NCT06651385

Pilot of Exercise and Asthma Control

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Vermont · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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\[31\]). 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.

Conditions

• Asthma
• Obesity

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-10-01
• Primary completion: 2025-12-19
• Completion: 2025-12-19
• First posted: 2024-10-21
• Last updated: 2026-03-23

Locations

1 site across 1 country: United States