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Effect of Pulmonary Telerehabilitation and Telemonitoring for Patients With Chronic Respiratory Diseases

Effect of Pulmonary Telerehabilitation and Telemonitoring for Patients With Chronic Respiratory Diseases: a Feasibility Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05824910
Enrollment
16
Registered
2023-04-24
Start date
2024-05-20
Completion date
2024-12-31
Last updated
2025-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD, Interstitial Lung Disease

Keywords

chronic respiratory diseases, telemonitoring, telerehabilitation, pulmonary rehabilitation

Brief summary

This research study is being conducted to evaluate the feasibility of using technology to deliver a remote home exercise program and assess the health outcomes of patients with chronic lung diseases. Specific objectives are to assess the interventions on patients: 1) Lung function, 2) Dyspnea, 3) Fatigue, 4) Exercise capacity, 5) Self-efficacy, and 6) Health-related quality of life. The investigators will also be evaluating the practicality of using videoconferencing and commercial wearable telemonitoring devices (ie. smart watches) for the implementation of the intervention in this group of patients.

Detailed description

This feasibility study uses a one group pre-post intervention study. In a subsequent stage, the possibility of conducting a matched (age, gender, diagnosis) case-control study comparing the effects of this study with the current Pulmonary Rehab WRHA program on patients' outcomes will be explored. Participants who meet the inclusion criteria will be invited to an initial assessment session of approximately 1 hour (week 0) at the RespirabilityLab (Riverview Health Centre - 4th floor of the Princess Elizabeth Building). A registered therapist 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. Using the participants' initial assessment and personal characteristics, the therapists will provide personalized recommendations (e.g. maximum heart rate, minimum SpO2), and instruct patients on safety precautions (how to pace themselves, when to seek professional or emergency care). All will receive training in 1) basic device management (join a Zoom meeting, and apps needed), 2) use of a portable spirometer, pulse oximeter and smartwatch, and their associated apps. Two groups of 6 patients will complete an 8-week program (2 rounds of 12 participants for a total of 24 participants in total). The exercise program will involve a small group of peers (2 groups/6 participants each) in a Zoom meeting 2 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 RA will organize the Zoom meetings, will resolve general questions (e.g. equipment, platforms, etc.) and will act as a direct point of contact between the therapist and the participants. An education session (\ 30-45 min) will be offered to all participants (12 at a given time) once a week over the 8 weeks on key topics such as managing smoking cessation, managing shortness of breath, exercising with chronic lung disease, managing fatigue, etc. Patients will be asked to always wear a smartwatch and a pulse oximeter while exercising so that they can control their pace while avoiding exceeding target values (HR, Sp02). After each exercise session, participants will be asked to open apps on their smartphone or tablet linked to the wearable devices via Bluetooth so that the data can be transmitted to the research team (Labfront dashboard) or emailed to the RA (CVS format). Participants will be able to contact the therapist or the RA at any time during the study if they have questions or concerns. Otherwise, the patients will be contacted if abnormal values are identified in the telemonitoring data.

Interventions

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

Sponsors

Manitoba Medical Service Foundation
CollaboratorOTHER
University of Manitoba
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

one group pre/post assessment (feasability study)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* confirmed diagnosis of COPD or ILD * living in Manitoba * Access to smart phone or tablet and home internet service

Exclusion criteria

* acute exacerbation of their 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

Design outcomes

Primary

MeasureTime frameDescription
Impact of cough on quality of life8 weeksAssessed with the Leicester Cough Questionnaire (3 - 21 points). Lower scores indicate higher impact of cough on quality of life
Level of Dysphagia8 weeksAssessed with the Sydney Swallow Questionnaire(0-100mm higher represent worse outcome).
Change in Lung Function8 weeks% predicted FEV1 and FVC 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).
Change in Dyspnea8 weeksModified Borg Scale (0 best to 10 worse) will be used to assess dyspnea.
Change in Fatigue8 weeksFatigue severity scale (0 -7 higher worse) will be used to measure the severity of fatigue.
Change in Exercise Capacity8 weeksAssessed with the one-minute sit-to-stand test (number of times the persons can complete the task in one minute).
Change in Self-efficacy8 weeksAssessed using the Self-Efficacy for Managing Chronic Disease 6-Item Scale each rated from 0 not at all confident to 10 totally confident)
Change in Health Relate quality of life8 weeksAssessed with the Clinical COPD Questionnaire (Scored from 0 - 6 \[worse\])
Change in Dyspnea severity8 weeksAssessed with the modified Medical Research Council (0-4 higher is worse outcome).

Secondary

MeasureTime frameDescription
Participant feedback questionnaire8 weeksA questionnaire will be used to capture the participants' level of satisfaction with the study using a 5-points liker scale.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026