Sedentary Behaviour, Physical Activity and Cardiometabolic Risk in Chronic Obstructive Pulmonary Disease (SPAaRC)
調査の概要
状態
条件
詳細な説明
Chronic Obstructive Pulmonary Disease (COPD) is a condition associated with low levels of physical activity and sedentary behaviour (i.e. too much sitting). In addition there is a higher level of heart disease and diabetes in those with COPD. This adds to the burden of the disease. This study will be measuring sitting time using a specific waist-worn monitoring device. The amount of sitting time will then be compared with cardiovascular (heart disease) risk markers, diabetes risk markers and body composition (i.e. fat and muscle mass).
The measurement of cardiovascular and diabetes risk markers will include blood tests to look at blood sugar levels, lipids, cholesterol and insulin resistance as well as blood pressure and heart rate measurement. Body composition measurements will include height, weight, waist circumference, hip circumference as well as scales that will measure body fat and muscle mass and a scan called a dual energy x-ray absorptiometer (DEXA) which uses a type of x-ray to measure body tissues. This involves a very low dose of radiation, much smaller than a normal x-ray.
Quadriceps strength will be measured to provide information on the strength of the muscles.
The sitting device will be worn for 1 week and at the end of this week it will be delivered or sent back by the participant together with a questionnaire about how acceptable the device is to wear.
Additional measures will be included in the assessment in order to examine the results appropriately and reduce bias. These measurements include lung function (breathing) tests, fitness tests (4 metre gait speed and incremental shuttle walk test) and questionnaires about age, gender, ethnicity, medical diagnoses, medications (with detail about oral steroid use), smoking (including pack yrs), exacerbation history, breathlessness, anxiety, depression and motivation, frailty, Physical Activity and Sedentary Behaviour Questionnaire, Employment and Occupational status and history, device Acceptability questionnaire.
Participants will attend an assessment visit. As some of the blood tests need to be done under fasting conditions, i.e. without consuming food or liquids other than water for 8 hours, this will normally take place in the morning. Following the blood tests they will be offered a drink and snack before undertaking any physical measures.
Healthy volunteers of a similar age will also be recruited and attend the same assessment visit to allow comparison between groups to be made.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Leicestershire
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Leicester、Leicestershire、イギリス、LE3 9QP
- Respiratory Biomedical Research Centre
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Loughborough、Leicestershire、イギリス、LE11 3TU
- Loughborough Universtiy
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Those with COPD recruited from both secondary care and an existing primary care database.
Healthy volunteers recruited from an existing database recruited through community advertisement.
説明
Inclusion Criteria:
- People with COPD or healthy volunteers without any respiratory conditions
- Over age of 40
- Body Mass Index below 35
Exclusion Criteria:
- Age below 40
- BMI above 35
- Unable to complete assessment visit
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 観測モデル:ケースコントロール
- 時間の展望:断面図
コホートと介入
グループ/コホート |
|---|
|
Chronic Obstructive Pulmonary Disease
Patients with a diagnosis of Chronic Obstructive Pulmonary Disease
|
|
Healthy Volunteers
Volunteers without any respiratory condition or symptoms
|
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 |
|---|---|---|
|
cardiometabolic risk
時間枠:baseline
|
aggregated measure based on lipid levels, fasting glucose, glycated haemoglobin (A1c) (HbA1c), homeostatic model assessment (HOMA) and blood pressure
|
baseline
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- SPAaRCLUprotocol1.2
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。
COPDの臨床試験
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Ryme Medical, Inc.まだ募集していませんCOPD | 肺疾患、慢性閉塞性疾患 | COPD患者 | COPDの急性増悪 | COPD(慢性閉塞性肺疾患) | 肺疾患気道 | COPDの増悪
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Insel Gruppe AG, University Hospital BernUniversity Hospital, Geneva; Cantonal Hospital St. Gallen, Switzerlandまだ募集していません
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Istituto Nazionale di Ricovero e Cura per Anziani募集
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Bio-Sensing Solutions S.L. (DyCare)Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau; Centre de Validació...募集
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The First Affiliated Hospital of Guangzhou Medical...募集
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Association des Réseaux BronchioliteLaboratoire Système et Matériaux pour la Mécatronique (SYMME)募集
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Polytechnic Institute of PortoNippon Gases Portugal募集