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.
BACKGROUND
Individuals with chronic lung disease are more susceptible to present reduction in exercise tolerance and muscles strength not only due to pulmonary limitations but also due systemic repercussions of the pulmonary disease. The aim of this study is to assess the physical capacity, peripheral muscle function, physical activity in daily life, and the inflammatory markers in children and adolescents with asthma after pulmonary rehabilitation program.


METHODS
This is a study protocol of randomized controlled trial in asthmatic patients between 6 to 18 years old. The assessments will be conducted in three different days and will be performed at the beginning and at the end of the protocol. First visit: quality of life questionnaire, asthma control questionnaire, pre- and post-bronchodilator spirometry (400 μcg salbutamol), inflammatory assessment (blood collection), and cardiopulmonary exercise test on a cycle ergometer to determine aerobic capacity. Second visit: assessment of strength and endurance of the quadriceps femoris and biceps brachii muscles with concomitant electromyography to assess peripheral muscle strength. Third visit: incremental shuttle walk test (ISWT) and accelerometer to evaluate functional capacity and physical activity in daily life during 7 days. Then, the volunteers will be randomized to receive pulmonary rehabilitation program (intervention group) or chest physiotherapy + stretching exercises (control group). Both groups will have a supervised session, twice a week, each session will have 60 minutes duration, with minimum interval of 24 hours, for a period of 8 weeks. Intervention group: aerobic training (35 minutes) intensity between 60 to 80 % of the maximum workload of cardiopulmonary exercise testing or of ISWT; strength muscle training will be applied to the quadriceps femoris, biceps brachii and deltoid muscles (intensity: 40 to 70 % of maximal repetition, 3 x 8 repetition); finally the oral high-frequency oscillation device (Flutter®) will be used for 5 minutes. The control group: oral high-frequency oscillation device (Flutter®) for 10 minutes followed by the stretching of upper and lower limbs for 40 minutes. It is expected to observe the improvement in aerobic capacity, physical activity in daily life, muscle strength and quality of life of patients in the intervention group, and reduction in inflammatory markers.


BACKGROUND



BACKGROUND
NCT02383069. Data of registration: 03/03/2015.
Master Degree in progress at Postgraduate Program in Rehabilitation Sciences, Universidade Nove de Julho - UNINOVE, Sao Paulo/SP, Brazil. mamreimberg@yahoo.com.br.
Mariana Mazzuca
MM
Reimberg
Master Degree in progress at Postgraduate Program in Rehabilitation Sciences, Universidade Nove de Julho - UNINOVE, Sao Paulo/SP, Brazil. rejaneagnelo@gmail.com.
Rejane Agnelo Silva
RA
Castro
Master Degree in progress at Postgraduate Program in Rehabilitation Sciences, Universidade Nove de Julho - UNINOVE, Sao Paulo/SP, Brazil. jessycapachir_selman@hotmail.com.
Jessyca Pachi Rodrigues
JP
Selman
Master Degree in progress at Postgraduate Program in Rehabilitation Sciences, Universidade Nove de Julho - UNINOVE, Sao Paulo/SP, Brazil. ft.alinemeseses@hotmail.com.
Aline Santos
AS
Meneses
Affiliated with the Postgraduate Program in Rehabilitation Sciences, Universidade Nove de Julho - UNINOVE, Sao Paulo/SP, Brazil. politti@uninove.br.
Fabiano
F
Politti
Division of Allergy, Clinical Immunology and Rheumatology, Department of Pediatrics, Federal University of Sao Paulo, Sao Paulo/SP, Brazil. m.mallozi@globo.com.
Márcia Carvalho
MC
Mallozi
Division of Allergy, Clinical Immunology and Rheumatology, Department of Pediatrics, Federal University of Sao Paulo, Sao Paulo/SP, Brazil. gfwandalsen@unifesp.br.
Gustavo Falbo
GF
Wandalsen
Division of Allergy, Clinical Immunology and Rheumatology, Department of Pediatrics, Federal University of Sao Paulo, Sao Paulo/SP, Brazil. dirceu.sole@unifesp.br.
Dirceu
D
Solé
Affiliated with the Postgraduate Program in Rehabilitation Sciences, Universidade Nove de Julho - UNINOVE, Sao Paulo/SP, Brazil. prof.kangelis@uninove.br.
Kátia
K
De Angelis
Affiliated with the Postgraduate Program in Rehabilitation Sciences, Universidade Nove de Julho - UNINOVE, Sao Paulo/SP, Brazil. simonedc@uninove.br.
Simone
S
Dal Corso
Affiliated with the Postgraduate Program in Rehabilitation Sciences, Universidade Nove de Julho - UNINOVE, Sao Paulo/SP, Brazil. lanzafe@gmail.com.|Post Graduation Department, Universidade Nove de Julho - UNINOVE, Vergueiro St, 235/249, São Paulo, SP, 01504-001, Brazil. lanzafe@gmail.com.
Fernanda Cordoba
FC
Lanza
D000203:Activities of Daily Living; D000293:Adolescent; D000367:Age Factors; D001249:Asthma / Q000097:blood / Q000175:diagnosis / Q000503:physiopathology / Q000534:rehabilitation*; D015415:Biomarkers / Q000097:blood; D001938:Brazil; D002648:Child; D002985:Clinical Protocols; D004576:Electromyography; D005080:Exercise Test; D017079:Exercise Tolerance; D005260:Female; D006801:Humans; D018836:Inflammation Mediators / Q000097:blood*; D008168:Lung / Q000503:physiopathology*; D008297:Male; D053580:Muscle Strength; D052097:Quadriceps Muscle / Q000503:physiopathology*; D011788:Quality of Life; D020127:Recovery of Function; D012107:Research Design; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D016138:Walking
D015415:Biomarkers; D018836:Inflammation Mediators