Behavioral Intervention to Increase Physical Activity in Patients With Asthma
2020년 4월 13일 업데이트: 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.
연구 개요
상태
상태
완전한
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
중재적
등록 (실제)
등록
46
단계
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
-
São Paulo, 브라질, 05360-160
- Clinical Hospital of São Paulo University medical school (HCFMUSP)
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
18년 (성인)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
팔의 수
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
활성 비교기: 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.
|
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.
|
|
가짜 비교기: Control Group (CG)
The intervention of sham comparator will be an education program in asthma and physical activity recommendations.
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in asthma clinical control
기간: 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
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in physical activity levels
기간: 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
기간: 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
기간: 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
기간: 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
|
기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Pulmonary function
기간: At baseline
|
Lung volumes will be assessed by spirometry
|
At baseline
|
|
Change in anthropometric indexes
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
협력자
수사관
수사관
- 연구 책임자: Celso RF Carvalho, PhD, University of Sao Paulo General Hospital
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
연구 시작
2018년 10월 5일
기본 완료 (실제)
기본 완료
2019년 8월 27일
연구 완료 (실제)
연구 완료
2019년 11월 30일
연구 등록 날짜
최초 제출
최초 제출
2018년 10월 4일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2018년 10월 8일
처음 게시됨 (실제)
처음 게시됨
2018년 10월 15일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2020년 4월 15일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2020년 4월 13일
마지막으로 확인됨
마지막으로 확인됨
2018년 10월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- BIPAA
- 2016/17093-0 (기타 보조금/기금 번호: São Paulo Research Foundation (FAPESP))
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Education Program에 대한 임상 시험
-
NCT06939699아직 모집하지 않음자궁경부암 검진 | 유방암 검진 | 대장암 검진 | 디지털 건강 리터러시