Pilot of Exercise and Asthma Control (PEAC)

March 18, 2026 updated by: Mariel Sullivan, University of Vermont

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Vermont
      • Burlington, Vermont, United States, 05401
        • University of Vermont Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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
  • Obese: BMI ≥30 kg/m2
  • Poorly controlled asthma (defined as one or more of the following criteria:
  • Asthma Control Test Score ≤19, or
  • Use of rescue inhaler on average >2 uses/week for preceding month, or
  • Nocturnal asthma awakening on average ≥1 times/week in preceding month, or
  • ED/hospital visit or prednisone course for asthma in past six months
  • 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
  • Current use of prescription weight loss medication, or within 30 days or 5- half lives, whichever is longer, prior to enrollment.
  • Failing to meet criteria on the PAR-Q+ screening questionnaire for safe exercise [32, 33]

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Remote digital therapeutic exercise program
Other: Remote digital therapeutic exercise program
Participants will be introduced to the digital therapeutic exercise program during Screening and Consent (Visit 0, V0). Participants will be provided with an orientation to the Vitala platform and assistance will be offered in the download and access to the application, as needed. The study team will ensure access has been obtained via the health care professionals' dashboard on the Vitala app. Information obtained in the assessments outlined above will inform the tailored exercise prescription to meet the participant's needs. Participants will be encouraged to complete a total of 150 minutes of remote exercise sessions each week for 12 weeks via the Vitala platform. Participants will receive daily notifications to remind them to complete their assigned daily exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 12 weeks
Successful feasibility 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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Vermont

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Actual)

December 19, 2025

Study Completion (Actual)

December 19, 2025

Study Registration Dates

First Submitted

October 17, 2024

First Submitted That Met QC Criteria

October 17, 2024

First Posted (Actual)

October 21, 2024

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00002796

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This is a pilot study to examine the feasibility of an exercise program in subjects with poorly controlled asthma and obesity. The data may be used for future research by the local study team only for projects examining the impact of exercise on asthma control.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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