Self-management of Post COVID-19 Syndrome Using Wearable Biometric Technology

May 2, 2025 updated by: Diana C Sanchez-Ramirez, PhD, University of Manitoba
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3L 2P4
        • Riverview Health Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Post-COVID-19 ≥ 3 months after infection.
  • Mild to severe persistent respiratory symptoms
  • Access to a home internet

Exclusion Criteria:

  • History of neurological disease or mental illness
  • Inability to ambulate independently without supervision
  • Inability to complete basic tasks on a smart phone or tablet

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: One arm
Self-management group. This pilot-study uses a one-group before-after design.
Other: Self-management of post COVID-19 respiratory outcomes
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6 weeks
Change in dyspnea
Time Frame: 6 weeks
Modified Borg Scale (0 "best" to 10 "worse dyspnea") will be used to assess dyspnea.
6 weeks
Change in fatigue
Time Frame: 6 weeks
Fatigue severity scale (0 -7 "more fatigue") will be used to measure the severity of fatigue.
6 weeks
Chronic fatigue syndrome
Time Frame: 6 weeks
DePaul Symptoms Questionnaire short form (DSQ-SF) (0 "not present" - 4 "very severe")
6 weeks
Health-related quality of life
Time Frame: 6 weeks
EuroQol five-dimensional questionnaire (0 "worse health" to 100 "best health")
6 weeks
Postural orthostatic hypotension
Time Frame: 6 weeks
Orthostatic Stress Test (Postural transitions)
6 weeks
Exercise capacity
Time Frame: 6 weeks
The 6-min walk test (6 MWT) and the one-minute sit-to-stand test
6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Symptoms change
Time Frame: 6 weeks
Participants will be ask to rate their symptoms from 0-10 using an online form (base on the baseline symptoms)
6 weeks
Patient satisfaction with the study
Time Frame: 6 week
Participants will complete a short summary with questions regarding their satisfaction with the study
6 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Manitoba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 28, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 18, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HS25512(B2020:042

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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