Lung Sounds as Indicators of Severity and Recovery of Lung Disease

NCT02053870 | Completed

• 1 other identifier: PTDC/SAU-BEB/101943/2008
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess the responsiveness to change of adventitious lung sounds (ALS) in patients with lower respiratory tract infection (LRTI). Patients will be recruited from a central Hospital and their demographic and anthropometric data, lung sounds, lung function, breathlessness, oxygen saturation and chest HRCT scan will be collected within 24h of the first appointment. Then, patients will be randomly allocated to either conventional treatment or conventional treatment plus respiratory physiotherapy. Conventional treatment will consist on daily medical treatment prescribed by the physician. Respiratory physiotherapy will involve 9 sessions (3 times a week during 2 weeks) of breathing retraining and chest clearance techniques, exercises for thoracic mobility, expansion and flexibility, cardiorespiratory exercise training and education about the disease. It is expected that ALS will be responsive to changes in patients' lung function after treatment. It is also expected that, by including a respiratory physiotherapy component in the treatment of patients with LRTI, they will express more improvements in a shorter period of time.

Conditions

Lower Respiratory Tract Infections

Keywords

Adventitious lung sounds; Crackles; Wheezes; Sputum location

Outcome Measures

Primary Outcomes (1)

• Change in adventitious lung sounds

  Adventitious lung sounds are sounds superimposed on the normal respiratory sound. There are continuous (wheezes) and discontinuous (crackles) adventitious sounds. The presence of adventitious lung sound generally indicates pulmonary disorders.

  24 hours after hospital presentation (baseline) and 3 weeks after intervention

Secondary Outcomes (5)

• Change in High Resolution Computed Tomography (HRCT scans)

  assessment at baseline and 3 weeks after intervention

• Change in exercise tolerance

  assessment at baseline and 3 weeks after intervention

• Change in activities limitation resulting from breathlessness

  assessment at baseline and 3 weeks after intervention

• Change in lung function

  assessment at baseline and 3 weeks after intervention

• Change in peripheral oxygen saturation

  assessment at baseline and 3 weeks after intervention

Other Outcomes (1)

• Change in Body Mass Index

  assessment at baseline and 3 weeks after intervention

Study Arms (2)

Physiotherapy+conventional treatment

EXPERIMENTAL

Patients will be treated with daily medication prescribed by the physician, during 3 weeks. Additionally, they will be involved in 9 sessions (3 times a week during 2 weeks) of respiratory physiotherapy including breathing retraining and chest clearance techniques, exercises for thoracic mobility, expansion and flexibility, cardiorespiratory exercise training and education about the disease.

Other: Physiotherapy+conventional treatment

Conventional treatment

ACTIVE COMPARATOR

Patients will be treated with daily medication prescribed by the physician, during 3 weeks.

Drug: Conventional treatment

Interventions

Physiotherapy+conventional treatment OTHER

Patients will be treated with daily medication prescribed by the physician, during 3 weeks. Additionally, they will be involved in 9 sessions (3 times a week during 2 weeks) of respiratory physiotherapy including breathing retraining and chest clearance techniques, exercises for thoracic mobility, expansion and flexibility, cardiorespiratory exercise training and education about the disease.

Physiotherapy+conventional treatment

Conventional treatment DRUG

Patients will be treated with daily medication prescribed by the physician, during 3 weeks.

Conventional treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• clinical diagnosis of LRTI according to the international guidelines (i.e., presence cough and at least one of the following symptoms: sputum, dyspnoea, wheezes or chest pain)
• ≥ 18 years old
• able to provide their own informed consent

You may not qualify if:

• cognitive impairments
• inability to understand and co-operate
• bedridden or complete dependence on a wheelchair
• score \>2 in the CURB criteria
• presence of severe comorbidities (e.g., past history of pulmonary lobectomy and current history of neoplasia, tuberculosis or other infectious disease)

Sponsors & Collaborators

• Aveiro University: lead
• Fundação para a Ciência e a Tecnologia: collaborator

Study Sites (1)

University of Aveiro

Aveiro, Aveiro District, 3810-193, Portugal

Location

Related Publications (4)

• Oliveira A, Pinho C, Monteiro S, Marcos A, Marques A. Usability testing of a respiratory interface using computer screen and facial expressions videos. Comput Biol Med. 2013 Dec;43(12):2205-13. doi: 10.1016/j.compbiomed.2013.10.010. Epub 2013 Oct 17.

  PMID: 24290937 BACKGROUND

• Marques A, Oliveira A, Jacome C. Computerized adventitious respiratory sounds as outcome measures for respiratory therapy: a systematic review. Respir Care. 2014 May;59(5):765-76. doi: 10.4187/respcare.02765. Epub 2013 Sep 17.

  PMID: 24046460 BACKGROUND

• Marques A, Pinho C, De Francesco S, Martins P, Neves J, Oliveira A. A randomized controlled trial of respiratory physiotherapy in lower respiratory tract infections. Respir Med. 2020 Feb;162:105861. doi: 10.1016/j.rmed.2019.105861. Epub 2020 Jan 1.

  PMID: 31916533 DERIVED

• Oliveira A, Marques A. Exploratory mixed methods study of respiratory physiotherapy for patients with lower respiratory tract infections. Physiotherapy. 2016 Mar;102(1):111-8. doi: 10.1016/j.physio.2015.03.3723. Epub 2015 May 14.

  PMID: 26067286 DERIVED

MeSH Terms

Conditions

Respiratory Sounds

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alda S. Marques, PhD

  Aveiro University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Study Record Dates

• First Submitted: January 31, 2014
• First Posted: February 4, 2014
• Study Start: September 1, 2009
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: February 4, 2014

Record last verified: 2014-02

Locations

PT (1)