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Completed

NCT Number: NCT04946708

Virtual Exercise Program in Interstitial Lung Disease (ILD) Patients

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.

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Key information

Conditions

Interstitial Lung Disease Lung Diseases Lung Diseases, Interstitial Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

U of Manitoba

Winnipeg, Manitoba, R3E 0T6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in lung capacity

    Time frame: 8 weeks

    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.

  2. Change in dyspnea

    Time frame: 8 weeks

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

  3. Change in fatigue

    Time frame: 8 weeks

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

  4. Change in exercise capacity

    Time frame: 8 weeks

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

  5. Change in post-exercise saturation

    Time frame: 8 weeks

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

  6. Change in physical function

    Time frame: 8 weeks

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

  7. Changes in health-related quality of life (HRQoL)

    Time frame: 8 weeks

    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).

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Registry information

Official study title

Using Technology to Engage Patients With Interstitial Lung Disease (ILD) in a Home a Home Exercise Program.

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Jul 1, 2021
Registry last updated
May 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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