Skip to main content
OpenTrials
Completed

NCT Number: NCT05241223

An Online Behavior Change Intervention to Promote Physical Activity in Adults With Asthma

The aims of this study are to investigate the effectiveness of an online behavior change (BC) intervention in increasing physical activity (PA) and reducing sedentary behavior in adults with asthma, as well as, in improving other clinical outcomes, in short and medium term. In this single-blind randomized clinical trial, patients with clinically stable moderate to severe asthma, who are physically inactive and do not have cardiovascular and/or osteoneuromuscular impairments will be randomized into control (CG) or intervention (IG) groups (23 in each group). Both groups will carry out a minimum educational program. Additionally, the IG will receive weekly individual and/or group online sessions for 12 weeks of motivation-based BC intervention to promote PA and reduce sedentary behavior, based on both self-determination theory (SDT) and transtheoretical model (TTM). The IG will also receive a pedometer with specific strategies related to it. Both groups will be reassessed immediately after the intervention as well as 6 months after the end of the intervention. The primary outcomes are PA and sedentary behavior, which will be objectively assessed by a triaxial accelerometer (Actigraph wGT3X-BT). Secondary outcomes are: asthma control, functional capacity, quality of life, sleep quality and symptoms of anxiety and depression.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Asthma Behavior Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Physical Inactivity Respiratory Hypersensitivity Respiratory Tract Diseases Sedentary Behavior

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro de Pesquisa e Pós Graduação na Unopar

Londrina, Paraná, 86041-14, Brazil

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • people aged from 18 to 60 years
  • diagnosis of moderate to severe asthma, who underwent drug treatment for at least 6 months
  • clinical stability for at least 1 month (without hospitalizations, emergency care use or medication changes)
  • absence of cardiovascular and/or osteoneuromuscular diseases that could interfere/hinder the performance of tests and physical activity
  • absence of lung diseases other than asthma
  • preserved cognitive function
  • non-smokers or ex-smokers with <10 pack-years
  • report being physically inactive in accordance with current physical activity guidelines
  • able to make video calls through any platform and/or free app available

Exclusion criteria

  • presence of any new orthopedic limitation that hinders the performance of physical activity during the study
  • perform ≥150 minutes per week of moderate to vigorous physical activity during the initial assessment

Treatment and study plan

Behavior change intervention

Other

This is an online intervention based on the transtheoretical model, along with self-determination theory strategies. This intervention will take place weekly summing up 12 online individual and/or group sessions of approximately 20 minutes. The sessions will be made through a platform and/or application that makes video calls privately. Each session will address a topic. In addition, in all sessions, the patients gain during the previous week will be recognized, as well as new goals will be set for the next week. The goals will always be individualized, realistic and achievable, based on the identification of each person's capacity and motivation. A Fitbit Zip will be used to propose objective goals aimed at increasing physical activity and reduce sedentary behavior. Additionally, a complex practice environment will be created around this device, such as the visualization of the number of steps evolution and competitions/games with other participants, among others.

Educational program

Other

The educational program will be delivered similarly to both groups through videos and booklets, which will be sent in all weekdays during de first week after the initial assessment. Later, one educational material will be sent every two weeks until de 11th week. In the first day, patients will receive a quick welcome video call, in which information will be provided on how this program will work. In the subsequent days, the material will be sent daily and the participants will be able to ask questions, if they want to. The program will cover information regarding the respiratory system, pathophysiology of asthma, asthma treatment, prevention strategies and medication instructions. It will also be briefly addressed the subjects: understanding physical activity and sedentarism, as well as the importance and benefits of being physically active and less sedentary.

Primary outcomes

  1. Time spent in physical activity

    Time frame: 12 weeks from randomization

    Time spent (in minutes and percentage of the day) in light-intensity and moderate to vigorous physical activities, measured by a triaxial activity monitor.

  2. Number of steps per day

    Time frame: 12 weeks from randomization

    Number of steps per day measured by a triaxial activity monitor

  3. Time spent in sedentary behavior

    Time frame: 12 weeks from randomization

    Time spent (in minutes and percentage of the day) in sedentary activities, measured by a triaxial activity monitor.

Secondary outcomes

  1. Time spent in physical activity

    Time frame: 36 weeks from randomization

    Time spent (in minutes and percentage of the day) in light-intensity and moderate to vigorous physical activities, measured by a triaxial activity monitor.

  2. Number of steps per day

    Time frame: 36 weeks from randomization

    Number of steps per day measured by a triaxial activity monitor.

  3. Time spent in sedentary behavior

    Time frame: 36 weeks from randomization

    Time spent (in minutes and percentage of the day) in sedentary activities, measured by a triaxial activity monitor.

