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

NCT05507190 | Completed

• 1 other identifier: HS25512(B2020:042
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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 future large-scale study.

Conditions

COVID-19

Keywords

Long COVID-19; Persistent symptoms; Self-management

Outcome Measures

Primary Outcomes (7)

• 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.

  6 weeks

• Change in dyspnea

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

  6 weeks

• Change in fatigue

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

  6 weeks

• Chronic fatigue syndrome

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

  6 weeks

• Health-related quality of life

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

  6 weeks

• Postural orthostatic hypotension

  Orthostatic Stress Test (Postural transitions)

  6 weeks

• Exercise capacity

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

  6 weeks

Secondary Outcomes (2)

• Symptoms change

  6 weeks

• Patient satisfaction with the study

  6 week

Study Arms (1)

One arm

EXPERIMENTAL

Self-management group. This pilot-study uses a one-group before-after design.

Other: Self-management of post COVID-19 respiratory outcomes

Interventions

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.

One arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Riverview Health Centre

Winnipeg, Manitoba, R3L 2P4, Canada

Location

MeSH Terms

Conditions

COVID-19; Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 18, 2022
• Study Start: December 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: May 4, 2025

Record last verified: 2025-05

Locations

CA (1)