Exercise Training to Lose Weight in Obese Asthmatics

Not Applicable

Completed

• Conditions: Obesity; Asthma
• Interventions: Behavioral: Dietary; Behavioral: Education Program; Behavioral: Behavioral Therapy; Other: Stretching and Breathing exercise; Other: Exercise Training

• Registration Number: NCT02188940
• Lead Sponsor: University of Sao Paulo General Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2014-07
• Study Start: 2014-07
• Study First Submitted: 2014-07-10
• Study First Submitted QC: 2014-07-11
• Study First Posted: 2014-07-14
• Primary Completion: 2015-02
• Study Completion: 2015-10
• Last Update Submitted: 2016-02-19
• Last Update Posted: 2016-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise, dietary and behavioral therapy	Behavioral Therapy	The interventions of active comparator will be education program, dietary and behavioral therapy and exercise training.
Dietary and behavioral therapy	Stretching and Breathing exercise	The intervention in sham comparator will be education program, dietary and behavioral therapy and stretching and breathing exercise.
Exercise, dietary and behavioral therapy	Exercise Training	The interventions of active comparator will be education program, dietary and behavioral therapy and exercise training.
Dietary and behavioral therapy	Behavioral Therapy	The intervention in sham comparator will be education program, dietary and behavioral therapy and stretching and breathing exercise.
Dietary and behavioral therapy	Dietary	The intervention in sham comparator will be education program, dietary and behavioral therapy and stretching and breathing exercise.
Exercise, dietary and behavioral therapy	Dietary	The interventions of active comparator will be education program, dietary and behavioral therapy and exercise training.
Exercise, dietary and behavioral therapy	Education Program	The interventions of active comparator will be education program, dietary and behavioral therapy and exercise training.
Dietary and behavioral therapy	Education Program	The intervention in sham comparator will be education program, dietary and behavioral therapy and stretching and breathing exercise.

Primary Outcome Measures

Name	Time	Method
Clinical Control	Before and after 3 months of intervention	Clinical control will be evaluated by asthma control questionnaire (ACQ)

Secondary Outcome Measures

Name	Time	Method
Health related quality of life	Before and after 3 months of intervention	Health related quality of life will be assessed by Asthma Quality Life Questionnaire (AQLQ)
Level of depression and anxiety	Before and after 3 months of intervention	the symptoms of depression and anxiety will be assessed by Hospital Anxiety and Depression (HAD)

Trial Locations

Locations (1)

Clinical Hospital of São Paulo University medical school (HCFMUSP); 🇧🇷 São Paulo, Brazil