Behavioral Intervention to Increase Physical Activity in Patients With Asthma

NCT03705702 | Completed DMC

• 2 other identifiers: BIPAA2016/17093-0
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Physical activity; Behavioral intervention; Asthma clinical control

Outcome Measures

Primary Outcomes (1)

• Change in asthma clinical control

  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.

  Change from baseline asthma clinical control at 8 weeks of intervention

Secondary Outcomes (4)

• Change in physical activity levels

  Change from baseline physical activity levels at 8 weeks of intervention

• Change in health related quality of life

  Change from baseline health related quality of life at 8 weeks of intervention

• Change in asthma exacerbation

  Change from baseline asthma exacerbation at 8 weeks of intervention

• Change in sleep quality

  Change from baseline sleep quality at 8 weeks of intervention

Other Outcomes (4)

• Pulmonary function

  At baseline

• Change in anthropometric indexes

  Change from baseline anthropometric indexes at 8 weeks of intervention

• Change in body composition

  Change from baseline body composition at 8 weeks of intervention

Study Arms (2)

Intervention Group (IG)

ACTIVE COMPARATOR

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; Behavioral: Behavioral intervention

Control Group (CG)

SHAM COMPARATOR

The intervention of sham comparator will be an education program in asthma and physical activity recommendations.

Other: Education Program

Interventions

Education Program OTHER

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.

Control Group (CG); Intervention Group (IG)

Behavioral intervention BEHAVIORAL

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.

Intervention Group (IG)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• University of Sao Paulo: collaborator
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Clinical Hospital of São Paulo University medical school (HCFMUSP)

São Paulo, 05360-160, Brazil

Location

Related Publications (2)

• Passos NF, Freitas PD, Carvalho-Pinto RM, Cukier A, Carvalho CRF. Increased physical activity reduces sleep disturbances in asthma: A randomized controlled trial. Respirology. 2023 Jan;28(1):20-28. doi: 10.1111/resp.14359. Epub 2022 Sep 6.

  PMID: 36068181 DERIVED

• Freitas PD, Passos NFP, Carvalho-Pinto RM, Martins MA, Cavalheri V, Hill K, Stelmach R, Carvalho CRF. A Behavior Change Intervention Aimed at Increasing Physical Activity Improves Clinical Control in Adults With Asthma: A Randomized Controlled Trial. Chest. 2021 Jan;159(1):46-57. doi: 10.1016/j.chest.2020.08.2113. Epub 2020 Sep 12.

  PMID: 32931821 DERIVED

MeSH Terms

Conditions

Asthma; Motor Activity

Interventions

Early Intervention, Educational; Behavior Therapy

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Celso RF Carvalho, PhD

  University of Sao Paulo General Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2018
• First Posted: October 15, 2018
• Study Start: October 5, 2018
• Primary Completion: August 27, 2019
• Study Completion: November 30, 2019
• Last Updated: April 15, 2020

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)