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AsthmaACTION E2INCT05726487

Physical Activity Intervention for Black Women With Asthma

A study testing ACTION Intervention in people with Asthma, run by University of Chicago at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Asthma
What is being tested?
ACTION Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
224 participants
Where
2 sitesUnited States
Study dates
4 May 2023to 30 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Self-identify as female and Black or African-American
  • Age >/= 18
  • Physician-diagnosed persistent asthma that is sub-optimally controlled based on Asthma Control Test (ACT < 20) OR history in the past year of an asthma exacerbation (a need for systemic corticosteroids or hospital admission or emergency treatment for worsening asthma)
  • Willing to enroll and provide written-informed consent
  • Willing to be randomly assigned to treatment or control group
  • Low- active: engages in less than 150 minutes per week of moderate-to- vigorous physical activity
  • Has a smartphone and texts every day or almost everyday

Who cannot join

  • Plans to relocate outside of the Chicagoland area during the study period
  • Unable to ambulate without the use of a wheelchair or scooter
  • Diagnosis of COPD (emphysema or chronic bronchitis) suggested by patient report of doctor diagnosis or smoking history (≥ 20 pack years)
  • Current tobacco smoker
  • A contraindication to exercise as indicated by the Physical Activity Readiness Questionnaire unless written permission by a health care provider
  • Significant medical (e.g., unstable heart disease, uncontrolled high blood pressure, active cancer treatment in past 1 year, end-stage organ failure) or psychiatric (e.g., active bipolar disorder, psychosis) comorbidities
Show all 12Show fewer
  • Participation in another physical activity or asthma research program
  • Asthma exacerbation, defined by an urgent care visit for asthma in the last 4 weeks, or need for acute course of systemic corticosteroids for asthma in the last 4 weeks
  • 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
  • Unable or unwilling to provide complete accelerometry data at the baseline assessment after two opportunities to wear the monitor

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Illinois Chicago

    Chicago, Illinois, 60607

  • University of Chicago

    Chicago, Illinois, 60637

Other trials in United States

About this study

Official title: ACTION (physicAl aCtiviTy In minOrity womeN With Asthma) Intervention: Efficacy to Implementation

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.

Conditions
Asthma
Being tested
ACTION Intervention, Education Control
Keywords
Black women, Asthma Control Questionnaire, Physical Activity
Medical subject headings
Asthma, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ACTION InterventionBehavioural

    Participants in the ACTION Intervention arm of the study will have group sessions, physical activity self-monitoring, text-based support for goal setting. Following this intervention participants will be followed for an additional 24-weeks to assess for the maintenance of intervention effects on asthma health outcomes.

  • Education ControlOther

    Participants in the Education Control arm of the study will receive and individual asthma education session and text messages related to asthma education. Following this intervention participants will be followed for an additional 24-weeks to assess for the maintenance of intervention effects on asthma health outcomes.

Study groups in NCT05726487
Study groupRoleWhat they receive
ACTION InterventionExperimentalOrientation (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)
Receives: Behavioral: ACTION Intervention
Education ControlOtherOrientation (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)
Receives: Other: Education Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Asthma Control Questionnaire

    Validated questionnaire

    Measured: 24-weeks

Secondary outcomes (13)

  1. Asthma Control Questionnaire

    Validated questionnaire

    Measured: 48-weeks

  2. Mini-asthma quality of life questionnaire

    Validated questionnaire

    Measured: 24- and 48-weeks

  3. Asthma exacerbations

    Self-reported measure

    Measured: 24- and 48-weeks

  4. Healthcare Utilization (ED, urgent care, and hospitalizations)

    Self-reported measure

    Measured: 24- and 48-weeks

  5. Self-efficacy for walking scale

    Survey

    Measured: 24- and 48-weeks

  6. Social support for exercise

    Survey

    Measured: 24- and 48-weeks

  7. Self-regulation

    Measured by exercise self-regulation questionnaire (SRQ-E) and step goals achieved

    Measured: 24- and 48-weeks

  8. Light Physical Activity

    Physical activity measure. Measured by Actigraph GT3XP-BTLE waist-based Accelerometer.

    Measured: 24-weeks

  9. Moderate Physical Activity

    Physical activity measure. Measured by Actigraph GT3XP-BTLE waist-based Accelerometer.

    Measured: 24-weeks

  10. Moderate-Vigorous Physical Activity

    Physical activity measure. Measured by Actigraph GT3XP-BTLE waist-based Accelerometer.

    Measured: 24-weeks

  11. Vigorous Physical Activity

    Physical activity measure. Measured by Actigraph GT3XP-BTLE waist-based Accelerometer.

    Measured: 24-weeks

  12. Daily Steps

    Physical activity measure. Measured by Actigraph GT3XP-BTLE waist-based Accelerometer

    Measured: 24-weeks

  13. PWMAQ

    Physical activity measure. Validated questionnaire

    Measured: 24-weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2023
  2. Study start4 May 2023
  3. Primary completion8 May 2026
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
224 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05726487
Sponsor's protocol ID
IRB22-0911
Acronym
ACTION E2I
Status last verified
May 2026
First submitted
11 Jan 2023
Last updated
4 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Avallone KM, McLeish AC. Asthma and aerobic exercise: a review of the empirical literature. J Asthma. 2013 Mar;50(2):109-16. doi: 10.3109/02770903.2012.759963. Epub 2013 Jan 31.

