Effects of Pilates Exercises in Asthmatic Patients

NCT ID: NCT03670654

Last Updated: 2018-09-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2018-12-14

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Pilates Method

The intervention of active comparator will be Pilates Method exercises.

Group Type: ACTIVE_COMPARATOR

Pilates

Intervention Type: OTHER

The Pilates exercises will be performed in 12 weeks with 40-minute sessions, three times a week: 2 at ambulatory and 1 at home. Ambulatory sessions will be supervised by a physical therapist in non-consecutive days. Patients could be grouped in classes with a maximum of 4 subjects. The first two weeks will be spent learning the technique and, in the third week, patients will receive an exercise booklet for in-home training. Will be used the classical solo Pilates exercises, adapted for non-trained individuals. Before and after each session, patients will be evaluated in relation to expiratory peak flow, blood pressure, heart rate and asthma symptoms.

Muscle stretching exercises

The intervention of sham comparator will be muscle stretching exercises.

Group Type: SHAM_COMPARATOR

Muscle stretching

Intervention Type: OTHER

The muscle stretching exercises will be performed in 12 weeks with 40-minute sessions, three times a week: 2 at ambulatory and 1 at home. Ambulatory sessions will be supervised by a physical therapist in non-consecutive days. Patients could be grouped in classes with a maximum of 4 subjects. Patients will practice muscle stretching exercises for principal muscle groups, performed with 3 repetitions, 15 seconds sustain and 1 minute interval. Before and after each session, the patients will be evaluated in relation to expiratory peak flow, blood pressure, heart rate and asthma symptoms.

Interventions

Pilates

The Pilates exercises will be performed in 12 weeks with 40-minute sessions, three times a week: 2 at ambulatory and 1 at home. Ambulatory sessions will be supervised by a physical therapist in non-consecutive days. Patients could be grouped in classes with a maximum of 4 subjects. The first two weeks will be spent learning the technique and, in the third week, patients will receive an exercise booklet for in-home training. Will be used the classical solo Pilates exercises, adapted for non-trained individuals. Before and after each session, patients will be evaluated in relation to expiratory peak flow, blood pressure, heart rate and asthma symptoms.

Intervention Type: OTHER

Muscle stretching

The muscle stretching exercises will be performed in 12 weeks with 40-minute sessions, three times a week: 2 at ambulatory and 1 at home. Ambulatory sessions will be supervised by a physical therapist in non-consecutive days. Patients could be grouped in classes with a maximum of 4 subjects. Patients will practice muscle stretching exercises for principal muscle groups, performed with 3 repetitions, 15 seconds sustain and 1 minute interval. Before and after each session, the patients will be evaluated in relation to expiratory peak flow, blood pressure, heart rate and asthma symptoms.

Intervention Type: OTHER

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: collaborator

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role: collaborator

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Celso RF Carvalho, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

Clinical Hospital of São Paulo University medical school (HCFMUSP)

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

EPEAP

Identifier Type: -

Identifier Source: org_study_id