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High-Flow Nasal Cannula on Exercise Tolerance in Heart Failure Patients Undergoing Cardiac Rehabilitation

2026年5月30日 更新者:Manuel Gálvez Reyes、Universidad de Santiago de Chile

Effect of High-Flow Nasal Cannula Use on Exercise Tolerance and Physical Performance in Heart Failure Patients Enrolled in a Cardiac Rehabilitation Program: A Randomized Crossover Trial

The goal of this clinical trial is to learn if a high-flow nasal cannula (HFNC) - a device that delivers warm, humidified air through a small tube placed in the nostrils - can improve exercise tolerance in adults with heart failure (HF) who are entering a cardiac rehabilitation program. The main questions it aims to answer are: Can HFNC help people with heart failure exercise for a longer time during a treadmill test? and does HFNC lower how hard people feel they are working during exercise?

Researchers will compare exercise performance with HFNC to exercise performance without HFNC to see if HFNC helps people with HF tolerate exercise better. Participants will:

Complete two treadmill exercise tests, one with HFNC and one without, in a randomly assigned order.

Wait 48 to 72 hours between the two tests to allow full recovery. Have their heart rate, blood pressure, oxygen level, and breathing rate measured before and after each test.

調査の概要

詳細な説明

Heart failure is a chronic syndrome characterized by reduced cardiac output, exercise intolerance, and dyspnea. Despite the well-established benefits of cardiac rehabilitation, many HF patients have severely limited exercise capacity, which restricts the intensity and duration of training they can safely perform.

High-flow nasal cannula (HFNC) delivers heated, humidified air at flow rates of 50-60 L/min. Its physiological effects include reduction of inspiratory work, washout of nasopharyngeal dead space, generation of positive end-expiratory pressure, and improved mucociliary transport. These mechanisms may facilitate exercise in patients with cardiorespiratory limitations.

STUDY DESIGN. Randomized crossover trial. Each participant acts as their own control, completing two incremental treadmill tests in random order, separated by a washout period of 48-72 hours: Condition A (experimental): HFNC via AIRVO 2™ device (Fisher & Paykel Healthcare) with asymmetric nasal cannula at 50-60 L/min, FiO₂ 0.21, temperature 34-37°C. Condition B (control): no ventilatory support device. Randomization will be performed using randomizer.org. Before the experimental condition, participants will undergo an acclimatization period in which flow is increased by 10 L/min every 5-10 minutes until reaching the target flow or maximum tolerated flow.

EXERCISE PROTOCOL. An incremental protocol will be used on the treadmill, which will consist of incline and a progressive increase in speed and grade. The test ends at voluntary exhaustion or when predefined safety stopping criteria are met.

SAFETY. The test will be stopped if any of the following occur: chest pain, severe dyspnea (Borg ≥8), nausea or presyncope, cyanosis, SpO₂ below 90%, or heart rate above 85% of age-predicted maximum. The testing site will be equipped with automated external defibrillator, bag-valve mask, emergency oxygen, and at least one team member certified in advanced life support. Direct transfer to the hospital emergency service is available on-site (Complejo Hospitalario San José).

OUTCOMES. Primary outcomes are maximum treadmill test duration (seconds) and perceived exertion (Modified Borg Scale, 0-10), measured immediately after each test. Secondary outcomes - blood pressure, heart rate, SpO₂, respiratory rate, and rate-pressure product - are measured at baseline and immediately post-test.

STATISTICAL ANALYSIS. Data normality will be assessed using the Shapiro-Wilk test (n<50). Paired t-test or Wilcoxon signed-rank test will be applied depending on data distribution. Sample size was calculated for a crossover design (two-tailed, α=0.05, power=80%, dz=0.8), yielding 23 participants; 28 will be recruited assuming 20% dropout.

CO-INVESTIGATORS: Monserrat Delgado Valverde, Monserrat Orellana Morales, Emily Quiñileo Riffo, and Sergio Silva Valverde (Escuala de Kinesiología, Universidad de Santiago de Chile). Claudia Román Ureta, Paulina Castro Olivares (Complejo Hospitalario San José).

