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

20 Participants Needed

Trial Summary

What is the purpose of this 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. Participants will be recruited from the University of Vermont Medical Center adult Pulmonary Clinic, Internal Medicine Clinic, and from the greater community via flyers and referrals, as needed. The primary outcome of interest will be the feasibility and acceptability of a remote digital therapeutic exercise program using a mobile application, called Vitala. Vitala is a FDA Registered, HIPAA Compliant CE-marked MDR class 1 medical device developed by doctors and physiotherapists. It is a mobile application tool that enables health care providers to prescribe and monitor diagnosis-specific exercise prescriptions that allows patients to remotely access their tailored therapeutic exercise program. URL: Medical exercise and digital rehabilitation - Vitala Feasibility and acceptability will be defined as ≥60% of subjects enrolled in the exercise program completing, on average, ≥50% (≥75 minutes/ week) of the digital exercise program during their 12-week period, respectively. The secondary outcome of interest will be the efficacy of a remote digital therapeutic exercise program in participants with obesity and poorly controlled asthma by comparing asthma symptoms before, during, and at the end of the intervention. Efficacy will be defined as ≥30% of subjects who achieving a minimal clinically important difference in Asthma Control Test scores (defined as increase of ≥3 points\[31\]). The Investigators plan to enroll participants on a rolling basis. Prospective participants will be contacted by phone, mail, or e-mail to establish interest and eligibility in the study. Once confirmed interested and eligible to participate in the study, they will be scheduled for eConsent and enrollment in the study (V0). Participants will receive a tailored exercise prescription unique to their individual needs, space, and available equipment and will be encouraged to complete 150 minutes of activity per week via their customized exercise program through the Vitala platform remotely for 12 weeks. Participants will be contacted when the program has been made available to them for program start, which will also be guided based on the participant's availability and preferred program start date (P0). During the 12 week exercise program, participants will have 3 remote contacts/visits (RC, V1, and 2), approximately every 4 - 6 weeks, over the 12 week intervention period including a final remote visit (V2) after completion of the program to assess adherence to the program, asthma control, and asthma-related quality of life.

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 data supports the effectiveness of the remote digital therapeutic exercise program for asthma?

Research on similar remote exercise programs for lung diseases, like COPD, shows they can be effective. These programs have been successfully delivered through telerehabilitation, improving patient outcomes and reducing healthcare costs. This suggests that a remote exercise program for asthma might also be beneficial. ^{1 2 3 4 5}

Is the exercise program for asthma safe for humans?

Exercise programs for asthma, including high-intensity training and physical conditioning, have been shown to be generally safe for both adults and children with asthma. No serious adverse events or fatalities were reported, and with proper screening and medical management, the risk of exercise-related issues is low. ^{6 7 8 9 10}

How does the remote digital therapeutic exercise program for asthma differ from other treatments?

The remote digital therapeutic exercise program for asthma is unique because it offers a structured exercise regimen that can be accessed remotely, allowing patients to improve their physical fitness and reduce asthma symptoms without needing to visit a clinic. This approach is different from traditional treatments that often focus on medication and in-person therapy, providing a flexible and convenient option for managing asthma. ^{8 11 12 13 14}

Eligibility Criteria

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.

I am 18 years old or older.

My BMI is 30 or higher.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

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

The feasibility and validity of a remote pulse oximetry system for pulmonary rehabilitation: a pilot study. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Usability of Remote Assessment of Exercise Capacity for Pulmonary Telerehabilitation Program. [2020]

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

Home-based or remote exercise testing in chronic respiratory disease, during the COVID-19 pandemic and beyond: A rapid review. [2020]

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

A Systematic Review of the Effects of Telerehabilitation in Patients With Cardiopulmonary Diseases. [2018]

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

Long-term telerehabilitation of COPD patients in their homes: interim results from a pilot study in Northern Norway. [2013]

6. England pubmed.ncbi.nlm.nih.gov

Exercise training for adults hospitalized with an acute respiratory condition: a systematic scoping review. [2022]

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

High-intensity physical training in adults with asthma. A 10-week rehabilitation program. [2019]

8. Australia pubmed.ncbi.nlm.nih.gov

Physical conditioning programme for children with bronchial asthma. [2019]

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

Prevention with and without the use of medications for exercise-induced asthma. [2019]

10. Canada pubmed.ncbi.nlm.nih.gov

Evidence-based risk assessment and recommendations for physical activity clearance: respiratory disease. [2018]

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

Physical activity and asthma. [2022]

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

Physical exercise program for children with bronchial asthma. [2019]

13. England pubmed.ncbi.nlm.nih.gov

A short exercise and living course for asthmatics. [2019]

14. England pubmed.ncbi.nlm.nih.gov

Exercise for asthma patients: little risk, big rewards. [2010]