  4. Asthma control

    Time frame: 12 weeks from randomization

    Asthma Control Questionnaire score ranging from 0 to 6; the lower, the better.

  5. Asthma control

    Time frame: 36 weeks from randomization

    Asthma Control Questionnaire score ranging from 0 to 6; the lower, the better.

  6. Asthma symptoms and exacerbations

    Time frame: 12 weeks from randomization

    Frequency of asthma symptoms and exacerbations

  7. Asthma symptoms and exacerbations

    Time frame: 36 weeks from randomization

    Frequency of asthma symptoms and exacerbations

  8. Asthma medication use

    Time frame: 12 weeks from randomization

    Frequency of asthma rescue medication use

  9. Asthma medication use

    Time frame: 36 weeks from randomization

    Frequency of asthma rescue medication use

  10. Incremental Step Test

    Time frame: 12 weeks from randomization

    Number of steps climbed; the more the better

  11. Incremental Step Test

    Time frame: 36 weeks from randomization

    Number of steps climbed; the more the better

  12. Sit-To-Stand test

    Time frame: 12 weeks from randomization

    Number of repetitions in 1 minute; the more the better

  13. Sit-To-Stand test

    Time frame: 36 weeks from randomization

    Number of repetitions in 1 minute; the more the better

  14. Timed Up-and-Go test

    Time frame: 12 weeks from randomization

    Time to perform the test; the faster the better

  15. Timed Up-and-Go test

    Time frame: 36 weeks from randomization

    Time to perform the test; the faster the better

  16. 4-Metre Gait Speed test

    Time frame: 12 weeks from randomization

    Time to perform the test; the faster the better

  17. 4-Metre Gait Speed test

    Time frame: 36 weeks from randomization

    Time to perform the test; the faster the better

  18. Quality of life score

    Time frame: 12 weeks from randomization

    Asthma Quality of Life Questionnaire; ranges from 1 to 7 points; the higher the score, the better the quality of life

  19. Quality of life score

    Time frame: 36 weeks from randomization

    Asthma Quality of Life Questionnaire; ranges from 1 to 7 points; the higher the score, the better the quality of life

  20. Sleep quality

    Time frame: 12 weeks from randomization

    Subjectively measured by Pittsburgh Sleep Quality Index (score ranges from 0 to 21; the lower, the better) and objectively measured by Actiwatch 2 (Philips Respironics, Murrysville, Pennsylvania, USA).

  21. Sleep quality

    Time frame: 36 weeks from randomization

    Subjectively measured by Pittsburgh Sleep Quality Index (score ranges from 0 to 21; the lower, the better) and objectively measured by Actiwatch 2 (Philips Respironics, Murrysville, Pennsylvania, USA).

  22. Anxiety and depression symptoms

    Time frame: 12 weeks from randomization

    Hospital Anxiety and Depression Scale; ranges from 0 to 21 points; the higher the score, the worse the anxiety and depression symptoms

  23. Anxiety and depression symptoms

    Time frame: 36 weeks from randomization

    Hospital Anxiety and Depression Scale; ranges from 0 to 21 points; the higher the score, the worse the anxiety and depression symptoms

  24. Basic psychological needs

    Time frame: 12 weeks from randomization

    Basic Psychological Needs in Exercise Scale; ranges from 4 to 20; higher scores indicate greater levels of satisfaction of basic psychological needs

  25. Basic psychological needs

    Time frame: 36 weeks from randomization

    Basic Psychological Needs in Exercise Scale; ranges from 4 to 20; higher scores indicate greater levels of satisfaction of basic psychological needs

  26. Motivational regulations

    Time frame: 12 weeks from randomization

    Behavioral Regulation in Exercise Questionnaire; ranges from 0 to 4; the higher the score, the more regulated the individual is for a given level

  27. Motivational regulations

    Time frame: 36 weeks from randomization

    Behavioral Regulation in Exercise Questionnaire; ranges from 0 to 4; the higher the score, the more regulated the individual is for a given level

  28. Lung function

    Time frame: 12 weeks from randomization

    Spirometry determining the forced expiratory volume in the first second (FEV1), forced vital capacity (FVC) and FEV1/FVC index.

  29. Lung function

    Time frame: 36 weeks from randomization

    Spirometry determining the forced expiratory volume in the first second (FEV1), forced vital capacity (FVC) and FEV1/FVC index.

Sponsors and collaborators

Lead sponsor

Universidade Norte do Paraná

Other

Registry information

Official study title

An Online Behavior Change Intervention to Promote Physical Activity in Adults With Asthma: a Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 15, 2022
Registry last updated
Dec 18, 2023

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.