Clinical trial NCT05244044: Pulmonary Rehabilitation for Long COVID (Post COVID-19 Condition)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Long COVID
Post COVID-19 Condition
Keywords: Pulmonary rehabilitation
Physiotherapy
Respiratory physiotherapy
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
Collaborators: name: Ziekenhuis Oost-Limburg
name: Universiteit Antwerpen
name: Hasselt University
First posted: 2022-02-17
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Exercise capacity
timeFrame: Baseline - 12 weeks
Secondary outcomes:
measure: Change in physical activity
timeFrame: Baseline - 12 weeks
measure: Change in COVID-19 related symptoms
timeFrame: Baseline - 12 weeks - 24 weeks - 36 weeks
measure: Change in quality of life
timeFrame: Baseline - 12 weeks - 24 weeks - 36 weeks
measure: Change in fatigue
timeFrame: Baseline - 12 weeks - 24 weeks - 36 weeks
measure: Change in dyspnoea
timeFrame: Baseline - 24 weeks - 36 weeks
measure: Change in functional status
timeFrame: Baseline - 12 weeks - 24 weeks - 36 weeks
measure: Change in work productivity and activity impairment.
timeFrame: Baseline - 24 weeks - 36 weeks
measure: Change in anxiety and depression symptoms.
timeFrame: Baseline - 24 weeks - 36 weeks
measure: Change in dysfunctional breathing
timeFrame: Baseline - 24 weeks - 36 weeks
measure: Change in exercise capacity
timeFrame: Baseline - 24 weeks
measure: Predictors of response in 6- minute walk distance (6MWD)
timeFrame: Post pulmonary rehabilitation
Other outcomes:
measure: Evaluate the change in 6MWD after 6weeks or 12weeks PR.
timeFrame: Baseline - 6 weeks / 12 weeks
measure: Change in hand grip strength.
timeFrame: Baseline - 12 weeks
measure: Change in respiratory muscle and diaphragm strength.
timeFrame: Baseline - 12 weeks
measure: The cost-effectiveness of the intervention.
timeFrame: Baseline - end of the study
measure: Change in dyspnoea
timeFrame: Baseline - 12 weeks
measure: Change in sleep efficiency.
timeFrame: Baseline - 12 weeks
measure: Change in functional status
timeFrame: Baseline - 12 weeks
measure: Change in anxiety and depression symptoms.
timeFrame: Baseline - 12 weeks
measure: Change in work productivity and activity impairment.
timeFrame: Baseline - 12 weeks
measure: Change in dysfunctional breathing
timeFrame: Baseline - 12 weeks
Locations:
city: Edegem
country: Belgium
facility: UHAntwerp
state: Antwerp
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
state: Limburg
Study officials:
affiliation: University Hospital, Antwerp
name: Thérèse Lapperre, Prof.
role: PRINCIPAL_INVESTIGATOR
References: