Aerobic Training Versus Behavioral Intervention to Increase Physical Activity in Patients With Asthma

Официальное название

Effects of Aerobic Training Versus Behavioral Intervention to Increase Physical Activity in Patients With Asthma: a Randomized, Blinded Clinical Trial.

Обзор

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.

Подробное описание

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).

Вмешательства

• Поведенческое Behavioral Intervention to Increase Physical Activity
  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 un
• Другое Aerobic Training
  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 anae

Первичные конечные точки

• Change in asthma clinical control [Срок оценки: [Change from baseline at 8 weeks of intervention and at 16 weeks post intervention]]

Вторичные конечные точки (9)

• Change in sedentary behaviour [Срок оценки: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention]
• Change in physical activity levels [Срок оценки: [Time Frame: 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 [Срок оценки: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention]
• Change in psychosocial symptoms [Срок оценки: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention]
• Change in body composition - Weight [Срок оценки: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention]
• Change in body composition - Fat mass [Срок оценки: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention]
• Change in body composition - Visceral adiposity area [Срок оценки: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention.]
• Change in body composition - Fat-free mass [Срок оценки: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention]]
• Change in body composition - Skeletal muscle mass [Срок оценки: Change from baseline at 8 weeks of intervention and at 16 weeks post intervention]]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Бразилия · 1 центр

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

Публикации

• Araujo Pinheiro DH, Silva RAD, Lunardi AC, Cervera VZ, Carvalho-Pinto RM, de Lima FF, Carvalho CRF. Effects of Aerobic Training Versus Behavioral Intervention to Increase Physical Activity for Disease Control in Patients With Asthma: Protocol for a Randomized Trial. JMIR Res Protoc. 2025 Oct 30;14:e78603. doi: 10.2196/78603. PMID 41166708

Идентификаторы

NCT: NCT05364632 · 2021/03745-3

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