Exercise Training to Lose Weight in Obese Asthmatics
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ClinicalTrials.gov Identifier: NCT02188940 |
Recruitment Status :
Completed
First Posted : July 14, 2014
Last Update Posted : February 22, 2016
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Condition or disease | Intervention/treatment | Phase |
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Asthma Obesity | Behavioral: Dietary Behavioral: Education Program Behavioral: Behavioral Therapy Other: Exercise Training Other: Stretching and Breathing exercise | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 55 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Effects of Exercise Training in a Weight-loss Lifestyle Intervention on Clinical Control and Psychosocial Morbidity in Obese Asthmatics: a Randomized and Controlled Trial |
Study Start Date : | July 2014 |
Actual Primary Completion Date : | February 2015 |
Actual Study Completion Date : | October 2015 |

Arm | Intervention/treatment |
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Active Comparator: Exercise, dietary and behavioral therapy
The interventions of active comparator will be education program, dietary and behavioral therapy and exercise training.
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Behavioral: Dietary
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. Behavioral: Education Program 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. Behavioral: Behavioral Therapy 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. Other: Exercise Training 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. |
Sham Comparator: Dietary and behavioral therapy
The intervention in sham comparator will be education program, dietary and behavioral therapy and stretching and breathing exercise.
|
Behavioral: Dietary
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. Behavioral: Education Program 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. Behavioral: Behavioral Therapy 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. Other: Stretching and Breathing exercise 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. |
- Clinical Control [ Time Frame: Before and after 3 months of intervention ]Clinical control will be evaluated by asthma control questionnaire (ACQ)
- Health related quality of life [ Time Frame: 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 [ Time Frame: Before and after 3 months of intervention ]the symptoms of depression and anxiety will be assessed by Hospital Anxiety and Depression (HAD)
- Airway inflammation [ Time Frame: Before and after 3 months of intervention ]Airway inflammation will be quantified using the exhaled fraction of nitric oxide (FeNO)
- serum cytokines and adipokines levels [ Time Frame: Before and after 3 months of intervention ]The method Cytometric Beat Array (CBA) (BD Biosciences, USA) will be used to analyze the levels of interleukins (IL) IL-4, IL-5, IL-6, IL-8, IL -10,IL-1ra, IL-13,Tumor Necrosis Factor (TNF-α), leptin, adiponectin and C-reactive protein (CRP)
- Daily life physical activity [ Time Frame: Before and after 3 months of intervention ]Daily life physical activity will be assessed using an accelerometer (actigraph activity monitor) and physical capacity will be assessed by an incremental cardiopulmonary exercise testing
- Sleep disorders [ Time Frame: Before and after 3 months of intervention ]sleep disorders will be assessed by Berlin Questionnaire for Sleep Apnea and Actisleep activity monitor
- Lung function [ Time Frame: Before and after 3 months of intervention ]Static and dynamic lung volumes will be assessed by Spirometry and Plethysmograph
- Physical fitness [ Time Frame: Before and after 3 months of intervention ]Aerobic potency will be assessed by Cardiopulmonary exercise test
- Asthma symptoms and exacerbations [ Time Frame: Before and after 3 months of intervention ]Asthma symptoms will be assessed using a daily diary of symptoms and exacerbation will be defined by an increase in symptoms associated with at least one of the following criteria: use of rescue medication ≥4 puffs per 24 hours during a 48-hour period, need for systemic corticosteroids, unscheduled medical appointment, visit to an emergency room or hospitalization.
- Body composition [ Time Frame: Before and after 3 months of intervention ]Body composition will be analyzed by using a tetrapolar 8-point tactile bioelectrical impedance

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Ages Eligible for Study: | 30 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02188940
Brazil | |
Clinical Hospital of São Paulo University medical school (HCFMUSP) | |
São Paulo, Brazil, 05360-160 |
Principal Investigator: | Celso RF Carvalho, PhD | University of Sao Paulo General Hospital |
Responsible Party: | University of Sao Paulo General Hospital |
ClinicalTrials.gov Identifier: | NCT02188940 |
Other Study ID Numbers: |
ETLWOA 2012/16700-9 ( Other Grant/Funding Number: São Paulo Research Foundation (FAPESP) ) |
First Posted: | July 14, 2014 Key Record Dates |
Last Update Posted: | February 22, 2016 |
Last Verified: | July 2014 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Asthma Obesity Clinical control Exercise Weight-loss |
Obesity Overnutrition Nutrition Disorders Overweight Body Weight |