Clinical trial NCT05364632: 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
Overall status: RECRUITING
Phase: NA
Conditions: Asthma
Keywords: asthma
physical activity
physical exercise
quality of life
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2022-05-06
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: Inclusion Criteria:

1. Participants not physically active;
2. Uncontrolled asthma (ACQ\>1,5);
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;
5. Presence of another chronic lung, neurological or musculoskeletal disease that hinders or prevents physical activity;
6. 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).

Primary outcomes:
measure: Change in asthma clinical control
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 physical activity levels
timeFrame: [Time Frame: 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
measure: Sleep quality assessment
timeFrame: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention
measure: Cardiopulmonary Exercise Test
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: