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Completed

NCT Number: NCT05003271

Pulmonary Rehabilitation Post-COVID-19

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.

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Key information

Conditions

COVID-19 Chronic Disease Coronaviridae Infections Coronavirus Infections Disease Attributes Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Post-Acute COVID-19 Syndrome Post-Infectious Disorders RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

U of Manitoba

Winnipeg, Manitoba, R3E 0T6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. Recruitment rate

    Time frame: 8 weeks (beginning of the study)

    Calculated as percentage of potentially eligible participants that were recruited.

  3. 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.

  4. 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.

  5. Patient safety

    Time frame: 8 weeks

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

  6. 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

  1. Change in lung capacity

    Time frame: 8 weeks

    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.

  2. Change in dyspnea

    Time frame: 8 weeks

    Modified Borg Scale (0 "best" to 10 "worse") was used to assess dyspnea.

  3. Changes in fatigue severity assessed with the Fatigue Severity Scale

    Time frame: 8 weeks

    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").

  4. Changes in fatigue assesses with the DePaul Symptom Questionnaire short-form

    Time frame: 8 weeks

    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.

  5. Change in sit-to-stand capacity

    Time frame: 8 weeks

    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).

  6. Change in post-exercise saturation

    Time frame: 8 weeks

    SpO2 will be measured using a digital fingertip pulse oximeter (LOOKEE®, New York, USA) before-after the one- minute sit-to-stand test.

  7. Change in HRQoL

    Time frame: 8 weeks

    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. Change in activities participation

    Time frame: 8 weeks

    Assessed using the Canadian Occupational Performance Measure (COPM) which focuses on occupational performance in all areas of life, including self-care, leisure, and productivity.

  9. Feasibility of collecting data using wearable technology

    Time frame: 1 week

    A subgroup of participants were asked to use a wrist-worn smartwatch and waist-worn accelerometer (non-dominant hip) for seven days.

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Collaborators

  • Health Sciences Centre Foundation, Manitoba
  • Health Sciences Centre, Winnipeg, Manitoba

Registry information

Official study title

Pulmonary Rehabilitation Post-COVID-19: a Pilot Study

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Aug 12, 2021
Registry last updated
Jan 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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