Pulmonary Rehabilitation in Asthmatic Patient

NCT02383069 | Completed

• 1 other identifier: CPR-UNI9
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Asthma is one of the main chronic diseases in childhood and it is characterized by the inflammation of airways. Individuals with chronic lung disease are more susceptible to present reduction in exercise tolerance due to pulmonary limitations. The pulmonary rehabilitation may improve the physical capacity in asthmatic patients, as observed in other chronic lung diseases.

Conditions

Asthmatic; Children

Keywords

Pulmonary rehabilitation; Asthma; Children; Teenager; Physical capacity

Outcome Measures

Primary Outcomes (1)

• Physical capacity as measure by distance walked of shuttle walk test and oxygen consumption (VO2)

  Modified shuttle test was conducted

  Physiscal capacity will be measured at the beginning and at the end of the protocol (after 8 weeks)

Secondary Outcomes (4)

• Muscle strength as measure by electromyography (EMG)

  Muscles strenght will be measured at the begening and at the end of the protocol (after 8 weeks).

• Muscle endurance as measure by electromyography (EMG)

  Muscles endurance will be measured at the begening and at the end of the protocol (after 8 weeks).

• Quality of life measured by Pediatric questionnaire

  Quesitionnaire will be measured at the begening and at the end of the protocol (after 8 weeks).

• Inflammatory markers as measure by interleukines

  Inflamatory markers will be measured at the begening and at the end of the protocol (after 8 weeks).

Study Arms (2)

Intervention Group

EXPERIMENTAL

The intervention group will have supervised rehabilitation program held twice a week, each session will have 60 minutes duration, with minimum interval of 24 hours, for a period of 8 weeks. Each session will consist of three parts: aerobic training, strength training and respiratory physiotherapy. The aerobic training will be held for 35 minutes (10 min of warm up, 20 min on target load and 5 min of slowdown) with initial intensity of 60% of the maximum load obtained in the maximal cardiopulmonary exercise testing or in incremental shuttle walk test (ISWT). The intensity will be gradually increased up to 80%, so that fatigue or dyspnea values are kept between 4 and 6, according to the modified Borg scale.

Other: Intervention Group

Control Group

ACTIVE COMPARATOR

The control group will be subjected to supervised respiratory physiotherapy and stretching exercises twice a week, each session with duration of 60 minutes, with minimum interval of 24 hours, for a period of 8 weeks. The oral high-frequency oscillation device (Flutter®) will be used for 10 minutes, 5 minutes in each lateral decubitus, followed by the stretching of upper and lower limbs for 40 minutes. All exercises will be active, performed in sitting and lying positions without increasing the heart rate. The remaining 10 minutes will be used to discuss doubts about the disease and the use of the booklet.

Other: Control Group

Interventions

Intervention Group OTHER

Aerobic training

Also known as: Pulmonary Rehabilitation

Intervention Group

Control Group OTHER

Chest physiotherapy: Flutter and muscle stretching

Also known as: Chest Physiotherapy

Control Group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• between six and 18 years old
• asthma-diagnosed patients
• under medical treatment and disease control

You may not qualify if:

• fail to carry out the protocol evaluations
• interrupt the medical care and/or drug-based treatment
• acute lung infection or other chronic lung diseases
• other comorbidities (neuropathies, heart disease)
• missing in more than 20% the rehabilitation protocol

Sponsors & Collaborators

• Fernanda de Cordoba Lanza: lead
• University of Nove de Julho: collaborator
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator
• Federal University of Minas Gerais: collaborator

Study Sites (1)

Fernanda C Lanza

São Paulo, 01504001, Brazil

Location

Related Publications (2)

• Silva EP, Soares BA, Reimberg MM, Ritti-Dias R, Nascimento KS, Anjos FS, Wandalsen GF, Sole D, Dal Corso S, Lanza FC. Heart rate recovery in asthmastic children and adolescents after clinical field test. BMC Pulm Med. 2021 Feb 19;21(1):61. doi: 10.1186/s12890-020-01355-9.

  PMID: 33607978 DERIVED

• Reimberg MM, Castro RA, Selman JP, Meneses AS, Politti F, Mallozi MC, Wandalsen GF, Sole D, De Angelis K, Dal Corso S, Lanza FC. Effects of a pulmonary rehabilitation program on physical capacity, peripheral muscle function and inflammatory markers in asthmatic children and adolescents: study protocol for a randomized controlled trial. Trials. 2015 Aug 13;16:346. doi: 10.1186/s13063-015-0876-x.

  PMID: 26268930 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Dirceu Solé, PhD

  Unifesp, Federal University of Sao Paulo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD, Professor

Study Record Dates

• First Submitted: February 10, 2015
• First Posted: March 9, 2015
• Study Start: February 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: August 1, 2018
• Last Updated: August 7, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)