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

Primary Purpose

Asthma, Sedentary Behavior, Physical Inactivity

Status
Active
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Behavior change intervention
Educational program
Sponsored by
Universidade Norte do Paraná
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centro de Pesquisa e Pós Graduação na Unopar

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Control group

Experimental group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Number of steps per day
Number of steps per day measured by a triaxial activity monitor.
Time spent in sedentary behavior
Time spent (in minutes and percentage of the day) in sedentary activities, measured by a triaxial activity monitor.
Asthma control
Asthma Control Questionnaire score ranging from 0 to 6; the lower, the better.
Asthma control
Asthma Control Questionnaire score ranging from 0 to 6; the lower, the better.
Asthma symptoms and exacerbations
Frequency of asthma symptoms and exacerbations
Asthma symptoms and exacerbations
Frequency of asthma symptoms and exacerbations
Asthma medication use
Frequency of asthma rescue medication use
Asthma medication use
Frequency of asthma rescue medication use
Incremental Step Test
Number of steps climbed; the more the better
Incremental Step Test
Number of steps climbed; the more the better
Sit-To-Stand test
Number of repetitions in 1 minute; the more the better
Sit-To-Stand test
Number of repetitions in 1 minute; the more the better
Timed Up-and-Go test
Time to perform the test; the faster the better
Timed Up-and-Go test
Time to perform the test; the faster the better
4-Metre Gait Speed test
Time to perform the test; the faster the better
4-Metre Gait Speed test
Time to perform the test; the faster the better
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
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
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).
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).
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
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
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
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
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
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
Lung function
Spirometry determining the forced expiratory volume in the first second (FEV1), forced vital capacity (FVC) and FEV1/FVC index.
Lung function
Spirometry determining the forced expiratory volume in the first second (FEV1), forced vital capacity (FVC) and FEV1/FVC index.

Full Information

First Posted
January 22, 2022
Last Updated
February 19, 2023
Sponsor
Universidade Norte do Paraná
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1. Study Identification

Unique Protocol Identification Number
NCT05241223
Brief Title
An Online Behavior Change Intervention to Promote Physical Activity in Adults With Asthma
Official Title
An Online Behavior Change Intervention to Promote Physical Activity in Adults With Asthma: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 3, 2022 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Norte do Paraná

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Sedentary Behavior, Physical Inactivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
This group will receive an education program which will cover information regarding asthma, physical activity and sedentary behavior.
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Behavior change intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Educational program
Intervention Description
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 Outcome Measure Information:
Title
Time spent in physical activity
Description
Time spent (in minutes and percentage of the day) in light-intensity and moderate to vigorous physical activities, measured by a triaxial activity monitor.
Time Frame
12 weeks from randomization
Title
Number of steps per day
Description
Number of steps per day measured by a triaxial activity monitor
Time Frame
12 weeks from randomization
Title
Time spent in sedentary behavior
Description
Time spent (in minutes and percentage of the day) in sedentary activities, measured by a triaxial activity monitor.
Time Frame
12 weeks from randomization
Secondary Outcome Measure Information:
Title
Time spent in physical activity
Description
Time spent (in minutes and percentage of the day) in light-intensity and moderate to vigorous physical activities, measured by a triaxial activity monitor.
Time Frame
36 weeks from randomization
Title
Number of steps per day
Description
Number of steps per day measured by a triaxial activity monitor.
Time Frame
36 weeks from randomization
Title
Time spent in sedentary behavior
Description
Time spent (in minutes and percentage of the day) in sedentary activities, measured by a triaxial activity monitor.
Time Frame
36 weeks from randomization
Title
Asthma control
Description
Asthma Control Questionnaire score ranging from 0 to 6; the lower, the better.
Time Frame
12 weeks from randomization
Title
Asthma control
Description
Asthma Control Questionnaire score ranging from 0 to 6; the lower, the better.
Time Frame
36 weeks from randomization
Title
Asthma symptoms and exacerbations
Description
Frequency of asthma symptoms and exacerbations
Time Frame
12 weeks from randomization
Title
Asthma symptoms and exacerbations
Description
Frequency of asthma symptoms and exacerbations
Time Frame
36 weeks from randomization
Title
Asthma medication use
Description
Frequency of asthma rescue medication use
Time Frame
12 weeks from randomization
Title
Asthma medication use
Description
Frequency of asthma rescue medication use
Time Frame
36 weeks from randomization
Title
Incremental Step Test
Description
Number of steps climbed; the more the better
Time Frame
12 weeks from randomization
Title
Incremental Step Test
Description
Number of steps climbed; the more the better
Time Frame
36 weeks from randomization
Title
Sit-To-Stand test
Description
Number of repetitions in 1 minute; the more the better
Time Frame
12 weeks from randomization
Title
Sit-To-Stand test
Description
Number of repetitions in 1 minute; the more the better
Time Frame
36 weeks from randomization
Title
Timed Up-and-Go test
Description
Time to perform the test; the faster the better
Time Frame
12 weeks from randomization
Title
Timed Up-and-Go test
Description
Time to perform the test; the faster the better
Time Frame
36 weeks from randomization
Title
4-Metre Gait Speed test
Description
Time to perform the test; the faster the better
Time Frame
12 weeks from randomization
Title
4-Metre Gait Speed test
Description
Time to perform the test; the faster the better
Time Frame
36 weeks from randomization
Title
Quality of life score
Description
Asthma Quality of Life Questionnaire; ranges from 1 to 7 points; the higher the score, the better the quality of life
Time Frame
12 weeks from randomization
Title
Quality of life score
Description
Asthma Quality of Life Questionnaire; ranges from 1 to 7 points; the higher the score, the better the quality of life
Time Frame
36 weeks from randomization
Title
Sleep quality
Description
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).
Time Frame
12 weeks from randomization
Title
Sleep quality
Description
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).
Time Frame
36 weeks from randomization
Title
Anxiety and depression symptoms
Description
Hospital Anxiety and Depression Scale; ranges from 0 to 21 points; the higher the score, the worse the anxiety and depression symptoms
Time Frame
12 weeks from randomization
Title
Anxiety and depression symptoms
Description
Hospital Anxiety and Depression Scale; ranges from 0 to 21 points; the higher the score, the worse the anxiety and depression symptoms
Time Frame
36 weeks from randomization
Title
Basic psychological needs
Description
Basic Psychological Needs in Exercise Scale; ranges from 4 to 20; higher scores indicate greater levels of satisfaction of basic psychological needs
Time Frame
12 weeks from randomization
Title
Basic psychological needs
Description
Basic Psychological Needs in Exercise Scale; ranges from 4 to 20; higher scores indicate greater levels of satisfaction of basic psychological needs
Time Frame
36 weeks from randomization
Title
Motivational regulations
Description
Behavioral Regulation in Exercise Questionnaire; ranges from 0 to 4; the higher the score, the more regulated the individual is for a given level
Time Frame
12 weeks from randomization
Title
Motivational regulations
Description
Behavioral Regulation in Exercise Questionnaire; ranges from 0 to 4; the higher the score, the more regulated the individual is for a given level
Time Frame
36 weeks from randomization
Title
Lung function
Description
Spirometry determining the forced expiratory volume in the first second (FEV1), forced vital capacity (FVC) and FEV1/FVC index.
Time Frame
12 weeks from randomization
Title
Lung function
Description
Spirometry determining the forced expiratory volume in the first second (FEV1), forced vital capacity (FVC) and FEV1/FVC index.
Time Frame
36 weeks from randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joice Oliveira, Msc
Organizational Affiliation
Universidade Norte do Paraná
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro de Pesquisa e Pós Graduação na Unopar
City
Londrina
State/Province
Paraná
ZIP/Postal Code
86041-14
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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

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