Back to resultsAerobic Training Versus Behavioral Intervention to Increase Physical Activity in Patients With Asthma
Primary Purpose
Asthma
Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Behavioral Intervention to Increase Physical Activity
Aerobic Training
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring asthma, physical activity, physical exercise, quality of life
Eligibility Criteria
Inclusion Criteria:
- Participants not physically active;
- Uncontrolled asthma (ACQ>1,5);
- Diagnosis of asthma based on the recommendations of the Global Initiative for Asthma (GINA 2020);
- Be under outpatient follow-up at the Pulmonology or Immunology service of the University of Sao Paulo General Hospital;
- Be under outpatient medical treatment for at least six months, with a stable clinical condition for at least 30 days;
- Being using optimized drug therapy for asthma.
Exclusion Criteria:
- Participation in another research protocol;
- Difficulty in understanding any of the questionnaires used;
- Practitioners of regular physical activity;
- Pregnancy and psychiatric problems that make it difficult to understand the questionnaires and the study protocol;
- Presence of another chronic lung, neurological or musculoskeletal disease that hinders or prevents physical activity;
- Patients who are smokers or ex-smokers (who have quit smoking for less than 1 year or who have smoked more than 15 pack-years).
Sites / Locations
- Clinical Hospital of São Paulo University medical school (HCFMUSP)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Behavioral Intervention
Aerobic Training
Arm Description
Participants will undergo an eight-week behavioral intervention protocol (once a week) aimed at increasing the level of physical activity, consisting of a brief educational program: brief education for asthma and benefits of physical activity and behavioral intervention based on Social Cognitive Theory and the Theory of Stages of Behavior Change.
Participants will undergo an eight-week aerobic training protocol (twice a week) on a treadmill, each aerobic training session will consist of 45 minutes divided into 5 minutes of warm-up, 35 minutes of aerobic exercise and 5 minutes of cool-down.
Outcomes
Primary Outcome Measures
Change in asthma clinical control
Clinical control will be evaluated by the Asthma Control Questionnaire (ACQ). The ACQ contains 7 items rated on a 7- point scale (0 = without limitation, 6 = maximum limitation), with a higher score indicating worse control. Scores lower than 0.75 are associated with good asthma control, whereas scores greater than 1.5 are indicative of poorly controlled asthma, and a change of at least 0.5 points in the ACQ score is regarded as clinically significant.
Secondary Outcome Measures
Change in sedentary behaviour
Sedentary behaviour will be objectively quantified using a movement sensor (ActiGraph, Pensacola, USA) for 7 consecutive days on the hip using an elastic belt. Sedentary behaviour will be quantify by the time spent sedentary (<100 counts/min).
Change in physical activity levels
Physical activity will be objectively quantified using a movement sensor (ActiGraph, Pensacola, USA) for 7 consecutive days on the hip using an elastic belt.
Change in Health Factors Related to Quality of Life in Asthma
Health related quality of life will be assessed by Asthma Quality Life Questionnaire (AQLQ). The AQLQ consists of 32 items rated on a 7-point scale (1 = great deal, 7 = not at all) divided into the following 4 domains: activity limitations, symptoms, emotional function and environmental stimuli. Higher AQLQ scores indicate a better quality of life, and treatments resulting in a 0.5-point increase in scores following an intervention are considered to be clinically effective.
Change in psychosocial symptoms
Symptoms of anxiety and depression symptoms will be assessed by the Hospital Anxiety and Depression scale (HADs), which consists of 14 items divided into 2 subscales (7 for anxiety and 7 for depression). Each item is scored from 0 to 3, with a maximum score of 21 points for each subscale. A score greater than 8/9 in each subscale suggests a diagnosis of either anxiety and/or depression.
Change in body composition - Weight
Bioimpedance (Octopolar InBody 720).
Change in body composition - Fat mass
Bioimpedance (Octopolar InBody 720).
Change in body composition - Visceral adiposity area
Bioimpedance (Octopolar InBody 720). ,Fat-free mass, and skeletal muscle mass will be calculated.
Change in body composition - Fat-free mass
Bioimpedance (Octopolar InBody 720).
Change in body composition - Skeletal muscle mass
muscle mass Bioimpedance (Octopolar InBody 720).
Full Information
NCT ID
NCT05364632
First Posted
May 3, 2022
Last Updated
October 2, 2023
Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT05364632
Brief Title
Aerobic Training Versus Behavioral Intervention to Increase Physical Activity in Patients With Asthma
Official Title
Effects of Aerobic Training Versus Behavioral Intervention to Increase Physical Activity in Patients With Asthma: a Randomized, Blinded Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 23, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To compare the effects of aerobic training and behavioural intervention to increase physical activity in the clinical control of asthma and in the quality of life of patients with asthma.
