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Aerobic and Respiratory Exercises on Asthma

U

University of Sao Paulo General Hospital

Status

Completed

Conditions

Asthma

Treatments

Other: Aerobic and Breathing Exercises
Other: Aerobic and Stretching Exercises

Study type

Interventional

Funder types

Other

Identifiers

NCT04412720
2491900

Details and patient eligibility

About

Many studies have reported the benefits of aerobic and breathing exercises such as, reduction of symptoms and reduced the use of medications, the number of crises, exercise induced bronchoconstriction (EIB), and improvement in health-related quality of life (HRQoL). This study will be a randomized and controlled trial (RCT) with 2 parallel arms and blinded assessment. Fifty-four moderate or severe patients with asthma under optimized medication will be randomly assigned (computer-generated) into either aerobic+breathing exercises (AB) or aerobic+stretching exercises (AS). All patients will receive the same educational session and will perform the physical exercise proposed for the group for 12 weeks, 2 times/week, 60-minute sessions; however, the AB group will perform Buteyko breathing technique and AS will perform muscle stretching exercise. All patients will be assessed to clinical control, quality of life, psychosocial symptoms, pulmonary function, functional capacity, physical activity levels, sleep quality, thoracoabdominal mechanics, hyperventilation symptoms, and asthma exacerbation. The data normality will be analyzed by Kolmogorov-Smirnov. The variables obtained before interventions will be compared using the t-test or Mann-Whitney U-test. Comparisons of the outcomes initial and final data will be analyzed with repeated measures ANOVA with appropriate post hoc test. The significance level will be set to 5% for all tests.

Full description

Many studies have reported the benefits of aerobic and breathing exercises such as, reduction of symptoms and reduced the use of medications, the number of crises, exercise induced bronchoconstriction (EIB), and improvement in health-related quality of life (HRQoL). This study will be a randomized and controlled trial (RCT) with 2 parallel arms and blinded assessment. Fifty-four moderate or severe patients with asthma under optimized medication will be randomly assigned (computer-generated) into either aerobic+breathing exercises (AB) or aerobic+stretching exercises (AS). All patients will receive the same educational session and will perform the physical exercise proposed for the group for 12 weeks, 2 times/week, 60-minute sessions; however, the AB group will perform Buteyko breathing technique and AS will perform muscle stretching exercise. All patients will be assessed to clinical control, quality of life, psychosocial symptoms, pulmonary function, functional capacity, physical activity levels, sleep quality, thoracoabdominal mechanics, hyperventilation symptoms, and asthma exacerbation. The data normality will be analyzed by Kolmogorov-Smirnov. The variables obtained before interventions will be compared using the t-test or Mann-Whitney U-test. Comparisons of the outcomes initial and final data will be analyzed with repeated measures ANOVA with appropriate post hoc test. The significance level will be set to 5% for all tests.

Enrollment

52 patients

Sex

All

Ages

18 to 59 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Asthma moderate and severe with diagnosed according to the Global Initiative for Asthma (GINA) 2020
  • Sedentary (< 150 min of moderate to vigorous physical activity/week)
  • Body Mass Index ≥18.5 kg/m2 and <35 kg/m2
  • Medical treatment, for at least 6 months
  • Clinically stable (i.e., no exacerbation or changes in medication for at least 30 days)

Exclusion criteria

  • Cardiovascular, musculoskeletal or other chronic lung diseases
  • Active Cancer
  • Pregnant
  • Uncontrolled hypertension or diabetes
  • Current smoker or ex smoker (>10 pack-years)
  • Psychiatric disease or cognitive deficit

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

52 participants in 2 patient groups

Aerobic and Breathing Exercises
Experimental group
Description:
The experimental intervention will be aerobic and breathing exercises.
Treatment:
Other: Aerobic and Breathing Exercises
Aerobic and Stretching Exercises
Active Comparator group
Description:
The active comparative intervention will be aerobic and stretching exercises.
Treatment:
Other: Aerobic and Stretching Exercises

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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