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Behavioral Intervention to Increase Physical Activity in Patients With Asthma: Identifying Responders

Primary Purpose

Asthma

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Behavioral Intervention to Increase Physical Activity
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, Physical activity, Behavioral intervention, Responders

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Participants not physically active;
  2. Partially/uncontrolled asthma;
  3. Diagnosis of asthma based on the recommendations of the Global Initiative for Asthma (GINA 2020);
  4. Be under outpatient follow-up at the Pulmonology or Immunology service of the University of Sao Paulo General Hospital;
  5. Be under outpatient medical treatment for at least six months, with a stable clinical condition for at least , 30 days;
  6. Being using optimized drug therapy for asthma.

Exclusion Criteria:

  1. Participation in another research protocol;
  2. Difficulty in understanding any of the questionnaires used;
  3. Practitioners of regular physical activity;
  4. Pregnancy and psychiatric problems that make it difficult to understand the questionnaires and the study protocol.

Sites / Locations

  • Clinical Hospital of São Paulo University medical school (HCFMUSP)Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Behavioral Intervention

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.

Outcomes

Primary Outcome Measures

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.

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 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.
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
Bioimpedance (Octopolar InBody 720).

Full Information

First Posted
November 3, 2021
Last Updated
June 28, 2023
Sponsor
University of Sao Paulo General Hospital
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT05159076
Brief Title
Behavioral Intervention to Increase Physical Activity in Patients With Asthma: Identifying Responders
Official Title
Behavioral Intervention to Increase Physical Activity in Patients With Asthma: Identifying the Profile of Responders
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico, 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 identify clinical, personal and anthropometric characteristics among patients with asthma who respond and non-responders to a behavioral intervention to increase the level of physical activity.
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. After two days of evaluations, with an interval of 7 days between them, the participants will be included in a behavioral intervention program to increase physical activity for 8 weeks (once a week).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Physical activity, Behavioral intervention, Responders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Longitudinal intervention study
Masking
None (Open Label)
Masking Description
Evaluations will be conducted blindly, that is, by an evaluator who will not be directly involved in the intervention.
Allocation
N/A
Enrollment
100 (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.
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.
Primary Outcome Measure Information:
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
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 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
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
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

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; Partially/uncontrolled asthma; 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.
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

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Behavioral Intervention to Increase Physical Activity in Patients With Asthma: Identifying Responders

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