SETTING. Cardiovascular rehabilitation program, Complejo Hospitalario San José, Independencia, Santiago, Chile.

研究の種類

介入

入学 (推定)

28

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

研究場所

    • Santiago Metropolitan
      • Santiago、Santiago Metropolitan、チリ、8380418
        • Complejo Hospitalario San José
        • コンタクト:

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

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  • Age 18 years or older
  • Medical diagnosis of heart failure (documented in clinical record or referral)
  • Electrocardiogram performed within the last 6 months
  • Functional capacity class II or III according to the New York Heart Association (NYHA) classification
  • Stable pharmacological treatment
  • Stable and controlled comorbidities
  • Available to complete two evaluation sessions
  • Able and willing to provide written informed consent

Exclusion Criteria:

  • Diagnosis of respiratory disease (chronic obstructive pulmonary disease, interstitial lung disease, or pulmonary hypertension)
  • Myocardial infarction within the past 3 months
  • Hospitalization due to heart failure within the past 4 weeks
  • Cognitive impairment or inability to follow the study protocol
  • Neuromuscular or osteoarticular conditions that limit treadmill test performance

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:基礎科学
  • 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: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:HFNC (Experimental)
Participants will perform an incremental treadmill test while using high-flow nasal cannula (HFNC) via AIRVO 2™ device with a nasal cannula at 50-60 L/min, FiO₂ 0.21, and temperature set at 34-37°C according to participant comfort. An acclimatization period will be performed before the test, increasing flow by 10 L/min every 5-10 minutes until reaching the target flow.
HFNC delivered via AIRVO 2™ (Fisher & Paykel Healthcare, Auckland, New Zealand) with a nasal cannula at 50-60 L/min, FiO₂ 0.21, temperature 34-37°C. The cannula is removed immediately after the test is completed.
介入なし:No HFNC (Control)
Participants will perform an incremental treadmill test without any ventilatory support device.

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
Maximum treadmill test duration
時間枠:Immediately after each test session (up to 24 minutes)
Maximum time achieved by the participant during the incremental treadmill test, measured in seconds
Immediately after each test session (up to 24 minutes)
Perceived exertion
時間枠:Immediately after each test session
Participant's subjective perception of effort measured using the Modified Borg Scale (0-10), where 0 is nothing at all and 10 is extremely heavy
Immediately after each test session

二次結果の測定

結果測定
メジャーの説明
時間枠
Heart rate
時間枠:Baseline and immediately after each test session
Heart rate measured in beats per minute using pulse oximetry
Baseline and immediately after each test session
Blood pressure
時間枠:Baseline and immediately after each test session
Systolic and diastolic blood pressure measured in mmHg using a sphygmomanometer
Baseline and immediately after each test session
Oxygen saturation
時間枠:Baseline and immediately after each test session
Peripheral oxygen saturation (SpO₂) measured as a percentage using pulse oximetry
Baseline and immediately after each test session
Respiratory rate
時間枠:Baseline and immediately after each test session
Respiratory rate measured in breaths per minute using a vital signs monitor
Baseline and immediately after each test session
Rate-pressure product
時間枠:Baseline and immediately after each test session
Calculated as systolic blood pressure multiplied by heart rate (mmHg × beats/min), used as an indirect indicator of myocardial oxygen demand
Baseline and immediately after each test session

協力者と研究者

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出版物と役立つリンク

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一般刊行物

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 (推定)

2026年6月1日

一次修了 (推定)

2026年10月1日

研究の完了 (推定)

2027年3月1日

試験登録日

最初に提出

2026年5月21日

QC基準を満たした最初の提出物

2026年5月21日

最初の投稿 (実際)

2026年5月29日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月2日

QC基準を満たした最後の更新が送信されました

2026年5月30日

最終確認日

2026年5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

IPD プランの説明

Individual participant data will not be shared during the study period. Data will be stored on a password-protected server at Universidad de Santiago de Chile for 5 years after study completion. Only anonymized data, with no information that could identify participants, may be deposited in a public repository after the custody period ends. Any future use of the data will require a specific and separate consent process.

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

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。

心不全の臨床試験

High-Flow Nasal Cannula (HFNC)の臨床試験

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