asthma and whether gender moderated these relationships.
A feasibility randomised controlled trial of Novel Activity Management in severe ASthma-Tailored Exercise (NAMASTE): yoga and mindfulness. [2021]Physical inactivity is common in severe asthma and associated with poor health outcomes. New approaches are needed to address physical inactivity in this group.
Psychosocial predictors of physical activity in older aged asthmatics. [2008]there is little information available on physical activity (PA) patterns and the psychosocial determinants of PA in older adults with asthma.
A Walking Intervention Supplemented With Mobile Health Technology in Low-Active Urban African American Women With Asthma: Proof-of-Concept Study. [2020]Physical inactivity is associated with worse asthma outcomes. African American women experience disparities in both physical inactivity and asthma relative to their white counterparts. We conducted a modified evidence-based walking intervention supplemented with mobile health (mHealth) technologies to increase physical activity (PA).
PHYSICAL ACTIVITY LEVEL IN ASTHMATIC ADOLESCENTS: CROSS-SECTIONAL POPULATION-BASED STUDY. [2020]To assess the level of physical activity in asthmatics in comparison with non-asthmatics in a population study.