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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-19

Study Completion Date

2024-02-29

Brief Summary

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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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Detailed Description

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Conditions

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COVID-19 Long COVID Post COVID-19 Condition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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Pulmonary rehabilitation group

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).

Group Type ACTIVE_COMPARATOR

Pulmonary rehabilitation in primary care

Intervention Type OTHER

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

Control group without rehabilitation

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Pulmonary rehabilitation in primary care

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No