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Completed

NCT Number: NCT05244044

Pulmonary Rehabilitation for Long COVID (Post COVID-19 Condition)

In the PuRe COVID study (a randomized, controlled, multicenter, pragmatic trial) the investigators aim to assess the effect of a pulmonary rehabilitation program in primary care on exercise capacity (6MWT) and daily life physical activity in patients with long COVID.

134 patients with long COVID, defined by self-reported persistent COVID related symptoms ≥6 weeks after COVID-19 infection and a positive symptom score (CAT score ≥10 or mMRC score ≥2 or CIS-fatigue ≥36 or PCFS score of ≥2), will be recruited and divided into an intervention group or a control group. The intervention group will get twelve weeks of primary care pulmonary rehabilitation (PR) including coaching by primary care physiotherapists. The control group consists of usual care, which does not include a pulmonary rehabilitation program.

This study will help determine whether the type of symptoms or affected body system can impact recovery form long covid during rehabilitation and after follow-up. The investigators will analyze determinants and risk factors that characterize non-responders and non-adherers to better understand which patients with long COVID benefit from rehabilitation.

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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 Condition 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

UHAntwerp, Edegem, Antwerp, Belgium

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients with status post COVID-19 (positive COVID-19 PCR or an official pharmacy performed antigen test or a self-performed test confirmed by a physician during the acute COVID-19 ≥ 6 weeks ago or positive antibodies before vaccination or positive antibodies before vaccination).
  • Persistent COVID related symptoms that were not present pre-COVID-19 or were less severe pre-COVID.
  • Symptomatic: quantified by dyspnea on exertion, loss of energy, fatigue or sleep impairment based upon the score of four questionnaires:
  • COPD Assessment Test (CAT) ≥10, and/or
  • modified Medical Research Council dyspnea scale (mMRC) ≥2, and/or
  • CIS-fatigue ≥36, and/or
  • post-COVID-19 Functional Status (PCFS) ≥2.

Exclusion criteria

  • Patients with known or self-reported cognitive, hearing, visual, neurological or musculoskeletal conditions that make it impossible to participate in pulmonary rehabilitation.
  • Prior physiotherapy for long COVID if:
  • patients who have completed ≥9 sessions of physiotherapy in total for long COVID.
  • patients who completed any physiotherapy session in the previous 12 weeks for long COVID (primary care or hospital based; pulmonary or non-pulmonary).
  • Patients with predominantly neurological disorders impacting respiratory function will not be eligible for the study.
  • Patients that are not able to give informed consent or not able to complete questionnaires.
  • Patients who have had any organ transplatation in the past, have to undergo any transplantation or are on an active transplantation list.
  • Patients with active malignancy and/or (maintenance) treatment for active malignancy or curatively treated carcinoma within the past year.

Treatment and study plan

Pulmonary rehabilitation in primary care

Other

Pulmonary rehabilitation consists breathing exercises, exercise capacity, muscle strength and change towards an active lifestyle.

Primary outcomes

  1. Exercise capacity

    Time frame: Baseline - 12 weeks

    Change in functional exercise capacity measured by 6-minute walk test (6MWT).

Secondary outcomes

  1. Change in physical activity

    Time frame: Baseline - 12 weeks

    Change in physical activity as objectively measured by an activity tracker (number of steps).

  2. Change in COVID-19 related symptoms

    Time frame: Baseline - 12 weeks - 24 weeks - 36 weeks

    The COVID-19 related symptoms will be measured with the COPD assessment test (CAT). The total CAT score ranges from 0 to 40 where 0 represents no symptoms and 40 very bad symptoms.

  3. Change in quality of life

    Time frame: Baseline - 12 weeks - 24 weeks - 36 weeks

    The quality of life will be measured with the EQ-5D-5L.

  4. Change in fatigue

    Time frame: Baseline - 12 weeks - 24 weeks - 36 weeks

    The changes of the level of fatigue will be measured with the Checklist Individual Strength -fatigue (CIS-fatigue) score. The total CIS-fatigue score ranges from 20 to 140 where 20 represents no symptoms and 140 very bad symptoms.

  5. Change in dyspnoea

    Time frame: Baseline - 24 weeks - 36 weeks

    Changes in dyspnoea, measured with the modified medical research council (mMRC). The total mMRC scale ranges from 0 to 4 score where 0 represents no dyspnoea and 4 a lot of dyspnoea.

