COVID-19NCT05003271
Pulmonary Rehabilitation Post-COVID-19
A study testing Exercise program (virtual/remote) in people with COVID-19, run by University of Manitoba at 1 site in Canada.
Trial summary
The main objective of this pilot study was to evaluate the feasibility, safety, and satisfaction of a remote interdisciplinary PR program delivered using two exercise approaches (video conference and self-directed) on the recovery of long-term post-COVD-19 outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Exercise program (virtual/remote)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteCanada
- Study dates
- 4 Apr 2022to 1 Oct 2023
- 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
- Post-COVID-19 ≥ 3 months after infection.
- Mild to severe persistent respiratory symptoms
- Access to a smart phone, tablet or computer, and home internet
Who cannot join
- History of neurological disease or mental illness
- Inability to ambulate independently without supervision
- Inability to complete basic tasks on a smart phone or tablet
- Did not return calls after the initial contact
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pulmonary Rehabilitation Post-COVID-19: a Pilot Study
The main objective of this pilot study was to evaluate the feasibility, safety, and satisfaction of a remote interdisciplinary PR program delivered using two exercise approaches (video conference and self-directed) on the recovery of long-term post-COVD-19 outcomes. The specific aims were i) to evaluate the effect of each of the approaches on patients': 1) lung capacity, 2) dyspnea and fatigue, 3) exercise capacity, 4) physical function, 5) participation, and 5) HRQoL.
Read the detailed description
This pilot study used a two-arm randomized pre- and post-trial design to evaluate the feasibility, safety, and satisfaction of a remote interdisciplinary PR program, delivered using two exercise approaches (video conference and self-directed), on the recovery of long-term post-COVD-19 outcomes (≥ 3 months after infection). Group one (video conference): participants were 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 and perceptions). The therapist organized and led the Zoom meetings to resolve general questions (e.g. equipment, platforms, etc.). Group two: participants were asked to follow the exercise program 3 times a week/30 min each while watching a pre-recorded video created by the research team and uploaded on YouTube. Patients were asked to wear the finger pulse oximeter at all times while exercising, so that they could control their pace while avoiding exceeding target values (HR and SpO2). They were also asked to record their HR and SpO2 values before and after participation in every session of the exercise program in a diary. All participants from both groups could contact the therapist at any time during the study if they had questions or concerns. They also received a follow-up phone call once a week from the therapist.
- Conditions
- COVID-19
- Being tested
- Exercise program (virtual/remote)
- Keywords
- Long COVID-19, Persistent respiratory symptoms
- Medical subject headings
- COVID-19, Post-Acute COVID-19 Syndrome
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 | Group one: participants were 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.). Receives: Other: Exercise program (virtual/remote) |
| YouTube pre-recorded video | Experimental | Group two: participants were asked to follow the exercise program 3 times a week/30 min each while watching a pre-recorded YouTube video. Receives: Other: Exercise program (virtual/remote) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the program
This was determined according to the following criteria: (1) 70% of participants completed the PR program, (2) data on primary outcomes collected in ≥ 70% of participants after the PR program, and (3) < 10% of adverse events related to the intervention.
Measured: 8 weeks (end of the study)
Recruitment rate
Calculated as percentage of potentially eligible participants that were recruited.
Measured: 8 weeks (beginning of the study)
Intervention completion rate
Calculated as the percentage of sessions attended by participants. The number of sessions in the vide conference group was recorded by the therapist who attended Zoom meeting, whereas those in the self-directed group were asked to record the number of sessions in the diary.
Measured: 8 weeks
Dropout rate
Calculated as the proportion of individuals who ceased participation after randomization and before completing 80% of sessions due to adverse events or personal preferences.
Measured: 8 weeks
Patient safety
Represented as the incidence of adverse events caused by the interventions.
Measured: 8 weeks
Patient satisfaction with the program
Participants will complete a short summary with questions regarding their satisfaction with the study
Measured: after 8 weeks (end of the study)
Secondary outcomes (9)
Change in lung capacity
It was 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. The following main variables were used: forced vital capacity, forced expiratory volume in the first second, ratio between forced expiratory volume in the first second and forced vital capacity, and peak expiratory flow.
Measured: 8 weeks
Change in dyspnea
Modified Borg Scale (0 "best" to 10 "worse") was used to assess dyspnea.
Measured: 8 weeks
Changes in fatigue severity assessed with the Fatigue Severity Scale
The Fatigue Severity Scale (0 -7 "higher worse") was used to measure the severity of fatigue. Overall fatigue severity was assessed using the visual analog scale included in the Fatigue Severity Scale (0 "worst" - 10"normal").
Measured: 8 weeks
Changes in fatigue assesses with the DePaul Symptom Questionnaire short-form
The DePaul Symptom Questionnaire short-form assessed the frequency and severity of 14 symptoms (0 - 100, "higher is worst") related to fatigue at rest, post-exertional fatigue, pain, and neurocognitive, autonomic/neuroendrocrine, and immune systems.
Measured: 8 weeks
Change in sit-to-stand capacity
Sit-to-stand capacity was used as a measure of exercise capacity. It was assessed using the one-minute sit-to-stand test (number of times the persons can complete the task in one minute).
Measured: 8 weeks
Change in post-exercise saturation
SpO2 will be measured using a digital fingertip pulse oximeter (LOOKEE®, New York, USA) before-after the one- minute sit-to-stand test.
Measured: 8 weeks
Change in HRQoL
Assessed using the EQ-5D-5L scale (https://euroqol.org/eq-5d-instruments/eq-5d-5l-about/)(mobility, self-care, usual activities, pain/discomfort and anxiety/depression). General health was assessed using a visual analog scale (EQVAS): 0 (worst imaginable health state) and 100 (best imaginable health state today).
Measured: 8 weeks
Change in activities participation
Assessed using the Canadian Occupational Performance Measure (COPM) which focuses on occupational performance in all areas of life, including self-care, leisure, and productivity.
Measured: 8 weeks
Feasibility of collecting data using wearable technology
A subgroup of participants were asked to use a wrist-worn smartwatch and waist-worn accelerometer (non-dominant hip) for seven days.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start4 Apr 2022
- Primary completion30 Aug 2022
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups pre-post assessment (pilot/feasibility study)
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Health Sciences Centre Foundation, Manitoba, Health Sciences Centre, Winnipeg, Manitoba
- 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
- NCT05003271
- Sponsor's protocol ID
- HS25183(B2021:101)
- Status last verified
- Dec 2023
- First submitted
- 6 Aug 2021
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sarmento A, Adodo R, Hodges G, Webber SC, Sanchez-Ramirez DC. Virtual pulmonary rehabilitation approaches in patients with post COVID syndrome: a pilot study. BMC Pulm Med. 2024 Mar 18;24(1):139. doi: 10.1186/s12890-024-02965-3.
PubMed 38500051
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Rehabilitation Post-COVID-19: a Pilot Study
- ClinicalTrials.gov ID
- NCT05003271
- Acronym / sponsor ID
- HS25183(B2021:101)
- Conditions
- COVID-19
- Keywords
- Long COVID-19, Persistent respiratory symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Health Sciences Centre Foundation, Manitoba, Health Sciences Centre, Winnipeg, Manitoba
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 12 Aug 2021 (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.
The main objective of this pilot study was to evaluate the feasibility, safety, and satisfaction of a remote interdisciplinary PR program delivered using two exercise approaches (video conference and self-directed) on the recovery of long-term post-COVD-19 outcomes. The specific aims were i) to evaluate the effect of each of the approaches on patients': 1) lung capacity, 2) dyspnea and fatigue, 3) exercise capacity, 4) physical function, 5) participation, and 5) HRQoL.
