Aerobic Training Versus Behavioral Intervention to Increase Physical Activity in Patients With Asthma

NCT ID: NCT05364632

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-23
• Study Completion Date: 2025-12-31

Brief Summary

To compare the effects of aerobic training and behavioural intervention to increase physical activity in the clinical control of asthma and in the quality of life of patients with asthma.

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. Participants will be randomized to aerobic training or behavioral intervention group. Both interventions will consist of 8 weeks. Aerobic training will be performed on a treadmill (2xweek; 45 min/session). The behavioral intervention will be a program to increase physical activity (1xweek; up to 90 min / session). The maximum HR will be estimated according to the Tanaka's equation (208 - 0.7 x age).

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

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.

Aerobic Training

Participants will undergo an eight-week aerobic training protocol (twice a week) on a treadmill, each aerobic training session will consist of 45 minutes divided into 5 minutes of warm-up, 35 minutes of aerobic exercise and 5 minutes of cool-down.

Group Type: EXPERIMENTAL

Aerobic Training

Intervention Type: OTHER

The same initial educational program described for the Behavioral Intervention group will be delivered to this group. Each aerobic training session will consist of 45 minutes divided into 5 minutes of warm-up, 35 minutes of aerobic exercise and 5 minutes of cool-down. During physical training, heart rate and level of respiratory distress will be monitored. The intensity of aerobic physical training will be based on the heart rate (HR) corresponding to one third of the difference between the anaerobic threshold (LA) and the respiratory compensation point (CRP). The patient may interrupt physical exercise if he presents any clinical symptoms and/or respiratory discomfort, returning as soon as his respiratory condition improves.

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

Aerobic Training

The same initial educational program described for the Behavioral Intervention group will be delivered to this group. Each aerobic training session will consist of 45 minutes divided into 5 minutes of warm-up, 35 minutes of aerobic exercise and 5 minutes of cool-down. During physical training, heart rate and level of respiratory distress will be monitored. The intensity of aerobic physical training will be based on the heart rate (HR) corresponding to one third of the difference between the anaerobic threshold (LA) and the respiratory compensation point (CRP). The patient may interrupt physical exercise if he presents any clinical symptoms and/or respiratory discomfort, returning as soon as his respiratory condition improves.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Participants not physically active;

2. Uncontrolled asthma (ACQ>1,5);

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;

5. Presence of another chronic lung, neurological or musculoskeletal disease that hinders or prevents physical activity;

6. Patients who are smokers or ex-smokers (who have quit smoking for less than 1 year or who have smoked more than 15 pack-years).

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

Sponsors

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

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Celso RF Carvalho, PhD

Role: CONTACT

cscarval@usp.br

55 11 98415-3234

Facility Contacts

Celso RF Carvalho, PhD

Role: primary

cscarval@usp.br

Other Identifiers

2021/03745-3

Identifier Type: -

Identifier Source: org_study_id