Comparison Between Continuous Versus Interval Exercise Training in Asthmatic Patients

NCT ID: NCT02489383

Last Updated: 2015-10-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2017-11-30

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Continuous Exercise Training

The interventions of active comparator will be education program and exercise training.

Group Type: ACTIVE_COMPARATOR

Continuous Exercise Training

Intervention Type: OTHER

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).

Education Program

Intervention Type: BEHAVIORAL

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.

Interval Exercise Training

The interventions of active comparator will be education program and exercise training.

Group Type: ACTIVE_COMPARATOR

Interval Exercise Training

Intervention Type: OTHER

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 Program

Intervention Type: BEHAVIORAL

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.

Interventions

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).

Intervention Type: 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.

Intervention Type: OTHER

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: collaborator

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role: collaborator

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Celso RF Carvalho, PhD

Role: PRINCIPAL_INVESTIGATOR

University of São Paulo General Hospital

Locations

Physical Therapy, and Clinical Hospital of Sao Paulo University Medical School (HCFMUSP)

São Paulo, São Paulo, Brazil

Site Status: NOT_YET_RECRUITING

Hospital das Clínicas da Faculadade de Medicina da USP

São Paulo, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Celso RF Carvalho, PhD

Role: CONTACT

cscarval@usp.br

+55 11 30617317

Other Identifiers

Asthmatic exercise training

Identifier Type: -

Identifier Source: org_study_id