Detailed description
This pilot study used a two-arm randomized pre- and post-trial design to evaluate the feasibility, safety, and satisfaction of a remote interdisciplinary PR program, delivered using two exercise approaches (video conference and self-directed), on the recovery of long-term post-COVD-19 outcomes (≥ 3 months after infection). Group one (video conference): participants were 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 and perceptions). The therapist organized and led the Zoom meetings to resolve general questions (e.g. equipment, platforms, etc.). Group two: participants were asked to follow the exercise program 3 times a week/30 min each while watching a pre-recorded video created by the research team and uploaded on YouTube. Patients were asked to wear the finger pulse oximeter at all times while exercising, so that they could control their pace while avoiding exceeding target values (HR and SpO2). They were also asked to record their HR and SpO2 values before and after participation in every session of the exercise program in a diary. All participants from both groups could contact the therapist at any time during the study if they had questions or concerns. They also received a follow-up phone call once a week from the therapist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups pre-post assessment (pilot/feasibility study)
| Arm | Type | Receives |
|---|---|---|
| Small group zoom meeting | Experimental | Other: Exercise program (virtual/remote)Group one: participants were 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.). |
| YouTube pre-recorded video | Experimental | Other: Exercise program (virtual/remote)Group two: participants were asked to follow the exercise program 3 times a week/30 min each while watching a pre-recorded YouTube video. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Post-COVID-19 ≥ 3 months after infection.
- Mild to severe persistent respiratory symptoms
- Access to a smart phone, tablet or computer, and home internet
Key exclusion criteria (4 listed)
- History of neurological disease or mental illness
- Inability to ambulate independently without supervision
- Inability to complete basic tasks on a smart phone or tablet
- Did not return calls after the initial contact
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, YouTube pre-recorded video |
Primary outcome
Feasibility of the program
Time frame: 8 weeks (end of the study)
This was determined according to the following criteria: (1) 70% of participants completed the PR program, (2) data on primary outcomes collected in ≥ 70% of participants after the PR program, and (3) < 10% of adverse events related to the intervention.
Recruitment rate
Time frame: 8 weeks (beginning of the study)
Calculated as percentage of potentially eligible participants that were recruited.
Intervention completion rate
Time frame: 8 weeks
Calculated as the percentage of sessions attended by participants. The number of sessions in the vide conference group was recorded by the therapist who attended Zoom meeting, whereas those in the self-directed group were asked to record the number of sessions in the diary.
Dropout rate
Time frame: 8 weeks
Calculated as the proportion of individuals who ceased participation after randomization and before completing 80% of sessions due to adverse events or personal preferences.
Patient safety
Time frame: 8 weeks
Represented as the incidence of adverse events caused by the interventions.
Patient satisfaction with the program
Time frame: after 8 weeks (end of the study)
Participants will complete a short summary with questions regarding their satisfaction with the study
9 secondary outcomes
Change in lung capacity
Time frame: 8 weeks
Change in dyspnea
Time frame: 8 weeks
Changes in fatigue severity assessed with the Fatigue Severity Scale
Time frame: 8 weeks
Changes in fatigue assesses with the DePaul Symptom Questionnaire short-form
Time frame: 8 weeks
Change in sit-to-stand capacity
Time frame: 8 weeks
Change in post-exercise saturation
Time frame: 8 weeks
Change in HRQoL
Time frame: 8 weeks
Change in activities participation
Time frame: 8 weeks
Feasibility of collecting data using wearable technology
Time frame: 1 week
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 3 Jan 2024.
- Derived from this study: PubMed 38500051Sarmento A, Adodo R, Hodges G, Webber SC, Sanchez-Ramirez DC. Virtual pulmonary rehabilitation approaches in patients with post COVID syndrome: a pilot study. BMC Pulm Med. 2024 Mar 18;24(1):139. doi: 10.1186/s12890-024-02965-3.
- Individual participant dataSharing planned: Undecided
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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 COVID-19, 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 3 Jan 2024. 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?
Feasibility of the program (time frame: 8 weeks (end of the study)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05003271, which also lists 1 linked publication.
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 3 Jan 2024.