High-Intensity Aerobic Lifelong Training--AF (HALT-AF)
2019年12月18日 更新者:University of Minnesota
High-Intensity Interval Training and Moderate-Intensity Continuous Training in Reducing Atrial Fibrillation Burden
This study is a single-center RCT.
Potential subjects with symptomatic non-permanent AF will be enrolled to determine the effect of sprint interval training (SIT) in comparison to moderate-intensity continuous training (MICT) and non-exercise control in reducing AF burden.
The Investigators will enroll 60 patients during the first 12 months of the study.
Baseline data collection will be conducted during the first month after enrollment.
After baseline data collection, subjects will be randomized (1:1:1) to SIT vs. MICT vs. non-exercise controls.
The exercise training will last for 3 months followed by final data collection which will be completed in 1 month.
調査の概要
状態
完了
条件
詳細な説明
Atrial fibrillation (AF) is the most common heart rhythm abnormality in the general population.
Current recommended methods to maintain sinus rhythm or reduce AF burden (% time a person is in AF) in patients with non-permanent AF are costly and ineffective.
Hence, there is an urgent need to discover novel inexpensive strategies to reduce AF burden.
It is well-established that regular aerobic exercise reduces cardiovascular morbidity and mortality; however, adherence to regular exercise is poor rendering it an ineffective public health strategy.
Evidence is emerging to suggest that traditional moderate-intensity continuous training (MICT) and high-intensity interval training (HIIT) may be associated with lower AF burden.
Compared with traditional MICT, HIIT is possibly more time-efficient; hence, it may promote adherence.
Since lack of time is the most common reason for poor adherence to regular exercise, the time-efficiency of HIIT holds promise to be a "game-changer".
However, many knowledge gaps remain.
First, HIIT has never been compared directly with MICT in relation to AF burden; thus, whether HIIT is comparable or superior to MICT is unknown.
Second, the time commitment required for a "conventional" HIIT program (120 mins/week) is not substantially less than the recommended MICT (150 mins/week); hence, it is doubtful that it can be a real "game-changer" in terms of promoting adherence.
Third, HIIT performed using a cycle ergometer is a safer alternative to the treadmill in older adults, but has not been evaluated in patients with AF.
Finally, mechanisms underlying the salutary benefits of exercise in relation to AF burden remain unknown.
To address these knowledge gaps, the investigators will evaluate an innovative HIIT program-sprint interval training (SIT)-using a cycle ergometer that only requires 10 minutes per session and 30 minutes per week, in contrast to the "conventional" HIIT program that requires 40 minutes per session and 120 minutes per week.
In this pilot randomized controlled trial (RCT), the investigators will randomize 60 subjects with non-permanent AF (1:1:1) to SIT vs. MICT vs. no exercise control.
At enrollment, these subjects will undergo heart rhythm monitoring by a non-invasive ambulatory heart rhythm monitor, V02 max testing, assessment of cardiac size and function by cardiac MRI, and assessment of AF symptom severity; these measures will be repeated at 3 months.
研究の種類
介入
入学 (実際)
60
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
-
-
Minnesota
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Minneapolis、Minnesota、アメリカ、55455
- University of Minnesota
-
-
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~65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:
- : Patients with symptomatic non-permanent AF and aged 18-65 years who are sedentary (activity ≤0.5 hours/week of regular exercise) and seen by Dr. Chen or his cardiology colleagues at Clinics and Surgery Center (CSC), other Fairview cardiology clinics, and University of Minnesota Medical Center (UMMC). Patients will be screened and enrolled by a research coordinator.
Exclusion Criteria:
- Individuals lacking the capacity to consent for themselves will not be included, previous open heart surgery, previous catheter ablation for AF, LVEF <45%, significant cardiac valve disease, coronary heart disease without complete revascularization, implanted cardiac electronic device, or GFR <30 mL/min/1.73 m2
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: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 |
|---|---|
|
アクティブコンパレータ:High intensity interval training
Exercise training will be conducted 3 times per week using cycle ergometers at commercial fitness facilities for 12 weeks 2 minute warmup/3 minute cooldown- at 50W Intensity- 3 X 20-second sprint interval cycling -as fast as possible at 90-95% peak power low intensity- 2 X 2 minute cycling at slow pace 50W
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exercise by use of stationary cycles
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アクティブコンパレータ:Moderate intensity continuous training
Exercise training will be conducted 3 times per week using cycle ergometers at commercial fitness facilities for 12 weeks 2 minute warmup/3 minute cooldown- at 50W Intensity- 45 minutes of continuous cycling at 45-60% peak power
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exercise by use of stationary cycles
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アクティブコンパレータ:No exercise
No excercise training will be done
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no exercise training will be given and no exercise will be added to subjects routine
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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 |
|---|---|---|
|
Change in AF burden
時間枠:3 months
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After 12 weeks of exercise training , HIIT and MICT will be comparable but better than non-exercise control in AFburden(% of time a person is in AF) by using an ambulatory patch monitor
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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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Change in left atrial and left ventricular size and function
時間枠:3 months
|
After 12 weeks of exercise training HIIT and MICT will be comparable but better than non-exercise control as Cardiac MRI will be completed to assess LV and LA volumes and function and LV fibrosis
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3 months
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change in clinical outcomes
時間枠:3 months
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The favorable effect of HIIT and MICT over non exercise control on clinical outcomes will be attenuated after after for secondary outcomes, suggesting that the latter mediate the clinical benefits of regular aerobic exercise
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3 months
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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。
スポンサー
捜査官
- 主任研究者:Lin Yee Chen, MD,MBBS,MS、University of Minnesota
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)
2018年5月1日
一次修了 (実際)
2019年12月18日
研究の完了 (実際)
2019年12月18日
試験登録日
最初に提出
2017年7月27日
QC基準を満たした最初の提出物
2017年8月1日
最初の投稿 (実際)
2017年8月7日
学習記録の更新
投稿された最後の更新 (実際)
2019年12月20日
QC基準を満たした最後の更新が送信されました
2019年12月18日
最終確認日
2019年12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。