AsthmaNCT02188940
Exercise Training to Lose Weight in Obese Asthmatics
A study testing Dietary, Education Program and Behavioral Therapy in people with Asthma and Obesity, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- What is being tested?
- Dietary, Education Program and Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2014to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- Using overnight continuous positive airway pressure
- Lactating
- Current or ex-smoker
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Clinical Hospital of São Paulo University medical school (HCFMUSP)
São Paulo, São Paulo, 05360-160
About this study
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
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.
Read the 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.
- Being tested
- Dietary, Education Program, Behavioral Therapy, Exercise Training, Stretching and Breathing exercise
- Keywords
- Asthma, Obesity, Clinical control, Exercise, Weight-loss
- Medical subject headings
- Asthma, Obesity, Motor Activity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietaryBehavioural
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 ProgramBehavioural
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 TherapyBehavioural
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 TrainingOther
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 exerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise, dietary and behavioral therapy | Active comparator | The interventions of active comparator will be education program, dietary and behavioral therapy and exercise training. Receives: Behavioral: Dietary; Behavioral: Education Program; Behavioral: Behavioral Therapy; Other: Exercise Training |
| Dietary and behavioral therapy | Sham comparator | The intervention in sham comparator will be education program, dietary and behavioral therapy and stretching and breathing exercise. Receives: Behavioral: Dietary; Behavioral: Education Program; Behavioral: Behavioral Therapy; Other: Stretching and Breathing exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Control
Clinical control will be evaluated by asthma control questionnaire (ACQ)
Measured: Before and after 3 months of intervention
Secondary outcomes (2)
Health related quality of life
Health related quality of life will be assessed by Asthma Quality Life Questionnaire (AQLQ)
Measured: Before and after 3 months of intervention
Level of depression and anxiety
the symptoms of depression and anxiety will be assessed by Hospital Anxiety and Depression (HAD)
Measured: Before and after 3 months of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionFeb 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo, Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Sponsor
- Investigators
- Celso RF Carvalho, PhD, Principal investigator, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02188940
- Sponsor's protocol ID
- ETLWOA
- Other IDs
- 2012/16700-9
- Status last verified
- Jul 2014
- First submitted
- 10 Jul 2014
- Last updated
- 22 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
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.
PubMed 27744739Freitas 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.
PubMed 26487563
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02188940
- Acronym / sponsor ID
- ETLWOA
- Keywords
- Asthma, Obesity, Clinical control, Exercise, Weight-loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- University of Sao Paulo, Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Jul 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 14 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise, dietary and behavioral therapy | Active comparator | Behavioral: Dietary, Behavioral: Education Program, Behavioral: Behavioral Therapy, Other: Exercise TrainingThe interventions of active comparator will be education program, dietary and behavioral therapy and exercise training. |
| Dietary and behavioral therapy | Sham comparator | Behavioral: Dietary, Behavioral: Education Program, Behavioral: Behavioral Therapy, Other: Stretching and Breathing exerciseThe intervention in sham comparator will be education program, dietary and behavioral therapy and stretching and breathing exercise. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- Cardiovascular, musculoskeletal or other chronic lung diseases
- Active Cancer
- Pregnant
- Weight loss more than 5 % in the preceding 6 months
- Using weight-loss medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DietaryThe 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. | Behavioural | Dietary and behavioral therapy, Exercise, dietary and behavioral therapy |
| Education ProgramThe 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. | Behavioural | Dietary and behavioral therapy, Exercise, dietary and behavioral therapy |
| Behavioral TherapyThe 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. | Behavioural | Dietary and behavioral therapy, Exercise, dietary and behavioral therapy |
| Exercise TrainingThe 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. | Other | Exercise, dietary and behavioral therapy |
| Stretching and Breathing exerciseBreathing 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. | Other | Dietary and behavioral therapy |
Primary outcome
Clinical Control
Time frame: Before and after 3 months of intervention
Clinical control will be evaluated by asthma control questionnaire (ACQ)
2 secondary outcomes
Health related quality of life
Time frame: Before and after 3 months of intervention
Level of depression and anxiety
Time frame: Before and after 3 months of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2016.
- Derived from this study: PubMed 27744739Freitas 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.
- Derived from this study: PubMed 26487563Freitas 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Celso RF Carvalho, PhD principal investigator
University of Sao Paulo General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary, Education Program and Behavioral Therapy in people with Asthma and Obesity, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Control (time frame: Before and after 3 months of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02188940, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2016.