NCT07046442

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 4, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

2.8 years

First QC Date

June 27, 2025

Last Update Submit

April 29, 2026

Conditions

Keywords

long COVID, Pulmonary rehabilitation, ACBT

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

Other: Pulmonary Rehabilitation

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.

A group of patients affected by Long Covid 19 disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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)

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

Study Sites (1)

University of Parma

Parma, Italy, 43126, Italy

Location

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.

  • 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.

  • 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.

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

    RESULT
  • 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.

  • 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.

  • 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.

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

  • 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.

  • 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.

  • 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

    RESULT
  • 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.

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

    RESULT
  • 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.

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

  • Huang 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.

  • Interim guidance on Long-COVID Management Principles. ISS COVID-19 Report no. 15/2021 https://www.iss.it

    RESULT
  • COVID-19 rapid guideline: managing COVID-19. NICE guideline Last updated: 13 April 2022.

    RESULT
  • Gupta 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.

  • Lopes 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.

  • Lv 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.

  • Jiandani 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.

  • Barker-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.

  • Greenhalgh 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.

MeSH Terms

Conditions

COVID-19Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

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

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.

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.

Locations