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Completed

NCT Number: NCT05159076

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

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Key information

Conditions

Asthma Behavior Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Motor Activity Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Hospital of São Paulo University medical school (HCFMUSP)

São Paulo, 05360-160, Brazil

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Change in physical activity levels

    Time frame: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention

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

Secondary outcomes

  1. Change in sedentary behaviour

    Time frame: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention

    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).

  2. Change in asthma clinical control

    Time frame: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention

    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.

  3. Change in Health Factors Related to Quality of Life in Asthma

    Time frame: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention

    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.

  4. Change in psychosocial symptoms

    Time frame: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention

    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.

  5. Change in body composition - Weight

    Time frame: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention

    Bioimpedance (Octopolar InBody 720).

  6. Change in body composition - Fat mass

    Time frame: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention

    Bioimpedance (Octopolar InBody 720).

  7. Change in body composition - Visceral adiposity area

    Time frame: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention

    Bioimpedance (Octopolar InBody 720). , Fat-free mass, and skeletal muscle mass will be calculated.

  8. Change in body composition - Fat-free mass

    Time frame: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention

    Bioimpedance (Octopolar InBody 720).

  9. Change in body composition - Skeletal muscle mass

    Time frame: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention

    Bioimpedance (Octopolar InBody 720).

Other outcomes

  1. Changes in Barriers to the practice of Physical Activities of Daily Living

    Time frame: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention

    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.

  2. Change in asthma exacerbation

    Time frame: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention

    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

  3. Change in Behavioral Stage for physical activity practice

    Time frame: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention

    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.

  4. Pulmonary function

    Time frame: Baseline

    Lung volumes will be assessed by spirometry

  5. Change in anthropometric indexes

    Time frame: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention

    Waist circumference (cm) and hip circumference (cm) will be combined to report wait to hip ratio (WHR)

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 15, 2021
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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