Systemic Effects of A Continuous Blood Flow Restricted Aerobic Exercise Session in COPD Patients: A Randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- oxidative stress markers
研究概览
简要总结
Patients with COPD that a pulmonologist classifies between Stage 1-2 in accordance with the GOLD criteria and age and gender-matched healthy individuals will be included in the study.
In both groups (n = COPD: 17, Healthy: 17), aerobic exercise (AE) in the target heart rate range of 50% intensity, performed by cycling accompanied by blood flow restriction, will be applied.
详细描述
Target heart rate will be calculated from the formula "(Maximal heart rate-resting heart rate) x% desired intensity ratio + resting heart rate".
The target occlusion amount in the lower extremity will be calculated by calculating 45% of the complete occlusion rates reported by Michael et al. The proximal border of the thigh cuffs will be tied in line with the gluteal lines on both sides.
Exercise tolerance and dyspnea condition; Measurement properties in COPD will be evaluated using a well-defined modified Borg scale (MBS). Individuals will use any bronchodilator that their doctor sees fit before trying.
The target aerobic exercise intensity will be reached in the last minute of the first five-minute warm-up period by maintaining a 4-6 feeling of dyspnea in the MBS, by increasing pedal resistance and speed. In case of extreme shortness of breath, exercise intensity will be reduced to resting heart rate.
In the event of oxygen desaturation (85%) during the intervention, the intervention will be terminated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
25 COPD patients were referred to the study from the pulmonology clinic of the hospital where the study was conducted by a medical secretary who was blinded to the intervention. In addition, 21 healthy individuals volunteered to participate in the study from the same hospital where the study was previously announced.
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •No drug change for at least 30 days for the COPD group
- •Not participating in a structured activity program for at least six months
- •Have the ability to cooperate
排除标准
- •Presence of any pathology that limits physical activity performance
- •Presence of severe or unstable heart disease
- •Presence of peripheral artery disease
- •Being in an exacerbation period of the disease
- •Presence of another active disease (rheumatic, oncological, traumatic etc.)
- •Any neurological or orthopedic disease that prevents exercise
研究组 & 干预措施
healthy group
25 healthy individuals between the ages of 40-70 will be contacted by phone and included in the initiative.
干预措施: aerobic exercise with blood flow restriction (Procedure)
patient group
25 individuals will be selected randomly from 103 patients with COPD from hospital records.
干预措施: aerobic exercise with blood flow restriction (Procedure)
结局指标
主要结局
oxidative stress markers
时间窗: up to 18 weeks
uric acid, lactate dehydrogenase
creatine kinase
时间窗: 30 minutes
rhabdomyolysis marker
C reactive protein, neutrophil
时间窗: 30 minutes
inflammatory marker
modified borg scale
时间窗: up to 18 weeks.
dyspnoea measurement, Minimum 1, maximum 7 points are obtained. 5 indicates the best respiratory condition, 10 the worst respiratory condition.
heart rate
时间窗: 30 minutes
determination of aerobic exercise dose
oxygen saturation
时间窗: 30 minutes
blood oxygen saturation
systolic and diastolic pressure
时间窗: up to 18 weeks
to mean arterial pressure calculation
次要结局
未报告次要终点
研究者
Ahmet Gunes
PhD Student
Medipol University