Comparison Between Continuous Versus Interval Exercise Training in Asthmatic Patients
Primary Purpose
Asthma
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Continuous Exercise Training
Interval Exercise Training
Education Program
Sponsored by

About this trial
This is an interventional treatment trial for Asthma focused on measuring Asthma, Continuous Exercise Training, interval Exercise Training, Clinical Control, Inflammation
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Cardiovascular, musculoskeletal or other different chronic lung diseases
- Active cancer
- Pregnant
- Smokers
Sites / Locations
- Physical Therapy, and Clinical Hospital of Sao Paulo University Medical School (HCFMUSP)
- Hospital das Clínicas da Faculadade de Medicina da USPRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Continuous Exercise Training
Interval Exercise Training
Arm Description
The interventions of active comparator will be education program and exercise training.
The interventions of active comparator will be education program and exercise training.
Outcomes
Primary Outcome Measures
Endurance test
Measurements at isotime: at identical work rates before and after training, heart rate, perception exertion and dyspnea.
Secondary Outcome Measures
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).
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).
Analysis of cortisol in the serum
The level plasmatic of cortisol hormone will be quantified by fluoroimmunoassay by AutoDelfia (Turku, Finland).
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.
Clinical Control
Clinical control will be evaluated by asthma control questionnaire (ACQ)
Health related quality of life
Health related quality of life will be assessed by Asthma Quality Life Questionnaire (AQLQ)
Level of depression and anxiety
The symptoms of depression and anxiety will be assessed by Hospital Anxiety and Depression (HAD)
Lung function
Lung volumes will be assessed by Spirometry
Physical capacity
Maximal aerobic capacity (VO2max) will be assessed by Cardiopulmonary exercise test
Full Information
NCT ID
NCT02489383
First Posted
May 12, 2015
Last Updated
October 16, 2015
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
NCT02489383
Brief Title
Comparison Between Continuous Versus Interval Exercise Training in Asthmatic Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
November 2017 (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
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Continuous Exercise Training, interval Exercise Training, Clinical Control, Inflammation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Continuous Exercise Training
Arm Type
Active Comparator
Arm Description
The interventions of active comparator will be education program and exercise training.
Arm Title
Interval Exercise Training
Arm Type
Active Comparator
Arm Description
The interventions of active comparator will be education program and exercise training.
Intervention Type
Other
Intervention Name(s)
Continuous Exercise Training
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Interval Exercise Training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Education Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Endurance test
Description
Measurements at isotime: at identical work rates before and after training, heart rate, perception exertion and dyspnea.
Time Frame
After 3 months of intervention
Secondary Outcome Measure Information:
Title
Nitric oxide exhaled measurement
Description
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).
Time Frame
Before and after 3 months of intervention
Title
Quantification of Inflammatory mediators
Description
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).
Time Frame
Before and after 3 months of intervention
Title
Analysis of cortisol in the serum
Description
The level plasmatic of cortisol hormone will be quantified by fluoroimmunoassay by AutoDelfia (Turku, Finland).
Time Frame
Before and after 3 months of intervention
Title
Level of physical activity
Description
The level of Physical activity will be analyzed using a pedometer Yamax model PW 610 (Yamasa, Japan) during 7 consecutive days.
Time Frame
Before and after 3 months of intervention, and after 3 months of follow up
Title
Clinical Control
Description
Clinical control will be evaluated by asthma control questionnaire (ACQ)
Time Frame
Before and after 3 months os intervention, ans after 3 months of follow up
Title
Health related quality of life
Description
Health related quality of life will be assessed by Asthma Quality Life Questionnaire (AQLQ)
Time Frame
Before and after 3 months os intervention, and after 3 months of follow up
Title
Level of depression and anxiety
Description
The symptoms of depression and anxiety will be assessed by Hospital Anxiety and Depression (HAD)
Time Frame
Before and after 3 months os intervention, and after 3 months of follow up
Title
Lung function
Description
Lung volumes will be assessed by Spirometry
Time Frame
Before and after 3 months os intervention, and after 3 months of follow up
Title
Physical capacity
Description
Maximal aerobic capacity (VO2max) will be assessed by Cardiopulmonary exercise test
Time Frame
Before and after 3 months os 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)
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)
Exclusion Criteria:
Cardiovascular, musculoskeletal or other different chronic lung diseases
Active cancer
Pregnant
Smokers
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Celso RF Carvalho, PhD
Phone
+55 11 30617317
Email
cscarval@usp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Celso RF Carvalho, PhD
Organizational Affiliation
University of São Paulo General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Physical Therapy, and Clinical Hospital of Sao Paulo University Medical School (HCFMUSP)
City
Sao Paulo
ZIP/Postal Code
05360-160
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Celso RF Carvalho, PT, MSc, PhD
First Name & Middle Initial & Last Name & Degree
Patricia GL Rocco, PT
First Name & Middle Initial & Last Name & Degree
Ronaldo A Silva, MSc and PhD
Facility Name
Hospital das Clínicas da Faculadade de Medicina da USP
City
São Paulo
ZIP/Postal Code
05403-010
Country
Brazil
Individual Site Status
Recruiting
12. IPD Sharing Statement
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Comparison Between Continuous Versus Interval Exercise Training in Asthmatic Patients
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