Virtual Exercise Program in Interstitial Lung Disease (ILD) Patients

NCT04946708 | Completed

• 1 other identifier: HS24936 (B2021:051)
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Interstitial Lung Disease

Outcome Measures

Primary Outcomes (7)

• Change in lung capacity

  It will be assessed using a SpiroBank Smart F/V multi parameter spirometer (MIR) at pre-post intervention and once a week in between to monitor changes. This portable spirometer, which is MDSAP approved and complaint with ATS/ERS guidelines, connects automatically via Bluetooth to an iOS \& Android compatible App (MIR Spirobank). It provides real time feedback through messages and animation on smartphone, to improve personal compliance during the test. The app can generate test results PDF printout with information regarding 19 parameters of lung capacity.

  8 weeks

• Change in dyspnea

  Modified Borg Scale (0 "none" to 10 "maximum") will be used to assess dyspnea.

  8 weeks

• Change in fatigue

  Fatigue severity scale (0 -7 "higher worse") will be used to measure the severity of fatigue.

  8 weeks

• Change in exercise capacity

  Assessed with the one-minute sit-to-stand test (number of times the persons can complete the task in one minute).

  8 weeks

• Change in post-exercise saturation

  SpO2 will be measured using a digital fingertip pulse oximeter before-after the one- minute sit-to-stand test.

  8 weeks

• Change in physical function

  Assessed using the EQ-5D-5L scale (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) (0-100 higher better function).

  8 weeks

• Changes in health-related quality of life (HRQoL)

  Assessed with the King's Brief Interstitial Lung Disease (KBILD), which is an ILD-specific measure of HRQoL. Total score ranges are 0-100 (100 represents best HRQoL).

  8 weeks

Study Arms (2)

Small group zoom meeting

EXPERIMENTAL

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.).

Other: Exercise program (virtual/remote)

YouTube pre-recorded video

EXPERIMENTAL

Group two: will be asked to follow the exercise program 3 times a week/30 min each while watching a pre-recorded YouTube video.

Other: Exercise program (virtual/remote)

Interventions

Exercise program (virtual/remote) OTHER

Intervention (8 weeks): using the participants' initial assessment and personal characteristics, the therapist will provide personalized recommendations (e.g. maximum heart rate, minimum SpO2), explain the educational materials, and instruct patients on safety precautions. All participants (and immediate caregiver if necessary) will receive training in: 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.

Small group zoom meeting; YouTube pre-recorded video

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

U of Manitoba

Winnipeg, Manitoba, R3E 0T6, Canada

Location

Related Publications (23)

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MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: Two groups pre-post assessment (pilot/feasibility study)

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: July 1, 2021
• Study Start: September 1, 2021
• Primary Completion: December 17, 2021
• Study Completion: May 17, 2022
• Last Updated: May 18, 2022

Record last verified: 2022-05

Locations

CA (1)