Exercise Program for Asthma

(PEAC Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Vermont

Must be taking: Controller therapy

Must not be taking: Weight loss medication

Disqualifiers: Pregnancy, Other exercise program, others

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

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a digital exercise program for individuals with obesity and poorly controlled asthma. Researchers aim to determine if a mobile app for guided exercises can improve asthma symptoms and if participants find the program easy and enjoyable. The app, called Vitala, provides a personalized exercise plan for participants to follow at home. Ideal candidates have struggled with asthma control, often needing rescue inhalers or experiencing nighttime symptoms, and are not currently in another exercise or weight loss program. Participants need a smartphone with internet access to use the app. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance asthma management through digital health solutions.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must have been on regular prescribed asthma controller therapy for at least 3 months before joining the study.

What prior data suggests that this remote digital therapeutic exercise program is safe for adults with obesity and poorly controlled asthma?

Research has shown that digital tools for managing asthma, like the one in this study, can be safe for people with asthma. One study found that using a digital asthma tool reduced asthma flare-ups and doctor visits. Another study suggested that these tools might help control asthma better and lower the risk of severe attacks. This indicates that digital exercise programs are generally safe and well-tolerated by patients. Although specific safety data for the exact program used in this trial is not available, similar digital tools have demonstrated positive safety results. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the remote digital therapeutic exercise program for asthma because it offers a novel delivery method that sets it apart from traditional treatments like inhalers, oral medications, and biologics. Unlike these standard options, which often focus on managing symptoms with medication, this program leverages technology to provide an exercise regimen that can be accessed remotely. This approach not only empowers patients to manage their condition actively but also makes the treatment more accessible, as it can be done from the comfort of home. This innovative method could lead to improved patient engagement and potentially better long-term management of asthma symptoms.

What evidence suggests that this remote digital therapeutic exercise program is effective for asthma?

Research has shown that digital health programs can improve asthma management. One study found that digital asthma tools significantly reduced asthma flare-ups and related doctor visits. Another study discovered that using digital inhalers increased the chances of better asthma control by 85.3%. These findings suggest that the remote digital therapeutic exercise program tested in this trial could help individuals with obesity and poorly controlled asthma manage their symptoms more effectively. The program offers personalized exercise plans, which might improve asthma control. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults with obesity and poorly controlled asthma. Participants will be recruited from the University of Vermont Medical Center and community. They must be able to use a mobile app for exercise, and willing to complete an exercise program remotely for 12 weeks.

Inclusion Criteria

My asthma is not well-controlled.

Ability and willingness to provide informed consent

Internet access on a mobile smart phone to access the digital exercise program

Exclusion Criteria

Any condition that precludes participation in regular exercise as judged by the investigator and/or study physician

Pregnancy (by self-report)

Active participation in another exercise or weight loss program, or within 30 days prior to enrollment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a remote digital therapeutic exercise program using the Vitala mobile application

12 weeks

3 remote visits approximately every 4-6 weeks

Follow-up

Participants are monitored for adherence to the program, asthma control, and asthma-related quality of life after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Remote digital therapeutic exercise program

Trial Overview The study tests a remote digital therapeutic exercise program called Vitala, which prescribes tailored exercises through a mobile app. The goal is to see if participants can stick to the program (completing at least 75 minutes per week) and if it improves their asthma control over 12 weeks.

How Is the Trial Designed?

Group I: Remote digital therapeutic exercise program Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Vermont

Lead Sponsor

Trials

283

Recruited

3,747,000+

Published Research Related to This Trial

A pilot study involving 10 COPD patients showed that a long-term telerehabilitation program, including home exercise training and telemonitoring, was feasible and maintained participant engagement over more than a year with no drop-outs.

The program led to a significant 27% reduction in COPD-related hospital costs, indicating potential benefits in healthcare utilization and positive feedback from participants about the service.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term telerehabilitation of COPD patients in their homes: interim results from a pilot study in Northern Norway. Zanaboni, P., Lien, LA., Hjalmarsen, A., et al.[2013]

A systematic review of 20 studies involving 2018 hospitalized adults with respiratory conditions found that exercise programs, including aerobic and resistance training, were generally well tolerated and had infrequent adverse events, with only seven reported across 7420 training sessions.

The exercise programs varied widely in their design and implementation, with some using objective measures to tailor the initial sessions, highlighting the need for standardized approaches in prescribing exercise for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise training for adults hospitalized with an acute respiratory condition: a systematic scoping review. Rice, H., Harrold, M., Fowler, R., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06651385

NCT06651385 | Pilot of Exercise and Asthma Control The primary objective of this study is to determine the feasibility and acceptability of a remote digital therapeutic exercise program in people ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11682130/

Clinically-enhanced digital health program for respiratory care ... Among patients with uncontrolled asthma at baseline (ACT < 20), we observed significantly better program retention (55% vs. 41%, p < 0.001) in ...

3. bmcpulmmed.biomedcentral.com bmcpulmmed.biomedcentral.com/articles/10.1186/s12890-023-02467-8

Impact of a digital web-based asthma platform, a real-life study In this study, the digital asthma platform significantly reduced total number of exacerbation events and asthma-related health care visits among ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2213219822008285

Effectiveness of a Digital Inhaler System for Patients With ... In this study, participants using the RDS were found to have an 85.3% probability of achieving greater odds of improvement in asthma control than those using ...

5. withpower.com withpower.com/trial/phase-asthma-9-2024-43287

Exercise Program for Asthma (PEAC Trial) This will be a pilot, single arm, un-blinded study of a remote digital therapeutic exercise program in adults with obesity and poorly controlled asthma.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11405314/

Asthma management in the digital age - PMC For instance, RPM can preemptively detect signs of an asthma attack by monitoring data such as peak-flow measurements and inhaler usage, ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2213219825004088

Patient-Facing Digital Inhalers for Asthma: A Systematic ... Patient-facing digital inhalers probably improve asthma control and may reduce severe asthma exacerbations in patients at high risk for future exacerbations ...

8. jaci-inpractice.org jaci-inpractice.org/article/S2213-2198(22)00828-5/fulltext

A 12-Week, Open-Label, Randomized Study (CONNECT1) Participants using the RDS (n = 167) had an 85.3% probability of greater odds of clinically meaningful asthma control improvements than those ...