Rehabilitation of Idiopathic Pulmonary Fibrosis (IPF) Patients
Rehabilitation of IPF Patients: Effects of Exercise and Oxidant Stress
The incidence and prevalence of IPF increase exponentially with age, and IPF occurs more often in older males. Cigarette smoking and environmental dust exposures are known risk factors for developing IPF. For example, the recently deployed military population, as it ages, is at especially increased risk of IPF. No effective therapies exist, although lung transplantation is used to extend survival of selected patients.
Defining specific therapy to improve exercise tolerance and dyspnea in IPF patients is thus an urgent priority of veteran-oriented research programs.
調査の概要
詳細な説明
Chronic lung disease is common in the veteran population. While chronic obstructive pulmonary disease (COPD) is most prominent, fibrotic lung diseases, typified by idiopathic pulmonary fibrosis (IPF), are clearly increasing. We have developed extensive experience with a VA idiopathic pulmonary fibrosis (IPF) population in the context of a randomized, controlled clinical trial of vasodilator therapy.
Based on the current literature and our preliminary experience with exercise testing in IPF patients, we hypothesize that:
Formal pulmonary rehabilitation (i.e., an aerobic exercise program) will result in improved outcomes for IPF patients, demonstrable as an:
- Increase in exercise tolerance as quantified by 6-minute walk test (MWT) distance;
- Decrease in post-exercise dyspnea as quantified by the Borg dyspnea scale; and an
- Overall subjective improvement in quality of life as quantified by Saint George's Respiratory Questionnaire.
Metabolic and physiologic mechanisms of improved exercise tolerance and decreased dyspnea will include:
- More efficient oxygen metabolism demonstrated by maximum O2 uptake (VO2max);
- Decreased post-exercise oxidant stress demonstrated by post-exercise isoprostanes and plasma total antioxidant capacity (TAC); and,
- Maintenance of maximum inspiratory and expiratory pressures (PInmax and PExmax).
Our Specific Objectives are:
To investigate formal pulmonary rehabilitation and exercise tolerance in IPF patients
The following important endpoints will be assessed to test the working hypothesis that pulmonary rehabilitation improves exercise capacity and lessens dyspnea:
- 6-MWT distance;
- Dyspnea index; and,
- Quality of life (Saint George's Respiratory Questionnaire [SGRQ] and International Physical Activity Questionnaire [IPAQ]).
- To assess changes in oxygen uptake, markers of oxidant stress and pulmonary function resulting from pulmonary rehabilitation
To test the working hypothesis that improved outcomes are associated with more efficient O2 utilization, decreased markers of oxidant stress and maintained effort dependent pulmonary function, the following variables will be measured:
- Peak oxygen uptake (VO2peak) during constant load exercise;
- Markers of oxidant stress, including plasma and urine isoprostanes; and,
- Maximum inspiratory and expiratory pressures (PInmax and PExmax). Completion of these Specific Objectives will position our research group to conduct future studies of 1) mechanisms of exercise limitation and 2) antioxidant therapies, both in this defined population and those who are at risk of developing pulmonary fibrosis. The long term impact of this application is thus to develop effective pulmonary rehabilitation strategies for IPF patients, based on knowledge of underlying changes in oxygen metabolism and oxidant stress.
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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Florida
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Miami、Florida、アメリカ、33125
- VA Medical Center, Miami
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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:
- Clinical presentation consistent with IPF with onset between three months and 48 months prior to screening.
- Diagnosis made by high-resolution computed tomographic scan showing highly probable IPF.
- Absence of severe pulmonary hypertension (i.e., PAsys must be less than 55 mm Hg, based on echocardiography) and absence of decompensated right heart failure (NYHA class I or II acceptable).
- Age 40 through 80, inclusive.
- Abnormal pulmonary function tests (FVC 40-90% predicted or DLCO 30-90% predicted or impaired gas exchange with rest or exercise).
- Six-minute walk distance 150 m and 500 m.
- Worsening as demonstrated by any one of the following within the past year: > 10% decrease in percent predicted forced vital capacity or worsening dyspnea at rest or upon exertion, based on history.
- Ability to understand and sign a written informed consent form and comply with the requirements of the study.
- Absence of clinical features suggesting infection, neoplasm, sarcoidosis or collagen-vascular disease.
Exclusion Criteria:
- Echocardiographic evidence of severe pulmonary hypertension (PAsys>55 mm Hg, based on echocardiography or TR velocity 3.2 m/sec).
- Severe heart failure (NYHA class III or IV or LVEF < 45%).
- Six-minute walk distance < 150 m or > 500 m.
- FEV1/FVC ratio < 0.7 at screening (post-bronchodilator).
- Residual volume > 100% predicted.
- Any condition other than IPF likely to result in the death of the participant within the next two years.
- History of unstable or deteriorating cardiac or neurologic disease.
- Pregnancy or lactation. Patients who are: (a) pregnant or (b) breast feeding are excluded from the study.
- Current treatment with corticosteroids (either oral or inhaled), Cytoxan, azathioprine, colchicine, pirfenidone, anti-tumor necrosis factor therapy or endothelin receptor blockers. Prior treatment is permitted, but at least four weeks of treatment washout prior to inclusion in this study are required.
- Investigational therapy for any indication within 28 days prior to enrollment.
- Degenerative arthritis, cerebrovascular accident or other limitation to mobility preventing completion of the 6-minute walk test.
- Oxygen saturation on room air <80% at rest.
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：並列代入
- 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 |
|---|---|
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実験的：Arm 1
enroll in pulmonary rehabilitation program
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structured exercise program
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介入なし：Arm 2
no structured exercise
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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 |
|---|---|---|
|
6 Minute Walk Distance
時間枠：The 6-MWD will be measured at 0 and 3 months.
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Change in 6 Minute Walk Distance from Baseline to 3 Months
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The 6-MWD will be measured at 0 and 3 months.
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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 |
|---|---|---|
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Systemic Markers of Oxidant Stress
時間枠：Markers of oxidant stress will be measured in all subjects before randomization after exercise testing at 0 months.
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Plasma F2-isoprostanes measured in all subjects before and after exercise testing at baseline.
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Markers of oxidant stress will be measured in all subjects before randomization after exercise testing at 0 months.
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Maximum Oxygen Uptake
時間枠：Maximum O2 uptake will be measured at 0 and 3 months.
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Change in 6 peak O2 uptake from Baseline to 3 Months
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Maximum O2 uptake will be measured at 0 and 3 months.
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協力者と研究者
捜査官
- 主任研究者：Robert M Jackson, MD、VA Medical Center, Miami
出版物と役立つリンク
一般刊行物
- Jackson RM, Gomez-Marin OW, Ramos CF, Sol CM, Cohen MI, Gaunaurd IA, Cahalin LP, Cardenas DD. Exercise limitation in IPF patients: a randomized trial of pulmonary rehabilitation. Lung. 2014 Jun;192(3):367-76. doi: 10.1007/s00408-014-9566-9. Epub 2014 Apr 5.
- Gaunaurd IA, Gomez-Marin OW, Ramos CF, Sol CM, Cohen MI, Cahalin LP, Cardenas DD, Jackson RM. Physical activity and quality of life improvements of patients with idiopathic pulmonary fibrosis completing a pulmonary rehabilitation program. Respir Care. 2014 Dec;59(12):1872-9. doi: 10.4187/respcare.03180. Epub 2014 Sep 2.
研究記録日
主要日程の研究
研究開始
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 (見積もり)
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
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。
pulmonary rehabilitationの臨床試験
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