Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Sao Paulo | OTHER |
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
| Conselho Nacional de Desenvolvimento CientÃfico e Tecnológico | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pilates Method | Active Comparator | The intervention of active comparator will be Pilates Method exercises. |
|
| Muscle stretching exercises | Sham Comparator | The intervention of sham comparator will be muscle stretching exercises. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pilates | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Celso RF Carvalho, PhD | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Hospital of São Paulo University medical school (HCFMUSP) | São Paulo | 05360-160 | Brazil |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001249 | Asthma |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D026241 | Exercise Movement Techniques |
| D052580 | Muscle Stretching Exercises |
| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| D013812 | Therapeutics |
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
Not provided
Not provided
Not provided
Not provided
Not provided
All the measurements will be performed by a blinded professional, who will be masked from randomization and other results. For each test, the same investigator will be maintained before and after the intervention. The participants will know what treatment (exercise) they will receive, but they don't will know what exercise belongs to the control group.
|
| Muscle stretching | 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. |
|
| Change from baseline after 3 months of intervention |
| 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 |
| Change in thoracoabdominal mechanics | The thoracoabdominal mechanics will be assessed by optoelectronic plethysmography | Change from baseline after 3 months of intervention |
| Change in respiratory muscle strength | The strength of the respiratory muscles will be assessed by manovacuometry | Change from baseline after 3 months of intervention |
| Change in pulmonary function | Lung volumes will be assessed by Spirometry | Change from baseline after 3 months of intervention |
| 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 |
| 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 |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D001519 | Behavior |
| D000359 |
| Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |