Comparison Between Continuous Versus Interval Exercise Training in Asthmatic Patients

• ClinicalTrials.gov Identifier: NCT02489383
• Recruitment Status: Unknown
• First Posted: July 3, 2015
• Last Update Posted: October 19, 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
• Information provided by (Responsible Party): University of Sao Paulo General Hospital

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.

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Condition or disease	Intervention/treatment	Phase
Asthma	Other: Continuous Exercise Training; Other: Interval Exercise Training; Behavioral: Education Program	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: October 2015
• Estimated Primary Completion Date: June 2017
• Estimated Study Completion Date: November 2017

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Continuous Exercise Training; The interventions of active comparator will be education program and exercise training.	Other: Continuous Exercise Training; 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).; Behavioral: Education Program; 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.
Active Comparator: Interval Exercise Training; The interventions of active comparator will be education program and exercise training.	Other: Interval Exercise Training; 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.; Behavioral: Education Program; 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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. Nitric oxide exhaled measurement [ Time Frame: Before and after 3 months of intervention ]
   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).
2. Quantification of Inflammatory mediators [ Time Frame: Before and after 3 months of intervention ]
   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).
3. Analysis of cortisol in the serum [ Time Frame: Before and after 3 months of intervention ]
   The level plasmatic of cortisol hormone will be quantified by fluoroimmunoassay by AutoDelfia (Turku, Finland).
4. Level of physical activity [ Time Frame: Before and after 3 months of intervention, and after 3 months of follow up ]
   The level of Physical activity will be analyzed using a pedometer Yamax model PW 610 (Yamasa, Japan) during 7 consecutive days.
5. Clinical Control [ Time Frame: Before and after 3 months os intervention, ans after 3 months of follow up ]
   Clinical control will be evaluated by asthma control questionnaire (ACQ)
6. Health related quality of life [ Time Frame: Before and after 3 months os intervention, and after 3 months of follow up ]
   Health related quality of life will be assessed by Asthma Quality Life Questionnaire (AQLQ)
7. Level of depression and anxiety [ Time Frame: Before and after 3 months os intervention, and after 3 months of follow up ]
   The symptoms of depression and anxiety will be assessed by Hospital Anxiety and Depression (HAD)
8. Lung function [ Time Frame: Before and after 3 months os intervention, and after 3 months of follow up ]
   Lung volumes will be assessed by Spirometry
9. Physical capacity [ Time Frame: Before and after 3 months os intervention ]
   Maximal aerobic capacity (VO2max) will be assessed by Cardiopulmonary exercise test

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 59 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Celso RF Carvalho, PhD; +55 11 30617317; cscarval@usp.br

Locations

Brazil

Physical Therapy, and Clinical Hospital of Sao Paulo University Medical School (HCFMUSP); Not yet recruiting

Sao Paulo, Brazil, 05360-160

Principal Investigator: Celso RF Carvalho, PT, MSc, PhD

Principal Investigator: Patricia GL Rocco, PT

Principal Investigator: Ronaldo A Silva, MSc and PhD

Hospital das Clínicas da Faculadade de Medicina da USP; Recruiting

São Paulo, Brazil, 05403-010

Sponsors and Collaborators

University of Sao Paulo General Hospital

University of Sao Paulo

Fundação de Amparo à Pesquisa do Estado de São Paulo

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Investigators

• Principal Investigator: Celso RF Carvalho, PhD; University of São Paulo General Hospital

More Information

• Responsible Party: University of Sao Paulo General Hospital
• ClinicalTrials.gov Identifier: NCT02489383
• Other Study ID Numbers: Asthmatic exercise training
• First Posted: July 3, 2015
• Last Update Posted: October 19, 2015
• Last Verified: October 2015

Keywords provided by University of Sao Paulo General Hospital:

Asthma; Continuous Exercise Training; interval Exercise Training; Clinical Control; Inflammation

Additional relevant MeSH terms:

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases