AsthmaNCT02489383
Comparison Between Continuous Versus Interval Exercise Training in Asthmatic Patients
A study testing Continuous Exercise Training, Interval Exercise Training and Education Program in people with Asthma, run by University of Sao Paulo General Hospital at 2 sites in Brazil.
Trial summary
The treatment of asthma is based in clinical control. However, previous studies have been shown that patients that participate of the programs of regular or aerobic continuous exercise training (CT) presented improvements in the physical conditioning, and quality life, as well as decreased the levels of anxiety and… Read more about this study
- Who is it for?
- Ages 20 to 59 years
- Conditions the study is for
- Asthma
- What is being tested?
- Continuous Exercise Training, Interval Exercise Training and Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesBrazil
- Study dates
- Oct 2015to Nov 2017
- 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)
- Body Mass Index (BMI) < 35kg/m2
- Medical Treatment for at least 6 months
- Clinically stable (i.e., no exacerbation or medication changes for at least 30 days)
Who cannot join
- Cardiovascular, musculoskeletal or other different chronic lung diseases
- Active cancer
- Pregnant
- Smokers
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites, 2 recruiting
- Not yet recruiting
Physical Therapy, and Clinical Hospital of Sao Paulo University Medical School (HCFMUSP)
São Paulo, São Paulo, 05360-160
Celso RF Carvalho, PT, MSc, PhD
Patricia GL Rocco, PT
- Recruiting
Hospital das Clínicas da Faculadade de Medicina da USP
São Paulo, São Paulo, 05403-010
About this study
Official title: Comparison to Short and Medium-term Effects of Continuous and Interval Aerobic Exercise Training in Improving Aerobic Capacity, Psychosocial Factors and Impact on the Level of Physical Activity in Patients With Asthma Moderate and Severe
The treatment of asthma is based in clinical control. However, previous studies have been shown that patients that participate of the programs of regular or aerobic continuous exercise training (CT) presented improvements in the physical conditioning, and quality life, as well as decreased the levels of anxiety and depression, reduced the oxide nitric exhaled and leukocyte migration at the airways and reduced the airway hyperresponsiveness. The regular exercise also is important part in the rehabilitation of other lung disease as well as chronic obstructive pulmonary disease (COPD). Additionally, others studies have been shown the effects of high intensity interval training (IT) in the pulmonary rehabilitation of COPD patients, that after performed IT presented reduction of dyspnea, and increase the physical capacity. In this sense, the impact of IT in the asthmatic patients at the present moment is poorly studied, and necessity of the more investigation to prove the efficiency of this training model for asthma patients.
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Read the detailed description
The present study will compare the impact of IT and CT in patients with moderate or severe asthma, and investigate what is the most efficient and increases the physical capacity, and quality of life and reduces the inflammatory mediators.
Sixty asthmatic adults will be randomly assigned into two groups: CT (Continuous training) or IT (Interval training). CT will have treatment 2x week, 40 min./session, 60-75% of maximum heart rate intensity and IT also 2x week, 40 min./session, 80-140% of the maximum load intensity, both performed in ergometer cycle by 24 weeks.
- Conditions
- Asthma
- Being tested
- Continuous Exercise Training, Interval Exercise Training, Education Program
- Keywords
- Asthma, Continuous Exercise Training, interval Exercise Training, Clinical Control, Inflammation
- Medical subject headings
- Asthma, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Exercise TrainingOther
The continuous training (CT) will be held in two weekly sessions lasting total of 40 minutes and 5 minutes for heating and 5 to slowdown, and the duration will be 24 sessions (3 months). The exercise sessions will be will be performed on a stationary bicycle, with the initial intensity of 70% of VO2max. If the subject sustain continuously training intensity for 2 consecutive sessions without symptoms breathing, exercise intensity will be increased by 5% of heart rate. The patient may stop the activity if he has any symptoms or respiratory distress, returning it as soon present improvement. Throughout the training, will be monitored heart rate and the level of perception subjective effort (modified Borg scale).
Interval Exercise TrainingOther
The interval training (IT) will be held in two weekly sessions. The IT is individualized and will be performed on a stationary bicycle. Training sessions will be performed with total duration of 40 minutes consisting of 5 minutes extender, 30 minutes from the main part (IT), finishing with five minutes back to calm. In the main part (of 5 to 30 minutes), the patient will perform the exercise with high intensity in the first two weeks, the exercise will be conducted with an intensity 80% of maximum capacity obtained in cycle ergometer test and will cycle for 30 seconds followed by a 30 second recovery period. In the 3rd and 4th weeks, the intensity will be increased to 100% of the maximum obtained. After this period, the intensity will be increased by 5% charge.
