EFFECTIVENESS OF COMBINED CONCENTRIC AND ECCENTRIC AEROBIC EXERCISE ON A TREADMILL IN PATIENTS WITH COPD: A RANDOMIZED CLINICAL TRIAL.
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Teresa Fernandez Pardo, PT, Msc, PhD
- 電話番号：0034650193112
- メール：teresa.fernandez@universidadeuropea.es
研究場所
-
-
Madrid
-
Madrid、Madrid、スペイン
- Hospital Ramon y Cajal
-
コンタクト：
- Teresa Fernandez Pardo
- 電話番号：0034650193112
- メール：teresa.fernandez@universidadeuropea.es
-
コンタクト：
-
主任研究者：
- Teresa Fernandez Pardo
-
-
参加基準
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
説明
Inclusion Criteria: • Subjects >18 years old.
- Present with dyspnea grade 2-3 on the mMRC scale.
- Sufficient cognitive and functional level to understand, learn, and carry out the exercise program.
- No contraindications to physical training.
- Active participants.
Exclusion Criteria: • Recent cardiovascular events such as congestive heart failure, angioplasty or cardiac surgery within the last four weeks, valvular abnormalities requiring surgical correction, myopericarditis, or exercise-induced ventricular arrhythmias.
- Renal failure requiring dialysis.
- Patients with uncontrolled bronchospasm due to intrinsic asthma.
- Patients undergoing chemotherapy after surgery.
- Severe exercise intolerance due to untreated cardiac arrhythmias, ischemia during low-intensity exercise (unstable angina), severe pulmonary hypertension, or heart failure (NYHA class III or IV).
- Pulmonary embolism with anticoagulant therapy for less than 5 days.
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：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Eccentric concentric exercice
Aerobic exercise will be performed in interval mode, alternating between treadmill walking with a negative incline of up to -6% and treadmill walking with an positive incline.
For the intervention group, this will consist of a 2-minute interval at the estimated MET workload, followed by a 4-minute interval at half the intensity.
The total duration will be between 20 and 30 minutes.
|
For the experimental group: Aerobic exercise will be performed in interval mode, alternating between treadmill walking with a negative incline of up to -6% and treadmill walking with an positive incline. For the intervention group, this will consist of a 2-minute interval at the estimated MET workload, followed by a 4-minute interval at half the intensity. The total duration will be between 20 and 30 minutes. For the control group: The aerobic exercise will be performed in interval mode, on a treadmill with an incline and/or cycle ergometer, consisting of a 2-minute interval at the estimated workload in METs, followed by another 4-minute interval at half the intensity. It will last between 20 and 30 minutes. |
|
アクティブコンパレータ：Concentric exercice
The aerobic exercise will be performed in interval mode, on a treadmill with an incline and/or cycle ergometer, consisting of a 2-minute interval at the estimated workload in METs, followed by another 4-minute interval at half the intensity.
It will last between 20 and 30 minutes.
|
For the experimental group: Aerobic exercise will be performed in interval mode, alternating between treadmill walking with a negative incline of up to -6% and treadmill walking with an positive incline. For the intervention group, this will consist of a 2-minute interval at the estimated MET workload, followed by a 4-minute interval at half the intensity. The total duration will be between 20 and 30 minutes. For the control group: The aerobic exercise will be performed in interval mode, on a treadmill with an incline and/or cycle ergometer, consisting of a 2-minute interval at the estimated workload in METs, followed by another 4-minute interval at half the intensity. It will last between 20 and 30 minutes. |
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 |
|---|---|---|
|
Sit-to-stand test-5 (STS)
時間枠：Baseline and 1 month after
|
It is a safe and simple test that provides a reliable and objective measure of functional capacity in patients with lung disease, allowing for a rapid interpretation of the patient's progress.
It is therefore the primary variable of this study.
In this test, the patient is asked to stand up from and sit down from a chair at maximum speed five times, and the time is recorded.
The protocol described by Jones et al. will be followed, with a minimum reduction of 1.7 seconds considered significant improvement.
|
Baseline and 1 month after
|
|
PIM and PEM pressures
時間枠：Baseline and 1 month after
|
The pressure gauge we use is the RP Check.
To measure peak expiratory pressure (PEM), the patient places the mouthpiece in their mouth, with the bite blocks between their teeth; they inhale as much air as possible until their lungs are completely full (to total lung capacity) and then exhale with maximum effort and for as long as possible (at least 1.5 seconds).
To measure peak inspiratory pressure (PIP), the patient places the mouthpiece in their mouth, exhales as much air as possible to empty their lungs to residual volume, and then inhales with maximum effort and for as long as possible (at least 1.5 seconds).
We take three consecutive measurements of each pressure, allowing the patient to rest for one minute between each measurement, and record the best result.
|
Baseline and 1 month after
|
|
Handgrip
時間枠：Baseline and 1 month after
|
Hand Grip Dynamometer Jamar®, taking into account the dominant hand and possible upper limb injuries that may interfere with the test result
|
Baseline and 1 month after
|
|
Quadriceps strength
時間枠：Baseline and 1 month after
|
The measurement will be taken on the dominant leg using the MicroFET®2 Digital Handheld Dynamometer following the protocol described by Bohannon et al (
|
Baseline and 1 month after
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Dyspnea
時間枠：Baseline and 1 month after
|
It consists of a vertical scale from 0-10 that relates the perceived exertion of physical activity to a numerical value ranging from 0 (minimal effort) to 10 (extreme effort).
It does not require measuring instruments, as it is a subjective scale.
|
Baseline and 1 month after
|
協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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 (実際)
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
追加の関連 MeSH 用語
その他の研究ID番号
- 400-25
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?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。