  6. Change in functional status

    Time frame: Baseline - 12 weeks - 24 weeks - 36 weeks

    The functional status will be measured by the post COVID-19 functional status scale (PCFS). It is an ordinal score ranging from 0 to 4 where 4 means the patient has a lot of limitations in daily life.

  7. Change in work productivity and activity impairment.

    Time frame: Baseline - 24 weeks - 36 weeks

    This will be measured with the "work productivity and activity impairment" questionnaire (WPAI), consisting of 6 questions.

  8. Change in anxiety and depression symptoms.

    Time frame: Baseline - 24 weeks - 36 weeks

    This will be measured by the Hospital Anxiety and depression scale (HADS). The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains. Patients were defined as having anxiety or depression or both if the score was 8 or more in the corresponding subscale.

  9. Change in dysfunctional breathing

    Time frame: Baseline - 24 weeks - 36 weeks

    This will be measured with the Nijmegen questionnaire. 16 questions will be asked, ranging from 0 to 4. The higher the score, the more likely it is that they have dysfunctional breathing.

  10. Change in exercise capacity

    Time frame: Baseline - 24 weeks

    The functional exercise capacity will be measured by 6-minute walk test (6MWT).

  11. Predictors of response in 6- minute walk distance (6MWD)

    Time frame: Post pulmonary rehabilitation

    The predictors will be based on baseline symptom scores (CAT, mMRC, CIS), baseline 6MWD and hospitalisation status.

Other outcomes

  1. Evaluate the change in 6MWD after 6weeks or 12weeks PR.

    Time frame: Baseline - 6 weeks / 12 weeks

    The investigators will evaluate the 6MWD at 6 weeks and 12 weeks, as well as change in 6MWD from baseline to 6 weeks versus from baseline to 12 weeks PR.

  2. Change in hand grip strength.

    Time frame: Baseline - 12 weeks

    This change will be objectived by measuring the hand grip strength with the Jamar hand-held dynamometer.

  3. Change in respiratory muscle and diaphragm strength.

    Time frame: Baseline - 12 weeks

    This change will be objectived by measuring the maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP).

  4. The cost-effectiveness of the intervention.

    Time frame: Baseline - end of the study

    In case the study findings on the primary outcome is positive, a cost-effectiveness analysis will be done to evaluate if the intervention had an impact on the health care costs verified through the financial expenses of patients.

  5. Change in dyspnoea

    Time frame: Baseline - 12 weeks

    Changes in dyspnoea, measured with the modified medical research council (mMRC). The total mMRC scale ranges from 0 to 4 score where 0 represents no dyspnoea and 4 a lot of dyspnoea.

  6. Change in sleep efficiency.

    Time frame: Baseline - 12 weeks

    The change in sleep efficiency will be measured by an activity tracker.

  7. Change in functional status

    Time frame: Baseline - 12 weeks

    The functional status will be measured by the post COVID-19 functional status scale (PCFS). It is an ordinal score ranging from 0 to 4 where 4 means the patient has a lot of limitations in daily life.

  8. Change in anxiety and depression symptoms.

    Time frame: Baseline - 12 weeks

    This will be measured by the Hospital Anxiety and depression scale (HADS). The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains. Patients were defined as having anxiety or depression or both if the score was 8 or more in the corresponding subscale.

  9. Change in work productivity and activity impairment.

    Time frame: Baseline - 12 weeks

    This will be measured with the "work productivity and activity impairment" questionnaire (WPAI), consisting of 6 questions.

  10. Change in dysfunctional breathing

    Time frame: Baseline - 12 weeks

    This will be measured with the Nijmegen questionnaire. 16 questions will be asked, ranging from 0 to 4. The higher the score, the more likely it is that they have dysfunctional breathing.

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Collaborators

  • Hasselt University
  • Universiteit Antwerpen
  • Ziekenhuis Oost-Limburg

Registry information

Official study title

Changes in Functional Exercise Capacity After PUlmonary REhabilitation in Primary Care: a Randomized, Controlled, Multicenter, Pragmatic Trial in 134 Patients With Long COVID (PuRe-COVID)

Acronym: PuRe-COVID

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Feb 17, 2022
Registry last updated
Oct 1, 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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