Ignite Creation Date:
2024-05-06 @ 4:18 PM
Last Modification Date:
2024-10-26 @ 2:08 PM
Study NCT ID:
NCT04946708
Status:
COMPLETED
Last Update Posted:
2022-05-18
First Post:
2021-06-15
Brief Title:
Virtual Exercise Program in Interstitial Lung Disease ILD Patients
Sponsor:
University of Manitoba
Organization:
University of Manitoba
Study Overview
Official Title:
Using Technology to Engage Patients With Interstitial Lung Disease ILD in a Home a Home Exercise Program
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Design this pilot-study uses a two-group random assignment pretest-posttest design Once the groups are being selected an envelope will be mailed to the participant with the printed version of the exercise program and surveys a portable SpiroBank Smart FN multi parameter spirometer MIR a finger pulse oximeter LOOKEE a diary and a prepaid envelop for a subsequent post-intervention return of the equipment and surveys and the diary
Intervention A Exercise program evidence-based and user friendly educational materials with recommendations on breathing and physical exercises will be developed B Patients intake in a zoom meeting a registered therapist Pl in charge of implementing the intervention will request informed consent to participate in the study explain specifics of the intervention to each participant and will conduct an initial assessment C Intervention 8 weeks using the participants initial assessment and personal characteristics the therapist will provide personalized recommendations eg maximum heart rate minimum Sp02 explain the educational materials and instruct patients on safety precautions how to pace themselves when to seek professional or emergency care All participants and immediate caregiver I necessary will receive training 1 basic device management join a zoom meeting watch a YouTube video 2 use of the portable spirometer and its associated app 3 use of finger pulse oximeter and 4 recording of the values in a dairy Group one will be asked to follow the exercise program with a small group of peers 2 groups6 participants each in a zoom meeting 3 times a week45 min each including 5 min before and 10 min after the meeting for free talk-chat between the participants eg questions perceptions etc The therapist will lead the first three meetings gradually encourage participants to take turns leading the exercises with the goal of identifying empowering potential patient leaders Beginning with the fourth meeting participants will be encouraged to connect to the meeting and follow their exercise program on their own taking into account their individualized recommendations The RA will organize and attend the zoom meetings to resolve general questions eg equipment platforms etc and will act as a direct point of contact between the therapist and the participants Group two will be asked to follow the exercise program 3 times a week30 min each while watching a pre-recorded YouTube video D Self-monitoring patients will be asked to wear the finger pulse oximeter at all times while exercising so that they can control their pace while avoiding exceeding target values HR Sp02 They will be asked to record in their HR and Sp02 values before and after participation in every session of the exercise program in a diary E Support participants will be able to contact the therapist at any time during the study if they have questions or concerns Otherwise they will receive a follow-up phone call once a week from the RA
Intervention A Exercise program evidence-based and user friendly educational materials with recommendations on breathing and physical exercises will be developed B Patients intake in a zoom meeting a registered therapist Pl in charge of implementing the intervention will request informed consent to participate in the study explain specifics of the intervention to each participant and will conduct an initial assessment C Intervention 8 weeks using the participants initial assessment and personal characteristics the therapist will provide personalized recommendations eg maximum heart rate minimum Sp02 explain the educational materials and instruct patients on safety precautions how to pace themselves when to seek professional or emergency care All participants and immediate caregiver I necessary will receive training 1 basic device management join a zoom meeting watch a YouTube video 2 use of the portable spirometer and its associated app 3 use of finger pulse oximeter and 4 recording of the values in a dairy Group one will be asked to follow the exercise program with a small group of peers 2 groups6 participants each in a zoom meeting 3 times a week45 min each including 5 min before and 10 min after the meeting for free talk-chat between the participants eg questions perceptions etc The therapist will lead the first three meetings gradually encourage participants to take turns leading the exercises with the goal of identifying empowering potential patient leaders Beginning with the fourth meeting participants will be encouraged to connect to the meeting and follow their exercise program on their own taking into account their individualized recommendations The RA will organize and attend the zoom meetings to resolve general questions eg equipment platforms etc and will act as a direct point of contact between the therapist and the participants Group two will be asked to follow the exercise program 3 times a week30 min each while watching a pre-recorded YouTube video D Self-monitoring patients will be asked to wear the finger pulse oximeter at all times while exercising so that they can control their pace while avoiding exceeding target values HR Sp02 They will be asked to record in their HR and Sp02 values before and after participation in every session of the exercise program in a diary E Support participants will be able to contact the therapist at any time during the study if they have questions or concerns Otherwise they will receive a follow-up phone call once a week from the RA
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None