- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04080583
Short Active Lives Survey in Chronic Lung Conditions
Short Active Lives Survey in Chronic Lung Conditions: an Exploratory Study
Short Actives Lives Survey is a common tool used to measure physical activity in the UK population. Self-reported measures such as the Short Active Lives Survey can be prone to bias. As such, during project evaluations, benefits may be exaggerated due to over-reporting of physical activity or downplayed due to underreporting of physical activity. There is also a lack of research reporting the typical short-term and long-term changes in physical activity (measured by the Short Active Lives Survey) in people with chronic lung conditions who are not receiving support to become active (i.e. usual care, control groups). Accelerometers are small lightweight activity monitors that can be worn on the waist. These monitors are known to provide accurate and reliable objective assessment of physical activity in people with lung conditions.
This research study will recruit a cohort of inactive people with lung conditions and determine changes in physical activity measured by both the Short Active Lives Survey and one of the most valid accelerometers used in people with lung conditions (Actigraph GT3X). The study will also evaluate how these physical activity measures relate to general health (health status and health care use) of people with lung conditions over 12 months. This study will provide information on the usefulness of using the Short Active Lives Survey in the future for measuring physical activity in people with lung conditions.
연구 개요
상태
정황
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Lincolnshire
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Lincoln, Lincolnshire, 영국, LN6 7TS
- University of Lincoln
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Diagnosis of Chronic Obstructive Pulmonary Disease, Bronchiectasis, Interstitial Lung Disease, Lung Cancer, Mesothelioma or Asthma
- Physically inactive defined as completing less than 30 minutes ore more of moderate intensity equivalent physical activity per week (measured by the Short Active Lives Survey)
Exclusion Criteria:
- Adults without a diagnosis of Chronic Obstructive Pulmonary Disease, Bronchiectasis, Interstitial Lung Disease, Lung Cancer, Mesothelioma or Asthma
- Age < 18 Years
- Completing 30 minutes or more of moderate intensity equivalent (MIE) physical activity per week
- Inability or unwillingness to sign informed consent
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Usual Care
People with a chronic lung condition who are physically inactive
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Minutes of self-reported moderate intensity equivalent physical activity per week
기간: Baseline to 12 months
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Short Active Lives Survey
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Baseline to 12 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Accelerometer measured physical activity: time (minutes per day) spent in moderate intensity activity
기간: Baseline to 12 months
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Actigraph wGT3X-BT
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Baseline to 12 months
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Accelerometer measured physical activity: time (minutes per week) spent in light activity
기간: Baseline to 12 months
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Actigraph wGT3X-BT
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Baseline to 12 months
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Accelerometer measured physical activity including: time (minutes per week) spent in vigorous activity
기간: Baseline to 12 months
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Actigraph wGT3X-BT
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Baseline to 12 months
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Accelerometer measured physical activity: time (minutes per day) spent in sedentary state
기간: Baseline to 12 months
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Actigraph wGT3X-BT
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Baseline to 12 months
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Accelerometer measured physical activity: average daily steps
기간: Baseline to 12 months
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Actigraph wGT3X-BT
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Baseline to 12 months
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Accelerometer measured physical activity including: daily vector magnitude units
기간: Baseline to 12 months
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Actigraph wGT3X-BT
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Baseline to 12 months
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EQ5D index
기간: Baseline to 12 months
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Based on self-rating of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression).
Each dimension is rated between 1 (no problems) to 5 (unable to/extreme problems).
Dimensions are combined to produce a five-digit number describing the individual's health status (ranging from 11111 to 55555).
Five digit number converted to an index based on the EQ-5D-5L value set for England.
Index ranges from -0.208 (worst possible health) to 1.000 (best possible health).
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Baseline to 12 months
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EQ VAS
기간: Baseline to 12 months
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Self-report of health status on a scale, 0 (worst health) - 100 (best health)
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Baseline to 12 months
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Cost questionnaire
기간: Baseline to 12 months
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NHS resource use questionnaire
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Baseline to 12 months
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Demographics:
기간: Baseline to 12 months
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Age, gender, ethnicity, comorbidities, social deprivation, MRC degree of breathlessness, oxygen use
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Baseline to 12 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Arwel W Jones, PhD, University of Lincoln
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .
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