Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Behavioral Intervention to Increase Physical Activity in Patients With Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03705702
Recruitment Status : Completed
First Posted : October 15, 2018
Last Update Posted : April 15, 2020
Sponsor:
Collaborators:
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Asthma Other: Education Program Behavioral: Behavioral intervention Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: All the measurements will be performed by a blinded professional, who will be masked from randomization and other results. For each test, the same investigator will be maintained before and after the intervention. The participants will know what treatment they will receive, but they don't will know what intervention belongs to the control group.
Primary Purpose: Treatment
Official Title: Effects of Behavioral Intervention to Increase Physical Activity on the Asthma Clinical Control: a Randomized Controlled Trial
Actual Study Start Date : October 5, 2018
Actual Primary Completion Date : August 27, 2019
Actual Study Completion Date : November 30, 2019

Resource links provided by the National Library of Medicine


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.
Other: Education Program
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.

Behavioral: Behavioral intervention
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.

Sham Comparator: Control Group (CG)
The intervention of sham comparator will be an education program in asthma and physical activity recommendations.
Other: Education Program
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.




Primary Outcome Measures :
  1. Change in asthma clinical control [ Time Frame: Change from baseline asthma clinical control at 8 weeks of intervention ]
    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.


Secondary Outcome Measures :
  1. Change in physical activity levels [ Time Frame: Change from baseline physical activity levels at 8 weeks of intervention ]
    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).

  2. Change in health related quality of life [ Time Frame: Change from baseline health related quality of life at 8 weeks of intervention ]
    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.

  3. Change in asthma exacerbation [ Time Frame: Change from baseline asthma exacerbation at 8 weeks of intervention ]
    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

  4. Change in sleep quality [ Time Frame: Change from baseline sleep quality at 8 weeks of intervention ]
    Sleep quality will be objectively quantified using a movement sensor (ActiGraph, Pensacola, USA) for 7 consecutive nights on the wrist (non-dominant side).


Other Outcome Measures:
  1. Pulmonary function [ Time Frame: At baseline ]
    Lung volumes will be assessed by spirometry

  2. Change in anthropometric indexes [ Time Frame: Change from baseline anthropometric indexes at 8 weeks of intervention ]
    Height (m) and weight (kg) will be combined to report BMI (kg/m^2)

  3. Change in body composition [ Time Frame: Change from baseline body composition at 8 weeks of intervention ]
    Waist circumference (cm) and hip circumference (cm) will be combined to report wait to hip ratio (WHR)

  4. Change in psychosocial symptoms [ Time Frame: Change from baseline psychosocial symptoms at 8 weeks of intervention ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03705702


Locations
Layout table for location information
Brazil
Clinical Hospital of São Paulo University medical school (HCFMUSP)
São Paulo, Brazil, 05360-160
Sponsors and Collaborators
University of Sao Paulo General Hospital
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Layout table for investigator information
Study Director: Celso RF Carvalho, PhD University of Sao Paulo General Hospital
Layout table for additonal information
Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT03705702    
Other Study ID Numbers: BIPAA
2016/17093-0 ( Other Grant/Funding Number: São Paulo Research Foundation (FAPESP) )
First Posted: October 15, 2018    Key Record Dates
Last Update Posted: April 15, 2020
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Sao Paulo General Hospital:
Physical activity
Behavioral intervention
Asthma clinical control
Additional relevant MeSH terms:
Layout table for MeSH terms
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases