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COVID-19PuRe-COVIDNCT05244044

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

A study testing Pulmonary rehabilitation in primary care in people with COVID-19 and Long COVID, run by University Hospital, Antwerp at 2 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID-19, Long COVID, Post COVID-19 Condition
What is being tested?
Pulmonary rehabilitation in primary care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
2 sitesBelgium
Study dates
19 Apr 2022to 29 Feb 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Belgium2 sites

  • UHAntwerp

    Edegem, Antwerp, 2650

  • Ziekenhuis Oost-Limburg

    Genk, Limburg, 3600

Other trials in Belgium

About this study

Official 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)

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.

Being tested
Pulmonary rehabilitation in primary care
Keywords
Pulmonary rehabilitation, Physiotherapy, Respiratory physiotherapy
Medical subject headings
COVID-19, Post-Acute COVID-19 Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pulmonary rehabilitation in primary careOther

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

Study groups in NCT05244044
Study groupRoleWhat they receive
Pulmonary rehabilitation groupActive comparatorThe intervention group receives a 12 weeks pulmonary rehabilitation program supervised by a primary care physiotherapist consisting of maximum 36 sessions (3 sessions per week).
Receives: Other: Pulmonary rehabilitation in primary care
Control group without rehabilitationNo interventionThe control group will receive usual care that doesn't include pulmonary rehabilitation or a supervised physical activity program.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Exercise capacity

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

    Measured: Baseline - 12 weeks

Secondary outcomes (11)

  1. Change in physical activity

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

    Measured: Baseline - 12 weeks

  2. Change in COVID-19 related symptoms

    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.

    Measured: Baseline - 12 weeks - 24 weeks - 36 weeks

  3. Change in quality of life

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

    Measured: Baseline - 12 weeks - 24 weeks - 36 weeks

  4. Change in fatigue

    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.

    Measured: Baseline - 12 weeks - 24 weeks - 36 weeks

  5. Change in dyspnoea

    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.

    Measured: Baseline - 24 weeks - 36 weeks

  6. Change in functional status

    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.

    Measured: Baseline - 12 weeks - 24 weeks - 36 weeks

  7. Change in work productivity and activity impairment.

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

    Measured: Baseline - 24 weeks - 36 weeks

  8. Change in anxiety and depression symptoms.

    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.

    Measured: Baseline - 24 weeks - 36 weeks

  9. Change in dysfunctional breathing

    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.

    Measured: Baseline - 24 weeks - 36 weeks

  10. Change in exercise capacity

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

    Measured: Baseline - 24 weeks

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

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

    Measured: Post pulmonary rehabilitation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2022
  2. Study start19 Apr 2022
  3. Primary completion18 Dec 2023
  4. Study completion29 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05244044
Sponsor's protocol ID
UZA
Acronym
PuRe-COVID
Status last verified
May 2024
First submitted
14 Feb 2022
Last updated
1 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All of the individual participant data collected during the trial, after deidentification.

Publications

  • Volckaerts T, Ruttens D, Quadflieg K, Burtin C, Cops D, De Soomer K, Roelant E, Verhaegen I, Daenen M, Criel M, Vissers D, Lapperre T. Improved functional exercise capacity after primary care pulmonary rehabilitation in patients with long COVID (PuRe-COVID): a pragmatic randomised controlled trial. BMJ Open Respir Res. 2025 Nov 17;12(1):e003653. doi: 10.1136/bmjresp-2025-003653.

    PubMed 41253410

  • Volckaerts T, Vissers D, Burtin C, Van Meerbeeck X, de Soomer K, Oostveen E, Claes K, Roelant E, Verhaegen I, Thomeer M, Criel M, Quadflieg K, Cops D, Ruttens D, Lapperre TS. Randomised, controlled, open-label pragmatic trial evaluating changes in functional exercise capacity after primary care PUlmonary REhabilitation in patients with long COVID: protocol of the PuRe-COVID trial in Belgium. BMJ Open. 2023 Jun 2;13(6):e071098. doi: 10.1136/bmjopen-2022-071098.

    PubMed 37270195

Questions about this trial

What is this clinical trial studying?

A study testing Pulmonary rehabilitation in primary care in people with COVID-19 and Long COVID, run by University Hospital, Antwerp at 2 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Exercise capacity (time frame: Baseline - 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05244044, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.

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