Behavioral Intervention to Increase Physical Activity in Patients With Asthma
2020年4月13日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
46
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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São Paulo、ブラジル、05360-160
- Clinical Hospital of São Paulo University medical school (HCFMUSP)
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～60年 (大人)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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.
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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.
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.
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偽コンパレータ：Control Group (CG)
The intervention of sham comparator will be an education program in asthma and physical activity recommendations.
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in asthma clinical control
時間枠：Change from baseline asthma clinical control at 8 weeks of intervention
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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.
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Change from baseline asthma clinical control at 8 weeks of intervention
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in physical activity levels
時間枠：Change from baseline physical activity levels at 8 weeks of intervention
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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).
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Change from baseline physical activity levels at 8 weeks of intervention
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Change in health related quality of life
時間枠：Change from baseline health related quality of life at 8 weeks of intervention
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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.
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Change from baseline health related quality of life at 8 weeks of intervention
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Change in asthma exacerbation
時間枠：Change from baseline asthma exacerbation at 8 weeks of intervention
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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
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Change from baseline asthma exacerbation at 8 weeks of intervention
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Change in sleep quality
時間枠：Change from baseline sleep quality at 8 weeks of intervention
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Sleep quality will be objectively quantified using a movement sensor (ActiGraph, Pensacola, USA) for 7 consecutive nights on the wrist (non-dominant side).
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Change from baseline sleep quality at 8 weeks of intervention
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Pulmonary function
時間枠：At baseline
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Lung volumes will be assessed by spirometry
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At baseline
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Change in anthropometric indexes
時間枠：Change from baseline anthropometric indexes at 8 weeks of intervention
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Height (m) and weight (kg) will be combined to report BMI (kg/m^2)
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Change from baseline anthropometric indexes at 8 weeks of intervention
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Change in body composition
時間枠：Change from baseline body composition at 8 weeks of intervention
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Waist circumference (cm) and hip circumference (cm) will be combined to report wait to hip ratio (WHR)
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Change from baseline body composition at 8 weeks of intervention
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Change in psychosocial symptoms
時間枠：Change from baseline psychosocial symptoms at 8 weeks of intervention
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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.
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Change from baseline psychosocial symptoms at 8 weeks of intervention
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- スタディディレクター：Celso RF Carvalho, PhD、University of Sao Paulo General Hospital
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2018年10月5日
一次修了 (実際)
2019年8月27日
研究の完了 (実際)
2019年11月30日
試験登録日
最初に提出
2018年10月4日
QC基準を満たした最初の提出物
2018年10月8日
最初の投稿 (実際)
2018年10月15日
学習記録の更新
投稿された最後の更新 (実際)
2020年4月15日
QC基準を満たした最後の更新が送信されました
2020年4月13日
最終確認日
2018年10月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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