- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01758003
Physical Activity in Healthy Over 40s
Patterns of Physical Activity in a Healthy Population Aged Over 40 Years Old
The primary aim of this research is to examine physical activity in a healthy population aged over 40 years old.
Subsidiary aims of this research are:
- To establish normative values for physical activity levels, exercise capacity, quality of life and readiness to change physical activity behaviour (stages of change, self-efficacy, decisional balance and processes of change) in a healthy population age-matched to a population with bronchiectasis.
- To explore physical activity levels, exercise capacity and quality of life in a healthy population age-matched to a population with bronchiectasis.
- To explore readiness to change physical activity behaviour (stages of change, self-efficacy, processes of change and decisional balance) in a healthy population compared to a population with bronchiectasis.
연구 개요
상태
정황
상세 설명
The current study is running alongside an externally funded project measuring physical activity levels in patients with bronchiectasis (ClinicalTrials.gov ID: NCT01569009). In order to more fully understand physical activity behaviours in bronchiectasis, it is important to compare the patterns of physical activity, exercise capacity and quality of life of the patients with bronchiectasis to a healthy age-matched population.
For a healthy population of similar age to patients with bronchiectasis, little applicable research currently exists with regard to normative values of physical activity and sedentary behaviour. In this particular study, we will measure physical activity levels in healthy individuals age-matched to patients with bronchiectasis. The most commonly used questionnaire to assess physical activity is the International Physical Activity Questionnaire. Pedometers are inexpensive devices which can be used to assess daily step count and time spent in walking. Activity monitors are more expensive and require technical expertise for analysis and interpretation. However, they provide more in-depth information on pattern, quantity and intensity of activity including daily sedentary time. In this study, the investigators will use the ActiGraph activity monitor, ActivPAL activity monitor, DigiWalker pedometer and IPAQ to measure the physical activity levels in healthy individuals age-matched to patients with bronchiectasis. This study will not focus on participants who engage in high levels of physical activity as they are unlikely to represent the physical activity levels of patients with bronchiectasis.
This study will include the Modified Shuttle Test. Exercise capacity measured by the Modified Shuttle Test is normally only utilized in respiratory disease populations such as patients with cystic fibrosis. However, it has recently been highlighted that there is a need for reference data in healthy populations. This study will also use the EQ-5D-5L questionnaire to assess quality of life. Preliminary testing of the EQ-5D-5L questionnaire, an update to the well-researched EQ-5D-3L, has only recently been conducted. There is a need for studies to provide more normative data on the EQ-5D-5L.
This study will also assess readiness to change physical activity behaviour in a healthy population utilising transtheoretical model components such as stages of change, self-efficacy, decisional balance and processes of change; which have all been shown to be important in physical activity behaviour. Understanding healthy individuals' perspectives on readiness to change physical activity behaviour and the links between important outcomes will help to inform future physical activity interventions.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Antrim
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Jordanstown, Antrim, 영국, BT37 0QB
- University of Ulster
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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:
- aged ≥ 40 years
- does not participate in regular exercise or participates in regular exercise at a moderate level ≤ 3 hours/week
- ≤ 10 pack-year history of smoking
- does not suffer from any concomitant condition which may prevent participation in physical activity
- answered 'No' to all questions in the Medical Questionnaire
Exclusion Criteria:
- participates in regular exercise at a moderate level > 3 hours/week
- pregnancy
- any concomitant condition which may prevent participation in physical activity
- answered 'Yes' to any questions in the Medical Questionnaire
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Step counts measured by the ActiGraph GT3X+ activity monitor
기간: Seven days
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Participants will wear the ActiGraph GT3X+ activity monitor for seven consecutive full days between Visit 1 (Day 0) and Visit 2 (Day 8).
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Seven days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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수정된 셔틀 테스트를 사용한 운동 능력
기간: 8일차
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참가자는 방문 2(8일)에서 수정된 셔틀 테스트를 완료합니다.
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8일차
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변화 단계 설문지를 사용한 신체 활동 측면에서의 변화 단계
기간: 8일차
|
참가자는 방문 2(8일)에서 변화의 단계 설문지를 작성합니다.
변화의 단계 설문지는 초이론적 모델의 시간적 부분입니다.
참가자의 신체 활동 행동 측면에서 현재 변화 단계를 결정하는 데 사용됩니다.
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8일차
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Step counts measured by the ActivPAL activity monitor
기간: Seven days
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Participants will wear the ActivPAL activity monitor for seven consecutive full days between Visit 1 (Day 0) and Visit 2 (Day 8).
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Seven days
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Number of steps measured by the Yamax CW-700 DigiWalker pedometer
기간: Seven days
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Participants will wear the Yamax CW-700 DigiWalker pedometer for seven consecutive full days between Visit 1 (Day 0) and Visit 2 (Day 8).
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Seven days
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Physical activity levels and sitting time using the International Physical Activity Questionnaire
기간: Day 8
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Participants will complete the International Physical Activity Questionnaire at Visit 2 (Day 8).
It will be used to measure participants' time spent in physical activity in the last seven days and also to provide self-reported sitting time.
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Day 8
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Quality of Life using the EuroQOL-5D-5L
기간: Day 8
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Participants will complete the EuroQOL-5D-5L at Visit 2 (Day 8).
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Day 8
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Confidence to undertake physical activity using Marcus's Self-Efficacy Questionnaire
기간: Day 8
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Participants will complete Marcus's Self-Efficacy Questionnaire at Visit 2 (Day 8).
Marcus's Self-Efficacy Questionnaire is a component of the transtheoretical model.
It will provide more detailed information on each individual's confidence to undertake physical activity in different situations.
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Day 8
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Perception of the benefits and negative aspects of physical activity using Marcus's Decisional Balance Questionnaire
기간: Day 8
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Participants will complete Marcus's Decisional Balance Questionnaire at Visit 2 (Day 8).
Marcus's Decisional Balance Questionnaire is a component of the transtheoretical model.
It will assess each individual's perceptions of the benefits and negative aspects of physical activity.
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Day 8
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Strategies used to progress through the different stages of change using Marcus's Processes of Change Questionnaire
기간: Day 8
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Participants will complete Marcus's Processes of Change Questionnaire at Visit 2 (Day 8).
Marcus's Processes of Change Questionnaire is a component of the transtheoretical model.
It describes the strategies and techniques individuals use to progress through the different stages of change.
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Day 8
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Perception of the feasibility and acceptability of the physical activity outcome measures
기간: Day 8
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The researcher and the participants will answer the feasibility and acceptability questions at Visit 2 (Day 8).
The feasibility and acceptibility questions were designed for this study to assess the researchers' and participants' perspectives of the feasibility and acceptability of the physical activity outcome measures (ActiGraph, ActivPAL, pedometer and International Physical Activity Questionnaire.
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Day 8
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공동 작업자 및 조사자
수사관
- 수석 연구원: Judy Bradley, PhD, University of Ulster
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 (추정)
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. .
신체 활동에 대한 임상 시험
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Centre Hospitalier Universitaire de la Réunion아직 모집하지 않음선천성 심장 질환 | 미분획 헤파린 | Anti Xa Activity
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University Hospital, Grenoble완전한관절만곡증 Amyoplasia 또는 원위 관절만곡증의 진단 | National Reference Center의 AMC Clinic에서 5일 다학제 평가 | Grenoble Alpes 병원의 Physical Medecin, Medical Genetic and Imaging 부서와 함께프랑스