Clinical trial NCT04946708: Virtual Exercise Program in Interstitial Lung Disease (ILD) Patients
Official title: Using Technology to Engage Patients With Interstitial Lung Disease (ILD) in a Home a Home Exercise Program.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Interstitial Lung Disease
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2021-07-01
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups pre-post assessment (pilot/feasibility study)
Primary purpose: TREATMENT

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 (e.g. 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 groups/6 participants each) in a zoom meeting 3 times a week/45 min each {including 5 min before and 10 min after the meeting for free talk-chat between the participants e.g. 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 (e.g. 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 week/30 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.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of interstitial lung disease
* Access to a smart phone or tablet and home internet

Exclusion Criteria:

* Acute exacerbation of their ILDs condition
* History of neurological disease or mental illness
* Inability to ambulate independently without supervision
* Inability to complete basic tasks on a smart phone or tablet

Primary outcomes:
measure: Change in lung capacity
timeFrame: 8 weeks
measure: Change in dyspnea
timeFrame: 8 weeks
measure: Change in fatigue
timeFrame: 8 weeks
measure: Change in exercise capacity
timeFrame: 8 weeks
measure: Change in post-exercise saturation
timeFrame: 8 weeks
measure: Change in physical function
timeFrame: 8 weeks
measure: Changes in health-related quality of life (HRQoL)
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: U of Manitoba
state: Manitoba
Study officials:
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