- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03670654
Effects of Pilates Exercises in Asthmatic Patients
September 11, 2018 updated by: University of Sao Paulo General Hospital
The Effects of an Exercise Program With Pilates Method on Quality of Life and Clinical Control in Asthmatic Patients: a Randomized Controlled Trial
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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São Paulo, Brazil, 05360-160
- Clinical Hospital of São Paulo University medical school (HCFMUSP)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 57 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Pilates Method
The intervention of active comparator will be Pilates Method exercises.
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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.
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Sham Comparator: Muscle stretching exercises
The intervention of sham comparator will be muscle stretching exercises.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in health related quality of life
Time Frame: Change from baseline after 3 months of intervention
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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.
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Change from baseline after 3 months of intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in clinical control
Time Frame: Change from baseline after 3 months of intervention
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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).
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Change from baseline after 3 months of intervention
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Change in the level of anxiety and depression
Time Frame: Change from baseline after 3 months of intervention
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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.
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Change from baseline after 3 months of intervention
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Change in thoracoabdominal mechanics
Time Frame: Change from baseline after 3 months of intervention
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The thoracoabdominal mechanics will be assessed by optoelectronic plethysmography
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Change from baseline after 3 months of intervention
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Change in respiratory muscle strength
Time Frame: Change from baseline after 3 months of intervention
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The strength of the respiratory muscles will be assessed by manovacuometry
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Change from baseline after 3 months of intervention
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Change in pulmonary function
Time Frame: Change from baseline after 3 months of intervention
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Lung volumes will be assessed by Spirometry
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Change from baseline after 3 months of intervention
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Change in functional capacity
Time Frame: Change from baseline after 3 months of intervention
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The functional capacity will be assessed by the Incremental Shuttle Walking Test (ISWT)
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Change from baseline after 3 months of intervention
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Change in daily life physical activity
Time Frame: Change from baseline after 3 months of intervention
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Daily life physical activity will be assessed using an accelerometer (actigraph activity monitor)
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Change from baseline after 3 months of intervention
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in anthropometric dates
Time Frame: Change from baseline after 3 months of intervention
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The body mass index (BMI) will be calculated by the ration between weight in kilograms and height in meter squared (kg/m2).
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Change from baseline after 3 months of intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Celso RF Carvalho, PhD, University of Sao Paulo
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2017
Primary Completion (Actual)
August 1, 2018
Study Completion (Anticipated)
December 14, 2018
Study Registration Dates
First Submitted
September 4, 2018
First Submitted That Met QC Criteria
September 11, 2018
First Posted (Actual)
September 13, 2018
Study Record Updates
Last Update Posted (Actual)
September 13, 2018
Last Update Submitted That Met QC Criteria
September 11, 2018
Last Verified
November 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EPEAP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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