- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03705702
Behavioral Intervention to Increase Physical Activity in Patients With Asthma
April 13, 2020 updated by: University of Sao Paulo General Hospital
Effects of Behavioral Intervention to Increase Physical Activity on the Asthma Clinical Control: a Randomized Controlled Trial
The health benefits of physical activity (PA) are well documented and include improving in cardiovascular, obesity, mental health and all-cause mortality.
Although higher levels of activity in patients with asthma are also associated with better outcomes, patients still avoid physical activity due to concern about exacerbating their asthma symptoms by the exercise induced bronchoconstriction (EIB), sustaining a vicious cycle of inactivity and worse asthma control.
Many studies have reported the benefits of supervised exercise training on several asthma outcomes, such as exacerbations, asthma control, cardiopulmonary fitness, airway inflammation and psychosocial symptoms; however, the translation of the improvements in the exercise capacity into increments in PA levels is less evident and still controversial.
Therefore, the hypothesis of this study is that behavioural interventions using strategies based on well-established psychosocial models are effective in increasing physical activity levels and decrease sedentary behaviour in adults with asthma, which will be associated with improvements in the asthma control.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is prospective and randomized controlled trial (RCT) with 2 arms and blinded outcome assessments.
Forty-six moderate or severe patients with asthma under optimized medication will be randomly assigned (computer-generated) into either Control Group (CG) or Intervention Group (IG).
Both groups will receive similar educational program.
However, only the IG will be submitted to the behavioral intervention through physical activity counseling program combined with a monitoring-and-feedback tool aiming to increase physical activity levels (total of 8 weekly goal-setting consultation, face-to-face, each lasting 40 minutes).
Before and after the interventions, clinical control of asthma, physical activity levels, health-related quality of life, asthma exacerbation, levels of anxiety and depression symptoms and anthropometric indices will be assessed.
Data about onset of asthma, comorbidities, lung function and asthma medication will be collected from the patient's medical record.
The data normality will be analyzed by Kolmogorov-Smirnov, and a two-way ANOVA with repeated measures with appropriate post hoc of Holm-sidak will be used to compare inter and intra-groups differences.
The significance level will be set to 5% for all tests.
Study Type
Interventional
Enrollment (Actual)
46
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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São Paulo, Brazil, 05360-160
- Clinical Hospital of São Paulo University medical school (HCFMUSP)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Asthma moderate and severe with diagnosed according to the Global Initiative for Asthma (GINA) 2018
- Poorly controlled asthma (ACQ score > 1.5)
- Sedentary (< 150 min of moderate to vigorous physical activity/week)
- Medical treatment, for at least 6 months
- Clinically stable (i.e., no exacerbation or changes in medication for at least 30 days)
Exclusion Criteria:
- Cardiovascular, musculoskeletal or other chronic lung diseases
- Active Cancer
- Pregnant
- Uncontrolled hypertension or diabetes
- Current smoker or ex smoker (>10 pack-years)
- Psychiatric disease or cognitive deficit
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Intervention Group (IG)
The intervention of active comparator will be education program plus behavioral intervention through physical activity counseling program combined with a monitoring-and-feedback tool.
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The educational program will consist of 2 classes held once a week, each lasting 90 minutes.
The classes will be based on an education videotape, presentations and group discussions.
The first class will address the asthma education, which will include information about the pathophysiology of asthma, medication and peak flow meter instructions, self-monitoring techniques, environmental control techniques and avoidance strategies.
The second class will be about the current international physical activity recommendations and the importance and benefits of being physically active and maintain a healthy lifestyle.
The behavioural intervention will be performed in 8 weekly goal-setting consultation, face-to-face, each lasting 40 minutes.
Patients will be offered a commercially-available activity tracker to wear during 3 days prior to each consultation.
According to their own PA data and the behavioural change stage, an individual action plan will be established with realistic goals to increase PA.
Each participant will receive individual counselling with the goal of increasing participation in PA and reducing their sedentary time.
Techniques such as weekly goal-setting, motivational interviewing, activity tracker vibration instructions, self-management, positive reinforcement, relapse prevention and strategies to overcome barriers will be included.
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Sham Comparator: Control Group (CG)
The intervention of sham comparator will be an education program in asthma and physical activity recommendations.
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The educational program will consist of 2 classes held once a week, each lasting 90 minutes.
The classes will be based on an education videotape, presentations and group discussions.
The first class will address the asthma education, which will include information about the pathophysiology of asthma, medication and peak flow meter instructions, self-monitoring techniques, environmental control techniques and avoidance strategies.
The second class will be about the current international physical activity recommendations and the importance and benefits of being physically active and maintain a healthy lifestyle.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in asthma clinical control
Time Frame: Change from baseline asthma clinical control at 8 weeks of intervention
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Clinical control will be evaluated by the Asthma Control Questionnaire (ACQ).
The ACQ contains 7 items rated on a 7-point scale (0 = without limitation, 6 = maximum limitation), with a higher score indicating worse control.
Scores lower than 0.75 are associated with good asthma control, whereas scores greater than 1.5 are indicative of poorly controlled asthma, and a change of at least 0.5 points in the ACQ score is regarded as clinically significant.
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Change from baseline asthma clinical control at 8 weeks of intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in physical activity levels
Time Frame: Change from baseline physical activity levels at 8 weeks of intervention
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Physical activity and sedentary behaviour will be objectively quantified using a movement sensor (ActiGraph, Pensacola, USA) for 7 consecutive days on the hip using an elastic belt.
Sedentary behaviour will be quantify by the time spent sedentary (< 100 counts/min).
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Change from baseline physical activity levels at 8 weeks of intervention
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Change in health related quality of life
Time Frame: Change from baseline health related quality of life at 8 weeks of intervention
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Health related quality of life will be assessed by Asthma Quality Life Questionnaire (AQLQ).
The AQLQ consists of 32 items rated on a 7-point scale (1 = great deal, 7 = not at all) divided into the following 4 domains: activity limitations, symptoms, emotional function and environmental stimuli.
Higher AQLQ scores indicate a better quality of life, and treatments resulting in a 0.5-point increase in scores following an intervention are considered to be clinically effective.
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Change from baseline health related quality of life at 8 weeks of intervention
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Change in asthma exacerbation
Time Frame: Change from baseline asthma exacerbation at 8 weeks of intervention
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Asthma exacerbation will be assessed by the following criteria: the use of ≥4 puffs of rescue medication per 24 hours during a 48-hour period, a need for systemic corticosteroids, an unscheduled medical appointment, and either a visit to an emergency room or hospitalization
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Change from baseline asthma exacerbation at 8 weeks of intervention
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Change in sleep quality
Time Frame: Change from baseline sleep quality at 8 weeks of intervention
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Sleep quality will be objectively quantified using a movement sensor (ActiGraph, Pensacola, USA) for 7 consecutive nights on the wrist (non-dominant side).
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Change from baseline sleep quality at 8 weeks of intervention
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pulmonary function
Time Frame: At baseline
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Lung volumes will be assessed by spirometry
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At baseline
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Change in anthropometric indexes
Time Frame: Change from baseline anthropometric indexes at 8 weeks of intervention
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Height (m) and weight (kg) will be combined to report BMI (kg/m^2)
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Change from baseline anthropometric indexes at 8 weeks of intervention
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Change in body composition
Time Frame: Change from baseline body composition at 8 weeks of intervention
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Waist circumference (cm) and hip circumference (cm) will be combined to report wait to hip ratio (WHR)
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Change from baseline body composition at 8 weeks of intervention
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Change in psychosocial symptoms
Time Frame: Change from baseline psychosocial symptoms at 8 weeks of intervention
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Symptoms of anxiety and depression symptoms will be assessed by the Hospital Anxiety and Depression scale (HADs), which consists of 14 items divided into 2 subscales (7 for anxiety and 7 for depression).
Each item is scored from 0 to 3, with a maximum score of 21 points for each subscale.
A score greater than 8/9 in each subscale suggests a diagnosis of either anxiety and/or depression.
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Change from baseline psychosocial symptoms at 8 weeks of intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Celso RF Carvalho, PhD, University of Sao Paulo General Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 5, 2018
Primary Completion (Actual)
August 27, 2019
Study Completion (Actual)
November 30, 2019
Study Registration Dates
First Submitted
October 4, 2018
First Submitted That Met QC Criteria
October 8, 2018
First Posted (Actual)
October 15, 2018
Study Record Updates
Last Update Posted (Actual)
April 15, 2020
Last Update Submitted That Met QC Criteria
April 13, 2020
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BIPAA
- 2016/17093-0 (Other Grant/Funding Number: São Paulo Research Foundation (FAPESP))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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