The Acute Cardiorespiratory Response to Blood-flow Restricted Versus Traditional Exercise Training Regimens (CaRe BFR)
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: BFR-CYC 50% peak / 50% AOP (exhaustive), BFR-CYC 3x2min, BFR Resistance 80% LOP, BFR REsistance 48% vs. 80% LOP.
- Кому может быть актуально
- Состояния в реестре: COPD. Базовые параметры: 18 лет — 90 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
- Швейцария
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
The Acute Cardiorespiratory Response to Blood-flow Restricted Versus Traditional Exercise Training Regimens (CaRe BFR):4 Randomized Crossover Studies
Обзор
The investigators hypothesize that BFR exercise regimens result in a different acute cardiorespiratory response pattern compared to traditional exercise regimens. Furthermore, the investigators hypothesize that these patterns differ between healthy participants and participants with COPD. Regarding secondary objective, the investigators hypothesize that BFR results in lower blood pressure responses compared to traditional exercise training in both healthy and COPD participants.
Подробное описание
Detailed Description
This study investigates the acute physiological and perceptual responses to blood flow restriction (BFR) exercise compared with conventional endurance and resistance exercise in both patients with chronic obstructive pulmonary disease (COPD) and healthy individuals. The study consists of multiple experimental arms using randomized crossover designs to enable within-subject comparisons across exercise modalities and conditions.
Endurance Exercise - COPD Participants (Exhaustive Protocol)
Patients with COPD will complete three cycling exercise conditions in a randomized, crossover design:
Blood Flow Restriction Cycling (BFR-CYC)
Continuous Cycling (CONT-CYC)
Interval Cycling (INT-CYC)
All sessions will be performed on a cycle ergometer under standardized laboratory conditions, including a warm-up followed by the respective protocol. Exercise will be performed to symptom limitation (volitional exhaustion) unless predefined safety criteria are reached.
BFR-CYC: Continuous cycling at 50% peak work rate (PWR) with bilateral thigh cuffs inflated to 50% limb occlusion pressure (LOP). A maximum duration of 30 minutes is applied as a safety limit.
CONT-CYC: Continuous cycling at 65% PWR until symptom limitation.
INT-CYC: Interval cycling with repeated bouts at 80% PWR, interspersed with recovery periods at 50% PWR, until symptom limitation.
During all sessions, cardiorespiratory parameters (ventilation, oxygen uptake, carbon dioxide production), muscle oxygenation (NIRS), blood lactate, hemodynamic responses, and perceptual responses (dyspnea, perceived exertion) will be continuously measured.
Endurance Exercise - COPD and Healthy Participants (Fixed-Duration Protocol)
Both COPD patients and healthy participants will complete two endurance exercise conditions in a randomized, crossover design:
Blood Flow Restriction Cycling (BFR-CYC)
Non-BFR Control Cycling
All sessions will be conducted under standardized laboratory conditions on a cycle ergometer. Exercise will follow a fixed-duration protocol and will not be performed to volitional exhaustion, unless predefined safety criteria require early termination.
BFR-CYC: Three intervals of 2 minutes at 50% PWR, separated by 1-minute recovery periods, with bilateral thigh cuffs inflated to 50% LOP during exercise intervals.
Control: Time- and structure-matched protocol (3 × 2 minutes) without blood flow restriction at 65% PWR, with identical recovery periods.
During all sessions, cardiorespiratory, hemodynamic, and perceptual responses (dyspnea, perceived exertion) will be continuously measured.
Resistance Exercise - COPD and Healthy Participants (BFR vs Control, Fixed Protocol)
Both COPD patients and healthy participants will complete two resistance exercise conditions in a randomized, crossover design:
Blood Flow Restriction Resistance Exercise (BFR-RE)
Non-BFR Control Resistance Exercise
All sessions will be performed on a leg press device under standardized laboratory conditions. Exercise will follow a fixed set and repetition scheme and will not be performed to volitional exhaustion, unless predefined safety criteria require early termination.
BFR-RE: Unilateral right-leg press at 40% of one-repetition maximum (1RM) with cuffs inflated to 80% LOP. Protocol: 4 sets (30-15-15-15 repetitions).
Control: Bilateral leg press at 40% 1RM, 3 sets of 15 repetitions, without blood flow restriction.
During all sessions, cardiorespiratory, hemodynamic, and perceptual responses will be continuously measured.
Resistance Exercise - Healthy Participants (LOP Comparison Arm)
Healthy participants will complete two BFR resistance exercise conditions in a randomized, crossover design:
BFR at 40% LOP
BFR at 80% LOP
All sessions will be conducted on a leg press device under standardized laboratory conditions. Pneumatic cuffs will be applied to the proximal thigh of the right leg.
Participants will perform unilateral right-leg press exercise at 40% 1RM using a standardized protocol of 4 sets (30-15-15-15 repetitions) with fixed rest intervals. The protocol will be completed as prescribed (not to volitional exhaustion) unless predefined safety criteria require early termination.
Neuromuscular function will be assessed using maximal voluntary contraction (MVC) of the knee extensors measured before and immediately after exercise. Voluntary activation will be evaluated using the twitch interpolation technique with supramaximal electrical stimulation.
Вмешательства
- Другое BFR-CYC 50% peak / 50% AOP (exhaustive)
BFR-CYC: Continuous cycling at 50% peak work rate (PWR) with bilateral thigh cuffs inflated to 50% limb occlusion pressure (LOP). A maximum duration of 30 minutes is applied as a safety limit. - Другое BFR-CYC 3x2min
BFR-CYC: Three intervals of 2 minutes at 50% PWR, separated by 1-minute recovery periods, with bilateral thigh cuffs inflated to 50% LOP during exercise intervals. - Другое BFR Resistance 80% LOP
BFR-RE: Unilateral right-leg press at 40% of one-repetition maximum (1RM) with cuffs inflated to 80% LOP. Protocol: 4 sets (30-15-15-15 repetitions). - Другое BFR REsistance 48% vs. 80% LOP
* BFR at 40% LOP * BFR at 80% LOP All sessions will be conducted on a leg press device under standardized laboratory conditions. Pneumatic cuffs will be applied to the proximal thigh of the right leg. Participants will perform unilateral right-leg press exercise at 40% 1RM using a standardized protocol of 4 sets (30-15-15-15 repetitions) with fixed rest intervals. The protocol will be completed as prescribed (not to volitional exhaustion) unless predefined safety criteria require early terminat
Первичные конечные точки
- Endurance Exercise:(Fixed-Duration Protocol): [Срок оценки: Continuously during exercise and at end of exercise, with recovery measurements obtained within 4 minutes post-exercise]
- Resistance Exercise - Healthy Participants (LOP Comparison Arm): Within-subject difference change in Maximal Voluntary Contraction (MVC) [Срок оценки: Pre-exercise and immediately post-exercise (within minutes after completion of the exercise protocol)]
- Endurance Exercise - COPD Participants (Exhaustive Protocol): Within-subject difference in maximal minute ventilation (VE) between BFR and traditional exercise regimens [Срок оценки: Continuously during exercise, at end of exercise (peak value), and within 4 minutes post-exercise]
- Resistance Exercise:(Healthy and COPD): Ventilatory Response (Ventilation, VE) [Срок оценки: Continuously during exercise and at end of exercise, with recovery measurements obtained within 4 minutes post-exercise]
Вторичные конечные точки (11)
- Resistance Exercise - Healthy Participants (LOP Comparison Arm): Muscle Oxygenation (NIRS) [Срок оценки: Continuously during exercise and immediately post-exercise]
- Resistance Exercise - Healthy Participants (LOP Comparison Arm): Perceived Exertion / Dyspnea (Borg Scale) [Срок оценки: At baseline (pre-exercise), after each set, immediately post-exercise, and at 2 and 4 minutes post-exercise]
- Endurance Exercise - COPD Participants (Exhaustive Protocol): Cardiorespiratory Response (Vo2 , VCO2) [Срок оценки: Continuously during exercise and at end of exercise, with recovery measurements obtained within 4 minutes post-exercise]
- Endurance Exercise - COPD Participants (Exhaustive Protocol):NIRS [Срок оценки: Continuously during exercise and at end of exercise, with recovery measurements obtained within 4 minutes post-exercise]
- Endurance Exercise - COPD Participants (Exhaustive Protocol): Blood Lactate Concentration [Срок оценки: At baseline (pre-exercise) at peak and 3 min wpost-exercise]
- Endurance Exercise - COPD Participants (Exhaustive Protocol): Perceived Exertion and Dyspnea (Borg Scale) [Срок оценки: At baseline (pre-exercise), during exercise (at regular intervals), at end of exercise, and within 4 minutes post-exercise]
- Endurance Exercise - COPD Participants (Exhaustive Protocol): Exercise Tolerance (Time to Exhaustion) [Срок оценки: During exercise (recorded at end of exercise)]
- Endurance Exercise:(Fixed-Duration Protocol): Cardiorespiratory Response (Vo2 , VCO2) [Срок оценки: Continuously during exercise and at end of exercise, with recovery measurements obtained within 4 minutes post-exercise]
- Endurance Exercise:(Fixed-Duration Protocol): Borg Scale (Dyspnea/Perceived Exertion) [Срок оценки: At baseline (pre-exercise), during exercise (at regular intervals), at end of exercise, and within 4 minutes post-exercise]
- Resistance Exercise:(Healthy and COPD): Cardiorespiratory Response [Срок оценки: Continuously during exercise and at end of exercise, with recovery measurements obtained within 4 minutes post-exercise]
- Resistance Exercise:(Healthy and COPD): Dyspnea (Borg Scale/ Perceived Exertion ) [Срок оценки: At baseline (pre-exercise), during exercise (at regular intervals), at end of exercise, and within 4 minutes post-exercise]
Критерии участия
Inclusion and exclusion for the healthy participants are defined by the following criteria.
Критерии включения
- Age ≥ 18 years
- Clinically healthy
Критерии исключения
- Physical or intellectual impairment precluding informed consent or protocol adherence
- Non-German speaking (precluding informed consent)
- Pain during exercise of any origin
- Pregnancy
- History of thromboembolic event in the lower extremity
- Resting systolic blood pressure <100 mmHg
Inclusion and exclusion for the COPD participants are defined by the following criteria.
Критерии включения
- Age ≥ 18 years
- Diagnosed COPD according to GOLD-guidelines12
Критерии исключения
- Physical or intellectual impairment precluding informed consent or protocol adherence
- Non-German speaking (precluding informed consent)
- Acute or recent (within the last 6 weeks) exacerbation of COPD
- Pain during exercise of any origin
- Pregnancy
- History of thromboembolic event in the lower extremity
- Resting systolic blood pressure <100 mmHg
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Перекрёстный дизайн
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Швейцария · 1 центр
- University Hospital Zürich — Zurich
Публикации
- Kuhn M, Clarenbach CF, Klay A, Kohler M, Mayer LC, Luchinger M, Andrist B, Radtke T, Haile SR, Sievi NA, Kohlbrenner D. Exploring immediate cardiorespiratory responses: low-intensity blood flow restricted cycling vs. moderate-intensity traditional exercise in a randomized crossover trial. BMC Sports Sci Med Rehabil. 2024 Aug 15;16(1):172. doi: 10.1186/s13102-024-00951-0. PMID 39148127
Идентификаторы
NCT: NCT05163600 · 2021-02038