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Набор скоро начнётся NCT07627035

EFFECTIVENESS OF COMBINED CONCENTRIC AND ECCENTRIC AEROBIC EXERCISE ON A TREADMILL IN PATIENTS WITH COPD: A RANDOMIZED CLINICAL TRIAL.

Без фазы С лечением COPD (Chronic Obstructive Pulmonary Disease) Pulmonary Rehabilitation Eccentric Exercise Training

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Eccentric and concentric aerobic exercice versus only concentric aerobic exercice.
Кому может быть актуально
Состояния в реестре: COPD (Chronic Obstructive Pulmonary Disease), Pulmonary Rehabilitation, Eccentric Exercise Training. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Испания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The aim of this study is to demonstrate the effectiveness of combined concentric and eccentric aerobic training in subjects with COPD, in terms of strength, lung capacity, functionality, and short-term health quality. A randomized, examiner-blinded clinical trial has been designed for this purpose, following the CONSORT guidelines for clinical trials and the ethical principles of the Declaration of Helsinki. A total sample of 40 subjects has been estimated. The study is aimed at patients diagnosed with mild or moderate COPD. A program of 12 group sessions will be conducted over 4 weeks. Each session will last 75 minutes and will include strength exercises and respiratory physiotherapy, common to all subjects. The interval aerobic training will depend on the assigned group: treadmill with negative and positive (or neutral) incline (experimental group), treadmill with positive incline and/or cycle ergometer (control group). The following variables will be measured on the first and last day of treatment, as well as one month after the intervention ends: thickness, cross-sectional area, and ultrasound intensity of the rectus femoris muscle; diaphragmatic excursion and thickness; 5 sit to stand test; get up and go test; Borg scale; maximum respiratory pressures; grip strength in both hands and maximum quadriceps strength; spirometric assessment of FEV1 and SF-12 health quality questionnaire.

Вмешательства

  • Другое Eccentric and concentric aerobic exercice versus only concentric aerobic exercice
    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 t

Первичные конечные точки

  • Sit-to-stand test-5 (STS) [Срок оценки: Baseline and 1 month after]
  • PIM and PEM pressures [Срок оценки: Baseline and 1 month after]
  • Handgrip [Срок оценки: Baseline and 1 month after]
  • Quadriceps strength [Срок оценки: Baseline and 1 month after]
Вторичные конечные точки (1)
  • Dyspnea [Срок оценки: Baseline and 1 month after]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Испания · 1 центр
  • Hospital Ramón y Cajal — Madrid

Публикации

  • Magunagoikoetxea-Comins G, Jimenez-Garcia ME, Perez-Ferreiro M, Fernandez-Pardo TE. Effects on Exercise Tolerance and Functional Outcomes of Eccentric versus Concentric Aerobic Exercise in People with COPD: A Systematic Review and Meta-Analysis. Int J Chron Obstruct Pulmon Dis. 2025 Dec 18;20:4061-4078. doi: 10.2147/COPD.S558167. eCollection 2025. PMID 41446810

Идентификаторы

NCT: NCT07627035 · 400-25

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