Effect of Pulmonary Rehabilitation and Physical Activity on COVID-19 Long-Term Symptoms (PuReCOVID)
PuReCOVID
1 other identifier
observational
40
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2022
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 4, 2025
CompletedFirst Submitted
Initial submission to the registry
June 27, 2025
CompletedFirst Posted
Study publicly available on registry
July 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2025
CompletedMay 6, 2026
April 1, 2026
2.8 years
June 27, 2025
April 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
six weeks
Secondary Outcomes (1)
To determine whether respiratory symptoms are associated with small airway dysfunction due to mechanical insult from SARS-CoV infection
six weeks
Study Arms (1)
A group of patients affected by Long Covid 19 disease
Interventions
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.
Eligibility Criteria
The population will consist of 40 adult patients, referred at outpatient clinic of the Respiratory Disease Unit of the University Hospital of Parma (Italy)
You may qualify if:
- 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
You may not qualify if:
- Patients with other coexisting chronic lung diseases (asthma, fibrosis, bronchiectasis, sarcoidosis, interstitial diseases, pulmonary hypertension)
- Active smoking patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Parmalead
- Chiesi Farmaceutici S.p.A.collaborator
Study Sites (1)
University of Parma
Parma, Italy, 43126, Italy
Related Publications (24)
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.
PMID: 34129945RESULTCalzetta 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.
PMID: 33496163RESULTLi 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.
PMID: 33627138RESULTEQ-5D. Accessed January 13, 2022. https://euroqol.org/
RESULTWard 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.
PMID: 26320841RESULTBirring 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.
PMID: 12668799RESULTBestall 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.
PMID: 10377201RESULTHuskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. doi: 10.1016/s0140-6736(74)90884-8. No abstract available.
PMID: 4139420RESULTAoyagi 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.
PMID: 20590838RESULTTudor-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.
PMID: 14715035RESULTThe 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
RESULTLewis 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.
PMID: 22100537RESULTKellett C, Mullan J. Breathing control techniques in the management of asthma. Physiotherapy. 2002:88,12; 751-758
RESULTSallis 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.
PMID: 33849909RESULTMeeting the challenge of long COVID. Nat Med. 2020 Dec;26(12):1803. doi: 10.1038/s41591-020-01177-6. No abstract available.
PMID: 33288947RESULTHuang C, Huang L, Wang Y, Li X, Ren L, Gu X, Kang L, Guo L, Liu M, Zhou X, Luo J, Huang Z, Tu S, Zhao Y, Chen L, Xu D, Li Y, Li C, Peng L, Li Y, Xie W, Cui D, Shang L, Fan G, Xu J, Wang G, Wang Y, Zhong J, Wang C, Wang J, Zhang D, Cao B. 6-month consequences of COVID-19 in patients discharged from hospital: a cohort study. Lancet. 2021 Jan 16;397(10270):220-232. doi: 10.1016/S0140-6736(20)32656-8. Epub 2021 Jan 8.
PMID: 33428867RESULTInterim guidance on Long-COVID Management Principles. ISS COVID-19 Report no. 15/2021 https://www.iss.it
RESULTCOVID-19 rapid guideline: managing COVID-19. NICE guideline Last updated: 13 April 2022.
RESULTGupta N, Sachdev A, Gupta D. Oscillometry-A reasonable option to monitor lung functions in the era of COVID-19 pandemic. Pediatr Pulmonol. 2021 Jan;56(1):14-15. doi: 10.1002/ppul.25121. Epub 2020 Oct 26. No abstract available.
PMID: 33104290RESULTLopes AJ, Litrento PF, Provenzano BC, Carneiro AS, Monnerat LB, da Cal MS, Ghetti ATA, Mafort TT. Small airway dysfunction on impulse oscillometry and pathological signs on lung ultrasound are frequent in post-COVID-19 patients with persistent respiratory symptoms. PLoS One. 2021 Nov 29;16(11):e0260679. doi: 10.1371/journal.pone.0260679. eCollection 2021.
PMID: 34843598RESULTLv D, Chen X, Wang X, Mao L, Sun J, Wu G, Lin Z, Lin R, Yu J, Wu X, Jiang Y. Pulmonary function of patients with 2019 novel coronavirus induced-pneumonia: a retrospective cohort study. Ann Palliat Med. 2020 Sep;9(5):3447-3452. doi: 10.21037/apm-20-1688.
PMID: 33065795RESULTJiandani MP, Salagre SB, Kazi S, Iyer S, Patil P, Khot WY, Patil E, Sopariwala M. Preliminary Observations and Experiences of Physiotherapy Practice in Acute Care Setup of COVID 19: A Retrospective Observational Study. J Assoc Physicians India. 2020 Oct;68(10):18-24.
PMID: 32978920RESULTBarker-Davies RM, O'Sullivan O, Senaratne KPP, Baker P, Cranley M, Dharm-Datta S, Ellis H, Goodall D, Gough M, Lewis S, Norman J, Papadopoulou T, Roscoe D, Sherwood D, Turner P, Walker T, Mistlin A, Phillip R, Nicol AM, Bennett AN, Bahadur S. The Stanford Hall consensus statement for post-COVID-19 rehabilitation. Br J Sports Med. 2020 Aug;54(16):949-959. doi: 10.1136/bjsports-2020-102596. Epub 2020 May 31.
PMID: 32475821RESULTGreenhalgh T, Knight M, A'Court C, Buxton M, Husain L. Management of post-acute covid-19 in primary care. BMJ. 2020 Aug 11;370:m3026. doi: 10.1136/bmj.m3026. No abstract available.
PMID: 32784198RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Target Duration
- 6 Weeks
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2025
First Posted
July 1, 2025
Study Start
April 5, 2022
Primary Completion
February 4, 2025
Study Completion
December 30, 2025
Last Updated
May 6, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Data will be available during the course of the study. The Investigator will keep paper and electronic copies of all documentation at the Center for a period of at least 7 years after the completion of the study and then he will arrange for its destruction.
- Access Criteria
- Only the personal delegated to collaborate with this study will be able to access to the database using a password to login.
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.