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Completed

NCT Number: NCT05298878

Virtual Physical Rehabilitation for Patients Living with Long COVID

The purpose of this study is to investigate whether a timely, virtual home-based physical rehabilitation program for patients living with long COVID can improve functional mobility compared to usual care.

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Key information

Conditions

COVID-19 Chronic Disease Coronaviridae Infections Coronavirus Infections Disease Attributes Infections Long COVID Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Post Covid-19 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

McMaster University, Hamilton, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

(i) adult patients (18+ years old) who have had a confirmed or probable COVID-19 infection and who have self-reported persisting symptoms of either reduced mobility, muscle weakness, dyspnea, or fatigue;

(ii) participants must be technologically capable of connecting (either independently or through household members) with an online videoconferencing platform through an e-mail invitation; and

(iii) be able to collaborate with the research assistant to complete the virtual assessment sessions or have a family member available to help.

Exclusion criteria

(i) pre-existing or newly identified severe cognitive impairment;

(ii) inability to speak or comprehend English or French;

(iii) known or self-reported acute and/or uncontrolled cardiac, musculoskeletal, or neurological condition that might render rehabilitation participation unsafe.

Treatment and study plan

Intervention Group: Virtual home-based rehabilitation plus usual outpatient care

Other

14 supervised exercise virtual sessions with Kinesiologist and 10 independent exercise sessions. Each session lasts 40 minutes. The exercises consist of aerobic training; functional lower and upper body strengthening; balance; and flexibility exercises. During the first 10 minutes of the first session of each week, there is an educational session.

Week 1-2: three supervised virtual sessions Week 3-4: two supervised virtual sessions and one independent session. Week 5-8: one supervised virtual session and two independent sessions.

Primary outcomes

  1. Change in the basic mobility domain of the Activity Measure for Post-Acute Care (AM-PAC)

    Time frame: Baseline, Week 8 (up to 1 week), and at 6 months.

    The AM-PAC is a validated, self-reported instrument assessing activity limitations based on the International Classification of Functioning, Disability, and Health (ICF). Each item is scored from 1 (unable to perform) to 4 (none or no difficulty) with lower scores indicating lower levels of function.

Secondary outcomes

  1. Change in lower-body strength

    Time frame: Baseline, Week 8 (up to 1 week), and at 6 months.

    The 1-minute sit-to-stand test (1-min STS) is feasible to use in hospital survivors of COVID-19. It is used to assess lower body-strength, exercise tolerance, and exertional desaturation. The score is the total number of stands within one minute.

  2. Change in functional mobility

    Time frame: Baseline, Week 8 (up to 1 week), and at 6 months.

    The fast-Timed-Up-and-Go test (TUG) assesses physical function and functional mobility. The score consists of the time taken to complete the test activity, in seconds.

  3. Change in fatigue

    Time frame: Baseline, Week 8 (up to 1 week), and at 6 months.

    Measured by the Fatigue Visual Analog Scale.

  4. Change in dyspnea

    Time frame: Baseline, Week 8 (up to 1 week), and at 6 months.

    Measured by the Transition Dyspnea Index.

  5. Change in health-related quality of life

    Time frame: Baseline, Week 8 (up to 1 week), and at 6 months.

    Measured by the Short Form 12-item Health Survey (SF-12).

  6. Change in health state utilities

    Time frame: Baseline, Week 8 (up to 1 week), and at 6 months.

    Measured by the EuroQol 5-dimension 5-level Questionnaire (EQ-5D-5L).

  7. Change in anxiety and depression

    Time frame: Baseline, Week 8 (up to 1 week), and at 6 months.

    Measured by the Hospital Anxiety and Depression Scale.

  8. Change in cognitive function

    Time frame: Baseline, Week 8 (up to 1 week), and at 6 months.

    Measured by the AM-PAC Cognition Subscale.

  9. Change in the degree of distress in response to trauma

    Time frame: Baseline, Week 8 (up to 1 week), and at 6 months.

    Measured by the Impact of Event Scale - Revised.

  10. Self-reported health service use

    Time frame: 30 days after the 8-week period.

    Doctors visits, emergency department visits and hospital readmission etc.

Sponsors and collaborators

Lead sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • Canadian Thoracic Society
  • RESPIPLUS
  • Santé WillKin (WillKin Health)

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Mar 28, 2022
Registry last updated
Nov 27, 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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