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NCT06651385 · ClinicalTrials.gov registry record · NA
Pilot of Exercise and Asthma Control
A NA study, sponsored by University of Vermont.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
NCT06651385 is a NA study that has completed, run by University of Vermont. The registered enrollment target is 20 participants.
The verdict
NCT06651385, a NA study, has completed, sponsored by University of Vermont.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
Study 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 equip
Interventions
- OTHER Remote digital therapeutic exercise program
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-10-01 |
| Est. Completion | 2025-12-19 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06651385
The ClinicalTrials.gov registry entry for NCT06651385 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Vermont, which has 162 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Remote digital therapeutic exercise program is the first listed.
NCT06651385 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06651385 about?
NCT06651385 is a clinical study titled "Pilot of Exercise and Asthma Control". 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...
What is the current status of trial NCT06651385?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2024-10-01. Estimated completion is 2025-12-19.
What interventions are being tested in trial NCT06651385?
The interventions under investigation include: Remote digital therapeutic exercise program (OTHER).
Who is sponsoring clinical trial NCT06651385?
This trial is sponsored by University of Vermont, which has 162 total clinical trials registered on ClinicalTrials.gov.
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