The Effect of a Respiratory Muscle Warm-up Prior to Exercise in Patients With Chronic Obstructive Pulmonary Disease
2016年10月26日 更新者：Craig Williamson、University of Portsmouth
The Effect of a Respiratory Muscle Warm-up Prior to Exercise in Patients With Chronic Obstructive Pulmonary Disease (COPD)
The purpose of this study is to investigate the effects of performing a breathing muscle warm up before exercise in patients who have chronic obstructive pulmonary disease (COPD).
The main aim is to see whether performing a breathing muscle warm up can improve distance walked in a 6 minute walk test and also decrease perceptions of effort and breathlessness.
調査の概要
状態
終了しました
条件
詳細な説明
The study will follow a counter-balanced repeated measures design involving six visits to the exercise laboratory. Following pre-screening and familiarisation (visits 1 and 2), participants will perform inspiratory warm up, expiratory warm up, combination warm up and control trials (visits 3 - 6) in a counter-balanced order separated by at least 48 hours between trials.
The four separate sessions will contain: lung function measurements assessed by performing breathing manoeuvres through a mouthpiece (spirometery or body plethysmography) before performing a breathing muscle warm up by breathing against a resistance through a small handheld device (PowerLung). Participants will then be asked perform a second set of lung function measurements and will then be asked to perform a 6 minute walk test wearing a face mask and a portable device (gas analysis), a small device clipped to a finger (pulse oximeter) and wearing a heart rate monitor. During this 6 minute walk test participants will also be asked to rate their perceived effort and level of breathlessness at 60m intervals. Following the test there will be a period of seated rest wearing the face mask and portable device for up to 20 minutes with one more set of lung function measurements.
研究の種類
介入
入学 (実際)
5
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Hampshire
-
Portsmouth、Hampshire、イギリス、PO1 2ER
- University of Portsmouth - Department of Sport and Exercise Science
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
35年～90年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- A clinical diagnosis of COPD
- Aged between 35 and 90 years
- Able to fluently read and speak English
- Willing and able to sign informed consent
- Be able to comply with the procedures outlined for the study
Exclusion Criteria:
- Cardiac disease (including arrhythmias)
- A medicinal requirement for rate limiting calcium antagonists or beta blockers
- Cerebrovascular disease
- Peripheral vascular disease
- Requirement for supplemental oxygen therapy
- CO2 (carbon dioxide) retention
- Malignancy
- Orthopaedic or neurological conditions effecting the ability to exercise
- Clinically apparent heart failure
- Renal, hepatic or inflammatory disease
- Instability of COPD
- Any other reason leading to the inability to complete the requirements of the study.
Additionally: If participants have a resting HR above 120beats.min-1, systolic blood pressure above 180mm Hg or diastolic blood pressure above 100mm Hg prior to the 6 minute walk test they will not be able to commence the test.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 割り当て：ランダム化
- 介入モデル：階乗代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Inspiratory Warm Up
(IWU). Two sets of 15 breaths
|
Inspiratory muscle warm up.
Inhaling against a resistance for two sets of 15 breaths using a PowerLung.
|
|
実験的：Expiratory Warm Up
(EWU). Two sets of 15 breaths
|
Expiratory muscle warm up.
Exhaling against a resistance for two sets of 15 breaths using a PowerLung.
|
|
実験的：Combination Warm Up
(RWU).
One set of 15 breaths inspiratory and one set of 15 breaths expiratory
|
Combination of inspiratory and expiratory muscle warm up.
One set of 15 breaths inhaling followed by one set 15 breaths exhaling.
|
|
他の：Control Trial
No warm up
|
Control Trial.
No respiratory muscle warm up to act as a comparison to the other three intervention trials.
|
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 |
|---|---|---|
|
Distance walked in the 6 minute walk test
時間枠：Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
|
Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
|
|
|
Rating of perceived exertion (RPE) in the 6 minute walk test
時間枠：Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
|
Measured from 1 minute pre 6 minute walk test to cessation of the test and at 60 metre intervals throughout.
|
Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
|
|
Rating of dyspnoea during the six minute walk test
時間枠：Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
|
Measured from 1 minute pre 6 minute walk test to cessation of the test and at 60 metre intervals throughout.
|
Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Heart rate (HR)
時間枠：Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
|
Measured from 1 minute pre 6 minute walk test to cessation of the test and at 60 metre intervals throughout.
|
Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
|
|
Expired gas
時間枠：Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
|
Measured from a few minutes prior to the six minute walk test until 20 minutes post test (or until VO2 returns to baseline following test).
A brief gap in measurement will occur 5 minutes test to allow for a measure of pulmonary function.
|
Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
|
|
Peripheral arterial oxygen saturation (SpO2)
時間枠：Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
|
Measured from 1 minute pre 6 minute walk test to cessation of the test and at 60 metre intervals throughout.
|
Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
|
|
Pulmonary function: maximal inspiratory mouth pressure (MIP)
時間枠：Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
|
Measured pre respiratory warm up, post respiratory warm up and post 6 minute walk test (control trial will only be measured pre and post exercise test).
|
Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
|
|
Pulmonary function: maximal expiratory mouth pressure (MEP)
時間枠：Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
|
Measured pre respiratory warm up, post respiratory warm up and post 6 minute walk test (control trial will only be measured pre and post exercise test).
|
Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
|
|
Pulmonary function: specific airway resistance (sRaw)
時間枠：Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
|
Note: only if body plethysmography is available.
