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Clinical Trials/NCT05159076
NCT05159076
Completed
Not Applicable

Behavioral Intervention to Increase Physical Activity in Patients with Asthma: Identifying the Profile of Responders

University of Sao Paulo General Hospital1 site in 1 country100 target enrollmentMay 2, 2022
ConditionsAsthma

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Asthma
Sponsor
University of Sao Paulo General Hospital
Enrollment
100
Locations
1
Primary Endpoint
Change in physical activity levels
Status
Completed
Last Updated
last year

Overview

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).

Registry
clinicaltrials.gov
Start Date
May 2, 2022
End Date
November 13, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Celso R. Carvalho

Associate professor

University of Sao Paulo General Hospital

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.

Outcomes

Primary Outcomes

Change in physical activity levels

Time Frame: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention

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 Outcomes

  • Change in body composition - Skeletal muscle mass(Change from baseline at 8 weeks of intervention and at 16 weeks post intervention)
  • Change in asthma clinical control(Change from baseline at 8 weeks of intervention and at 16 weeks post intervention)
  • Change in sedentary behaviour(Change from baseline at 8 weeks of intervention and at 16 weeks post intervention)
  • Change in body composition - Weight(Change from baseline at 8 weeks of intervention and at 16 weeks post intervention)
  • Change in body composition - Fat mass(Change from baseline at 8 weeks of intervention and at 16 weeks post intervention)
  • Change in body composition - Fat-free mass(Change from baseline at 8 weeks of intervention and at 16 weeks post intervention)
  • Change in psychosocial symptoms(Change from baseline at 8 weeks of intervention and at 16 weeks post intervention)
  • Change in Health Factors Related to Quality of Life in Asthma(Change from baseline at 8 weeks of intervention and at 16 weeks post intervention)
  • Change in body composition - Visceral adiposity area(Change from baseline at 8 weeks of intervention and at 16 weeks post intervention)

Study Sites (1)

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