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Pulmonary Rehabilitation Post-COVID-19

Primary Purpose

COVID-19

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Exercise program (virtual/remote)
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring Long COVID-19, Persistent respiratory symptoms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Post-COVID-19 ≥ 3 months after infection.
  • Mild to severe persistent respiratory symptoms
  • Access to a smart phone, tablet or computer and 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

Sites / Locations

  • U of Manitoba

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Small group zoom meeting

YouTube pre-recorded video

Arm Description

Group one: will be asked to follow the exercise program with a small group of peers (2 groups/6 participants each) in a zoom meeting 3 times a week/45 min each (including 5 min before and 10 min after the meeting for free talk-chat between the participants e.g. questions, perceptions, etc.).

Group two: will be asked to follow the exercise program 3 times a week/30 min each while watching a pre-recorded YouTube video.

Outcomes

Primary Outcome Measures

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.
Change in dyspnea
Modified Borg Scale (0 "best" to 10 "worse") will be used to assess dyspnea.
Change in fatigue
Fatigue severity scale (0 -7 "higher worse") will be used to measure the severity of fatigue.
Change in exercise capacity
Assessed with the one-minute sit-to-stand test (number of times the persons can complete the task in one minute).
Change in post-exercise saturation
SpO2 will be measured using a digital fingertip pulse oximeter before-after the one- minute sit-to-stand test.
Change in physical function
Assessed using the EQ-5D-5L scale (https://euroqol.org/eq-5d-instruments/eq-5d-5l-about/)(mobility, self-care, usual activities, pain/discomfort and anxiety/depression) (0-100 higher better outcome).
Change in activities participation
Assessed using the Canadian Occupational Performance Measure (COPM) which focuses on occupational performance in all areas of life, including self-care, leisure and productivity.
Changes in health-related quality of life (HRQoL) assessed with the EQ-5D-5L
EQ-5D-5L scale (0-100 higher better outcome).
Changes in health-related quality of life (HRQoL) assessed with the Short form (SF)-36 questionnaire
Short form (SF)-36 questionnaire (0-100 higher better outcome).

Secondary Outcome Measures

Symptoms change
Participants will be ask to rate their symptoms from 0-10 using an online form (base on the baseline symptoms)
Patient satisfaction with the study
Participants will complete a short summary with questions regarding their satisfaction with the study

Full Information

First Posted
August 6, 2021
Last Updated
February 22, 2023
Sponsor
University of Manitoba
Collaborators
Health Sciences Centre Foundation, Manitoba, Health Sciences Centre, Winnipeg, Manitoba
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1. Study Identification

Unique Protocol Identification Number
NCT05003271
Brief Title
Pulmonary Rehabilitation Post-COVID-19
Official Title
Pulmonary Rehabilitation Post-COVID-19: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 4, 2022 (Actual)
Primary Completion Date
August 30, 2022 (Actual)
Study Completion Date
October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba
Collaborators
Health Sciences Centre Foundation, Manitoba, Health Sciences Centre, Winnipeg, Manitoba

