Clinical trial NCT05159076: 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
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Asthma
Physical activity
Behavioral intervention
Responders
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2021-12-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Longitudinal intervention study
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change in physical activity levels
timeFrame: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention
Secondary outcomes:
measure: Change in sedentary behaviour
timeFrame: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention
measure: Change in asthma clinical control
timeFrame: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention
measure: Change in Health Factors Related to Quality of Life in Asthma
timeFrame: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention
measure: Change in psychosocial symptoms
timeFrame: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention
measure: Change in body composition - Weight
timeFrame: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention
measure: Change in body composition - Fat mass
timeFrame: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention
measure: Change in body composition - Visceral adiposity area
timeFrame: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention
measure: Change in body composition - Fat-free mass
timeFrame: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention
measure: Change in body composition - Skeletal muscle mass
timeFrame: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention
Other outcomes:
measure: Changes in Barriers to the practice of Physical Activities of Daily Living
timeFrame: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention
measure: Change in asthma exacerbation
timeFrame: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention
measure: Change in Behavioral Stage for physical activity practice
timeFrame: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention
measure: Pulmonary function
timeFrame: Baseline
measure: Change in anthropometric indexes
timeFrame: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention
Locations:
city: São Paulo
country: Brazil
facility: Clinical Hospital of São Paulo University medical school (HCFMUSP)
Study officials:
affiliation: University of Sao Paulo General Hospital
name: Celso RF Carvalho, PhD
role: STUDY_DIRECTOR
References: