Pulmonary Rehabilitation in Asthmatic Patient

NCT ID: NCT02383069

Last Updated: 2019-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2018-08-31

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.

Detailed Description

The asthmatic patient's clinical changes may impair their functional capacity and exercise tolerance. Thus, the treatment of these individuals should be extended to pulmonary rehabilitation. Randomized clinical trials have shown interesting results, whether in cardiopulmonary conditions, quality of life or in the number of crises, after applying pulmonary rehabilitation program in asthmatic children and adolescents. In a systematic review on physical training with asthmatic children and adolescents the authors concluded that physical activity should be recommended to this population, although some issues have not yet been clarified due to limitations in the clinical trial. The control of the disease has not been evaluated by specific questionnaires in any study. The assessment of inflammatory markers was rarely addressed and the same occurred in the quality of life after physical training. In addition, it is possible to question the intensity and frequency of training, factors that can significantly contribute to the intervention results. All these information let us know that is necessary a randomized control trial to answer questions about physical characteristics, quality of life, inflammatory markers, and muscles strength.

Conditions

Asthmatic; Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention Group

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.

Group Type: EXPERIMENTAL

Intervention Group

Intervention Type: OTHER

Aerobic training

Control Group

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.

Group Type: ACTIVE_COMPARATOR

Control Group

Intervention Type: OTHER

Chest physiotherapy: Flutter and muscle stretching

Interventions

Intervention Group

Aerobic training

Intervention Type: OTHER

Control Group

Chest physiotherapy: Flutter and muscle stretching

Intervention Type: OTHER

Other Intervention Names

Pulmonary Rehabilitation; Chest Physiotherapy

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Nove de Julho

OTHER

Sponsor Role: collaborator

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

Federal University of Minas Gerais

OTHER

Sponsor Role: collaborator

Fernanda de Cordoba Lanza

OTHER

Sponsor Role: lead

Responsible Party

Fernanda de Cordoba Lanza

PhD, Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Dirceu Solé, PhD

Role: STUDY_CHAIR

Unifesp, Federal University of Sao Paulo

Locations

Fernanda C Lanza

São Paulo, , Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 33607978 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26268930 (View on PubMed)

Other Identifiers

CPR-UNI9

Identifier Type: -

Identifier Source: org_study_id