Aerobic and Respiratory Exercises on Asthma

Asthma Clinical Trial

Official title:

Effects of Aerobic and Respiratory Exercises on Asthma Clinical Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04412720
• Other study ID #: 2491900
• Status: Completed
• Phase: N/A
• Start date: March 5, 2020
• Est. completion date: July 31, 2021

Study information

• Verified date: January 2020
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: July 31, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Other:
• Aerobic 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.
• Aerobic 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.

Locations

Country	Name	City	State
Brazil	Celso Ricardo Fernandes de Carvalho	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in health related quality of life	Health 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 from baseline to 10 weeks of intervention
Secondary	Change in psychosocial symptoms	Symptoms 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 from baseline to 10 weeks of intervention
Secondary	Change in pulmonary function in absolute values	Lung 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 from baseline to 10 weeks of intervention
Secondary	Change in pulmonary function in predict values	The 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 from baseline to 10 weeks of intervention
Secondary	Change in functional capacity	The functional capacity will be assessed by the Incremental Shuttle Walking Test (ISWT)	Change from baseline to 10 weeks of intervention
Secondary	Change in physical activity levels	Physical 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).	Change from baseline to 10 weeks of intervention
Secondary	Change in sleep quality	Sleep 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 "5"or greater indicates a "poor" sleeper.	Change from baseline to 10 weeks of intervention
Secondary	Change in thoracoabdominal mechanics	The thoracoabdominal mechanics will be assessed by optoelectronic plethysmography	Change from baseline to 10 weeks of intervention
Secondary	Change in hyperventilation symptoms	Hyperventilation 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 from baseline to 10 weeks of intervention
Secondary	Change in asthma exacerbation	Asthma 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 from baseline to 10 weeks of intervention