Detailed Description
Adult participants of both genders with moderate to severe asthma, not physically active, will be evaluated after being informed about the study, agreeing and signing the informed consent form. Participants will be randomized to aerobic training or behavioral intervention group. Both interventions will consist of 8 weeks. Aerobic training will be performed on a treadmill (2xweek; 45 min/session). The behavioral intervention will be a program to increase physical activity (1xweek; up to 90 min / session). The maximum HR will be estimated according to the Tanaka's equation (208 - 0.7 x age).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
asthma, physical activity, physical exercise, quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
Evaluations will be conducted blindly, that is, by an evaluator who will not be directly involved in the intervention.
Allocation
Randomized
Enrollment
56 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Behavioral Intervention
Arm Type
Experimental
Arm Description
Participants will undergo an eight-week behavioral intervention protocol (once a week) aimed at increasing the level of physical activity, consisting of a brief educational program: brief education for asthma and benefits of physical activity and behavioral intervention based on Social Cognitive Theory and the Theory of Stages of Behavior Change.
Arm Title
Aerobic Training
Arm Type
Experimental
Arm Description
Participants will undergo an eight-week aerobic training protocol (twice a week) on a treadmill, each aerobic training session will consist of 45 minutes divided into 5 minutes of warm-up, 35 minutes of aerobic exercise and 5 minutes of cool-down.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Intervention to Increase Physical Activity
Intervention Description
The educational program will consist of 2 classes held once a week, each lasting 90 minutes. The classes will be based on an education videotape, presentations and group discussions. The first class will address the asthma education. The second class will be about the current international physical activity recommendations and the importance and benefits of being physically active. The behavioural intervention will be performed in 8 weekly goal-setting consultation, face-to-face, each lasting until 90 minutes. Patients will be offered a commercially-available activity tracker to wear during 3 days prior to each consultation. According to their own physical activity (PA) data and the behavioural change stage, an individual action plan will be established to increase physical activity. Each participant will receive individual counselling with the goal of increasing participation in PA and reducing their sedentary time.
Intervention Type
Other
Intervention Name(s)
Aerobic Training
Intervention Description
The same initial educational program described for the Behavioral Intervention group will be delivered to this group. Each aerobic training session will consist of 45 minutes divided into 5 minutes of warm-up, 35 minutes of aerobic exercise and 5 minutes of cool-down. During physical training, heart rate and level of respiratory distress will be monitored. The intensity of aerobic physical training will be based on the heart rate (HR) corresponding to one third of the difference between the anaerobic threshold (LA) and the respiratory compensation point (CRP). The patient may interrupt physical exercise if he presents any clinical symptoms and/or respiratory discomfort, returning as soon as his respiratory condition improves.
Primary Outcome Measure Information:
Title
Change in asthma clinical control
Description
Clinical control will be evaluated by the Asthma Control Questionnaire (ACQ). The ACQ contains 7 items rated on a 7- point scale (0 = without limitation, 6 = maximum limitation), with a higher score indicating worse control. Scores lower than 0.75 are associated with good asthma control, whereas scores greater than 1.5 are indicative of poorly controlled asthma, and a change of at least 0.5 points in the ACQ score is regarded as clinically significant.
Time Frame
[Change from baseline at 8 weeks of intervention and at 16 weeks post intervention]
Secondary Outcome Measure Information:
Title
Change in sedentary behaviour
Description
Sedentary behaviour will be objectively quantified using a movement sensor (ActiGraph, Pensacola, USA) for 7 consecutive days on the hip using an elastic belt. Sedentary behaviour will be quantify by the time spent sedentary (<100 counts/min).
Time Frame
Change from baseline at 8 weeks of intervention and at 16 weeks post intervention
Title
Change in physical activity levels
Description
Physical activity will be objectively quantified using a movement sensor (ActiGraph, Pensacola, USA) for 7 consecutive days on the hip using an elastic belt.
Time Frame
[Time Frame: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention]
Title
Change in Health Factors Related to Quality of Life in Asthma
Description
Health related quality of life will be assessed by Asthma Quality Life Questionnaire (AQLQ). The AQLQ consists of 32 items rated on a 7-point scale (1 = great deal, 7 = not at all) divided into the following 4 domains: activity limitations, symptoms, emotional function and environmental stimuli. Higher AQLQ scores indicate a better quality of life, and treatments resulting in a 0.5-point increase in scores following an intervention are considered to be clinically effective.
Time Frame
Change from baseline at 8 weeks of intervention and at 16 weeks post intervention
Title
Change in psychosocial symptoms
Description
Symptoms of anxiety and depression symptoms will be assessed by the Hospital Anxiety and Depression scale (HADs), which consists of 14 items divided into 2 subscales (7 for anxiety and 7 for depression). Each item is scored from 0 to 3, with a maximum score of 21 points for each subscale. A score greater than 8/9 in each subscale suggests a diagnosis of either anxiety and/or depression.
Time Frame
Change from baseline at 8 weeks of intervention and at 16 weeks post intervention
Title
Change in body composition - Weight
Description
Bioimpedance (Octopolar InBody 720).
Time Frame
Change from baseline at 8 weeks of intervention and at 16 weeks post intervention
Title
Change in body composition - Fat mass
Description
Bioimpedance (Octopolar InBody 720).
Time Frame
Change from baseline at 8 weeks of intervention and at 16 weeks post intervention
Title
Change in body composition - Visceral adiposity area
Description
Bioimpedance (Octopolar InBody 720). ,Fat-free mass, and skeletal muscle mass will be calculated.
Time Frame
Change from baseline at 8 weeks of intervention and at 16 weeks post intervention.
Title
Change in body composition - Fat-free mass
Description
Bioimpedance (Octopolar InBody 720).
Time Frame
Change from baseline at 8 weeks of intervention and at 16 weeks post intervention]
Title
Change in body composition - Skeletal muscle mass
Description
muscle mass Bioimpedance (Octopolar InBody 720).
Time Frame
Change from baseline at 8 weeks of intervention and at 16 weeks post intervention]
Other Pre-specified Outcome Measures:
Title
Changes in Barriers to the practice of Physical Activities of Daily Living
Description
The possible answers to the questionnaire Barriers to the practice of Physical Activities of Daily Living are never, rarely, sometimes, almost always or always and the score for each item varies from 0 to 4. It will be considered as limiting domain for physical activities those in which individuals report a value equal to or greater than 3 in at least half of the barriers.
Time Frame
Change from baseline at 8 weeks of intervention and at 16 weeks post intervention]
Title
Change in asthma exacerbation
Description
Asthma exacerbation will be assessed by the following criteria: the use of ≥4 puffs of rescue medication per 24 hours during a 48-hour period, a need for systemic corticosteroids, an unscheduled medical appointment, and either a visit to an emergency room or hospitalization
Time Frame
Change from baseline at 8 weeks of intervention and at 16 weeks post intervention
Title
Change in Behavioral Stage for physical activity practice
Description
The Behavioral Stage Assessment Questionnaire for the Practice of Physical Activity qualitatively assesses thinking in relation to the practice of physical activity, and may present the following stages of behavior: 1. Pre-contemplation; 2.
Contemplation; 3. Preparation; 4. Action; 5- Maintenance.
Time Frame
Change from baseline at 8 weeks of intervention and at 16 weeks post intervention
Title
Pulmonary function
Description
Lung volumes will be assessed by spirometry
Time Frame
Baseline
Title
Change in anthropometric indexes
Description
Waist circumference (cm) and hip circumference (cm) will be combined to report wait to hip ratio (WHR).
Time Frame
Change from baseline at 8 weeks of intervention and at 16 weeks post intervention
Title
Sleep quality assessment
Description
The assessment of sleep quality will be performed by the accelerometer (Actigraph, GT9) for seven nights before and after the interventions, throughout the day. The outcomes derived from the monitor will be sleep latency (the amount of time needed to fall asleep) and sleep efficiency (number of sleep minutes divided by the total number of minutes the participant was in bed).
Time Frame
Change from baseline at 8 weeks of intervention and at 16 weeks post intervention
Title
Cardiopulmonary Exercise Test
Description
CPET will be performed on an electric cycle ergometer (Corival; Lode BV Medical Technology, Netherlands) equipped with an electronic system (CPX System; CareFusion, Germany). During the test there will be verbal encouragement for the patient to reach maximum effort. The maximum oxygen consumption (VO2 peak in ml.kg.min) will be evaluated, considered the highest value in the test phase; anaerobic threshold (will be determined from the exponential growth of ventilation, additionally by the increase in VCO2, fall and/or stabilization of VO2, also considering the VCO2/VO2 ratio close to 1; respiratory compensation point (will be determined from the second point inflection, exponential growth in ventilation, additionally due to the increase in VCO2 and exponential fall in VO2, also considering the VCO2/VO2 ratio greater than or equal to 1.10; maximum heart rate (established by electrocardiogram examinatio).
Time Frame
Change from baseline at 8 weeks of intervention and at 16 weeks post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants not physically active;
Uncontrolled asthma (ACQ>1,5);
Diagnosis of asthma based on the recommendations of the Global Initiative for Asthma (GINA 2020);
Be under outpatient follow-up at the Pulmonology or Immunology service of the University of Sao Paulo General Hospital;
Be under outpatient medical treatment for at least six months, with a stable clinical condition for at least 30 days;
Being using optimized drug therapy for asthma.
Exclusion Criteria:
Participation in another research protocol;
Difficulty in understanding any of the questionnaires used;
Practitioners of regular physical activity;
Pregnancy and psychiatric problems that make it difficult to understand the questionnaires and the study protocol;
Presence of another chronic lung, neurological or musculoskeletal disease that hinders or prevents physical activity;
Patients who are smokers or ex-smokers (who have quit smoking for less than 1 year or who have smoked more than 15 pack-years).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Celso RF Carvalho, PhD
Phone
55 11 98415-3234
Email
cscarval@usp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Celso RF Carvalho, PhD
Organizational Affiliation
University of Sao Paulo General Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Hospital of São Paulo University medical school (HCFMUSP)
City
São Paulo
ZIP/Postal Code
05360-160
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Celso RF Carvalho, PhD
Email
cscarval@usp.br
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Aerobic Training Versus Behavioral Intervention to Increase Physical Activity in Patients With Asthma
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