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Aerobic and Respiratory Exercises on Asthma

Effects of Aerobic and Respiratory Exercises on Asthma Clinical Control

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04412720
Enrollment
52
Registered
2020-06-02
Start date
2020-03-05
Completion date
2021-07-31
Last updated
2023-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Aerobic exercises, Respiratory exercises, Asthma clinical control

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.

Detailed 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.

Interventions

OTHERAerobic and Breathing Exercises

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.

OTHERAerobic and Stretching Exercises

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.

Sponsors

University of Sao Paulo General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in asthma clinical controlChange from baseline to 10 weeks of interventionClinical 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.

Secondary

MeasureTime frameDescription
Change in psychosocial symptomsChange from baseline to 10 weeks of interventionSymptoms of anxiety and depression symptoms will be assessed by the Hospital Anxiety and Depression scale (HADs), which consists of 14 items divided into 2 subscales (7 for anxiety and 7 for depression). Each item is scored from 0 to 3, with a maximum score of 21 points for each subscale. A score greater than 8/9 in each subscale suggests a diagnosis of either anxiety and/or depression.
Change in pulmonary function in absolute valuesChange from baseline to 10 weeks of interventionLung volumes will be assessed by Spirometry. The variables which will be assessed are Forced Vital Capacity (FVC) and Forced Expiratory Volume in first 1 second (FEV1), all them in liters.
Change in pulmonary function in predict valuesChange from baseline to 10 weeks of interventionThe variables which will be assessed are predicted values for brazilian population of Forced Vital Capacity (FVC), Forced Expiratory Volume in first 1 second (FEV1), and FEV1/FVC ratio.
Change in functional capacityChange from baseline to 10 weeks of interventionThe functional capacity will be assessed by the Incremental Shuttle Walking Test (ISWT)
Change in health related quality of lifeChange from baseline to 10 weeks of interventionHealth related quality of life will be assessed by Asthma Quality Life Questionnaire (AQLQ). The AQLQ consists of 32 items rated on a 7-point scale (1 = great deal, 7 = not at all) divided into the following 4 domains: activity limitations, symptoms, emotional function and environmental stimuli. Higher AQLQ scores indicate a better quality of life, and treatments resulting in a 0.5-point increase in scores following an intervention are considered to be clinically effective.
Change in sleep qualityChange from baseline to 10 weeks of interventionSleep quality will be objectively quantified using a movement sensor (ActiGraph, Pensacola, USA) for 7 consecutive nights on the wrist (non-dominant side), and by Pittsburgh Sleep Quality Index (PSQI). The PSQI consists of 9 items divided into the following 7 domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction over the last month. A global sum of 5or greater indicates a poor sleeper.
Change in thoracoabdominal mechanicsChange from baseline to 10 weeks of interventionThe thoracoabdominal mechanics will be assessed by optoelectronic plethysmography
Change in hyperventilation symptomsChange from baseline to 10 weeks of interventionHyperventilation symptoms will be assessed by the Nijmegen Questionnaire which consists of 16 items. Each item is scored from 0 to 4. A score greater than 23 suggest a positive diagnosis of hyperventilation. syndrome.
Change in asthma exacerbationChange from baseline to 10 weeks of interventionAsthma exacerbation will be assessed by the following criteria: the use of ≥4 puffs of rescue medication per 24 hours during a 48-hour period, a need for systemic corticosteroids, an unscheduled medical appointment, and either a visit to an emergency room or hospitalization.
Change in physical activity levelsChange from baseline to 10 weeks of interventionPhysical activity and sedentary behaviour will be objectively quantified using a movement sensor (ActiGraph, Pensacola, USA) for 7 consecutive days on the hip using an elastic belt. Sedentary behaviour will be quantify by the time spent sedentary (\< 100 counts/min).

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026