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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 14 March 2016
Main ID:  NCT02188940
Date of registration: 10/07/2014
Prospective Registration: No
Primary sponsor: University of Sao Paulo General Hospital
Public title: Exercise Training to Lose Weight in Obese Asthmatics
Scientific 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
Date of first enrolment: July 2014
Target sample size: 55
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02188940
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment  
Phase:  N/A
Countries of recruitment
Brazil
Contacts
Name:     Celso RF Carvalho, PhD
Address: 
Telephone:
Email:
Affiliation:  University of Sao Paulo General Hospital
Key inclusion & exclusion 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



Age minimum: 30 Years
Age maximum: 60 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Obesity
Asthma
Intervention(s)
Other: Exercise Training
Behavioral: Behavioral Therapy
Behavioral: Dietary
Behavioral: Education Program
Other: Stretching and Breathing exercise
Primary Outcome(s)
Clinical Control [Time Frame: Before and after 3 months of intervention]
Secondary Outcome(s)
Level of depression and anxiety [Time Frame: Before and after 3 months of intervention]
Health related quality of life [Time Frame: Before and after 3 months of intervention]
Secondary ID(s)
2012/16700-9
ETLWOA
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Fundação de Amparo à Pesquisa do Estado de São Paulo
University of Sao Paulo
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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