Exercise Training to Lose Weight in Obese Asthmatics

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02188940
• Other study ID #: ETLWOA
• Secondary ID: 2012/16700-9
• Status: Completed
• Phase: N/A
• First received: July 10, 2014
• Last updated: February 19, 2016
• Start date: July 2014
• Est. completion date: October 2015

Study information

• Verified date: July 2014
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: October 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Obesity

Intervention

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.
• 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 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.
• 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.

Locations

Country	Name	City	State
Brazil	Clinical Hospital of São Paulo University medical school (HCFMUSP)	São Paulo

Sponsors (3)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Fundação de Amparo à Pesquisa do Estado de São Paulo, University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Airway inflammation	Airway inflammation will be quantified using the exhaled fraction of nitric oxide (FeNO)	Before and after 3 months of intervention	No
Other	serum cytokines and adipokines levels	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-a), leptin, adiponectin and C-reactive protein (CRP)	Before and after 3 months of intervention	No
Other	Daily life physical activity	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	Before and after 3 months of intervention	No
Other	Sleep disorders	sleep disorders will be assessed by Berlin Questionnaire for Sleep Apnea and Actisleep activity monitor	Before and after 3 months of intervention	No
Other	Lung function	Static and dynamic lung volumes will be assessed by Spirometry and Plethysmograph	Before and after 3 months of intervention	No
Other	Physical fitness	Aerobic potency will be assessed by Cardiopulmonary exercise test	Before and after 3 months of intervention	No
Other	Asthma symptoms and exacerbations	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.	Before and after 3 months of intervention	No
Other	Body composition	Body composition will be analyzed by using a tetrapolar 8-point tactile bioelectrical impedance	Before and after 3 months of intervention	No
Primary	Clinical Control	Clinical control will be evaluated by asthma control questionnaire (ACQ)	Before and after 3 months of intervention	No
Secondary	Health related quality of life	Health related quality of life will be assessed by Asthma Quality Life Questionnaire (AQLQ)	Before and after 3 months of intervention	No
Secondary	Level of depression and anxiety	the symptoms of depression and anxiety will be assessed by Hospital Anxiety and Depression (HAD)	Before and after 3 months of intervention	No