Pulmonary Rehabilitation Post-COVID-19

University of Manitoba14 enrolled

Overview

The main objective of this pilot study was to evaluate the feasibility, safety, and satisfaction of a remote interdisciplinary PR program delivered using two exercise approaches (video conference and self-directed) on the recovery of long-term post-COVD-19 outcomes. The specific aims were i) to evaluate the effect of each of the approaches on patients': 1) lung capacity, 2) dyspnea and fatigue, 3) exercise capacity, 4) physical function, 5) participation, and 5) HRQoL.

This pilot study used a two-arm randomized pre- and post-trial design to evaluate the feasibility, safety, and satisfaction of a remote interdisciplinary PR program, delivered using two exercise approaches (video conference and self-directed), on the recovery of long-term post-COVD-19 outcomes (≥ 3 months after infection). Group one (video conference): participants were 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 and perceptions). The therapist organized and led the Zoom meetings to resolve general questions (e.g. equipment, platforms, etc.). Group two: participants were asked to follow the exercise program 3 times a week/30 min each while watching a pre-recorded video created by the research team and uploaded on YouTube. Patients were asked to wear the finger pulse oximeter at all times while exercising, so that they could control their pace while avoiding exceeding target values (HR and SpO2). They were also asked to record their HR and SpO2 values before and after participation in every session of the exercise program in a diary. All participants from both groups could contact the therapist at any time during the study if they had questions or concerns. They also received a follow-up phone call once a week from the therapist.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

COVID-19

Interventions

Exercise program (virtual/remote)OTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 * Did not return calls after the initial contact

Locations (1)

U of Manitoba

Winnipeg, Manitoba, Canada

Outcomes

Primary Outcomes

Feasibility of the program

This was determined according to the following criteria: (1) 70% of participants completed the PR program, (2) data on primary outcomes collected in ≥ 70% of participants after the PR program, and (3) \< 10% of adverse events related to the intervention.

Time frame: 8 weeks (end of the study)

Recruitment rate

Calculated as percentage of potentially eligible participants that were recruited.

Time frame: 8 weeks (beginning of the study)

Intervention completion rate

Calculated as the percentage of sessions attended by participants. The number of sessions in the vide conference group was recorded by the therapist who attended Zoom meeting, whereas those in the self-directed group were asked to record the number of sessions in the diary.

Time frame: 8 weeks

Dropout rate

Calculated as the proportion of individuals who ceased participation after randomization and before completing 80% of sessions due to adverse events or personal preferences.

Time frame: 8 weeks

Patient safety

Represented as the incidence of adverse events caused by the interventions.

Time frame: 8 weeks

Patient satisfaction with the program

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

Time frame: after 8 weeks (end of the study)

Secondary Outcomes

Change in lung capacity

It was 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. The following main variables were used: forced vital capacity, forced expiratory volume in the first second, ratio between forced expiratory volume in the first second and forced vital capacity, and peak expiratory flow.

Data from ClinicalTrials.gov

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