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

Behavioral Intervention to Increase Physical Activity in Patients With Asthma: Identifying the Profile of Responders

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.

Study Overview

• Status: Recruiting
• Conditions: Asthma
• Intervention / Treatment: Behavioral: Behavioral Intervention to Increase 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).

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Celso RF Carvalho, PhD; Phone Number: 55 11 98415-3234; Email: cscarval@usp.br

Study Locations

• Brazil
  • São Paulo, Brazil, 05360-160
    • Recruiting
    • Clinical Hospital of São Paulo University medical school (HCFMUSP)
    • Contact: Celso RF Carvalho, PhD; Email: cscarval@usp.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Health Factors Related to Quality of Life in Asthma	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.	Change from baseline at 8 weeks of intervention and at 16 weeks post intervention
Change in psychosocial symptoms	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.	Change from baseline at 8 weeks of intervention and at 16 weeks post intervention
Change in body composition - Weight	Bioimpedance (Octopolar InBody 720).	Change from baseline at 8 weeks of intervention and at 16 weeks post intervention
Change in body composition - Fat mass	Bioimpedance (Octopolar InBody 720).	Change from baseline at 8 weeks of intervention and at 16 weeks post intervention
Change in sedentary behaviour	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).	Change from baseline at 8 weeks of intervention and at 16 weeks post intervention
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 at 8 weeks of intervention and at 16 weeks post intervention
Change in body composition - Visceral adiposity area	Bioimpedance (Octopolar InBody 720). , Fat-free mass, and skeletal muscle mass will be calculated.	Change from baseline at 8 weeks of intervention and at 16 weeks post intervention
Change in body composition - Fat-free mass	Bioimpedance (Octopolar InBody 720).	Change from baseline at 8 weeks of intervention and at 16 weeks post intervention
Change in body composition - Skeletal muscle mass	Bioimpedance (Octopolar InBody 720).	Change from baseline at 8 weeks of intervention and at 16 weeks post intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in asthma exacerbation	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	Change from baseline at 8 weeks of intervention and at 16 weeks post intervention
Pulmonary function	Lung volumes will be assessed by spirometry	Baseline
Changes in Barriers to the practice of Physical Activities of Daily Living	The possible answers to the questionnaire Barriers to the practice of Physical Activities of Daily Living are never, rarely, sometimes, almost always or always and the score for each item varies from 0 to 4. It will be considered as limiting domain for physical activities those in which individuals report a value equal to or greater than 3 in at least half of the barriers.	Change from baseline at 8 weeks of intervention and at 16 weeks post intervention
Change in Behavioral Stage for physical activity practice	The Behavioral Stage Assessment Questionnaire for the Practice of Physical Activity qualitatively assesses thinking in relation to the practice of physical activity, and may present the following stages of behavior: 1. Pre-contemplation; 2. Contemplation; 3. Preparation; 4. Action; 5- Maintenance.	Change from baseline at 8 weeks of intervention and at 16 weeks post intervention
Change in anthropometric indexes	Waist circumference (cm) and hip circumference (cm) will be combined to report wait to hip ratio (WHR)	Change from baseline at 8 weeks of intervention and at 16 weeks post intervention

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo; Conselho Nacional de Desenvolvimento Científico e Tecnológico
• Investigators: Study Director: Celso RF Carvalho, PhD, University of Sao Paulo General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2022
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: November 3, 2021
• First Submitted That Met QC Criteria: December 1, 2021
• First Posted (Actual): December 15, 2021

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 28, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Asthma; Physical activity; Behavioral intervention; Responders
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: BIPAPA

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