Exercise Training to Lose Weight in Obese Asthmatics

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Exercise Training in a Weight-loss Lifestyle Intervention on Clinical Control and Psychosocial Morbidity in Obese Asthmatics: a Randomized and Controlled Trial

Conditions
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Asthma, Obesity

Intervention / Treatment
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* Behavioral: Dietary
* Behavioral: Education Program
* Behavioral: Behavioral Therapy
* Other: Exercise Training
* Other: Stretching and Breathing exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Exercise, dietary and behavioral therapy<br>The interventions of active comparator will be education program, dietary and behavioral therapy and exercise training. | Behavioral: Dietary<br>* The dietary therapy will be performed every 15 days, totaling 6 sessions of 60 minutes each by a dietitian. Patients will be advised to follow restricted-calorie diet based on the hypocaloric dietary guidance, multiplying the patient's weight by 20 to 25 calories. The Nutwin ® program will be used to structure the patient's diets, based on 24 hours food record and calories tables. Throughout the program, issues related to food control, the benefits of following a balanced diet and the changing food habits will be discussed.<br>Behavioral: Education Program<br>* The education program will consist of 4 classes lasting 6 hours at the beginning of the interventions, in which issues related to asthma and physical activity will be discussed. Presentations and group discussions will be carried out, including information about asthma pathophysiology, medication and peakflowmeter skills, self-monitoring techniques, environmental control, benefits and current recommendations of physical activity.<br>Behavioral: Behavioral Therapy<br>* The Behavioral therapy will be performed every 15 days, totaling 6 sessions of 60 minutes each by a psychologist. Sessions of group dynamics will be performed to increase the patient adherence in a weight loss program using behavior modification techniques, such as self-management, motivational strategies, positive reinforcement and relapse prevention. Relaxation techniques, experiences and patient's report will also be used.<br>Other: Exercise Training<br>* The aerobic training will be performed on a treadmill and a bike (or an elliptical), twice a week, totaling 24 sessions of 60 minutes each. The initial intensity will be 50% to 60% of VO2 max reaching a maximal 75% of VO2 max and the progression will take place according to the level of effort (Borg) in the last two sessions. Patients will be advised to walk outside at least twice a week for 30 minutes and write down their activity in a diary. Furthermore, they will be given an accelerometer in week 6 to record their daily steps. The resistance training will consist of exercises for the upper and lower limbs. Initially, the patients will perform 2 sets of 10 repetitions with load of 50% to 70% of 1-RM and the progression will take place in the number of repetition, and then in the load.<br>|
| Sham Comparator: Dietary and behavioral therapy<br>The intervention in sham comparator will be education program, dietary and behavioral therapy and stretching and breathing exercise. | Behavioral: Dietary<br>* The dietary therapy will be performed every 15 days, totaling 6 sessions of 60 minutes each by a dietitian. Patients will be advised to follow restricted-calorie diet based on the hypocaloric dietary guidance, multiplying the patient's weight by 20 to 25 calories. The Nutwin ® program will be used to structure the patient's diets, based on 24 hours food record and calories tables. Throughout the program, issues related to food control, the benefits of following a balanced diet and the changing food habits will be discussed.<br>Behavioral: Education Program<br>* The education program will consist of 4 classes lasting 6 hours at the beginning of the interventions, in which issues related to asthma and physical activity will be discussed. Presentations and group discussions will be carried out, including information about asthma pathophysiology, medication and peakflowmeter skills, self-monitoring techniques, environmental control, benefits and current recommendations of physical activity.<br>Behavioral: Behavioral Therapy<br>* The Behavioral therapy will be performed every 15 days, totaling 6 sessions of 60 minutes each by a psychologist. Sessions of group dynamics will be performed to increase the patient adherence in a weight loss program using behavior modification techniques, such as self-management, motivational strategies, positive reinforcement and relapse prevention. Relaxation techniques, experiences and patient's report will also be used.<br>Other: Stretching and Breathing exercise<br>* Breathing exercise will consist of 3 exercises adapted from yoga's breathing technique (kapalabhati, uddhiyana and agnisara) twice a week, totaling 24 sessions of 30 minutes each. Every exercise will be performed in sets of 3 (2 minutes each) with 60 seconds of rest between them. The stretching will consist of stretching exercises for the major muscle groups in 3 sets of 10 seconds each. The program will be performed twice a week, totaling 24 sessions of 30 minutes each. *Both breathing and stretching exercises will be performed as placebo to ensure the same duration of treatment between the two groups.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Control | Clinical control will be evaluated by asthma control questionnaire (ACQ) | Before and after 3 months of intervention | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Obesity, Clinical control, Exercise, Weight-loss