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

NCT ID: NCT05507190

Last Updated: 2025-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2024-06-30

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

One arm

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

Group Type: EXPERIMENTAL

Self-management of post COVID-19 respiratory outcomes

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Diana C Sanchez-Ramirez, PhD

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Riverview Health Centre

Winnipeg, Manitoba, Canada

Countries

Canada

Other Identifiers

HS25512(B2020:042

Identifier Type: -

Identifier Source: org_study_id