Effects of Pilates Exercises in Asthmatic Patients
Primary Purpose
Asthma
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Pilates
Muscle stretching
Sponsored by

About this trial
This is an interventional treatment trial for Asthma focused on measuring Asthma, Exercise, Pilates, Quality of life, Clinical control
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
Sites / Locations
- Clinical Hospital of São Paulo University medical school (HCFMUSP)
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Pilates Method
Muscle stretching exercises
Arm Description
The intervention of active comparator will be Pilates Method exercises.
The intervention of sham comparator will be muscle stretching exercises.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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 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 in thoracoabdominal mechanics
The thoracoabdominal mechanics will be assessed by optoelectronic plethysmography
Change in respiratory muscle strength
The strength of the respiratory muscles will be assessed by manovacuometry
Change in pulmonary function
Lung volumes will be assessed by Spirometry
Change in functional capacity
The functional capacity will be assessed by the Incremental Shuttle Walking Test (ISWT)
Change in daily life physical activity
Daily life physical activity will be assessed using an accelerometer (actigraph activity monitor)
Full Information
NCT ID
NCT03670654
First Posted
September 4, 2018
Last Updated
September 11, 2018
Sponsor
University of Sao Paulo General Hospital
Collaborators
University of Sao Paulo, Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico
1. Study Identification
Unique Protocol Identification Number
NCT03670654
Brief Title
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
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
August 1, 2018 (Actual)
Study Completion Date
December 14, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
University of Sao Paulo, Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Exercise, Pilates, Quality of life, Clinical control
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pilates Method
Arm Type
Active Comparator
Arm Description
The intervention of active comparator will be Pilates Method exercises.
Arm Title
Muscle stretching exercises
Arm Type
Sham Comparator
Arm Description
The intervention of sham comparator will be muscle stretching exercises.
Intervention Type
Other
Intervention Name(s)
Pilates
Intervention Description
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
Intervention Name(s)
Muscle stretching
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in health related quality of life
Description
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.
Time Frame
Change from baseline after 3 months of intervention
Secondary Outcome Measure Information:
Title
Change in clinical control
Description
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).
Time Frame
Change from baseline after 3 months of intervention
Title
Change in the level of anxiety and depression
Description
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.
Time Frame
Change from baseline after 3 months of intervention
Title
Change in thoracoabdominal mechanics
Description
The thoracoabdominal mechanics will be assessed by optoelectronic plethysmography
Time Frame
Change from baseline after 3 months of intervention
Title
Change in respiratory muscle strength
Description
The strength of the respiratory muscles will be assessed by manovacuometry
Time Frame
Change from baseline after 3 months of intervention
Title
Change in pulmonary function
Description
Lung volumes will be assessed by Spirometry
Time Frame
Change from baseline after 3 months of intervention
Title
Change in functional capacity
Description
The functional capacity will be assessed by the Incremental Shuttle Walking Test (ISWT)
Time Frame
Change from baseline after 3 months of intervention
Title
Change in daily life physical activity
Description
Daily life physical activity will be assessed using an accelerometer (actigraph activity monitor)
Time Frame
Change from baseline after 3 months of intervention
Other Pre-specified Outcome Measures:
Title
Change in anthropometric dates
Description
The body mass index (BMI) will be calculated by the ration between weight in kilograms and height in meter squared (kg/m2).
Time Frame
Change from baseline after 3 months of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Celso RF Carvalho, PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Hospital of São Paulo University medical school (HCFMUSP)
City
São Paulo
ZIP/Postal Code
05360-160
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of Pilates Exercises in Asthmatic Patients
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