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Behavioural Intervention

Remote digital therapeutic exercise program for Asthma (PEAC Trial)

N/A
Waitlist Available
Research Sponsored by University of Vermont
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Physician diagnosis of asthma on regular prescribed controller therapy for 3 months prior to enrollment (per EMR or self-report)
* Age: ≥18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
No Placebo-Only Group

Summary

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\[31\]). We 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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves an exercise program, potential side effects may include typical risks associated with physical activity such as muscle strains or sprains. However, specific side effects related to the digital nature of the intervention are not detailed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The primary objective of this study is to determine the feasibility and acceptability of a remote digital therapeutic exercise program in people with obesity and poorly controlled asthma.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Remote digital therapeutic exercise programExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

University of VermontLead Sponsor
276 Previous Clinical Trials
3,744,066 Total Patients Enrolled
10 Trials studying Asthma
4,794 Patients Enrolled for Asthma
~13 spots leftby Sep 2026