Pulmonary Rehabilitation Post-COVID-19

COVID-19 Clinical Trial

Official title:

Pulmonary Rehabilitation Post-COVID-19: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05003271
• Other study ID #: HS25183(B2021:101)
• Status: Completed
• Phase: N/A
• Start date: April 4, 2022
• Est. completion date: October 1, 2023

Study information

• Verified date: December 2023
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: October 1, 2023
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Other:
• Exercise program (virtual/remote)
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.

Locations

Country	Name	City	State
Canada	U of Manitoba	Winnipeg	Manitoba

Sponsors (3)

Lead Sponsor	Collaborator
University of Manitoba	Health Sciences Centre Foundation, Manitoba, Health Sciences Centre, Winnipeg, Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 weeks (end of the study)
Primary	Recruitment rate	Calculated as percentage of potentially eligible participants that were recruited.	8 weeks (beginning of the study)
Primary	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.	8 weeks
Primary	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.	8 weeks
Primary	Patient safety	Represented as the incidence of adverse events caused by the interventions.	8 weeks
Primary	Patient satisfaction with the program	Participants will complete a short summary with questions regarding their satisfaction with the study	after 8 weeks (end of the study)
Secondary	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.	8 weeks
Secondary	Change in dyspnea	Modified Borg Scale (0 "best" to 10 "worse") was used to assess dyspnea.	8 weeks
Secondary	Changes in fatigue severity assessed with the Fatigue Severity Scale	The Fatigue Severity Scale (0 -7 "higher worse") was used to measure the severity of fatigue. Overall fatigue severity was assessed using the visual analog scale included in the Fatigue Severity Scale (0 "worst" - 10"normal").	8 weeks
Secondary	Changes in fatigue assesses with the DePaul Symptom Questionnaire short-form	The DePaul Symptom Questionnaire short-form assessed the frequency and severity of 14 symptoms (0 - 100, "higher is worst") related to fatigue at rest, post-exertional fatigue, pain, and neurocognitive, autonomic/neuroendrocrine, and immune systems.	8 weeks
Secondary	Change in sit-to-stand capacity	Sit-to-stand capacity was used as a measure of exercise capacity. It was assessed using the one-minute sit-to-stand test (number of times the persons can complete the task in one minute).	8 weeks
Secondary	Change in post-exercise saturation	SpO2 will be measured using a digital fingertip pulse oximeter (LOOKEE®, New York, USA) before-after the one- minute sit-to-stand test.	8 weeks
Secondary	Change in HRQoL	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). General health was assessed using a visual analog scale (EQVAS): 0 (worst imaginable health state) and 100 (best imaginable health state today).	8 weeks
Secondary	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
Secondary	Feasibility of collecting data using wearable technology	A subgroup of participants were asked to use a wrist-worn smartwatch and waist-worn accelerometer (non-dominant hip) for seven days.	1 week