Skip to main content
OpenTrials
Completed

NCT Number: NCT02188940

Exercise Training to Lose Weight in Obese Asthmatics

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary

Behavioral

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.

Education program

Behavioral

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 therapy

Behavioral

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.

Exercise training

Other

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.

Stretching and Breathing exercise

Other

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.

Primary outcomes

  1. Clinical Control

    Time frame: Before and after 3 months of intervention

    Clinical control will be evaluated by asthma control questionnaire (ACQ)

Secondary outcomes

  1. 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)

  2. 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)

Other outcomes

  1. Airway inflammation

    Time frame: Before and after 3 months of intervention

    Airway inflammation will be quantified using the exhaled fraction of nitric oxide (FeNO)

  2. 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)

  3. 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

  4. 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

  5. Lung function

    Time frame: Before and after 3 months of intervention

    Static and dynamic lung volumes will be assessed by Spirometry and Plethysmograph

  6. Physical fitness

    Time frame: Before and after 3 months of intervention

    Aerobic potency will be assessed by Cardiopulmonary exercise test

  7. 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.

  8. 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

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo
  • University of Sao Paulo

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 14, 2014
Registry last updated
Feb 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.