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

NCT05159076 | Completed DMC

• 1 other identifier: BIPAPA
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Asthma; Physical activity; Behavioral intervention; Responders

Outcome Measures

Primary Outcomes (1)

• Change in physical activity levels

  Physical activity will be objectively quantified using a movement sensor (ActiGraph, Pensacola, USA) for 7 consecutive days on the hip using an elastic belt.

  Change from baseline at 8 weeks of intervention and at 16 weeks post intervention

Secondary Outcomes (9)

• Change in sedentary behaviour

  Change from baseline at 8 weeks of intervention and at 16 weeks post intervention

• Change in asthma clinical control

  Change from baseline at 8 weeks of intervention and at 16 weeks post intervention

• Change in Health Factors Related to Quality of Life in Asthma

  Change from baseline at 8 weeks of intervention and at 16 weeks post intervention

• Change in psychosocial symptoms

  Change from baseline at 8 weeks of intervention and at 16 weeks post intervention

• Change in body composition - Weight

  Change from baseline at 8 weeks of intervention and at 16 weeks post intervention

Other Outcomes (5)

• Changes in Barriers to the practice of Physical Activities of Daily Living

  Change from baseline at 8 weeks of intervention and at 16 weeks post intervention

• Change in asthma exacerbation

  Change from baseline at 8 weeks of intervention and at 16 weeks post intervention

• Change in Behavioral Stage for physical activity practice

  Change from baseline at 8 weeks of intervention and at 16 weeks post intervention

Study Arms (1)

Behavioral Intervention

EXPERIMENTAL

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.

Behavioral: Behavioral Intervention to Increase Physical Activity

Interventions

Behavioral Intervention to Increase Physical Activity 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.

Behavioral Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants not physically active;
• Partially/uncontrolled asthma;
• Diagnosis of asthma based on the recommendations of the Global Initiative for Asthma (GINA 2020);
• Be under outpatient follow-up at the Pulmonology or Immunology service of the University of Sao Paulo General Hospital;
• Be under outpatient medical treatment for at least six months, with a stable clinical condition for at least , 30 days;
• Being using optimized drug therapy for asthma.

You may not qualify if:

• Participation in another research protocol;
• Difficulty in understanding any of the questionnaires used;
• Practitioners of regular physical activity;
• Pregnancy and psychiatric problems that make it difficult to understand the questionnaires and the study protocol.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: 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, São Paulo, 05360-160, Brazil

Location

Related Publications (1)

• 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.

  PMID: 37651174 DERIVED

MeSH Terms

Conditions

Asthma; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Celso RF Carvalho, PhD

  University of Sao Paulo General Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Evaluations will be conducted blindly, that is, by an evaluator who will not be directly involved in the intervention.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: Longitudinal intervention study

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: December 15, 2021
• Study Start: May 2, 2022
• Primary Completion: November 13, 2024
• Study Completion: November 13, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)