Exercise Program for Asthma
(PEAC Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Vermont

No Placebo Group

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.

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.

+3 more

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

+2 more

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: Remote digital therapeutic exercise programExperimental Treatment1 Intervention