    PubMed 23252987

  • Garcia-Aymerich J, Varraso R, Anto JM, Camargo CA Jr. Prospective study of physical activity and risk of asthma exacerbations in older women. Am J Respir Crit Care Med. 2009 Jun 1;179(11):999-1003. doi: 10.1164/rccm.200812-1929OC. Epub 2009 Feb 26.

    PubMed 19246716

  • Hansen ESH, Pitzner-Fabricius A, Toennesen LL, Rasmusen HK, Hostrup M, Hellsten Y, Backer V, Henriksen M. Effect of aerobic exercise training on asthma in adults: a systematic review and meta-analysis. Eur Respir J. 2020 Jul 30;56(1):2000146. doi: 10.1183/13993003.00146-2020. Print 2020 Jul.

    PubMed 32350100

  • Carson KV, Chandratilleke MG, Picot J, Brinn MP, Esterman AJ, Smith BJ. Physical training for asthma. Cochrane Database Syst Rev. 2013 Sep 30;2013(9):CD001116. doi: 10.1002/14651858.CD001116.pub4.

    PubMed 24085631

  • Kuder MM, Clark M, Cooley C, Prieto-Centurion V, Danley A, Riley I, Siddiqi A, Weller K, Kitsiou S, Nyenhuis SM. A Systematic Review of the Effect of Physical Activity on Asthma Outcomes. J Allergy Clin Immunol Pract. 2021 Sep;9(9):3407-3421.e8. doi: 10.1016/j.jaip.2021.04.048. Epub 2021 May 6.

    PubMed 33964510

  • Akinbami LJ, Moorman JE, Bailey C, Zahran HS, King M, Johnson CA, Liu X. Trends in asthma prevalence, health care use, and mortality in the United States, 2001-2010. NCHS Data Brief. 2012 May;(94):1-8.

    PubMed 22617340

  • Roger VL, Go AS, Lloyd-Jones DM, Benjamin EJ, Berry JD, Borden WB, Bravata DM, Dai S, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Soliman EZ, Sorlie PD, Sotoodehnia N, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2012 update: a report from the American Heart Association. Circulation. 2012 Jan 3;125(1):e2-e220. doi: 10.1161/CIR.0b013e31823ac046. Epub 2011 Dec 15. No abstract available.

    PubMed 22179539

  • Nyenhuis SM, Shah N, Ma J, Marquez DX, Wilbur J, Cattamanchi A, Sharp LK. Identifying Barriers to Physical Activity Among African American Women with Asthma. Cogent Med. 2019;6(1):1582399. Epub 2019 Feb 27.

    PubMed 31754624

  • Joseph RP, Ainsworth BE, Keller C, Dodgson JE. Barriers to Physical Activity Among African American Women: An Integrative Review of the Literature. Women Health. 2015;55(6):679-99. doi: 10.1080/03630242.2015.1039184. Epub 2015 Apr 24.

    PubMed 25909603

  • Nyenhuis SM, Balbim GM, Ma J, Marquez DX, Wilbur J, Sharp LK, Kitsiou S. A Walking Intervention Supplemented With Mobile Health Technology in Low-Active Urban African American Women With Asthma: Proof-of-Concept Study. JMIR Form Res. 2020 Mar 11;4(3):e13900. doi: 10.2196/13900.

    PubMed 32159520

  • Nyenhuis SM, Dixon AE, Ma J. Impact of Lifestyle Interventions Targeting Healthy Diet, Physical Activity, and Weight Loss on Asthma in Adults: What Is the Evidence? J Allergy Clin Immunol Pract. 2018 May-Jun;6(3):751-763. doi: 10.1016/j.jaip.2017.10.026. Epub 2017 Dec 6.

    PubMed 29221919

  • Luten KA, Dijkstra A, Reijneveld SA, de Winter AF. Moderators of physical activity and healthy eating in an integrated community-based intervention for older adults. Eur J Public Health. 2016 Aug;26(4):645-50. doi: 10.1093/eurpub/ckw051. Epub 2016 Apr 19.

    PubMed 27095795

  • Clark NM, Valerio MA, Gong ZM. Self-regulation and women with asthma. Curr Opin Allergy Clin Immunol. 2008 Jun;8(3):222-7. doi: 10.1097/ACI.0b013e3282fe9d05.

    PubMed 18560296

  • Piercy KL, Troiano RP, Ballard RM, Carlson SA, Fulton JE, Galuska DA, George SM, Olson RD. The Physical Activity Guidelines for Americans. JAMA. 2018 Nov 20;320(19):2020-2028. doi: 10.1001/jama.2018.14854.

    PubMed 30418471

  • Juniper EF, O'Byrne PM, Guyatt GH, Ferrie PJ, King DR. Development and validation of a questionnaire to measure asthma control. Eur Respir J. 1999 Oct;14(4):902-7. doi: 10.1034/j.1399-3003.1999.14d29.x.

    PubMed 10573240

Questions about this trial

What is this clinical trial studying?

A study testing ACTION Intervention in people with Asthma, run by University of Chicago at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Asthma Control Questionnaire (time frame: 24-weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05726487, which also lists 42 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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