Education ProgramBehavioural
The education program will discuss issues related to asthma and physical activity. Presentations and group discussions will be carried out, including information about asthma pathophysiology, medication and peak flow meter skills, self-monitoring techniques, environmental control, benefits and current recommendations of physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Continuous Exercise Training | Active comparator | The interventions of active comparator will be education program and exercise training. Receives: Other: Continuous Exercise Training; Behavioral: Education Program |
| Interval Exercise Training | Active comparator | The interventions of active comparator will be education program and exercise training. Receives: Other: Interval Exercise Training; Behavioral: Education Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endurance test
Measurements at isotime: at identical work rates before and after training, heart rate, perception exertion and dyspnea.
Measured: After 3 months of intervention
Secondary outcomes (9)
Nitric oxide exhaled measurement
The level of nitric oxide exhaled (FEno) in the patients with asthma will be quantified with use of the equipment Niox Mino (Niox, Solna, Sweden).
Measured: Before and after 3 months of intervention
Quantification of Inflammatory mediators
The levels of inflammatory mediators interleukin (IL)-4, IL-5, IL-6, IL-8, IL-2, IL-12, IL-17, Interferon gamma (IFN-γ), Tumor necrosis factor alpha (TNF-α), IL-10, and chemokines IL-8, Regulated on Activation, Normal T cell Expressed and Secreted (RANTES), Monocyte Chemoattractant Protein-1 (MCP-1), Monokine induced by gamma interferon (MIG), Interferon gamma-induced protein-10 (IP-10) e Transforming Growing Factor-beta (TGF-b) in the serum will be analyzed by Cytometric bead array (CBA) technique (BD Biosciences, San Jose, California, EUA).
Measured: Before and after 3 months of intervention
Analysis of cortisol in the serum
The level plasmatic of cortisol hormone will be quantified by fluoroimmunoassay by AutoDelfia (Turku, Finland).
Measured: Before and after 3 months of intervention
Level of physical activity
The level of Physical activity will be analyzed using a pedometer Yamax model PW 610 (Yamasa, Japan) during 7 consecutive days.
Measured: Before and after 3 months of intervention, and after 3 months of follow up
Clinical Control
Clinical control will be evaluated by asthma control questionnaire (ACQ)
Measured: Before and after 3 months os intervention, ans after 3 months of follow up
Health related quality of life
Health related quality of life will be assessed by Asthma Quality Life Questionnaire (AQLQ)
Measured: Before and after 3 months os intervention, and after 3 months of follow up
Level of depression and anxiety
The symptoms of depression and anxiety will be assessed by Hospital Anxiety and Depression (HAD)
Measured: Before and after 3 months os intervention, and after 3 months of follow up
Lung function
Lung volumes will be assessed by Spirometry
Measured: Before and after 3 months os intervention, and after 3 months of follow up
Physical capacity
Maximal aerobic capacity (VO2max) will be assessed by Cardiopulmonary exercise test
Measured: Before and after 3 months os intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2015 (estimated)
- Study startOct 2015
- Primary completionJun 2017 (estimated)
- Study completionNov 2017 (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.
- 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
- 60 participants (estimated)
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 São Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02489383
- Sponsor's protocol ID
- Asthmatic exercise training
- Status last verified
- Oct 2015
- First submitted
- 12 May 2015
- Last updated
- 19 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison to Short and Medium-term Effects of Continuous and Interval Aerobic Exercise Training in Improving Aerobic Capacity, Psychosocial Factors and Impact on the Level of Physical Activity in Patients With Asthma Moderate and Severe
- ClinicalTrials.gov ID
- NCT02489383
- Acronym / sponsor ID
- Asthmatic exercise training
- Conditions
- Asthma
- Keywords
- Asthma, Continuous Exercise Training, interval Exercise Training, Clinical Control, Inflammation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- 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
- Oct 2015
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 3 Jul 2015 (estimated)
- 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.
The treatment of asthma is based in clinical control. However, previous studies have been shown that patients that participate of the programs of regular or aerobic continuous exercise training (CT) presented improvements in the physical conditioning, and quality life, as well as decreased the levels of anxiety and depression, reduced the oxide nitric exhaled and leukocyte migration at the airways and reduced the airway hyperresponsiveness. The regular exercise also is important part in the rehabilitation of other lung disease as well as chronic obstructive pulmonary disease (COPD). Additionally, others studies have been shown the effects of high intensity interval training (IT) in the pulmonary rehabilitation of COPD patients, that after performed IT presented reduction of dyspnea, and increase the physical capacity. In this sense, the impact of IT in the asthmatic patients at the present moment is poorly studied, and necessity of the more investigation to prove the efficiency of this training model for asthma patients.
