Clinical trial NCT05003271: Pulmonary Rehabilitation Post-COVID-19
Official title: Pulmonary Rehabilitation Post-COVID-19: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Keywords: Long COVID-19
Persistent respiratory symptoms
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Health Sciences Centre Foundation, Manitoba
name: Health Sciences Centre, Winnipeg, Manitoba
First posted: 2021-08-12
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups pre-post assessment (pilot/feasibility study)
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Feasibility of the program
timeFrame: 8 weeks (end of the study)
measure: Recruitment rate
timeFrame: 8 weeks (beginning of the study)
measure: Intervention completion rate
timeFrame: 8 weeks
measure: Dropout rate
timeFrame: 8 weeks
measure: Patient safety
timeFrame: 8 weeks
measure: Patient satisfaction with the program
timeFrame: after 8 weeks (end of the study)
Secondary outcomes:
measure: Change in lung capacity
timeFrame: 8 weeks
measure: Change in dyspnea
timeFrame: 8 weeks
measure: Changes in fatigue severity assessed with the Fatigue Severity Scale
timeFrame: 8 weeks
measure: Changes in fatigue assesses with the DePaul Symptom Questionnaire short-form
timeFrame: 8 weeks
measure: Change in sit-to-stand capacity
timeFrame: 8 weeks
measure: Change in post-exercise saturation
timeFrame: 8 weeks
measure: Change in HRQoL
timeFrame: 8 weeks
measure: Change in activities participation
timeFrame: 8 weeks
measure: Feasibility of collecting data using wearable technology
timeFrame: 1 week
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: U of Manitoba
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Diana C Sanchez-Ramirez, PhD
role: PRINCIPAL_INVESTIGATOR
References: