Sustainability of Pulmonary Rehab Gains
Sustainability of Rehabilitation Gains in COPD
調査の概要
詳細な説明
Rationale: Development of dynamic hyperinflation is a primary limiting factor of exercise tolerance in chronic obstructive pulmonary disease (COPD). To lessen the development of dynamic hyperinflation, and to improve exercise tolerance in COPD patients, the investigators have developed a breathing-retraining technique to be used during pulmonary rehabilitation. This breathing-retraining technique is designed to decrease respiratory rate and prolong exhalation. The investigators demonstrated that, in the short-term, hyperinflation and exercise duration improved more with breathing-retraining plus exercise-training than with exercise-training alone. Because a crucial aspect of pulmonary rehabilitation is the maintenance its short-term benefits over the long-term, the investigators now propose to test whether short-term benefits of breathing-retraining plus exercise followed by an adherence-intervention program are sustainable over the long-term Primary Hypothesis: (H1) In COPD patients, improvements in exercise duration on a constant- load treadmill test will be greater after 12 weeks of breathing-retraining plus exercise-training followed by a 42-week adherence-intervention program (1 yr. total) than after 12 weeks of exercise-training alone followed by a 42-week adherence-intervention program (1 yr. total). Secondary Hypotheses: One year after randomization, exercise-induced dynamic hyperinflation will be less during a constant-load treadmill test (H2), 6-minute walking distance will be longer (H3), and mastery over breathing will be greater (H4) in the breathing-retraining plus exercise-training group than in the exercise-alone group. Lastly (exploratory objective), the investigators will assess the effect of the patient's physiologic, psychologic and clinical phenotype on short- term and long-term responsiveness to pulmonary rehabilitation.
Methods: The proposed study is a randomized, controlled clinical trial in which 250 patients with moderate-to-severe COPD will be enrolled. One hundred forty of these patients are expected to qualify for randomization into the breathing-retraining plus exercise-training group or the exercise-training alone group. Patients will receive 12-weeks of supervised training according to group assignment (three times weekly) followed by an adherence-intervention program (weekly phone motivational interviews, home-exercise program, and monthly laboratory booster sessions). Follow-up testing will be completed at 12 weeks, and at 6 and 12 months. Testing will include pulmonary function test, incremental-load and constant-load treadmill tests, 6-minute walk test, measurements of dyspnea, assessment of respiratory and quadriceps muscle strength and endurance and quadriceps ultrasonography. Analysis: In the principal analysis of the primary outcome measure (exercise duration; H1) the investigators will compare changes in exercise duration (constant work-rate treadmill test) from baseline to end of study using 2-sample t-test (two-tailed =.05). The primary analysis will be based on intention-to-treat principles. Multiple imputation will be used for study subjects missing the 12-month measurement. This imputation model will be based on baseline characteristics of study participants. Several secondary analyses of the primary outcome measure will be performed (H2-H4). Linear regression will be used to determine whether the observed treatment benefits persist after adjustment for baseline covariates and measures of adherence to treatment. Since several measurements will be taken on each patient, mixed-models analysis will be used to compare the changes on the constant-load treadmill test over time between the two groups.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Illinois
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Hines、Illinois、アメリカ、60141-5000
- Edward Hines Jr. VA Hospital, Hines, IL
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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
説明
Inclusion Criteria:
- >/= 40 yrs
- FEV1 </= 70% predicted
- FEV1/FVC <70% predicted
- RV/TLC >/=120%
- SpO2 >/= 90% at peak exercise (with or without exercise)
- inspiratory capacity decline >.15L from rest to peak exercise
Exclusion Criteria:
- respiratory infection/exacerbation within the previous 4 weeks
- exercise limiting heart disease
- primary asthma
- congestive heart failure
- exercise limiting peripheral arterial disease
- stops exercise due to arthritic pain in the knee or hips
- inability to walk on the treadmill
- pregnancy
- methadone use
- any unforeseen illness or disability that would preclude exercise testing or training
- participation in a formal exercise program within the previous 12 weeks
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
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:階乗代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
アクティブコンパレータ:exercise
Patients will exercise for 12 weeks and then participate in an adherence program
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Patients will participate in a 12-week exercise program .
They will also participate in an adherence program.
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実験的:exercise plus breathing retraining
Patients will exercise plus breathing retraining for 12 weeks and then participate in an adherence program
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Patients will participate in a 12-week exercise program with breathing retraining.
They will also participate in an adherence program.
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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 |
---|---|---|
Duration of Exercise Time on a Constant Work-rate Treadmill Test
時間枠:52 week test
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Patients walk on a treadmill set at a constant workrate.
The difference in the time walked on the treadmill from baseline to study completion is the primary outcome measure.
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52 week test
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Inspiratory Capacity
時間枠:52 week test
|
Inspiratory capacity is measured at a set time during the constant workrate treadmill test.
The difference between the inspiratory capacity measured at baseline and 52 weeks is a secondary outcome.
Inspiratory capacity measured during exercise is a measure of dynamic hyperinflation.
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52 week test
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6 Minute Walk Distance
時間枠:52 weeks
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Six-minute walk distance will be measured at 52 weeks.
The difference in distance walked in meters between baseline and 52 weeks is the secondary outcome measure.
The 6 minute walk is conducted using the guidelines issued by the American Thoracic Society.
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52 weeks
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Mastery Over Breathing
時間枠:52 weeks
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Mastery over breathing is measured using the Chronic Respiratory Disease Questionnaire.
Specifically the subscale 'mastery" is the investigators' secondary outcome.
The difference in scores from baseline to 52 weeks is the investigators' outcome measure.
The Chronic Respiratory Disease Questionnaire is a valid and reliable questionnaire.
1=minimum score, 7=maximum with the higher score indicating greater mastery.
A higher score indicates better health.
A change of 0.5 indicates a small change, 1.0 indicates a moderate change and greater or equal to a change of 1.5 indicates a large change.
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52 weeks
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協力者と研究者
捜査官
- 主任研究者:Eileen G. Collins, PhD RN、Edward Hines Jr. VA Hospital, Hines, IL
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 (見積もり)
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
キーワード
その他の研究ID番号
- O1325-R
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?
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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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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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University Hospital, Brest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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Baylor Research Instituteまだ募集していません
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Polytechnic Institute of PortoNippon Gases Portugal募集
Exercise onlyの臨床試験
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University of Erlangen-Nürnberg Medical SchoolKlinikum Nürnberg完了
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Shanghai Jiao Tong University School of Medicine積極的、募集していない
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University of TorontoUniversity Health Network, Toronto; University of Western Ontario, Canada; Institute for Clinical... と他の協力者完了