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

NCT05244044 | Completed DMC

• 1 other identifier: UZA
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

COVID-19; Long COVID; Post COVID-19 Condition

Keywords

Pulmonary rehabilitation; Physiotherapy; Respiratory physiotherapy

Outcome Measures

Primary Outcomes (1)

• Exercise capacity

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

  Baseline - 12 weeks

Secondary Outcomes (11)

• Change in physical activity

  Baseline - 12 weeks

• Change in COVID-19 related symptoms

  Baseline - 12 weeks - 24 weeks - 36 weeks

• Change in quality of life

  Baseline - 12 weeks - 24 weeks - 36 weeks

• Change in fatigue

  Baseline - 12 weeks - 24 weeks - 36 weeks

• Change in dyspnoea

  Baseline - 24 weeks - 36 weeks

Other Outcomes (10)

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

  Baseline - 6 weeks / 12 weeks

• Change in hand grip strength.

  Baseline - 12 weeks

• Change in respiratory muscle and diaphragm strength.

  Baseline - 12 weeks

Study Arms (2)

Pulmonary rehabilitation group

ACTIVE COMPARATOR

The intervention group receives a 12 weeks pulmonary rehabilitation program supervised by a primary care physiotherapist consisting of maximum 36 sessions (3 sessions per week).

Other: Pulmonary rehabilitation in primary care

Control group without rehabilitation

NO INTERVENTION

The control group will receive usual care that doesn't include pulmonary rehabilitation or a supervised physical activity program.

Interventions

Pulmonary rehabilitation in primary care OTHER

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

Pulmonary rehabilitation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Antwerp: lead
• Ziekenhuis Oost-Limburg: collaborator
• Universiteit Antwerpen: collaborator
• Hasselt University: collaborator

Study Sites (2)

UHAntwerp

Edegem, Antwerp, 2650, Belgium

Location

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

Location

Related Publications (2)

• 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.

  PMID: 41253410 DERIVED

• 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.

  PMID: 37270195 DERIVED

Related Links

• Published PuRe-COVID protocol

MeSH Terms

Conditions

COVID-19; Post-Acute COVID-19 Syndrome

Interventions

Primary Health Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Thérèse Lapperre, Prof.

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessor of the 6MWT (the primary outcome) is blinded. Also the assessor of the lung function, MIP/MEP and hand grip strength is blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: February 17, 2022
• Study Start: April 19, 2022
• Primary Completion: December 18, 2023
• Study Completion: February 29, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data requests can be submitted starting after the publication of the primary endpoint and either publication of the follow-up data article or one year after the clinical study report is provided to the funder, whichever happens earlier. The data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
• Access Criteria: Access to anonymized trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) by the TSC and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact purecovid@uza.be . An administrative cost may apply.

Locations

BE (2)