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Exercise Training to Lose Weight in Obese Asthmatics

U

University of Sao Paulo General Hospital

Status

Completed

Conditions

Asthma
Obesity

Treatments

Behavioral: Education Program
Other: Exercise Training
Behavioral: Behavioral Therapy
Other: Stretching and Breathing exercise
Behavioral: Dietary

Study type

Interventional

Funder types

Other

Identifiers

NCT02188940
ETLWOA
2012/16700-9 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

55 patients

Sex

All

Ages

30 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

55 participants in 2 patient groups

Exercise, dietary and behavioral therapy
Active Comparator group
Description:
The interventions of active comparator will be education program, dietary and behavioral therapy and exercise training.
Treatment:
Other: Exercise Training
Behavioral: Education Program
Behavioral: Dietary
Behavioral: Behavioral Therapy
Dietary and behavioral therapy
Sham Comparator group
Description:
The intervention in sham comparator will be education program, dietary and behavioral therapy and stretching and breathing exercise.
Treatment:
Other: Stretching and Breathing exercise
Behavioral: Education Program
Behavioral: Dietary
Behavioral: Behavioral Therapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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