- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02188940
Exercise Training to Lose Weight in Obese Asthmatics
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 Overview
Status
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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São Paulo, Brazil, 05360-160
- Clinical Hospital of São Paulo University medical school (HCFMUSP)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Exercise, dietary and behavioral therapy
The interventions of active comparator will be education program, dietary and behavioral therapy and exercise training.
|
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.
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.
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.
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.
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Sham Comparator: Dietary and behavioral therapy
The intervention in sham comparator will be education program, dietary and behavioral therapy and stretching and breathing exercise.
|
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.
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.
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.
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Control
Time Frame: Before and after 3 months of intervention
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Clinical control will be evaluated by asthma control questionnaire (ACQ)
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Before and after 3 months of intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health related quality of life
Time Frame: Before and after 3 months of intervention
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Health related quality of life will be assessed by Asthma Quality Life Questionnaire (AQLQ)
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Before and after 3 months of intervention
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Level of depression and anxiety
Time Frame: Before and after 3 months of intervention
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the symptoms of depression and anxiety will be assessed by Hospital Anxiety and Depression (HAD)
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Before and after 3 months of intervention
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Airway inflammation
Time Frame: Before and after 3 months of intervention
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Airway inflammation will be quantified using the exhaled fraction of nitric oxide (FeNO)
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Before and after 3 months of intervention
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serum cytokines and adipokines levels
Time Frame: Before and after 3 months of intervention
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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)
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Before and after 3 months of intervention
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Daily life physical activity
Time Frame: Before and after 3 months of intervention
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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
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Before and after 3 months of intervention
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Sleep disorders
Time Frame: Before and after 3 months of intervention
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sleep disorders will be assessed by Berlin Questionnaire for Sleep Apnea and Actisleep activity monitor
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Before and after 3 months of intervention
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Lung function
Time Frame: Before and after 3 months of intervention
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Static and dynamic lung volumes will be assessed by Spirometry and Plethysmograph
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Before and after 3 months of intervention
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Physical fitness
Time Frame: Before and after 3 months of intervention
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Aerobic potency will be assessed by Cardiopulmonary exercise test
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Before and after 3 months of intervention
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Asthma symptoms and exacerbations
Time Frame: Before and after 3 months of intervention
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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.
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Before and after 3 months of intervention
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Body composition
Time Frame: Before and after 3 months of intervention
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Body composition will be analyzed by using a tetrapolar 8-point tactile bioelectrical impedance
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Before and after 3 months of intervention
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Collaborators and Investigators
Investigators
- Principal Investigator: Celso RF Carvalho, PhD, University of Sao Paulo General Hospital
Publications and helpful links
General Publications
- Freitas PD, Ferreira PG, Silva AG, Stelmach R, Carvalho-Pinto RM, Fernandes FL, Mancini MC, Sato MN, Martins MA, Carvalho CR. The Role of Exercise in a Weight-Loss Program on Clinical Control in Obese Adults with Asthma. A Randomized Controlled Trial. Am J Respir Crit Care Med. 2017 Jan 1;195(1):32-42. doi: 10.1164/rccm.201603-0446OC.
- Freitas PD, Ferreira PG, da Silva A, Trecco S, Stelmach R, Cukier A, Carvalho-Pinto R, Salge JM, Fernandes FL, Mancini MC, Martins MA, Carvalho CR. The effects of exercise training in a weight loss lifestyle intervention on asthma control, quality of life and psychosocial symptoms in adult obese asthmatics: protocol of a randomized controlled trial. BMC Pulm Med. 2015 Oct 21;15:124. doi: 10.1186/s12890-015-0111-2.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ETLWOA
- 2012/16700-9 (Other Grant/Funding Number: São Paulo Research Foundation (FAPESP))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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