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The main objective of this pilot study is to evaluate the effect of a remote interdisciplinary PR program that is delivered using two exercise approaches on the recovery of long-term post-COVD-19 outcomes. The specific aims are i) to evaluate the effect of the program and ii) each of the approaches on patients': 1) lung capacity, 2) dyspnea and fatigue, 3) exercise capacity, 4) physical function, 5) participation, and 5) HRQoL.
Detailed Description
This pilot study uses a two-arm randomized pre- and post-trial design to evaluate the effect of a remote interdisciplinary PR program, delivered using two exercise approaches, on the recovery of long-term post-COVD-19 outcomes (≥ 3 months after infection). Group one: will be asked to follow the exercise program with a small group of peers (2 groups/6 participants each) in a zoom meeting 3 times a week/45 min each {including 5 min before and 10 min after the meeting for free talk-chat between the participants e.g. questions, perceptions, etc.). The therapist will lead the first three meetings, gradually encourage participants to take turns leading the exercises with the goal of identifying /empowering potential patient leaders. Beginning with the fourth meeting, participants will be encouraged to connect to the meeting and follow their exercise program on their own, taking into account their individualized recommendations. The RA will organize and attend the zoom meetings to resolve general questions (e.g. equipment, platforms, etc.) and will act as a direct point of contact between the therapist and the participants. Group two: will be asked to follow the exercise program 3 times a week/30 min each while watching a pre-recorded YouTube video. D) Self-monitoring: patients will be asked to wear the finger pulse oximeter at all times while exercising, so that they can control their pace while avoiding exceeding target values (HR, Sp02). They will be asked to record in their HR and Sp02 values before and after participation in every session of the exercise program in a diary. E) Support: participants will be able to contact the therapist at any time during the study if they have questions or concerns. Otherwise, they will receive a follow-up phone call once a week from the RA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
Long COVID-19, Persistent respiratory symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups pre-post assessment (pilot/feasibility study)
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Small group zoom meeting
Arm Type
Experimental
Arm Description
Group one: will be asked to follow the exercise program with a small group of peers (2 groups/6 participants each) in a zoom meeting 3 times a week/45 min each (including 5 min before and 10 min after the meeting for free talk-chat between the participants e.g. questions, perceptions, etc.).
Arm Title
YouTube pre-recorded video
Arm Type
Experimental
Arm Description
Group two: will be asked to follow the exercise program 3 times a week/30 min each while watching a pre-recorded YouTube video.
Intervention Type
Other
Intervention Name(s)
Exercise program (virtual/remote)
Intervention Description
Intervention (8 weeks): using the participants' initial assessment and personal characteristics, the therapist will provide personalized recommendations (e.g. maximum heart rate, minimum SpO2), explain the educational materials, and instruct patients on safety precautions.
Primary Outcome Measure Information:
Title
Change in lung capacity
Description
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.
Time Frame
8 weeks
Title
Change in dyspnea
Description
Modified Borg Scale (0 "best" to 10 "worse") will be used to assess dyspnea.
Time Frame
8 weeks
Title
Change in fatigue
Description
Fatigue severity scale (0 -7 "higher worse") will be used to measure the severity of fatigue.
Time Frame
8 weeks
Title
Change in exercise capacity
Description
Assessed with the one-minute sit-to-stand test (number of times the persons can complete the task in one minute).
Time Frame
8 weeks
Title
Change in post-exercise saturation
Description
SpO2 will be measured using a digital fingertip pulse oximeter before-after the one- minute sit-to-stand test.
Time Frame
8 weeks
Title
Change in physical function
Description
Assessed using the EQ-5D-5L scale (https://euroqol.org/eq-5d-instruments/eq-5d-5l-about/)(mobility, self-care, usual activities, pain/discomfort and anxiety/depression) (0-100 higher better outcome).
Time Frame
8 weeks
Title
Change in activities participation
Description
Assessed using the Canadian Occupational Performance Measure (COPM) which focuses on occupational performance in all areas of life, including self-care, leisure and productivity.
Time Frame
8 weeks
Title
Changes in health-related quality of life (HRQoL) assessed with the EQ-5D-5L
Description
EQ-5D-5L scale (0-100 higher better outcome).
Time Frame
8 weeks
Title
Changes in health-related quality of life (HRQoL) assessed with the Short form (SF)-36 questionnaire
Description
Short form (SF)-36 questionnaire (0-100 higher better outcome).
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Symptoms change
Description
Participants will be ask to rate their symptoms from 0-10 using an online form (base on the baseline symptoms)
Time Frame
once a week (week 1 to week 8)
Title
Patient satisfaction with the study
Description
Participants will complete a short summary with questions regarding their satisfaction with the study
Time Frame
8 week (end of the study)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Post-COVID-19 ≥ 3 months after infection. Mild to severe persistent respiratory symptoms Access to a smart phone, tablet or computer and 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diana C Sanchez-Ramirez, PhD
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
U of Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0T6
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Pulmonary Rehabilitation Post-COVID-19

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