COPDNCT05824910
Effect of Pulmonary Telerehabilitation and Telemonitoring for Patients With Chronic Respiratory Diseases
A study testing Exercise program (virtual/remote) in people with COPD and Interstitial Lung Disease, run by University of Manitoba at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD, Interstitial Lung Disease
- What is being tested?
- Exercise program (virtual/remote)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- 20 May 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- confirmed diagnosis of COPD or ILD
- living in Manitoba
- Access to smart phone or tablet and home internet service
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Pulmonary Telerehabilitation and Telemonitoring for Patients With Chronic Respiratory Diseases: a Feasibility Study
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.
Read the 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.
- Conditions
- COPD, Interstitial Lung Disease
- Being tested
- Exercise program (virtual/remote)
- Keywords
- chronic respiratory diseases, telemonitoring, telerehabilitation, pulmonary rehabilitation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Small group zoom meeting | Experimental | 2 groups of 6 participants will be asked to follow the exercise program with their peers in a zoom meeting 3 times a week for 45 min each time. This time includes 5 min before and 10 min after for free talk and chat between participants. There will also be a weekly zoom education session for 30min. Receives: Other: Exercise program (virtual/remote) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Lung Function
% 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).
Measured: 8 weeks
Change in Dyspnea
Modified Borg Scale (0 "best" to 10 "worse") will be used to assess dyspnea.
Measured: 8 weeks
Change in Fatigue
Fatigue severity scale (0 -7 "higher worse") will be used to measure the severity of fatigue.
Measured: 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).
Measured: 8 weeks
Change in Self-efficacy
Assessed using the Self-Efficacy for Managing Chronic Disease 6-Item Scale each rated from 0 "not at all confident" to 10 "totally confident")
Measured: 8 weeks
Change in Health Relate quality of life
Assessed with the Clinical COPD Questionnaire (Scored from 0 - 6 [worse])
Measured: 8 weeks
Change in Dyspnea severity
Assessed with the modified Medical Research Council (0-4 "higher is worse outcome").
Measured: 8 weeks
Impact of cough on quality of life
Assessed with the Leicester Cough Questionnaire (3 - 21 points). Lower scores indicate higher impact of cough on quality of life
Measured: 8 weeks
Level of Dysphagia
Assessed with the Sydney Swallow Questionnaire(0-100mm "higher represent worse outcome").
Measured: 8 weeks
Change in Health Relate quality of life
Assessed with the St. George's Respiratory Questionnaire. Total score is calculated from 0 (no health impairment) to 100 (maximum health impairment)
Measured: 8 weeks
Secondary outcomes (1)
Participant feedback questionnaire
A questionnaire will be used to capture the participants' level of satisfaction with the study using a 5-points liker scale.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start20 May 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- one group pre/post assessment (feasability study)
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Manitoba Medical Service Foundation
- Responsible party
- Principal investigator, Diana C Sanchez-Ramirez, PhD, University of Manitoba
- Investigators
- Diana C Sanchez-Ramirez, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05824910
- Sponsor's protocol ID
- HS25892 (B2023:030)
- Status last verified
- May 2025
- First submitted
- 13 Mar 2023
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pulmonary Telerehabilitation and Telemonitoring for Patients With Chronic Respiratory Diseases: a Feasibility Study
- ClinicalTrials.gov ID
- NCT05824910
- Acronym / sponsor ID
- HS25892 (B2023:030)
- Conditions
- COPD, Interstitial Lung Disease
- Keywords
- chronic respiratory diseases, telemonitoring, telerehabilitation, pulmonary rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Manitoba Medical Service Foundation
- Study start
- 20 May 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 24 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- one group pre/post assessment (feasability study)
| Arm | Type | Receives |
|---|---|---|
| Small group zoom meeting | Experimental | Other: Exercise program (virtual/remote)2 groups of 6 participants will be asked to follow the exercise program with their peers in a zoom meeting 3 times a week for 45 min each time. This time includes 5 min before and 10 min after for free talk and chat between participants. There will also be a weekly zoom education session for 30min. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- confirmed diagnosis of COPD or ILD
- living in Manitoba
- Access to smart phone or tablet and home internet service
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise program (virtual/remote)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 | Other | Small group zoom meeting |
Primary outcome
Change in Lung Function
Time frame: 8 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 Dyspnea
Time frame: 8 weeks
Modified Borg Scale (0 "best" to 10 "worse") will be used to assess dyspnea.
Change in Fatigue
Time frame: 8 weeks
Fatigue severity scale (0 -7 "higher worse") will be used to measure the severity of fatigue.
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).
Change in Self-efficacy
Time frame: 8 weeks
Assessed 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 life
Time frame: 8 weeks
Assessed with the Clinical COPD Questionnaire (Scored from 0 - 6 [worse])
Change in Dyspnea severity
Time frame: 8 weeks
Assessed with the modified Medical Research Council (0-4 "higher is worse outcome").
Impact of cough on quality of life
Time frame: 8 weeks
Assessed with the Leicester Cough Questionnaire (3 - 21 points). Lower scores indicate higher impact of cough on quality of life
Level of Dysphagia
Time frame: 8 weeks
Assessed with the Sydney Swallow Questionnaire(0-100mm "higher represent worse outcome").
Change in Health Relate quality of life
Time frame: 8 weeks
Assessed with the St. George's Respiratory Questionnaire. Total score is calculated from 0 (no health impairment) to 100 (maximum health impairment)
1 secondary outcome
Participant feedback questionnaire
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diana C Sanchez-Ramirez, PhD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise program (virtual/remote) in people with COPD and Interstitial Lung Disease, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Lung Function (time frame: 8 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2025.