Exercise Training to Lose Weight in Obese Asthmatics

University of Sao Paulo General Hospital

Status: Completed

Conditions: Asthma; Obesity

Treatments: Behavioral: Education Program; Other: Exercise Training; Behavioral: Behavioral Therapy; Other: Stretching and Breathing exercise; Behavioral: Dietary

Study type: Interventional

Funder types: Other

Identifiers

NCT02188940

ETLWOA

2012/16700-9 (Other Grant/Funding Number)

Details and patient eligibility

About

Obese asthmatics have more severe symptoms, reduced lung function, poorer quality of life and a reduced response to inhaled corticosteroid medication compared to non-obese asthmatics. In addition, the impact of a weight-loss program on clinical control and psychological outcomes has been poorly demonstrated and the effect of exercise training remain unknown. The investigators aim to investigate the effect of exercise training in a weight-loss program on asthma clinical control (primary outcome), health factors related to quality of life and psychosocial symptoms (secondary outcomes) in obese patients with moderate-to-severe persistent asthma. Physical activity, inflammatory profiles and sleep disorders will also be evaluated. The investigators' hypothesis is that exercise as part of a weight-loss program is more effective to lose weight and improve asthma control, quality of life and psychosocial symptoms in obese asthmatics.

Full description

This is a randomized, controlled and single blinded trial. Fifty-four asthmatic adults will be randomly assigned into two groups: DBG (dietary and behavioral support group) or DBE (similar to DBG + exercise training). Both groups will complete a weight-loss program based on dietary and behavioral therapy. In addition, DBE will perform a training program based on aerobic and resistance training whereas DBG will perform a breathing and stretching program. Interventions will be performed twice a week for 3 months, 60 minutes each. The data normality will be analyzed by Kolmogorov-Smirnov, the variables obtained before interventions will be compared with the Student t-test or Mann-whitney U-test. Comparisons of the initial and final data on outcomes will be analyzed with repeated measures ANOVA with appropriate post hoc of Bonferroni. The significance level will be set to 5% for all tests.

Enrollment: 55 patients

Sex: All

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Asthma moderate and severe
• Asthma will diagnosed (Global Initiative for Asthma -GINA)
• Body Mass Index between 35 kg/ m2 and 39,9 kg/m2
• Sedentary
• Medical treatment, for at least 6 months
• Clinically stable (i.e., no exacerbation or medication changes for at least 30 days)

Exclusion criteria

• Cardiovascular, musculoskeletal or other chronic lung diseases
• Active Cancer
• Pregnant
• Weight loss more than 5 % in the preceding 6 months
• Using weight-loss medications
• History of bariatric surgery, uncontrolled hypertension or diabetes
• Using overnight continuous positive airway pressure
• Lactating
• Current or ex-smoker

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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55 participants in 2 patient groups

Exercise, dietary and behavioral therapy

Active Comparator group

Description:

The interventions of active comparator will be education program, dietary and behavioral therapy and exercise training.

Treatment:

Other: Exercise Training

Behavioral: Education Program

Behavioral: Dietary

Behavioral: Behavioral Therapy

Dietary and behavioral therapy

Sham Comparator group

Description:

The intervention in sham comparator will be education program, dietary and behavioral therapy and stretching and breathing exercise.

Treatment:

Other: Stretching and Breathing exercise

Behavioral: Education Program

Behavioral: Dietary

Behavioral: Behavioral Therapy