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

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

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.

Study Overview

• Status: Completed
• Conditions: Asthma; Sedentary Behavior; Physical Inactivity
• Intervention / Treatment: Other: Educational program; Other: Behavior change intervention

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Paraná
    • Londrina, Paraná, Brazil, 86041-14
      • Centro de Pesquisa e Pós Graduação na Unopar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Control group; This group will receive an education program which will cover information regarding asthma, physical activity and sedentary behavior.	Other: 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.
Experimental: Experimental group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Number of steps per day	Number of steps per day measured by a triaxial activity monitor.	36 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.	36 weeks from randomization
Asthma control	Asthma Control Questionnaire score ranging from 0 to 6; the lower, the better.	12 weeks from randomization
Asthma control	Asthma Control Questionnaire score ranging from 0 to 6; the lower, the better.	36 weeks from randomization
Asthma symptoms and exacerbations	Frequency of asthma symptoms and exacerbations	12 weeks from randomization
Asthma symptoms and exacerbations	Frequency of asthma symptoms and exacerbations	36 weeks from randomization
Asthma medication use	Frequency of asthma rescue medication use	12 weeks from randomization
Asthma medication use	Frequency of asthma rescue medication use	36 weeks from randomization
Incremental Step Test	Number of steps climbed; the more the better	12 weeks from randomization
Incremental Step Test	Number of steps climbed; the more the better	36 weeks from randomization
Sit-To-Stand test	Number of repetitions in 1 minute; the more the better	12 weeks from randomization
Sit-To-Stand test	Number of repetitions in 1 minute; the more the better	36 weeks from randomization
Timed Up-and-Go test	Time to perform the test; the faster the better	12 weeks from randomization
Timed Up-and-Go test	Time to perform the test; the faster the better	36 weeks from randomization
4-Metre Gait Speed test	Time to perform the test; the faster the better	12 weeks from randomization
4-Metre Gait Speed test	Time to perform the test; the faster the better	36 weeks from randomization
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Universidade Norte do Paraná
• Investigators: Principal Investigator: Joice Oliveira, Msc, Universidade Norte do Paraná

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2022
• Primary Completion (Actual): August 30, 2023
• Study Completion (Actual): August 30, 2023

Study Registration Dates

• First Submitted: January 22, 2022
• First Submitted That Met QC Criteria: February 2, 2022
• First Posted (Actual): February 15, 2022

Study Record Updates

• Last Update Posted (Actual): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: OliveiraJM_PhD_FurlanettoKC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No