Aerobic and Respiratory Exercises on Asthma

NCT04412720 | Completed DMC

• 1 other identifier: 2491900
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Asthma

Keywords

Aerobic exercises; Respiratory exercises; Asthma clinical control

Outcome Measures

Primary Outcomes (1)

• Change in asthma clinical control

  Clinical control will be evaluated by the Asthma Control Questionnaire (ACQ). The ACQ contains 7 items rated on a 7-point scale (0 = without limitation, 6 = maximum limitation), with a higher score indicating worse control. Scores lower than 0.75 are associated with good asthma control, whereas scores greater than 1.5 are indicative of poorly controlled asthma, and a change of at least 0.5 points in the ACQ score is regarded as clinically significant.

  Change from baseline to 10 weeks of intervention

Secondary Outcomes (10)

• Change in health related quality of life

  Change from baseline to 10 weeks of intervention

• Change in psychosocial symptoms

  Change from baseline to 10 weeks of intervention

• Change in pulmonary function in absolute values

  Change from baseline to 10 weeks of intervention

• Change in pulmonary function in predict values

  Change from baseline to 10 weeks of intervention

• Change in functional capacity

  Change from baseline to 10 weeks of intervention

Study Arms (2)

Aerobic and Breathing Exercises

EXPERIMENTAL

The experimental intervention will be aerobic and breathing exercises.

Other: Aerobic and Breathing Exercises

Aerobic and Stretching Exercises

ACTIVE COMPARATOR

The active comparative intervention will be aerobic and stretching exercises.

Other: Aerobic and Stretching Exercises

Interventions

Aerobic and Breathing Exercises OTHER

Aerobic exercises will be performed on a treadmill, twice a week, totaling 20 sessions of 60 minutes each. The initial intensity will be 50% to 60% of maximum heart rate and the progression will take place according to the level of effort (Borg) in the last two sessions. In addition, following the aerobic training, Buteyko Breathing Technique also will be performed during 20 minutes each exercise, in the same treatment session. During the first two weeks, the patient will learn the technique supervised by a physical therapist. In addition, the patients will receive a breathing exercise booklet for in-home training. Before and after each session, patients will be evaluated in relation to blood pressure, heart rate, oxygen saturation and asthma symptoms.

Aerobic and Breathing Exercises

Aerobic and Stretching Exercises OTHER

Aerobic exercises will be performed on a treadmill, twice a week, totaling 20 sessions of 60 minutes each. The initial intensity will be 50% to 60% of maximum heart rate and the progression will take place according to the level of effort (Borg) in the last two sessions. In addition, following the aerobic training, stretching exercises will be performing for major muscle groups, during 30 seconds each one. The patients will receive a stretching exercise booklet for in-home training.

Aerobic and Stretching Exercises

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Celso Ricardo Fernandes de Carvalho

São Paulo, 01246903, Brazil

Location

MeSH Terms

Conditions

Asthma

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Celso RF Carvalho, PhD

  University of Sao Paulo General Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All the measurements will be performed by a professional blinded to the groups. The same assessor will be maintained to perform the evaluations before and after the intervention. The professionals involved with the evaluations will be different from the professionals involved on the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2020
• First Posted: June 2, 2020
• Study Start: March 5, 2020
• Primary Completion: January 31, 2021
• Study Completion: July 31, 2021
• Last Updated: August 24, 2023

Record last verified: 2020-01

Locations

BR (1)