Pulmonary Rehabilitation Post-COVID-19

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pulmonary Rehabilitation Post-COVID-19: a Pilot Study

Conditions
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COVID-19

Intervention / Treatment
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* Other: Exercise program (virtual/remote)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two groups pre-post assessment (pilot/feasibility study)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Small group zoom meeting<br>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.). | Other: Exercise program (virtual/remote)<br>* 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.<br>|
| Experimental: YouTube pre-recorded video<br>Group two: will be asked to follow the exercise program 3 times a week/30 min each while watching a pre-recorded YouTube video. | Other: Exercise program (virtual/remote)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 8 weeks | 
| Change in dyspnea | Modified Borg Scale (0 best to 10 worse) will be used to assess dyspnea. | 8 weeks | 
| Change in fatigue | Fatigue severity scale (0 -7 higher worse) will be used to measure the severity of fatigue. | 8 weeks | 
| 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). | 8 weeks | 
| Change in post-exercise saturation | SpO2 will be measured using a digital fingertip pulse oximeter before-after the one- minute sit-to-stand test. | 8 weeks | 
| 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). | 8 weeks | 
| 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. | 8 weeks | 
| Changes in health-related quality of life (HRQoL) assessed with the EQ-5D-5L | EQ-5D-5L scale (0-100 higher better outcome). | 8 weeks | 
| 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). | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms change | Participants will be ask to rate their symptoms from 0-10 using an online form (base on the baseline symptoms) | once a week (week 1 to week 8) | 
| Patient satisfaction with the study | Participants will complete a short summary with questions regarding their satisfaction with the study | 8 week (end of the study) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Long COVID-19, Persistent respiratory symptoms