Comparison Between Continuous Versus Interval Exercise Training in Asthmatic Patients
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
1 other identifier
interventional
60
1 country
2
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. .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable asthma
Started Oct 2015
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 12, 2015
CompletedFirst Posted
Study publicly available on registry
July 3, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2017
CompletedOctober 19, 2015
October 1, 2015
1.7 years
May 12, 2015
October 16, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Endurance test
Measurements at isotime: at identical work rates before and after training, heart rate, perception exertion and dyspnea.
After 3 months of intervention
Secondary Outcomes (9)
Nitric oxide exhaled measurement
Before and after 3 months of intervention
Quantification of Inflammatory mediators
Before and after 3 months of intervention
Analysis of cortisol in the serum
Before and after 3 months of intervention
Level of physical activity
Before and after 3 months of intervention, and after 3 months of follow up
Clinical Control
Before and after 3 months os intervention, ans after 3 months of follow up
- +4 more secondary outcomes
Study Arms (2)
Continuous Exercise Training
ACTIVE COMPARATORThe interventions of active comparator will be education program and exercise training.
Interval Exercise Training
ACTIVE COMPARATORThe interventions of active comparator will be education program and exercise training.
Interventions
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).
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.
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Cardiovascular, musculoskeletal or other different chronic lung diseases
- Active cancer
- Pregnant
- Smokers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Physical Therapy, and Clinical Hospital of Sao Paulo University Medical School (HCFMUSP)
São Paulo, São Paulo, 05360-160, Brazil
Hospital das Clínicas da Faculadade de Medicina da USP
São Paulo, São Paulo, 05403-010, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Celso RF Carvalho, PhD
University of São Paulo General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2015
First Posted
July 3, 2015
Study Start
October 1, 2015
Primary Completion
June 1, 2017
Study Completion
November 1, 2017
Last Updated
October 19, 2015
Record last verified: 2015-10