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

Antwerp University Hospital (UZA)

Status: Completed

Conditions: COVID-19; Post COVID-19 Condition; Long COVID

Treatments: Other: Pulmonary rehabilitation in primary care

Study type: Interventional

Funder types: Other

Identifiers

NCT05244044

UZA

Details and patient eligibility

About

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.

Enrollment: 76 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

76 participants in 2 patient groups

Pulmonary rehabilitation group

Active Comparator group

Description:

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).

Treatment:

Other: Pulmonary rehabilitation in primary care

Control group without rehabilitation

No Intervention group

Description:

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