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

NCT05364632 | Recruiting DMC

• 1 other identifier: 2021/03745-3
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

asthma; physical activity; physical exercise; quality of life

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 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 physical activity levels

  [Time Frame: 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 (7)

• 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 (2)

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

Aerobic Training

EXPERIMENTAL

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.

Other: Aerobic Training

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

Aerobic Training 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.

Aerobic Training

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;
• Uncontrolled asthma (ACQ\>1,5);
• 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;
• Presence of another chronic lung, neurological or musculoskeletal disease that hinders or prevents physical activity;
• 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).

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• 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

RECRUITING

Related Publications (1)

• Araujo Pinheiro DH, Silva RAD, Lunardi AC, Cervera VZ, Carvalho-Pinto RM, de Lima FF, Carvalho CRF. Effects of Aerobic Training Versus Behavioral Intervention to Increase Physical Activity for Disease Control in Patients With Asthma: Protocol for a Randomized Trial. JMIR Res Protoc. 2025 Oct 30;14:e78603. doi: 10.2196/78603.

  PMID: 41166708 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

Central Study Contacts

Celso RF Carvalho, PhD

CONTACT

55 11 98415-3234; cscarval@usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• 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: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 3, 2022
• First Posted: May 6, 2022
• Study Start: August 23, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)