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Completed

NCT Number: NCT05507190

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-management of post COVID-19 respiratory outcomes

Other

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.

Primary outcomes

  1. 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.

  2. Change in dyspnea

    Time frame: 6 weeks

    Modified Borg Scale (0 "best" to 10 "worse dyspnea") will be used to assess dyspnea.

  3. Change in fatigue

    Time frame: 6 weeks

    Fatigue severity scale (0 -7 "more fatigue") will be used to measure the severity of fatigue.

  4. Chronic fatigue syndrome

    Time frame: 6 weeks

    DePaul Symptoms Questionnaire short form (DSQ-SF) (0 "not present" - 4 "very severe")

  5. Health-related quality of life

    Time frame: 6 weeks

    EuroQol five-dimensional questionnaire (0 "worse health" to 100 "best health")

  6. Postural orthostatic hypotension

    Time frame: 6 weeks

    Orthostatic Stress Test (Postural transitions)

  7. Exercise capacity

    Time frame: 6 weeks

    The 6-min walk test (6 MWT) and the one-minute sit-to-stand test

Secondary outcomes

  1. 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)

  2. Patient satisfaction with the study

    Time frame: 6 week

    Participants will complete a short summary with questions regarding their satisfaction with the study

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 18, 2022
Registry last updated
May 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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