AsthmaNCT03670654
Effects of Pilates Exercises in Asthmatic Patients
A study testing Pilates and Muscle stretching in people with Asthma, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 20 to 59 years
- Conditions the study is for
- Asthma
- What is being tested?
- Pilates and Muscle stretching
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2017to 14 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Clinical Hospital of São Paulo University medical school (HCFMUSP)
São Paulo, 05360-160
About this study
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
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.
Read the 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
- Being tested
- Pilates, Muscle stretching
- Keywords
- Asthma, Exercise, Pilates, Quality of life, Clinical control
- Medical subject headings
- Asthma, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PilatesOther
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 stretchingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Pilates Method | Active comparator | The intervention of active comparator will be Pilates Method exercises. Receives: Other: Pilates |
| Muscle stretching exercises | Sham comparator | The intervention of sham comparator will be muscle stretching exercises. Receives: Other: Muscle stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline after 3 months of intervention
Secondary outcomes (7)
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).
Measured: 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.
Measured: Change from baseline after 3 months of intervention
Change in thoracoabdominal mechanics
The thoracoabdominal mechanics will be assessed by optoelectronic plethysmography
Measured: Change from baseline after 3 months of intervention
Change in respiratory muscle strength
The strength of the respiratory muscles will be assessed by manovacuometry
Measured: Change from baseline after 3 months of intervention
Change in pulmonary function
Lung volumes will be assessed by Spirometry
Measured: 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)
Measured: 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)
Measured: Change from baseline after 3 months of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start1 Aug 2017
- Primary completion1 Aug 2018
- Study completion14 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo, Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Sponsor
- Investigators
- Celso RF Carvalho, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03670654
- Sponsor's protocol ID
- EPEAP
- Status last verified
- Nov 2017
- First submitted
- 4 Sep 2018
- Last updated
- 13 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03670654
- Acronym / sponsor ID
- EPEAP
- Conditions
- Asthma
- Keywords
- Asthma, Exercise, Pilates, Quality of life, Clinical control
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- University of Sao Paulo, Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 14 Dec 2018 (estimated)
- First posted
- 13 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilates Method | Active comparator | Other: PilatesThe intervention of active comparator will be Pilates Method exercises. |
| Muscle stretching exercises | Sham comparator | Other: Muscle stretchingThe intervention of sham comparator will be muscle stretching exercises. |
Who may qualify
- Ages
- 20 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PilatesThe 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. | Other | Pilates Method |
| Muscle stretchingThe 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. | Other | Muscle stretching exercises |
Primary outcome
Change in health related quality of life
Time frame: Change from baseline after 3 months of intervention
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.
7 secondary outcomes
Change in clinical control
Time frame: Change from baseline after 3 months of intervention
Change in the level of anxiety and depression
Time frame: Change from baseline after 3 months of intervention
Change in thoracoabdominal mechanics
Time frame: Change from baseline after 3 months of intervention
Change in respiratory muscle strength
Time frame: Change from baseline after 3 months of intervention
Change in pulmonary function
Time frame: Change from baseline after 3 months of intervention
Change in functional capacity
Time frame: Change from baseline after 3 months of intervention
Change in daily life physical activity
Time frame: Change from baseline after 3 months of intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Celso RF Carvalho, PhD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates and Muscle stretching in people with Asthma, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in health related quality of life (time frame: Change from baseline after 3 months of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2018.