Behavioral Intervention to Increase Physical Activity in Patients with Asthma: Identifying Responders

NCT ID: NCT05159076

Last Updated: 2024-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-02
• Study Completion Date: 2024-11-13

Brief Summary

To identify clinical, personal and anthropometric characteristics among patients with asthma who respond and non-responders to a behavioral intervention to increase the level of physical activity.

Detailed Description

Adult participants of both genders with moderate to severe asthma, not physically active, will be evaluated after being informed about the study, agreeing and signing the informed consent form. After two days of evaluations, with an interval of 7 days between them, the participants will be included in a behavioral intervention program to increase physical activity for 8 weeks (once a week).

Conditions

Asthma

Keywords

Asthma; Physical activity; Behavioral intervention; Responders

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Behavioral Intervention

Participants will undergo an eight-week behavioral intervention protocol (once a week) aimed at increasing the level of physical activity, consisting of a brief educational program: brief education for asthma and benefits of physical activity and behavioral intervention based on Social Cognitive Theory and the Theory of Stages of Behavior Change.

Group Type: EXPERIMENTAL

Behavioral Intervention to Increase Physical Activity

Intervention Type: BEHAVIORAL

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. The second class will be about the current international physical activity recommendations and the importance and benefits of being physically active.

The behavioural intervention will be performed in 8 weekly goal-setting consultation, face-to-face, each lasting until 90 minutes. Patients will be offered a commercially-available activity tracker to wear during 3 days prior to each consultation. According to their own physical activity (PA) data and the behavioural change stage, an individual action plan will be established to increase physical activity. Each participant will receive individual counselling with the goal of increasing participation in PA and reducing their sedentary time.

Interventions

Behavioral Intervention to Increase Physical Activity

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. The second class will be about the current international physical activity recommendations and the importance and benefits of being physically active.

The behavioural intervention will be performed in 8 weekly goal-setting consultation, face-to-face, each lasting until 90 minutes. Patients will be offered a commercially-available activity tracker to wear during 3 days prior to each consultation. According to their own physical activity (PA) data and the behavioural change stage, an individual action plan will be established to increase physical activity. Each participant will receive individual counselling with the goal of increasing participation in PA and reducing their sedentary time.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Participants not physically active;

2. Partially/uncontrolled asthma;

3. Diagnosis of asthma based on the recommendations of the Global Initiative for Asthma (GINA 2020);

4. Be under outpatient follow-up at the Pulmonology or Immunology service of the University of Sao Paulo General Hospital;

5. Be under outpatient medical treatment for at least six months, with a stable clinical condition for at least , 30 days;

6. Being using optimized drug therapy for asthma.

Exclusion Criteria

1. Participation in another research protocol;

2. Difficulty in understanding any of the questionnaires used;

3. Practitioners of regular physical activity;

4. Pregnancy and psychiatric problems that make it difficult to understand the questionnaires and the study protocol.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role: collaborator

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Celso R. Carvalho

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Celso RF Carvalho, PhD

Role: STUDY_DIRECTOR

University of Sao Paulo General Hospital

Locations

Clinical Hospital of São Paulo University medical school (HCFMUSP)

São Paulo, São Paulo, Brazil

Countries

Brazil

References

de Lima FF, Lunardi AC, Pinheiro DHA, Carvalho-Pinto RM, Stelmach R, Giavina-Bianchi P, Agondi RC, Carvalho CR. Identifying the Characteristics of Responders and Nonresponders in a Behavioral Intervention to Increase Physical Activity Among Patients With Moderate to Severe Asthma: Protocol for a Prospective Pragmatic Study. JMIR Res Protoc. 2023 Aug 31;12:e49032. doi: 10.2196/49032.

Reference Type: DERIVED

PMID: 37651174 (View on PubMed)

Other Identifiers

BIPAPA

Identifier Type: -

Identifier Source: org_study_id