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COVID - 19PuReCOVIDNCT07046442

Effect of Pulmonary Rehabilitation and Physical Activity on COVID-19 Long-Term Symptoms (PuReCOVID)

An observational study of COVID - 19, run by University of Parma at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This single-center, observational, longitudinal, retrospective and prospective study investigates the impact of Active Cycle of Breathing Technique (ACBT) and moderate daily physical activity on symptoms associated with long COVID, such as cough, dyspnea, and fatigue. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID - 19
What is being tested?
Pulmonary Rehabilitation
How many people
40 participants
Where
1 siteItaly
Study dates
5 Apr 2022to 30 Dec 2025
How long will I take part?
6 Weeks
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The population will consist of 40 adult patients, referred at outpatient clinic of the Respiratory Disease Unit of the University Hospital of Parma (Italy)

Who may be able to join

  • Male or female adults aged ≥18 years;
  • Signed informed consent;
  • Patients with long COVID
  • Patients with or without ventilatory deficit (FEV1/FVC>/≤70% and FVC>/≤80%)
  • Patients reporting at least one of the following symptoms: cough, dyspnea, and fatigue at 24 weeks post-infection

Who cannot join

  • Patients with other coexisting chronic lung diseases (asthma, fibrosis, bronchiectasis, sarcoidosis, interstitial diseases, pulmonary hypertension)
  • Active smoking patients

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • University of Parma

    Parma, Italy, 43126

Other trials in Italy

About this study

Official title: Effect of Pulmonary Rehabilitation and Physical Activity on the Symptoms of Long COVID. A Pilot Study

This single-center, observational, longitudinal, retrospective and prospective study investigates the impact of Active Cycle of Breathing Technique (ACBT) and moderate daily physical activity on symptoms associated with long COVID, such as cough, dyspnea, and fatigue. The study aims to assess whether these interventions can moderately alleviate or resolve these symptoms and evaluate their potential association with small airway dysfunction (SAD), as measured by Impulse Oscillometry (IOS).

The investigators will recruit 40 adult patients with long COVID who meet specific inclusion criteria. Participants will perform ACBT twice daily and complete at least 6000 steps per day for six weeks. The investigators will track clinical and lung function parameters, including spirometry, IOS, and exercise capacity.

Read the detailed description

Long COVID affects approximately 10% of COVID-19 survivors, with symptoms persisting beyond the acute phase and impacting multiple organ systems. While some individuals experience mild to moderate illness, others develop severe complications, such as Acute Respiratory Distress Syndrome (ARDS), increasing the risk of long-term pulmonary dysfunction. There is no universally accepted definition of long COVID, but it is often categorized based on symptom duration: post-acute COVID-19 (symptoms persisting beyond three weeks) and chronic COVID-19 (lasting beyond 12 weeks). According to NICE and the Italian National Institute of Health (ISS), long COVID includes symptoms lasting between 4 and 12 weeks (ongoing symptomatic COVID-19) or beyond 12 weeks (post-COVID-19 syndrome), provided they are not attributable to alternative diagnoses.

Common symptoms include fatigue, dyspnea, cough, and chest pain. Some patients recover spontaneously with rest, symptomatic treatment, and gradual physical activity, while others require targeted rehabilitation. Since 80% of breathing effort relies on the diaphragm, long COVID patients often exhibit altered breathing patterns, such as shallow breathing and increased reliance on accessory muscles, leading to dyspnea, fatigue, and inefficient respiration.

Rehabilitation programs have been shown to improve ambulation, hospital discharge rates, and overall recovery in COVID-19 patients, highlighting their potential role in long COVID management. Pulmonary rehabilitation, particularly the Active Cycle of Breathing Technique (ACBT), is a structured method aimed at restoring normal breathing patterns, improving respiratory muscle efficiency, and reducing airway irritation. ACBT consists of controlled breathing, thoracic expansion exercises, forced expiration, and huffing, facilitating airway clearance and optimizing lung function. Given the association between physical inactivity and worse COVID-19 outcomes, rehabilitation strategies incorporating breathing exercises and physical activity may be beneficial.

