Physical Activity Program for Asthma

(ACTION E2I Trial)

Recruiting at 1 trial location

Overseen By Sharmilee Nyenhuis, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Chicago

Disqualifiers: COPD, Current smoker, Unstable heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

224 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{6 7 8 9 10}

How 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. ^{6 10 11 12 13}

Research Team

Sharmilee Nyenhuis, MD

Principal Investigator

University of Chicago

Eligibility 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.

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.

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

Treatment Details

Interventions

• ACTION Intervention
• Education Control

Trial Overview 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.

Participant Groups

Group I: Education Control Experimental Treatment 1 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 Intervention Experimental Treatment 1 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)

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

University of Illinois at Chicago

Collaborator

Trials

653

Recruited

1,574,000+

University of Texas at Austin

Collaborator

Trials

387

Recruited

86,100+

Findings from Research

In a study of 92 asthmatic patients at a tertiary care center, 46% had an individualized written action plan, which is significantly higher than the Canadian average of 10%.

Patients reported high confidence (4.1 out of 5) and perceived efficacy (3.3 out of 4) in their action plans, with traditional tools being more effective than a simplified version, highlighting the importance of personalized management in asthma care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Action plans in asthma. Beauchesne, MF., Levert, V., El Tawil, M., et al.[2022]

Urban asthma patients face significant barriers to care, including difficulty accessing treatments and misconceptions about their condition, which contribute to high morbidity rates.

Effective asthma management requires a comprehensive action plan that addresses allergen exposure and airway inflammation, but implementing these plans can be challenging for both patients and healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Best practices for pediatric asthma: improved clinical management for the inner-city patient. Jones, CA.[2019]

An educational intervention for asthma patients, involving family education and improved doctor-patient interactions, led to significant improvements in knowledge, self-efficacy, and adherence to treatment among families in an urban Latino and African-American community over three months.

The intervention resulted in decreased asthma symptoms and activity restrictions, as well as increased prescriptions for anti-inflammatory medications, highlighting its efficacy in managing asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An individualized intervention to improve asthma management among urban Latino and African-American families. Bonner, S., Zimmerman, BJ., Evans, D., et al.[2022]

The Written Action Plan is an effective tool for asthma management, helping patients adjust their treatment based on symptoms and peak expiratory flow measurements, although its implementation is not consistent among patients and healthcare providers.

To enhance the effectiveness of Written Action Plans, it is crucial to incorporate patient-centered therapeutic education, which encourages patients to take ownership of their plans and ensures that these plans are personalized and meaningful to their lives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The role of written action plans in the management of asthma]. Ouksel, H., Pineau, A.[2021]

A specialized ambulatory asthma care program significantly improved patient outcomes, with a 60% reduction in emergency room visits and an increase in lung function (FEV1) from 2.41 to 2.64 liters over 6-12 months.

The program led to increased use of inhaled steroids and decreased reliance on theophylline, resulting in fewer asthma exacerbations and a shift in patient classification towards milder forms of asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of an ambulatory care asthma program. Dzyngel, B., Kesten, S., Chapman, KR.[2019]

A culturally tailored lifestyle physical activity intervention for Black women with asthma showed high feasibility and acceptability, with 92% of participants remaining in the program over 24 weeks.

The intervention group experienced a significant increase in asthma control, with 36.84% achieving controlled asthma compared to only 9.52% in the enhanced usual care group, indicating potential benefits of targeted lifestyle interventions for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Feasibility of a Lifestyle Physical Activity Intervention for Black Women with Asthma. Nyenhuis, SM., Shah, N., Kim, H., et al.[2022]

A study involving 20 sedentary African American women with asthma identified specific barriers to physical activity, including limited physical capability, lack of knowledge, and insufficient social support.

Based on feedback from participants, an existing walking intervention was tailored to include asthma education and support features, highlighting the need for further assessment of its feasibility and effectiveness in improving physical activity and asthma management among this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying Barriers to Physical Activity Among African American Women with Asthma. Nyenhuis, SM., Shah, N., Ma, J., et al.[2023]

Children with well-controlled asthma showed similar baseline physical activity levels compared to healthy controls, with both groups averaging around 6,300 steps per day.

A walking intervention significantly increased daily steps by approximately 1,485 for both groups, demonstrating that a simple, pedometer-based program can effectively enhance physical activity in children, regardless of asthma status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Encouraging physical activity in pediatric asthma: a case-control study of the wonders of walking (WOW) program. Walders-Abramson, N., Wamboldt, FS., Curran-Everett, D., et al.[2021]

In a study of 253 adolescents with asthma, habitual physical activity did not predict changes in psychosocial outcomes or asthma control over time for the entire group.

However, the study found that increased physical activity significantly reduced symptoms of anxiety and depression over time specifically in girls, suggesting a gender difference in the benefits of physical activity for mental health in adolescents with asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Moderating effect of gender on the prospective relation of physical activity with psychosocial outcomes and asthma control in adolescents: a longitudinal study. Tiggelman, D., van de Ven, MO., van Schayck, OC., et al.[2015]

A 12-week study involving 24 adults with severe asthma showed that a yoga and mindfulness intervention significantly improved health-related quality of life (HRQoL) compared to a minimal active control group.

Participants in the yoga group experienced greater improvements in their respiratory health as measured by the St George's Respiratory Questionnaire, while the control group showed increased physical activity, indicating that both interventions had positive effects on different aspects of health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A feasibility randomised controlled trial of Novel Activity Management in severe ASthma-Tailored Exercise (NAMASTE): yoga and mindfulness. Hiles, SA., Urroz, PD., Gibson, PG., et al.[2021]

Older adults with asthma are less physically active compared to their non-asthmatic peers, highlighting a need for targeted interventions to increase activity levels in this population.

Perceived health significantly influences physical activity levels in older asthmatics, suggesting that improving self-perceived health could enhance their engagement in physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychosocial predictors of physical activity in older aged asthmatics. Dogra, S., Meisner, BA., Baker, J.[2008]

A 7-week walking intervention using mobile health technologies showed promising feasibility for increasing physical activity among African American women with asthma, with 71% to 86% attendance in group sessions and high satisfaction reported by participants.

While there was a slight increase in moderate-to-vigorous physical activity (MVPA) measured by Fitbit, the overall step count decreased slightly, indicating the need for further modifications to enhance the intervention's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Walking Intervention Supplemented With Mobile Health Technology in Low-Active Urban African American Women With Asthma: Proof-of-Concept Study. Nyenhuis, SM., Balbim, GM., Ma, J., et al.[2020]

In a study of 1,591 adolescents aged 13 to 14, those diagnosed with asthma were found to be more physically active than their non-asthmatic peers, with 64.4% of asthmatic adolescents engaging in physical activity compared to 53.3% of non-asthmatics.

The research highlights that even adolescents with active asthma can maintain a level of physical activity, suggesting that asthma diagnosis does not necessarily limit physical engagement among young individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PHYSICAL ACTIVITY LEVEL IN ASTHMATIC ADOLESCENTS: CROSS-SECTIONAL POPULATION-BASED STUDY. Correia Junior, MAV., Costa, EC., Barros, LCB., et al.[2020]

References

1. Egypt pubmed.ncbi.nlm.nih.gov

Action plans in asthma. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Best practices for pediatric asthma: improved clinical management for the inner-city patient. [2019]

3. England pubmed.ncbi.nlm.nih.gov

An individualized intervention to improve asthma management among urban Latino and African-American families. [2022]

4. France pubmed.ncbi.nlm.nih.gov

[The role of written action plans in the management of asthma]. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Assessment of an ambulatory care asthma program. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

The Feasibility of a Lifestyle Physical Activity Intervention for Black Women with Asthma. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Identifying Barriers to Physical Activity Among African American Women with Asthma. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Encouraging physical activity in pediatric asthma: a case-control study of the wonders of walking (WOW) program. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Moderating effect of gender on the prospective relation of physical activity with psychosocial outcomes and asthma control in adolescents: a longitudinal study. [2015]

10. England pubmed.ncbi.nlm.nih.gov

A feasibility randomised controlled trial of Novel Activity Management in severe ASthma-Tailored Exercise (NAMASTE): yoga and mindfulness. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Psychosocial predictors of physical activity in older aged asthmatics. [2008]

12. Canada pubmed.ncbi.nlm.nih.gov

A Walking Intervention Supplemented With Mobile Health Technology in Low-Active Urban African American Women With Asthma: Proof-of-Concept Study. [2020]

13. Brazil pubmed.ncbi.nlm.nih.gov

PHYSICAL ACTIVITY LEVEL IN ASTHMATIC ADOLESCENTS: CROSS-SECTIONAL POPULATION-BASED STUDY. [2020]