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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
Sponsor:
Collaborators:
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

Tracking Information
First Submitted Date  ICMJE July 10, 2014
First Posted Date  ICMJE July 14, 2014
Last Update Posted Date February 22, 2016
Study Start Date  ICMJE July 2014
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2014)
Clinical Control [ Time Frame: Before and after 3 months of intervention ]
Clinical control will be evaluated by asthma control questionnaire (ACQ)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2014)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 22, 2015)
  • 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
Original Other Pre-specified Outcome Measures
 (submitted: July 11, 2014)
  • 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)
  • 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
 
Descriptive Information
Brief Title  ICMJE Exercise Training to Lose Weight in Obese Asthmatics
Official Title  ICMJE Effects of Exercise Training in a Weight-loss Lifestyle Intervention on Clinical Control and Psychosocial Morbidity in Obese Asthmatics: a Randomized and Controlled Trial
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Asthma
  • Obesity
Intervention  ICMJE
  • 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.
  • 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.

Study Arms  ICMJE
  • Active Comparator: Exercise, dietary and behavioral therapy
    The interventions of active comparator will be education program, dietary and behavioral therapy and exercise training.
    Interventions:
    • Behavioral: Dietary
    • Behavioral: Education Program
    • Behavioral: Behavioral Therapy
    • Other: Exercise Training
  • Sham Comparator: Dietary and behavioral therapy
    The intervention in sham comparator will be education program, dietary and behavioral therapy and stretching and breathing exercise.
    Interventions:
    • Behavioral: Dietary
    • Behavioral: Education Program
    • Behavioral: Behavioral Therapy
    • Other: Stretching and Breathing exercise
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 15, 2015)
55
Original Estimated Enrollment  ICMJE
 (submitted: July 11, 2014)
46
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02188940
Other Study ID Numbers  ICMJE ETLWOA
2012/16700-9 ( Other Grant/Funding Number: São Paulo Research Foundation (FAPESP) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party University of Sao Paulo General Hospital
Study Sponsor  ICMJE University of Sao Paulo General Hospital
Collaborators  ICMJE
  • University of Sao Paulo
  • Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators  ICMJE
Principal Investigator: Celso RF Carvalho, PhD University of Sao Paulo General Hospital
PRS Account University of Sao Paulo General Hospital
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP