- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01871246
Acute Exacerbation of COPD and Physical Activity - Preliminary Study
연구 개요
상태
정황
상세 설명
Individuals with chronic obstructive pulmonary disease (COPD) are very sedentary and their physical activity is often interrupted by acute exacerbations of COPD (AECOPD). Little is known about the expectations had by individuals with COPD and the effects of these expectations on their physical activity. To increase the understanding of these expectations in people with COPD, a study is proposed to explore their experience of daily fluctuations in symptoms and AECOPDs, focusing on how these experiences influence health promoting behaviors, especially physical activity (PA).
This study will involve an enrollment visit during which consent will be obtained, survey data will be administered (that they may take home), spirometry testing will be conducted, and a physical activity monitor (ActivPAL device) will be applied to be worn one week to allow us to understand their usual PA. A clinical ethnographic interview will then be conducted one week following enrollment, at which point the questionnaires and ActivPAL device will be collected. A second clinical ethnographic interview will be conducted one week following the first. Survey data will again collected at week 15 by mail.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
Michigan
-
Ann Arbor, Michigan, 미국, 48109
- University of Michigan - School of Nursing
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- People who have emphysema or chronic bronchitis as their primary health problem
- People who have had a respiratory infection or an exacerbation of their COPD within the last year.
- People who are 55 years or older
- Family member of someone who meets the above criteria.
Exclusion Criteria:
- Other lung diseases as their primary pulmonary problem.
- Mobility problems that limit physical activity
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
---|
People with COPD & recent exacerbation
The group consists of people with COPD who have had an exacerbation in the last year.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Physical activity during AECOPD
기간: week 1
|
Subjects will be asked to report how they managed their physical activity during the last AECOPD.
Current physical activity will be measured with accelerometry and by the CHAMPS questionnaire.
|
week 1
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Sense of coherence
기간: week 1 and week 15
|
Questionnaire that measures one's global orientation to life and the extent to which one sees life as comprehensible, manageable and meaningful.
|
week 1 and week 15
|
Barriers efficacy scale
기간: week 1 week 15
|
Questionnaire that measures barriers to exercise and physical activity.
The subjects reports the level of confidence they have that they can overcome each barrier.
|
week 1 week 15
|
Help seeking behavior
기간: week 1 and week 15
|
Questionnaire assesses help seeking with respect to healthcare services.
|
week 1 and week 15
|
COPD Stigma Scale
기간: week 1 and week 15
|
Questionnaire measures the stigma associated with having COPD.
|
week 1 and week 15
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Social Support for Exercise
기간: week 1
|
Questionnaire measures social support, positive and negative social influences for physical activity and social support for exercise.
|
week 1
|
COPD symptoms
기간: week 1
|
Questionnaire, the COPD Assessment Tests quantifies severity of the most recent exacerbation.
|
week 1
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Janet L Larson, PhD, University of Michigan - School of Nursing
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- HUM00062912
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. .