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

COVID-19 Clinical Trial

— PuRe-COVID  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05244044
• Other study ID #: UZA
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 19, 2022
• Est. completion date: September 1, 2024

Study information

• Verified date: July 2023
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 76
• Est. completion date: September 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Disease
• Long COVID

Intervention

Other:
• Pulmonary rehabilitation in primary care
Pulmonary rehabilitation consists breathing exercises, exercise capacity, muscle strength and change towards an active lifestyle.

Locations

Country	Name	City	State
Belgium	UHAntwerp	Edegem	Antwerp
Belgium	Ziekenhuis Oost-Limburg	Genk	Limburg

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Antwerp	Hasselt University, Universiteit Antwerpen, Ziekenhuis Oost-Limburg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evaluate the change in 6MWD after 6weeks or 12weeks PR.	The investigators will evaluate the 6MWD at 6 weeks and 12 weeks, as well as change in 6MWD from baseline to 6 weeks versus from baseline to 12 weeks PR.	Baseline - 6 weeks / 12 weeks
Other	Change in hand grip strength.	This change will be objectived by measuring the hand grip strength with the Jamar hand-held dynamometer.	Baseline - 12 weeks
Other	Change in respiratory muscle and diaphragm strength.	This change will be objectived by measuring the maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP).	Baseline - 12 weeks
Other	The cost-effectiveness of the intervention.	In case the study findings on the primary outcome is positive, a cost-effectiveness analysis will be done to evaluate if the intervention had an impact on the health care costs verified through the financial expenses of patients.	Baseline - end of the study
Other	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.	Baseline - 12 weeks
Other	Change in sleep efficiency.	The change in sleep efficiency will be measured by an activity tracker.	Baseline - 12 weeks
Other	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.	Baseline - 12 weeks
Other	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.	Baseline - 12 weeks
Other	Change in work productivity and activity impairment.	This will be measured with the "work productivity and activity impairment" questionnaire (WPAI), consisting of 6 questions.	Baseline - 12 weeks
Other	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.	Baseline - 12 weeks
Primary	Exercise capacity	Change in functional exercise capacity measured by 6-minute walk test (6MWT).	Baseline - 12 weeks
Secondary	Change in physical activity	Change in physical activity as objectively measured by an activity tracker (number of steps).	Baseline - 12 weeks
Secondary	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.	Baseline - 12 weeks - 24 weeks - 36 weeks
Secondary	Change in quality of life	The quality of life will be measured with the EQ-5D-5L.	Baseline - 12 weeks - 24 weeks - 36 weeks
Secondary	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.	Baseline - 12 weeks - 24 weeks - 36 weeks
Secondary	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.	Baseline - 24 weeks - 36 weeks
Secondary	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.	Baseline - 12 weeks - 24 weeks - 36 weeks
Secondary	Change in work productivity and activity impairment.	This will be measured with the "work productivity and activity impairment" questionnaire (WPAI), consisting of 6 questions.	Baseline - 24 weeks - 36 weeks
Secondary	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.	Baseline - 24 weeks - 36 weeks
Secondary	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.	Baseline - 24 weeks - 36 weeks
Secondary	Change in exercise capacity	The functional exercise capacity will be measured by 6-minute walk test (6MWT).	Baseline - 24 weeks
Secondary	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.	Post pulmonary rehabilitation

External Links

•   Published PuRe-COVID protocol