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Behavioral Intervention to Increase Physical Activity in Patients With Asthma

13 avril 2020 mis à jour par: University of Sao Paulo General Hospital

Effects of Behavioral Intervention to Increase Physical Activity on the Asthma Clinical Control: a Randomized Controlled Trial

The health benefits of physical activity (PA) are well documented and include improving in cardiovascular, obesity, mental health and all-cause mortality. Although higher levels of activity in patients with asthma are also associated with better outcomes, patients still avoid physical activity due to concern about exacerbating their asthma symptoms by the exercise induced bronchoconstriction (EIB), sustaining a vicious cycle of inactivity and worse asthma control. Many studies have reported the benefits of supervised exercise training on several asthma outcomes, such as exacerbations, asthma control, cardiopulmonary fitness, airway inflammation and psychosocial symptoms; however, the translation of the improvements in the exercise capacity into increments in PA levels is less evident and still controversial. Therefore, the hypothesis of this study is that behavioural interventions using strategies based on well-established psychosocial models are effective in increasing physical activity levels and decrease sedentary behaviour in adults with asthma, which will be associated with improvements in the asthma control.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

This is prospective and randomized controlled trial (RCT) with 2 arms and blinded outcome assessments. Forty-six moderate or severe patients with asthma under optimized medication will be randomly assigned (computer-generated) into either Control Group (CG) or Intervention Group (IG). Both groups will receive similar educational program. However, only the IG will be submitted to the behavioral intervention through physical activity counseling program combined with a monitoring-and-feedback tool aiming to increase physical activity levels (total of 8 weekly goal-setting consultation, face-to-face, each lasting 40 minutes). Before and after the interventions, clinical control of asthma, physical activity levels, health-related quality of life, asthma exacerbation, levels of anxiety and depression symptoms and anthropometric indices will be assessed. Data about onset of asthma, comorbidities, lung function and asthma medication will be collected from the patient's medical record. The data normality will be analyzed by Kolmogorov-Smirnov, and a two-way ANOVA with repeated measures with appropriate post hoc of Holm-sidak will be used to compare inter and intra-groups differences. The significance level will be set to 5% for all tests.

Type d'étude

Interventionnel

Inscription (Réel)

46

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Brésil
      • São Paulo, Brésil, 05360-160
        • Clinical Hospital of São Paulo University medical school (HCFMUSP)

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 60 ans (Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Asthma moderate and severe with diagnosed according to the Global Initiative for Asthma (GINA) 2018
  • Poorly controlled asthma (ACQ score > 1.5)
  • Sedentary (< 150 min of moderate to vigorous physical activity/week)
  • Medical treatment, for at least 6 months
  • Clinically stable (i.e., no exacerbation or changes in medication for at least 30 days)

Exclusion Criteria:

  • Cardiovascular, musculoskeletal or other chronic lung diseases
  • Active Cancer
  • Pregnant
  • Uncontrolled hypertension or diabetes
  • Current smoker or ex smoker (>10 pack-years)
  • Psychiatric disease or cognitive deficit

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Intervention Group (IG)
The intervention of active comparator will be education program plus behavioral intervention through physical activity counseling program combined with a monitoring-and-feedback tool.
Autre: Education Program
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, which will include information about the pathophysiology of asthma, medication and peak flow meter instructions, self-monitoring techniques, environmental control techniques and avoidance strategies. The second class will be about the current international physical activity recommendations and the importance and benefits of being physically active and maintain a healthy lifestyle.
Comportemental: Behavioral intervention
The behavioural intervention will be performed in 8 weekly goal-setting consultation, face-to-face, each lasting 40 minutes. Patients will be offered a commercially-available activity tracker to wear during 3 days prior to each consultation. According to their own PA data and the behavioural change stage, an individual action plan will be established with realistic goals to increase PA. Each participant will receive individual counselling with the goal of increasing participation in PA and reducing their sedentary time. Techniques such as weekly goal-setting, motivational interviewing, activity tracker vibration instructions, self-management, positive reinforcement, relapse prevention and strategies to overcome barriers will be included.
Comparateur factice: Control Group (CG)
The intervention of sham comparator will be an education program in asthma and physical activity recommendations.
Autre: Education Program
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, which will include information about the pathophysiology of asthma, medication and peak flow meter instructions, self-monitoring techniques, environmental control techniques and avoidance strategies. The second class will be about the current international physical activity recommendations and the importance and benefits of being physically active and maintain a healthy lifestyle.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in asthma clinical control
Délai: Change from baseline asthma clinical control at 8 weeks of intervention
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 from baseline asthma clinical control at 8 weeks of intervention

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in physical activity levels
Délai: Change from baseline physical activity levels at 8 weeks of intervention
Physical activity and 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 from baseline physical activity levels at 8 weeks of intervention
Change in health related quality of life
Délai: Change from baseline health related quality of life at 8 weeks of intervention
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 from baseline health related quality of life at 8 weeks of intervention
Change in asthma exacerbation
Délai: Change from baseline asthma exacerbation at 8 weeks of intervention
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
Change from baseline asthma exacerbation at 8 weeks of intervention
Change in sleep quality
Délai: Change from baseline sleep quality at 8 weeks of intervention
Sleep quality will be objectively quantified using a movement sensor (ActiGraph, Pensacola, USA) for 7 consecutive nights on the wrist (non-dominant side).
Change from baseline sleep quality at 8 weeks of intervention

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Pulmonary function
Délai: At baseline
Lung volumes will be assessed by spirometry
At baseline
Change in anthropometric indexes
Délai: Change from baseline anthropometric indexes at 8 weeks of intervention
Height (m) and weight (kg) will be combined to report BMI (kg/m^2)
Change from baseline anthropometric indexes at 8 weeks of intervention
Change in body composition
Délai: Change from baseline body composition at 8 weeks of intervention
Waist circumference (cm) and hip circumference (cm) will be combined to report wait to hip ratio (WHR)
Change from baseline body composition at 8 weeks of intervention
Change in psychosocial symptoms
Délai: Change from baseline psychosocial symptoms at 8 weeks of intervention
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 from baseline psychosocial symptoms at 8 weeks of intervention

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Sao Paulo General Hospital

Collaborateurs

University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo

Les enquêteurs

  • Directeur d'études: Celso RF Carvalho, PhD, University of Sao Paulo General Hospital

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

5 octobre 2018

Achèvement primaire (Réel)

27 août 2019

Achèvement de l'étude (Réel)

30 novembre 2019

Dates d'inscription aux études

Première soumission

4 octobre 2018

Première soumission répondant aux critères de contrôle qualité

8 octobre 2018

Première publication (Réel)

15 octobre 2018

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

15 avril 2020

Dernière mise à jour soumise répondant aux critères de contrôle qualité

13 avril 2020

Dernière vérification

1 octobre 2018

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • BIPAA
  • 2016/17093-0 (Autre subvention/numéro de financement: São Paulo Research Foundation (FAPESP))

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

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Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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