Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06651385
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-10-17
Brief Title:
Pilot of Exercise and Asthma Control
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pilot of Exercise and Asthma Control
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PEAC
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 points31
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 participants availability and preferred program start date P0 During the 12 week exercise program participants will have 3 remote contactsvisits 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
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 points31
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 participants availability and preferred program start date P0 During the 12 week exercise program participants will have 3 remote contactsvisits 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None