Effects of Pilates Exercises in Asthmatic Patients

Asthma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03670654
• Other study ID #: EPEAP
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: December 14, 2018

Study information

• Verified date: November 2017
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 14, 2018
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Brazil	Clinical Hospital of São Paulo University medical school (HCFMUSP)	São Paulo

Sponsors (4)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado de São Paulo, University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in anthropometric dates	The body mass index (BMI) will be calculated by the ration between weight in kilograms and height in meter squared (kg/m2).	Change from baseline after 3 months of intervention
Primary	Change in health related quality of life	Health related quality of life will be assessed by Asthma Quality Life Questionnaire (AQLQ). The AQLQ is composed by 32 items rated on a 7-point scale ranging from 7 = without limitation to 1 = maximum limitation and grouped in 4 domains: activity limitations (11 items), symptoms (12 items), emotional function (5 items) and environmental stimuli (4 items). Total score will be obtained by the average of the 32 items. The score of each domain will be obtained by the average of the items that compose the domain. A higher score indicates a better quality of life in relation asthma disease and a minimal important difference of 0.5 points results in clinically improvement or deterioration for total score and for each domain.	Change from baseline after 3 months of intervention
Secondary	Change in clinical control	Clinical control will be evaluated by asthma control questionnaire (ACQ). The ACQ consists of 7 items rated on a 7-point scale ranging from 0 = without limitation to 6 = maximum limitation and the score will be obtained by the average of the items. A higher score indicates worse control and a change of 0.5 point after intervention is clinically important. Asthma will be considered as controlled (ACQ <0.75 points), not well controlled and poorly controlled asthma (ACQ >1.5 points).	Change from baseline after 3 months of intervention
Secondary	Change in the level of anxiety and depression	The symptoms of anxiety and depression will be assessed by Hospital Anxiety and Depression Scale (HADS). The scale is composed by 14 items divided into 2 subscales, each containing 7 items. Each item was scored from 0 to 3, with a maximum score of 21 points for each subscale. The score of each subscale will be obtained by summing the items.	Change from baseline after 3 months of intervention
Secondary	Change in thoracoabdominal mechanics	The thoracoabdominal mechanics will be assessed by optoelectronic plethysmography	Change from baseline after 3 months of intervention
Secondary	Change in respiratory muscle strength	The strength of the respiratory muscles will be assessed by manovacuometry	Change from baseline after 3 months of intervention
Secondary	Change in pulmonary function	Lung volumes will be assessed by Spirometry	Change from baseline after 3 months of intervention
Secondary	Change in functional capacity	The functional capacity will be assessed by the Incremental Shuttle Walking Test (ISWT)	Change from baseline after 3 months of intervention
Secondary	Change in daily life physical activity	Daily life physical activity will be assessed using an accelerometer (actigraph activity monitor)	Change from baseline after 3 months of intervention