Pulmonary Rehabilitation Post-COVID-19: a Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- COVID-19
- Sponsor
- University of Manitoba
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Intervention completion rate
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Diana C Sanchez-Ramirez, PhD
Assistant professor
University of Manitoba
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
- •Did not return calls after the initial contact
Outcomes
Primary Outcomes
Intervention completion rate
Time Frame: 8 weeks
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.
Recruitment rate
Time Frame: 8 weeks (beginning of the study)
Calculated as percentage of potentially eligible participants that were recruited.
Dropout rate
Time Frame: 8 weeks
Calculated as the proportion of individuals who ceased participation after randomization and before completing 80% of sessions due to adverse events or personal preferences.
Feasibility of the program
Time Frame: 8 weeks (end of the study)
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.
Patient safety
Time Frame: 8 weeks
Represented as the incidence of adverse events caused by the interventions.
Patient satisfaction with the program
Time Frame: after 8 weeks (end of the study)
Participants will complete a short summary with questions regarding their satisfaction with the study
Secondary Outcomes
- Changes in fatigue assesses with the DePaul Symptom Questionnaire short-form(8 weeks)
- Change in lung capacity(8 weeks)
- Change in dyspnea(8 weeks)
- Changes in fatigue severity assessed with the Fatigue Severity Scale(8 weeks)
- Change in sit-to-stand capacity(8 weeks)
- Change in post-exercise saturation(8 weeks)
- Change in HRQoL(8 weeks)
- Feasibility of collecting data using wearable technology(1 week)
- Change in activities participation(8 weeks)