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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05241223
• Other study ID #: OliveiraJM_PhD_FurlanettoKC
• Status: Completed
• Phase: N/A
• Start date: February 3, 2022
• Est. completion date: August 30, 2023

Study information

• Verified date: December 2023
• Source: Universidade Norte do Paraná
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: August 30, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Physical Inactivity
• Sedentary Behavior

Intervention

Other:
• Behavior change intervention
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
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.

Locations

Country	Name	City	State
Brazil	Centro de Pesquisa e Pós Graduação na Unopar	Londrina	Paraná

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Norte do Paraná

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of steps per day	Number of steps per day measured by a triaxial activity monitor	12 weeks from randomization
Primary	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	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.	36 weeks from randomization
Secondary	Number of steps per day	Number of steps per day measured by a triaxial activity monitor.	36 weeks from randomization
Secondary	Time spent in sedentary behavior	Time spent (in minutes and percentage of the day) in sedentary activities, measured by a triaxial activity monitor.	36 weeks from randomization
Secondary	Asthma control	Asthma Control Questionnaire score ranging from 0 to 6; the lower, the better.	12 weeks from randomization
Secondary	Asthma control	Asthma Control Questionnaire score ranging from 0 to 6; the lower, the better.	36 weeks from randomization
Secondary	Asthma symptoms and exacerbations	Frequency of asthma symptoms and exacerbations	12 weeks from randomization
Secondary	Asthma symptoms and exacerbations	Frequency of asthma symptoms and exacerbations	36 weeks from randomization
Secondary	Asthma medication use	Frequency of asthma rescue medication use	12 weeks from randomization
Secondary	Asthma medication use	Frequency of asthma rescue medication use	36 weeks from randomization
Secondary	Incremental Step Test	Number of steps climbed; the more the better	12 weeks from randomization
Secondary	Incremental Step Test	Number of steps climbed; the more the better	36 weeks from randomization
Secondary	Sit-To-Stand test	Number of repetitions in 1 minute; the more the better	12 weeks from randomization
Secondary	Sit-To-Stand test	Number of repetitions in 1 minute; the more the better	36 weeks from randomization
Secondary	Timed Up-and-Go test	Time to perform the test; the faster the better	12 weeks from randomization
Secondary	Timed Up-and-Go test	Time to perform the test; the faster the better	36 weeks from randomization
Secondary	4-Metre Gait Speed test	Time to perform the test; the faster the better	12 weeks from randomization
Secondary	4-Metre Gait Speed test	Time to perform the test; the faster the better	36 weeks from randomization
Secondary	Quality of life score	Asthma Quality of Life Questionnaire; ranges from 1 to 7 points; the higher the score, the better the quality of life	12 weeks from randomization
Secondary	Quality of life score	Asthma Quality of Life Questionnaire; ranges from 1 to 7 points; the higher the score, the better the quality of life	36 weeks from randomization
Secondary	Sleep quality	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).	12 weeks from randomization
Secondary	Sleep quality	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).	36 weeks from randomization
Secondary	Anxiety and depression symptoms	Hospital Anxiety and Depression Scale; ranges from 0 to 21 points; the higher the score, the worse the anxiety and depression symptoms	12 weeks from randomization
Secondary	Anxiety and depression symptoms	Hospital Anxiety and Depression Scale; ranges from 0 to 21 points; the higher the score, the worse the anxiety and depression symptoms	36 weeks from randomization
Secondary	Basic psychological needs	Basic Psychological Needs in Exercise Scale; ranges from 4 to 20; higher scores indicate greater levels of satisfaction of basic psychological needs	12 weeks from randomization
Secondary	Basic psychological needs	Basic Psychological Needs in Exercise Scale; ranges from 4 to 20; higher scores indicate greater levels of satisfaction of basic psychological needs	36 weeks from randomization
Secondary	Motivational regulations	Behavioral Regulation in Exercise Questionnaire; ranges from 0 to 4; the higher the score, the more regulated the individual is for a given level	12 weeks from randomization
Secondary	Motivational regulations	Behavioral Regulation in Exercise Questionnaire; ranges from 0 to 4; the higher the score, the more regulated the individual is for a given level	36 weeks from randomization
Secondary	Lung function	Spirometry determining the forced expiratory volume in the first second (FEV1), forced vital capacity (FVC) and FEV1/FVC index.	12 weeks from randomization
Secondary	Lung function	Spirometry determining the forced expiratory volume in the first second (FEV1), forced vital capacity (FVC) and FEV1/FVC index.	36 weeks from randomization