Measured pre respiratory warm up, post respiratory warm up and post 6 minute walk test (control trial will only be measured pre and post exercise test).
|
Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
|
|
Pulmonary function: airway resistance (Raw)
時間枠：Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
|
Note: only if body plethysmography is available.
Measured pre respiratory warm up, post respiratory warm up and post 6 minute walk test (control trial will only be measured pre and post exercise test).
|
Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
|
|
Pulmonary function: functional residual capacity (FRCpleth)
時間枠：Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
|
Note: only if body plethysmography is available.
Measured pre respiratory warm up, post respiratory warm up and post 6 minute walk test (control trial will only be measured pre and post exercise test).
|
Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
|
|
Pulmonary function: peak inspiratory flow (PIF)
時間枠：Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
|
Measured pre respiratory warm up, post respiratory warm up and post 6 minute walk test (control trial will only be measured pre and post exercise test).
|
Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
|
|
Pulmonary function: peak expiratory flow (PEF)
時間枠：Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
|
Measured pre respiratory warm up, post respiratory warm up and post 6 minute walk test (control trial will only be measured pre and post exercise test).
|
Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
|
|
Pulmonary function: forced expiratory flow at 25, 50 and 75% maximal vital capacity) (FEF 25, 50, 75)
時間枠：Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
|
Measured pre respiratory warm up, post respiratory warm up and post 6 minute walk test (control trial will only be measured pre and post exercise test).
|
Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
|
|
Pulmonary function: forced expiratory volume in one second (FEV1)
時間枠：Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
|
Measured pre respiratory warm up, post respiratory warm up and post 6 minute walk test (control trial will only be measured pre and post exercise test).
|
Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
|
|
Pulmonary function: forced vital capacity (FVC)
時間枠：Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
|
Measured pre respiratory warm up, post respiratory warm up and post 6 minute walk test (control trial will only be measured pre and post exercise test).
|
Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
|
|
Pulmonary function: residual volume (RV)
時間枠：Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
|
Note: only if body plethysmography is available.
Measured pre respiratory warm up, post respiratory warm up and post 6 minute walk test (control trial will only be measured pre and post exercise test).
|
Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
|
|
Pulmonary function: tidal volume (VT)
時間枠：Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
|
Measured pre respiratory warm up, post respiratory warm up and post 6 minute walk test (control trial will only be measured pre and post exercise test).
|
Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
|
|
Pulmonary function: total lung capacity (TLC)
時間枠：Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
|
Note: only if body plethysmography is available.
Measured pre respiratory warm up, post respiratory warm up and post 6 minute walk test (control trial will only be measured pre and post exercise test).
|
Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
|
|
Pulmonary function: inspiratory residual volume (IRV)
時間枠：Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
|
Note: only if body plethysmography is available.
Measured pre respiratory warm up, post respiratory warm up and post 6 minute walk test (control trial will only be measured pre and post exercise test).
|
Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
|
|
Pulmonary function: expiratory residual volume (ERV)
時間枠：Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
|
Note: only if body plethysmography is available.
Measured pre respiratory warm up, post respiratory warm up and post 6 minute walk test (control trial will only be measured pre and post exercise test).
|
Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
|
|
Pulmonary function: inspiratory capacity (IC)
時間枠：Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
|
Measured pre respiratory warm up, post respiratory warm up and post 6 minute walk test (control trial will only be measured pre and post exercise test).
|
Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
|
|
Pulmonary function: inspiratory vital capacity (IVC)
時間枠：Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
|
Measured pre respiratory warm up, post respiratory warm up and post 6 minute walk test (control trial will only be measured pre and post exercise test).
|
Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Craig Williamson, MSc、PhD Research Student
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2016年2月1日
一次修了 (実際)
2016年10月1日
研究の完了 (実際)
2016年10月1日
試験登録日
最初に提出
2015年8月13日
QC基準を満たした最初の提出物
2015年8月20日
最初の投稿 (見積もり)
2015年8月25日
学習記録の更新
投稿された最後の更新 (見積もり)
2016年10月27日
QC基準を満たした最後の更新が送信されました
2016年10月26日
最終確認日
2016年10月1日
詳しくは
本研究に関する用語
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?
いいえ
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。
Inspiratory Warm Upの臨床試験
-
Shannon E. Sauer-ZavalaNational Institute of Mental Health (NIMH)完了
-
Instituto de Investigación Sanitaria Aragónまだ募集していません
-
University of MichiganNational Institute on Drug Abuse (NIDA); Brown University; Pennington Biomedical Research Center; Oregon Research Institute と他の協力者募集
-
Mary LacyNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)完了
-
Universidad Nacional de Educación a DistanciaPuerta de Hierro University Hospital完了
-
Universidad Nacional de Educación a DistanciaPuerta de Hierro University Hospital完了
-
VA Puget Sound Health Care System完了