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

NCT05241223 | Completed

• 1 other identifier: OliveiraJM_PhD_FurlanettoKC
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Asthma; Sedentary Behavior; Physical Inactivity

Outcome Measures

Primary Outcomes (3)

• Time spent in physical activity

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

  12 weeks from randomization

• Number of steps per day

  Number of steps per day measured by a triaxial activity monitor

  12 weeks from randomization

• Time spent in sedentary behavior

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

  12 weeks from randomization

Secondary Outcomes (29)

• Time spent in physical activity

  36 weeks from randomization

• Number of steps per day

  36 weeks from randomization

• Time spent in sedentary behavior

  36 weeks from randomization

• Asthma control

  12 weeks from randomization

• Asthma control

  36 weeks from randomization

Study Arms (2)

Control group

SHAM COMPARATOR

This group will receive an education program which will cover information regarding asthma, physical activity and sedentary behavior.

Other: Educational program

Experimental group

EXPERIMENTAL

In addition to the educational program, this group will receive weekly individual and/or group online sessions for 12 weeks of motivation-based on behavior change intervention to promote physical activity and reduce sedentary behavior, based on both self-determination theory and transtheoretical model. They will also receive a pedometer with specific strategies related to it.

Other: Behavior change intervention

Interventions

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.

Experimental group

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.

Control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Norte do Paraná: lead

Study Sites (1)

Centro de Pesquisa e Pós Graduação na Unopar

Londrina, Paraná, 86041-14, Brazil

Location

Related Publications (2)

• de Oliveira JM, Pedroso A, de Melo DIF, Cunha MCA, de Lima FF, Carvalho CRF, Karloh M, Matias TS, Furlanetto KC. Short and medium term efficacy of an online behaviour change intervention on physical activity in adults with asthma. Sci Rep. 2026 Jan 8. doi: 10.1038/s41598-025-34470-w. Online ahead of print.

  PMID: 41501383 DERIVED

• de Oliveira JM, Karloh M, Matias TS, Barbosa GB, Freitas PD, Carvalho CRF, Furlanetto KC. An online behavior change intervention to promote physical activity in adults with asthma: study protocol for a multicenter randomized controlled trial. Trials. 2022 Dec 7;23(1):983. doi: 10.1186/s13063-022-06881-x.

  PMID: 36476386 DERIVED

MeSH Terms

Conditions

Asthma; Sedentary Behavior

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Behavior

Study Officials

• Joice Oliveira, Msc

  Universidade Norte do Paraná

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 22, 2022
• First Posted: February 15, 2022
• Study Start: February 3, 2022
• Primary Completion: August 30, 2023
• Study Completion: August 30, 2023
• Last Updated: December 18, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)