Pulmonary function studies indicate that Forced Expiratory Volume in 1 second (FEV1) and the FEV1/FVC ratio generally remain within normal limits after COVID-19 recovery, regardless of disease severity. However, impairments in Mid-Expiratory Flow (MEF25-75%) suggest small airway dysfunction (SAD), which appears independent of disease severity but may contribute to persistent respiratory symptoms. Early detection of pulmonary abnormalities is crucial, and Impulse Oscillometry (IOS) is recommended for assessing SAD. Studies indicate that up to 70-90% of symptomatic long COVID patients exhibit persistent SAD up to five months post-infection, emphasizing the need for ongoing lung function monitoring.

This retrospective and prospective study aims to evaluate whether ACBT, combined with moderate daily physical activity, can alleviate symptoms such as cough, dyspnea, and fatigue in long COVID patients. Effectiveness will be assessed using validated clinical scales, including the Leicester Cough Questionnaire (LCQ), the Modified Medical Research Council (mMRC) dyspnea scale, and the Visual Analog Scale (VAS) for fatigue. Additionally, the study will investigate whether respiratory symptoms correlate with SAD, assessed through IOS by analyzing changes in distal airway resistance (R5-R20) and reactance (X5) before and after a six-week rehabilitation period. The rehabilitation protocol involves performing ACBT twice daily at home for six weeks. Clinical and respiratory functional parameters will be assessed before and after the intervention of six weeks. To ensure adherence, patients will receive instructional materials, including video tutorials and augmented reality tools. Additionally, participants will be encouraged to engage in moderate physical activity, aiming for at least 6,000 steps per day, tracked via smartphone applications.

Participants will be monitored over six weeks, with two scheduled visits: an initial baseline assessment (V1) and a follow-up evaluation (V2).

The study protocol was approved by Ethics Committee in the session of 05/07/2022 with protocol. No. 28421 of 07/06/2021.

Data will be collected in a dedicated electronic Clinical Records Form (CRF). The database will be saved on a password-protected company Personal Computer (PC) which will be updated at each visit and used exclusively for scientific research purposes. At the time of enrollment, each patient will receive an alphanumeric code so that any information collected during the study, and in particular sensitive data, is treated in an anonymous manner. Data reporting patients' identifications will only be used to file patients and collect informed consent.

Conditions
COVID - 19
Being tested
Pulmonary Rehabilitation
Keywords
long COVID, Pulmonary rehabilitation, ACBT
Medical subject headings
COVID-19, Post-Acute COVID-19 Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pulmonary RehabilitationOther

    The Active Cycle of Breathing Technique (ACBT), is a structured method aimed at restoring normal breathing patterns, improving respiratory muscle efficiency, and reducing airway irritation.

Study groups in NCT07046442
Study groupRoleWhat they receive
A group of patients affected by Long Covid 19 diseaseNot described
Receives: Other: Pulmonary Rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To investigate whether ACBT and moderate daily physical activity can improve cough (LCQ), dyspnea (mMRC) and fatigue (VAS) associated to Long COVID.

    Improvement of cough (LCQ), dyspnea (mMRC) and fatigue (VAS) associated to Long COVID after six weeks of pulmonary rehabilitation

    Measured: six weeks

Secondary outcomes (1)
  1. To determine whether respiratory symptoms are associated with small airway dysfunction due to mechanical insult from SARS-CoV infection

    Improvement of parameters of the small airways in terms of both distal resistance (R5-R20) and reactance (X5) as assessed by pulse oscillometry (IOS) before and after ACBT.

    Measured: six weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2025
  2. Study start5 Apr 2022
  3. Primary completion4 Feb 2025
  4. Study completion30 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
40 participants (actual)
Target duration
6 Weeks
IDs, dates and publications
ClinicalTrials.gov ID
NCT07046442
Sponsor's protocol ID
28421
Acronym
PuReCOVID
Status last verified
Apr 2026
First submitted
27 Jun 2025
Last updated
6 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data will be collected in a dedicated electronic Clinical Records Form (CRF). The database will be saved on a password- protected company personal computer which will be updated at each visit and used exclusively for scientific research purposes. At the time of enrolment, each patient will receive an alphanumeric code so that any information collected during the study, and in particular sensitive data, will be treated in an anonymous manner. Data reporting patients' identifications will only be used to file patients and collect informed consent.

Publications

  • Rogliani P, Ora J, Girolami A, Rossi I, de Guido I, Facciolo F, Cazzola M, Calzetta L. Ceiling effect of beclomethasone/formoterol/glycopyrronium triple fixed-dose combination in COPD: A translational bench-to-bedside study. Pulm Pharmacol Ther. 2021 Aug;69:102050. doi: 10.1016/j.pupt.2021.102050. Epub 2021 Jun 12.

    PubMed 34129945
  • Calzetta L, Aiello M, Frizzelli A, Bertorelli G, Chetta A. Small airways in asthma: from bench-to-bedside. Minerva Med. 2022 Feb;113(1):79-93. doi: 10.23736/S0026-4806.21.07268-2. Epub 2021 Jan 26.

    PubMed 33496163
  • Li LY, Yan TS, Yang J, Li YQ, Fu LX, Lan L, Liang BM, Wang MY, Luo FM. Impulse oscillometry for detection of small airway dysfunction in subjects with chronic respiratory symptoms and preserved pulmonary function. Respir Res. 2021 Feb 24;22(1):68. doi: 10.1186/s12931-021-01662-7.

    PubMed 33627138
  • EQ-5D. Accessed January 13, 2022. https://euroqol.org/

  • Ward N. The Leicester Cough Questionnaire. J Physiother. 2016 Jan;62(1):53. doi: 10.1016/j.jphys.2015.05.011. Epub 2015 Aug 29. No abstract available.

    PubMed 26320841
  • Birring SS, Prudon B, Carr AJ, Singh SJ, Morgan MD, Pavord ID. Development of a symptom specific health status measure for patients with chronic cough: Leicester Cough Questionnaire (LCQ). Thorax. 2003 Apr;58(4):339-43. doi: 10.1136/thorax.58.4.339.

    PubMed 12668799
  • Bestall JC, Paul EA, Garrod R, Garnham R, Jones PW, Wedzicha JA. Usefulness of the Medical Research Council (MRC) dyspnoea scale as a measure of disability in patients with chronic obstructive pulmonary disease. Thorax. 1999 Jul;54(7):581-6. doi: 10.1136/thx.54.7.581.

    PubMed 10377201
  • Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. doi: 10.1016/s0140-6736(74)90884-8. No abstract available.

    PubMed 4139420
  • Aoyagi Y, Shephard RJ. Habitual physical activity and health in the elderly: the Nakanojo Study. Geriatr Gerontol Int. 2010 Jul;10 Suppl 1:S236-43. doi: 10.1111/j.1447-0594.2010.00589.x.

    PubMed 20590838
  • Tudor-Locke C, Bassett DR Jr. How many steps/day are enough? Preliminary pedometer indices for public health. Sports Med. 2004;34(1):1-8. doi: 10.2165/00007256-200434010-00001.

    PubMed 14715035
  • The Active Cycle of Breathing Techniques, available at https://www.acprc.org.uk/Data/Publication_Downloads/GL-05ACBT.pdf. Assoc Chart Physiother Respir Care. Published online 2011. Accessed January 13, 2022. www.brit-thoracic.org.uk/clinical-information/physiotherapy/physiotherapy-guideline.aspx

  • Lewis LK, Williams MT, Olds TS. The active cycle of breathing technique: a systematic review and meta-analysis. Respir Med. 2012 Feb;106(2):155-72. doi: 10.1016/j.rmed.2011.10.014. Epub 2011 Nov 18.

    PubMed 22100537
  • Kellett C, Mullan J. Breathing control techniques in the management of asthma. Physiotherapy. 2002:88,12; 751-758

  • Sallis R, Young DR, Tartof SY, Sallis JF, Sall J, Li Q, Smith GN, Cohen DA. Physical inactivity is associated with a higher risk for severe COVID-19 outcomes: a study in 48 440 adult patients. Br J Sports Med. 2021 Oct;55(19):1099-1105. doi: 10.1136/bjsports-2021-104080. Epub 2021 Apr 13.

    PubMed 33849909
  • Meeting the challenge of long COVID. Nat Med. 2020 Dec;26(12):1803. doi: 10.1038/s41591-020-01177-6. No abstract available.

    PubMed 33288947

Questions about this trial

What is this clinical trial studying?

An observational study of COVID - 19, run by University of Parma at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To investigate whether ACBT and moderate daily physical activity can improve cough (LCQ), dyspnea (mMRC) and fatigue (VAS) associated to Long COVID. (time frame: six weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07046442, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.

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