Air as a Placebo: Increasing the Respiratory Performance of People With COPD Through Simple Expectations of Improvement
2022年1月30日 更新者:Paolo Banfi、Fondazione Don Carlo Gnocchi Onlus
Air as a Placebo: Increasing the Respiratory Performance of People With COPD Through Simple Expectations of Improvement. An Experimental, Randomised, Two-arm, Counterbalanced Study With Three Data Collection Sessions.
COPD (Chronic Obstructive Pulmonary Disease) is a disease of the respiratory system characterised by irreversible airway obstruction of varying severity.
The disease (known as COPD, Chronic Obstructive Pulmonary Disease) is progressive and is associated with a state of chronic inflammation of the lung tissue, which leads to a real remodelling of the bronchi causing a significant reduction in airway flow.
Among the possible treatments, while the placebo is considered as an inert treatment, lacking any intrinsic therapeutic properties, there is evidence in the literature that not all placebos are equivalent and some are more effective than others, as for example in the case of migraine or osteoarthritis.
The differences found between different types of placebos (e.g.
oral, subcutaneous, intra-articular...) indicate that placebos are not inert but rather consist of multiple psychosocial elements that are part of the ritual of the therapeutic act.
This is also the context for the studies by Lacasse et al. (for the International Nocturnal Oxygen (INOX) Research Group et al., 2017) and Jarosh et al., who investigated the effects of oxygen therapy both during sleep and during the course of daily life, studying its influences through the use of placebo in patients suffering from hypoxemia.
However, in the literature, there are no studies investigating the role of oxygen (O2) during the performance of a test such as the Walking Test, otherwise known as the 6 Minute Walking Test (6MWT) compared with a placebo in patients with Chronic Obstructive Pulmonary Disease (COPD), nor whether the use of the latter would lead to comparable results.
調査の概要
研究の種類
介入
入学 (予想される)
102
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。
研究連絡先
- 名前:Paolo Banfi, MD
- 電話番号:00390239703341
- メール:pabanfi@dongnocchi.it
研究連絡先のバックアップ
- 名前:Eleonora Volpato, PhD
- メール:evolpato@dongnocchi.it
研究場所
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Milan、イタリア、20148
- 募集
- IRCCS Santa Maria Nascente, Fondazione Don Carlo Gnocchi
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コンタクト:
- Paolo Banfi, MD
- 電話番号:0039 0240308812
- メール:pabanfi@dongnocchi.it
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コンタクト:
- Eleonora Volpato, PhD
- 電話番号:0039 0240308812
- メール:evolpato@dongnocchi.it
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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
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
Inclusion Criteria:
- Subjects who voluntarily agree to participate in the study;
- Subjects with moderate-grade Chronic Obstructive Pulmonary Disease (COPD) (GOLD 2-50% ≤ FEV1 <80% of predicted) according to GOLD criteria;
- Subjects undergoing treatment with oxygen therapy and non-smokers;
- Ex-smokers
- Outpatients and inpatients
Exclusion Criteria:
- Refusal of Informed Consent
- Severe cognitive impairment, detected by administration of the Mini Mental Status Examination Test (MMSE)
- Pregnancy
- Patients with oncological or psychiatric pathologies
- Main immunodepression
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
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:クロスオーバー割り当て
- マスキング:ダブル
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:Group 1, consisting of participants with COPD and usually using O2
In this group, in addition to the standard care, the participant undergoes the 6 Minute Walking Test (6MWT) using compressed medical air (RA) cylinders, believing that there is oxygen (O2) inside the cylinder.
The same, then, in addition to the standard care, is subjected to the execution of the 6 Minute Walking Test (6MWT), thanks to the use of cylinders of Oxygen (O2), believing that inside the cylinder there is Oxygen (O2).
The sequence of this group will then be characterised as follows: ABC (A=Baseline, B=Air, C=Oxygen).
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During the 6 Minute Walking Test (6MWT), the participant will be required to walk as fast as possible on a flat, straight surface on the ward (e.g.
corridor) in six minutes, including as many breaks as he/she deems necessary.
The performance of this test will be monitored continuously by a Respiratory Physiotherapist and will include the presence of a Physician, who will be ready to assist as needed.
The sequence of use of compressed medical air and oxygen used during the 6MWT in the first group will then be characterised as follows: ABC (A=Baseline, B=Air, C=Oxygen).
The sequence of the second group will be characterised as follows: ACB (A=Baseline, B=Air, C=Oxygen).
他の名前:
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プラセボコンパレーター:Group 2, consisting of participants with COPD and usually not using O2
In this group, in addition to standard care, the participant is given the 6 Minute Walking Test (6MWT) using oxygen (O2) cylinders, believing that there is oxygen (O2) inside the cylinder.
Next, the participant undergoes the 6 Minute Walking Test (6MWT), using compressed medical air (RA) cylinders, believing that there is oxygen (O2) inside the cylinder.
The sequence of this group will be characterised as follows: ACB (A=Baseline, B=Air, C=Oxygen).
|
During the 6 Minute Walking Test (6MWT), the participant will be required to walk as fast as possible on a flat, straight surface on the ward (e.g.
corridor) in six minutes, including as many breaks as he/she deems necessary.
The performance of this test will be monitored continuously by a Respiratory Physiotherapist and will include the presence of a Physician, who will be ready to assist as needed.
The sequence of use of compressed medical air and oxygen used during the 6MWT in the first group will then be characterised as follows: ABC (A=Baseline, B=Air, C=Oxygen).
The sequence of the second group will be characterised as follows: ACB (A=Baseline, B=Air, C=Oxygen).
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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 |
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Metres covered during 6 Minute Walking Test (6MWT)
時間枠:Changes from baseline at the metres covered after the completion of the 6MWT performed using oxygen or compressed medical air. Up to 1 hour and half
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Distance in metres during the 6 Minute Walking Test (6MWT)
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Changes from baseline at the metres covered after the completion of the 6MWT performed using oxygen or compressed medical air. Up to 1 hour and half
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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 |
---|---|---|
Feeling of fatigue, as measured by the Fatigue Severity Scale (FSS)
時間枠:Changes from baseline at the FSS after the completion of the 6MWT performed using oxygen or compressed medical air. Up to 1 hour and half
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Feeling of fatigue, as measured by the Fatigue Severity Scale (FSS).
The items are scored on a 7 point scale with 1=strongly disagree and 7=strongly agree.
The minimum score=9 and maximum score possible=63.
Higher the score=greater fatigue severity.
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Changes from baseline at the FSS after the completion of the 6MWT performed using oxygen or compressed medical air. Up to 1 hour and half
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VAS Dyspnoea, measured by the British Medical Research Council's Modified Questionnaire (mMRC)
時間枠:Change from baseline at the dyspnoea after the completion of the 6MWT performed using oxygen or compressed medical air. Up to 1 hour and half
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VAS Dyspnoea, measured by the British Medical Research Council's Modified Questionnaire (mMRC).
The mMRC breathlessness scale ranges from grade 0 to 4.
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Change from baseline at the dyspnoea after the completion of the 6MWT performed using oxygen or compressed medical air. Up to 1 hour and half
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Saturation (SpO2)
時間枠:Change from baseline at 3':30'' and at 6':00'' of the 6 Minute Walking Test (6MWT)
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Saturation (SpO2)
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Change from baseline at 3':30'' and at 6':00'' of the 6 Minute Walking Test (6MWT)
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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。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Bestall JC, Paul EA, Garrod R, Garnham R, Jones PW, Wedzicha JA. Usefulness of the Medical Research Council (MRC) dyspnoea scale as a measure of disability in patients with chronic obstructive pulmonary disease. Thorax. 1999 Jul;54(7):581-6. doi: 10.1136/thx.54.7.581.
- Bannuru RR, McAlindon TE, Sullivan MC, Wong JB, Kent DM, Schmid CH. Effectiveness and Implications of Alternative Placebo Treatments: A Systematic Review and Network Meta-analysis of Osteoarthritis Trials. Ann Intern Med. 2015 Sep 1;163(5):365-72. doi: 10.7326/M15-0623.
- Barnes PJ. Chronic obstructive pulmonary disease: a growing but neglected global epidemic. PLoS Med. 2007 May;4(5):e112. doi: 10.1371/journal.pmed.0040112.
- Benedetti F. Placebo and the new physiology of the doctor-patient relationship. Physiol Rev. 2013 Jul;93(3):1207-46. doi: 10.1152/physrev.00043.2012.
- Benedetti F. Placebo effects: from the neurobiological paradigm to translational implications. Neuron. 2014 Nov 5;84(3):623-37. doi: 10.1016/j.neuron.2014.10.023. Epub 2014 Nov 5.
- Benedetti F, Dogue S. Different Placebos, Different Mechanisms, Different Outcomes: Lessons for Clinical Trials. PLoS One. 2015 Nov 4;10(11):e0140967. doi: 10.1371/journal.pone.0140967. eCollection 2015.
- Benedetti F, Durando J, Giudetti L, Pampallona A, Vighetti S. High-altitude headache: the effects of real vs sham oxygen administration. Pain. 2015 Nov;156(11):2326-2336. doi: 10.1097/j.pain.0000000000000288.
- Benedetti F, Durando J, Vighetti S. Nocebo and placebo modulation of hypobaric hypoxia headache involves the cyclooxygenase-prostaglandins pathway. Pain. 2014 May;155(5):921-928. doi: 10.1016/j.pain.2014.01.016. Epub 2014 Jan 21.
- Berry MJ, Rejeski WJ, Adair NE, Zaccaro D. Exercise rehabilitation and chronic obstructive pulmonary disease stage. Am J Respir Crit Care Med. 1999 Oct;160(4):1248-53. doi: 10.1164/ajrccm.160.4.9901014.
- Blinderman CD, Homel P, Billings JA, Tennstedt S, Portenoy RK. Symptom distress and quality of life in patients with advanced chronic obstructive pulmonary disease. J Pain Symptom Manage. 2009 Jul;38(1):115-23. doi: 10.1016/j.jpainsymman.2008.07.006. Epub 2009 Feb 20.
- de Craen AJ, Tijssen JG, de Gans J, Kleijnen J. Placebo effect in the acute treatment of migraine: subcutaneous placebos are better than oral placebos. J Neurol. 2000 Mar;247(3):183-8. doi: 10.1007/s004150050560.
- Dowson CA, Kuijer RG, Mulder RT. Anxiety and self-management behaviour in chronic obstructive pulmonary disease: what has been learned? Chron Respir Dis. 2004;1(4):213-20. doi: 10.1191/1479972304cd032rs.
- Lacasse Y, Bernard S, Series F, Nguyen VH, Bourbeau J, Aaron S, Maltais F; International Nocturnal Oxygen (INOX) Research Group. Multi-center, randomized, placebo-controlled trial of nocturnal oxygen therapy in chronic obstructive pulmonary disease: a study protocol for the INOX trial. BMC Pulm Med. 2017 Jan 9;17(1):8. doi: 10.1186/s12890-016-0343-9.
- Jarosch I, Gloeckl R, Damm E, Schwedhelm AL, Buhrow D, Jerrentrup A, Spruit MA, Kenn K. Short-term Effects of Supplemental Oxygen on 6-Min Walk Test Outcomes in Patients With COPD: A Randomized, Placebo-Controlled, Single-blind, Crossover Trial. Chest. 2017 Apr;151(4):795-803. doi: 10.1016/j.chest.2016.11.044. Epub 2016 Dec 8.
- Kong J, Spaeth R, Cook A, Kirsch I, Claggett B, Vangel M, Gollub RL, Smoller JW, Kaptchuk TJ. Are all placebo effects equal? Placebo pills, sham acupuncture, cue conditioning and their association. PLoS One. 2013 Jul 31;8(7):e67485. doi: 10.1371/journal.pone.0067485. Print 2013.
- Wong CJ, Goodridge D, Marciniuk DD, Rennie D. Fatigue in patients with COPD participating in a pulmonary rehabilitation program. Int J Chron Obstruct Pulmon Dis. 2010 Oct 5;5:319-26. doi: 10.2147/COPD.S12321.
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 (実際)
2020年2月19日
一次修了 (予想される)
2022年3月30日
研究の完了 (予想される)
2022年12月31日
試験登録日
最初に提出
2021年12月28日
QC基準を満たした最初の提出物
2022年1月30日
最初の投稿 (実際)
2022年2月1日
学習記録の更新
投稿された最後の更新 (実際)
2022年2月1日
QC基準を満たした最後の更新が送信されました
2022年1月30日
最終確認日
2022年1月1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。
Compressed Medical Airの臨床試験
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Ann & Robert H Lurie Children's Hospital of Chicago完了
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University of Wisconsin, Madison完了
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Ann & Robert H Lurie Children's Hospital of Chicago完了
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Protalixわからない