Clinical trial NCT03670654: Effects of Pilates Exercises in Asthmatic Patients
Official title: The Effects of an Exercise Program With Pilates Method on Quality of Life and Clinical Control in Asthmatic Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma
Keywords: Asthma
Exercise
Pilates
Quality of life
Clinical control
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: University of Sao Paulo
name: Fundação de Amparo à Pesquisa do Estado de São Paulo
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2018-09-13
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Asthma is a chronic respiratory disease with high prevalence worldwide, considered an important cause of morbidity, mortality and high economic costs. Aerobic physical exercise has great merit as non-pharmacological treatment and other exercise modalities have being studied. However, there are few data in the literature about the effects of Pilates method in patients with asthma. The objective of this study is evaluate the effects of a program of exercise using Pilates on health factors related to quality of life in patients with moderate or severe persistent asthma. Patients will be also evaluated about disease control, anxiety and depression symptoms, functional capacity, lung function, respiratory muscle strength, thoracoabdominal mechanics and level of daily life physical activity. The investigators' hypothesis is that strengthening of the deep trunk muscles promotes a mechanical fixation of the thorax, contributing to the clinical improvement of patients with asthma.

Detailed description: This is a randomized, controlled and single blinded trial. Thirty adults with moderate or severe persistent asthma will be randomly assigned into two groups: Pilates method - PM (training group) or muscle stretching exercises - MSE (control group). All subjects will receive the same educational session and will perform the physical exercise proposed for the group for 12 weeks, 3 times/week, 40-minute sessions. The data normality will be analyzed by Kolmogorov-Smirnov, the variables obtained before interventions will be compared with the Student t-test or Mann-Whitney U-test. Comparisons of the initial and final data on outcomes will be analyzed with repeated measures ANOVA with appropriate post hoc of Holm-Sidak. The significance level will be set to 5% for all tests.

Eligibility criteria: Inclusion Criteria:

* Asthma moderate and severe
* Asthma will diagnosed (Global Initiative for Asthma -GINA)
* Asthma medication according recommendations from GINA
* Body Mass Index ≥18.5 kg/m2 and \<35 kg/m2
* Sedentary
* Medical treatment, for at least 6 months
* Clinically stable (i.e., no exacerbation or medication changes for at least 30 days)

Exclusion Criteria:

* Current or ex-smokers (who have given up smoking less than 1 year and/or tobacco charge greater than 10 pack-years)
* Cardiovascular, musculoskeletal and other chronic lung diseases
* Pregnant
* Active cancer
* Uncontrolled hypertension or diabetes
* Continuous use of oral corticosteroid
* Psychiatric disease or cognitive deficit

Primary outcomes:
measure: Change in health related quality of life
timeFrame: Change from baseline after 3 months of intervention
Secondary outcomes:
measure: Change in clinical control
timeFrame: Change from baseline after 3 months of intervention
measure: Change in the level of anxiety and depression
timeFrame: Change from baseline after 3 months of intervention
measure: Change in thoracoabdominal mechanics
timeFrame: Change from baseline after 3 months of intervention
measure: Change in respiratory muscle strength
timeFrame: Change from baseline after 3 months of intervention
measure: Change in pulmonary function
timeFrame: Change from baseline after 3 months of intervention
measure: Change in functional capacity
timeFrame: Change from baseline after 3 months of intervention
measure: Change in daily life physical activity
timeFrame: Change from baseline after 3 months of intervention
Other outcomes:
measure: Change in anthropometric dates
timeFrame: Change from baseline after 3 months of intervention
Locations:
city: São Paulo
country: Brazil
facility: Clinical Hospital of São Paulo University medical school (HCFMUSP)
Study officials:
affiliation: University of Sao Paulo
name: Celso RF Carvalho, PhD
role: PRINCIPAL_INVESTIGATOR
References: