The Acute Cardiorespiratory Response to Blood-flow Restricted Versus Traditional Exercise Training Regimens (CaRe BFR):4 Randomized Crossover Studies
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Within-subject difference in maximal minute ventilation (VE) between BFR and traditional exercise regimens
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion and exclusion for the healthy participants are defined by the following criteria.
- •Inclusion criteria:
- •Age ≥ 18 years
- •Clinically healthy
排除标准
- •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.
- •Inclusion criteria:
- •Age ≥ 18 years
- •Diagnosed COPD according to GOLD-guidelines12
- •Exclusion criteria:
- •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
结局指标
主要结局
Within-subject difference in maximal minute ventilation (VE) between BFR and traditional exercise regimens
时间窗: basline (CPET) 20 min, V1 Training (endurance or strengthwith) with or without BFR 20 min; V2 Training (endurance or strengthwith) with or without BFR 20 min
investigators will examine VE during strength training and endurance training with and without BFR. Each training sessions will last approximately 20 minutes including baseline CPET. There will be no measurements between the trainings. There will be a minimum wait of 48 hours (wash out timne) until training 2 is performed.
Endurance Exercise:(Fixed-Duration Protocol):
时间窗: Continuously during exercise and at end of exercise, with recovery measurements obtained within 4 minutes post-exercise
Minute ventilation (VE) will be continuously assessed during cycling exercise across all conditions to evaluate ventilatory demand.
Resistance Exercise - Healthy Participants (LOP Comparison Arm): Within-subject difference change in Maximal Voluntary Contraction (MVC)
时间窗: Pre-exercise and immediately post-exercise (within minutes after completion of the exercise protocol)
Maximal voluntary contraction (MVC) of the knee extensors will be assessed before and immediately after unilateral leg press exercise performed with blood flow restriction at 40% and 80% limb occlusion pressure (LOP). MVC will be measured using an isometric setup, and voluntary activation will be evaluated using the twitch interpolation technique with supramaximal electrical stimulation. The primary outcome is the change in MVC from pre- to post-exercise, reflecting exercise-induced neuromuscular fatigue.
Endurance Exercise - COPD Participants (Exhaustive Protocol): Within-subject difference in maximal minute ventilation (VE) between BFR and traditional exercise regimens
时间窗: Continuously during exercise, at end of exercise (peak value), and within 4 minutes post-exercise
Minute ventilation (VE) will be continuously assessed during cycling exercise across all conditions to evaluate ventilatory demand and response.
Resistance Exercise:(Healthy and COPD): Ventilatory Response (Ventilation, VE)
时间窗: Continuously during exercise and at end of exercise, with recovery measurements obtained within 4 minutes post-exercise
Minute ventilation (VE) will be continuously assessed during cycling exercise across all conditions to evaluate ventilatory demand.
次要结局
- Resistance Exercise - Healthy Participants (LOP Comparison Arm): Muscle Oxygenation (NIRS)(Continuously during exercise and immediately post-exercise)
- Resistance Exercise - Healthy Participants (LOP Comparison Arm): Perceived Exertion / Dyspnea (Borg Scale)(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)(Continuously during exercise and at end of exercise, with recovery measurements obtained within 4 minutes post-exercise)
- Endurance Exercise - COPD Participants (Exhaustive Protocol):NIRS(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(At baseline (pre-exercise) at peak and 3 min wpost-exercise)
- Endurance Exercise - COPD Participants (Exhaustive Protocol): Perceived Exertion and Dyspnea (Borg Scale)(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)(During exercise (recorded at end of exercise))
- Endurance Exercise:(Fixed-Duration Protocol): Cardiorespiratory Response (Vo2 , VCO2)(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)(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(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 )(At baseline (pre-exercise), during exercise (at regular intervals), at end of exercise, and within 4 minutes post-exercise)
研究者
Christian Clarenbach
PD Dr. med Head of Pneumology
University of Zurich