.
Detailed description
The present study will compare the impact of IT and CT in patients with moderate or severe asthma, and investigate what is the most efficient and increases the physical capacity, and quality of life and reduces the inflammatory mediators.
Sixty asthmatic adults will be randomly assigned into two groups: CT (Continuous training) or IT (Interval training). CT will have treatment 2x week, 40 min./session, 60-75% of maximum heart rate intensity and IT also 2x week, 40 min./session, 80-140% of the maximum load intensity, both performed in ergometer cycle by 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous Exercise Training | Active comparator | Other: Continuous Exercise Training, Behavioral: Education ProgramThe interventions of active comparator will be education program and exercise training. |
| Interval Exercise Training | Active comparator | Other: Interval Exercise Training, Behavioral: Education ProgramThe interventions of active comparator will be education program and exercise training. |
Who may qualify
- Ages
- 20 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Asthma moderate and severe
- Asthma will diagnosed (Global Initiative for Asthma - GINA)
- Body Mass Index (BMI) < 35kg/m2
- Medical Treatment for at least 6 months
- Clinically stable (i.e., no exacerbation or medication changes for at least 30 days)
Key exclusion criteria (4 listed)
- Cardiovascular, musculoskeletal or other different chronic lung diseases
- Active cancer
- Pregnant
- Smokers
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 |
|---|---|---|
| Continuous Exercise TrainingThe continuous training (CT) will be held in two weekly sessions lasting total of 40 minutes and 5 minutes for heating and 5 to slowdown, and the duration will be 24 sessions (3 months). The exercise sessions will be will be performed on a stationary bicycle, with the initial intensity of 70% of VO2max. If the subject sustain continuously training intensity for 2 consecutive sessions without symptoms breathing, exercise intensity will be increased by 5% of heart rate. The patient may stop the activity if he has any symptoms or respiratory distress, returning it as soon present improvement. Throughout the training, will be monitored heart rate and the level of perception subjective effort (modified Borg scale). | Other | Continuous Exercise Training |
| Interval Exercise TrainingThe interval training (IT) will be held in two weekly sessions. The IT is individualized and will be performed on a stationary bicycle. Training sessions will be performed with total duration of 40 minutes consisting of 5 minutes extender, 30 minutes from the main part (IT), finishing with five minutes back to calm. In the main part (of 5 to 30 minutes), the patient will perform the exercise with high intensity in the first two weeks, the exercise will be conducted with an intensity 80% of maximum capacity obtained in cycle ergometer test and will cycle for 30 seconds followed by a 30 second recovery period. In the 3rd and 4th weeks, the intensity will be increased to 100% of the maximum obtained. After this period, the intensity will be increased by 5% charge. | Other | Interval Exercise Training |
| Education ProgramThe education program will discuss issues related to asthma and physical activity. Presentations and group discussions will be carried out, including information about asthma pathophysiology, medication and peak flow meter skills, self-monitoring techniques, environmental control, benefits and current recommendations of physical activity. | Behavioural | Continuous Exercise Training, Interval Exercise Training |
Primary outcome
Endurance test
Time frame: After 3 months of intervention
Measurements at isotime: at identical work rates before and after training, heart rate, perception exertion and dyspnea.
9 secondary outcomes
Nitric oxide exhaled measurement
Time frame: Before and after 3 months of intervention
Quantification of Inflammatory mediators
Time frame: Before and after 3 months of intervention
Analysis of cortisol in the serum
Time frame: Before and after 3 months of intervention
Level of physical activity
Time frame: Before and after 3 months of intervention, and after 3 months of follow up
Clinical Control
Time frame: Before and after 3 months os intervention, ans after 3 months of follow up
Health related quality of life
Time frame: Before and after 3 months os intervention, and after 3 months of follow up
Level of depression and anxiety
Time frame: Before and after 3 months os intervention, and after 3 months of follow up
Lung function
Time frame: Before and after 3 months os intervention, and after 3 months of follow up
Physical capacity
Time frame: Before and after 3 months os intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2015.
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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 São Paulo General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Exercise Training, Interval Exercise Training and Education Program in people with Asthma, run by University of Sao Paulo General Hospital at 2 sites 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 5 inclusion and 4 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 19 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
Contact Celso RF Carvalho, PhD (+55 11 30617317, cscarval@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endurance test (time frame: 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 19 Oct 2015.