Clinical trial NCT02188940: Exercise Training to Lose Weight in Obese Asthmatics
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Obesity
Keywords: Asthma
Obesity
Clinical control
Exercise
Weight-loss
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: University of Sao Paulo
name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2014-07-14
Enrollment: 55
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical Control
timeFrame: Before and after 3 months of intervention
Secondary outcomes:
measure: Health related quality of life
timeFrame: Before and after 3 months of intervention
measure: Level of depression and anxiety
timeFrame: Before and after 3 months of intervention
Other outcomes:
measure: Airway inflammation
timeFrame: Before and after 3 months of intervention
measure: serum cytokines and adipokines levels
timeFrame: Before and after 3 months of intervention
measure: Daily life physical activity
timeFrame: Before and after 3 months of intervention
measure: Sleep disorders
timeFrame: Before and after 3 months of intervention
measure: Lung function
timeFrame: Before and after 3 months of intervention
measure: Physical fitness
timeFrame: Before and after 3 months of intervention
measure: Asthma symptoms and exacerbations
timeFrame: Before and after 3 months of intervention
measure: Body composition
timeFrame: Before and after 3 months of intervention
Locations:
city: São Paulo
country: Brazil
facility: Clinical Hospital of São Paulo University medical school (HCFMUSP)
Study officials:
affiliation: University of Sao Paulo General Hospital
name: Celso RF Carvalho, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.