COVID-19NCT05507190
Self-management of Post COVID-19 Syndrome Using Wearable Biometric Technology
A study testing Self-management of post COVID-19 respiratory outcomes in people with COVID-19, run by University of Manitoba at 1 site in Canada.
Trial summary
The main objective of this pilot study is to evaluate the impact of a self-management intervention using wearable biometric technology on post-COVID-19 syndrome. In addition, this pilot-study will provide information regarding validity, feasibility, patient compliance and satisfaction, valuable for the design of a… 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?
- Self-management of post COVID-19 respiratory outcomes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2023to 30 Jun 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
- Post-COVID-19 ≥ 3 months after infection.
- Mild to severe persistent respiratory symptoms
- Access to a 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
Trial locations and contacts
1 site in 1 country.
About this study
The main objective of this pilot study is to evaluate the impact of a self-management intervention using wearable biometric technology on post-COVID-19 syndrome. In addition, this pilot-study will provide information regarding validity, feasibility, patient compliance and satisfaction, valuable for the design of a future large-scale study.
Read the detailed description
This pilot-study uses a one-group before-after design. Subjects: a convenience sample of 20 adults 18 years and older in the Winnipeg Health Region with a post-COVID-19 infection (≥ 3 months since acute infection) complaining of mild to severe persistent respiratory symptoms. Intervention: using the participants' initial assessment, personal characteristics, main complaints/needs and goals, the therapist will adjust the exercise plan and personalize the recommendations (e.g. maximum heart rate) as well as instruct the patients about safety precautions (how to pace themselves, when to seek professional or emergency care). Participants will be encouraged to wear the smart shirt as much as they want during the 6 weeks (29), but at a minimum of 1-hour a day (M-F) including while performing the recommended exercises (30-45 min/3 times a week). They should self-monitor their biometric values trying to reach/stay within the target values while wearing the shirt using Hexoskin app installed on an iPad provided by the research team or on the participants' personal device if preferred. Patients will also complete an online survey reporting symptoms intensity and activities completed, 3 times a week (over 6 weeks). Participants would be able to contact the research assistant overseeing the intervention at any time of the study if they have questions or concerns (text message or email). Otherwise, they will receive a follow-up phone call every week or if a significant change in their biometrical data is identified.
- Conditions
- COVID-19
- Being tested
- Self-management of post COVID-19 respiratory outcomes
- Keywords
- Long COVID-19, Persistent symptoms, Self-management
- 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.
Self-management of post COVID-19 respiratory outcomesOther
Intervention: using the participants' initial assessment, personal characteristics, main complaints/needs and goals, the therapist will adjust the exercise plan and personalize the recommendations (e.g. maximum heart rate) as well as instruct the patients about safety precautions (how to pace themselves, when to seek professional or emergency care). Participants will be encouraged to wear the smart shirt as much as they want during the 6 weeks (29), but at a minimum of 1-hour a day (M-F) including while performing the recommended exercises (30-45 min/3 times a week). They should self-monitor their biometric values trying to reach/stay within the target values while wearing the shirt using Hexoskin app installed on an iPad provided by the research team or on the participants' personal device if preferred.
| Study group | Role | What they receive |
|---|---|---|
| One arm | Experimental | Self-management group. This pilot-study uses a one-group before-after design. Receives: Other: Self-management of post COVID-19 respiratory outcomes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Change in dyspnea
Modified Borg Scale (0 "best" to 10 "worse dyspnea") will be used to assess dyspnea.
Measured: 6 weeks
Change in fatigue
Fatigue severity scale (0 -7 "more fatigue") will be used to measure the severity of fatigue.
Measured: 6 weeks
Chronic fatigue syndrome
DePaul Symptoms Questionnaire short form (DSQ-SF) (0 "not present" - 4 "very severe")
Measured: 6 weeks
Health-related quality of life
EuroQol five-dimensional questionnaire (0 "worse health" to 100 "best health")
Measured: 6 weeks
Postural orthostatic hypotension
Orthostatic Stress Test (Postural transitions)
Measured: 6 weeks
Exercise capacity
The 6-min walk test (6 MWT) and the one-minute sit-to-stand test
Measured: 6 weeks
Secondary outcomes (2)
Symptoms change
Participants will be ask to rate their symptoms from 0-10 using an online form (base on the baseline symptoms)
Measured: 6 weeks
Patient satisfaction with the study
Participants will complete a short summary with questions regarding their satisfaction with the study
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start1 Dec 2023
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diana C Sanchez-Ramirez, PhD, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05507190
- Sponsor's protocol ID
- HS25512(B2020:042
- Status last verified
- May 2025
- First submitted
- 28 Jul 2022
- 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
- Self-management of Post COVID-19 Syndrome Using Wearable Biometric Technology
- ClinicalTrials.gov ID
- NCT05507190
- Acronym / sponsor ID
- HS25512(B2020:042
- Conditions
- COVID-19
- Keywords
- Long COVID-19, Persistent symptoms, Self-management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 18 Aug 2022 (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 is to evaluate the impact of a self-management intervention using wearable biometric technology on post-COVID-19 syndrome. In addition, this pilot-study will provide information regarding validity, feasibility, patient compliance and satisfaction, valuable for the design of a future large-scale study.
Detailed description
This pilot-study uses a one-group before-after design. Subjects: a convenience sample of 20 adults 18 years and older in the Winnipeg Health Region with a post-COVID-19 infection (≥ 3 months since acute infection) complaining of mild to severe persistent respiratory symptoms. Intervention: using the participants' initial assessment, personal characteristics, main complaints/needs and goals, the therapist will adjust the exercise plan and personalize the recommendations (e.g. maximum heart rate) as well as instruct the patients about safety precautions (how to pace themselves, when to seek professional or emergency care). Participants will be encouraged to wear the smart shirt as much as they want during the 6 weeks (29), but at a minimum of 1-hour a day (M-F) including while performing the recommended exercises (30-45 min/3 times a week). They should self-monitor their biometric values trying to reach/stay within the target values while wearing the shirt using Hexoskin app installed on an iPad provided by the research team or on the participants' personal device if preferred. Patients will also complete an online survey reporting symptoms intensity and activities completed, 3 times a week (over 6 weeks). Participants would be able to contact the research assistant overseeing the intervention at any time of the study if they have questions or concerns (text message or email). Otherwise, they will receive a follow-up phone call every week or if a significant change in their biometrical data is identified.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One arm | Experimental | Other: Self-management of post COVID-19 respiratory outcomesSelf-management group. This pilot-study uses a one-group before-after design. |
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 home internet
Key exclusion criteria (3 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
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 |
|---|---|---|
| Self-management of post COVID-19 respiratory outcomesIntervention: using the participants' initial assessment, personal characteristics, main complaints/needs and goals, the therapist will adjust the exercise plan and personalize the recommendations (e.g. maximum heart rate) as well as instruct the patients about safety precautions (how to pace themselves, when to seek professional or emergency care). Participants will be encouraged to wear the smart shirt as much as they want during the 6 weeks (29), but at a minimum of 1-hour a day (M-F) including while performing the recommended exercises (30-45 min/3 times a week). They should self-monitor their biometric values trying to reach/stay within the target values while wearing the shirt using Hexoskin app installed on an iPad provided by the research team or on the participants' personal device if preferred. | Other | One arm |
Primary outcome
Change in lung capacity
Time frame: 6 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.
Change in dyspnea
Time frame: 6 weeks
Modified Borg Scale (0 "best" to 10 "worse dyspnea") will be used to assess dyspnea.
Change in fatigue
Time frame: 6 weeks
Fatigue severity scale (0 -7 "more fatigue") will be used to measure the severity of fatigue.
Chronic fatigue syndrome
Time frame: 6 weeks
DePaul Symptoms Questionnaire short form (DSQ-SF) (0 "not present" - 4 "very severe")
Health-related quality of life
Time frame: 6 weeks
EuroQol five-dimensional questionnaire (0 "worse health" to 100 "best health")
Postural orthostatic hypotension
Time frame: 6 weeks
Orthostatic Stress Test (Postural transitions)
Exercise capacity
Time frame: 6 weeks
The 6-min walk test (6 MWT) and the one-minute sit-to-stand test
2 secondary outcomes
Symptoms change
Time frame: 6 weeks
Patient satisfaction with the study
Time frame: 6 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 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-management of post COVID-19 respiratory outcomes 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 3 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 capacity (time frame: 6 weeks). The study lists 7 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.