Pilot of Exercise and Asthma Control

NCT ID: NCT06651385

Last Updated: 2024-10-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2026-09-30

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Remote digital therapeutic exercise program

Group Type: EXPERIMENTAL

Remote digital therapeutic exercise program

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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]

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Vermont

OTHER

Sponsor Role: lead

Responsible Party

Kate M Huether

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Vermont Medical Center

Burlington, Vermont, United States

Countries

United States

Other Identifiers

STUDY00002796

Identifier Type: -

Identifier Source: org_study_id