The Effect of Remote Ischemic Preconditioning (RIPC) on Physical Performance and Exertional Rhabdomyolysis
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- creatine phosphokinase (CPK)
研究概览
简要总结
In order to examine the effect of RIPC on skeleton muscle exertional damage and on aerobic and anaerobic physical performances, 30 healthy volunteers will undergo a series of different physical tests twice; once without intervention and a second time with RIPC intervention or placebo (false) intervention.
详细描述
30 healthy civilians volunteers will be recruited and divided randomly into 2 groups: RIPC group and control group.
The experiment protocol consist 2 series (with a month between them), both series include the described 3 days:
Day 1 - anthropometry measurements and VO2max test (BRUCE protocol). Day 2 - steps test (heled protocol). Day 3 - anaerobic test (wingate protocol), 1 hour rest and time to exhaustion test (heled protocol).
The first series will be performed without applying any intervention and is considered as baseline measurements for both groups. the second series will be performed as follows: a. RIPC group: applying RIPC exposure (placing a sphygmomanometer on the non-dominant hand and applying pressure of 200 mmHg for 5 min followed by 5 min without pressure X 4 repeats) at the beginning of every meeting. b. control group: with placebo (false) exposure (placing a sphygmomanometer on the non-dominant hand and applying pressure of 100 mmHg for 5 min followed by 5 min without pressure X 4 repeats) at the beginning of every meeting.
Blood ample, lactic acid and urine sample will be tested at the beginning and end of every meeting (testing for muscle, skeleton and kidney function markers).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •aged 18-30
- •healthy civilians volunteers
- •with no background illnesses
- •above average fitness
排除标准
- •known chronic medical illness
- •routine medication usage
- •history of rhabdomyolysis
- •the physician decision
研究组 & 干预措施
RIPC intervention group
The experiment protocol consist 2 series (with a month between them), both series include the described 3 days:
Day 1 - anthropometry measurements and VO2max test (BRUCE protocol). Day 2 - steps test (heled protocol). Day 3 - anaerobic test (wingate protocol), 1 hour rest and time to exhaustion test (heled protocol).
the second series will be performed after RIPC intervention exposure at the beginning of every meeting.
干预措施: RIPC intervention exposure (Procedure)
false exopsure group
The experiment protocol consist 2 series (with a month between them), both series include the described 3 days:
Day 1 - anthropometry measurements and VO2max test (BRUCE protocol). Day 2 - steps test (heled protocol). Day 3 - anaerobic test (wingate protocol), 1 hour rest and time to exhaustion test (heled protocol).
the second series will be performed after placebo intervention exposure at the beginning of every meeting.
干预措施: placebo intervention exposure (Procedure)
结局指标
主要结局
creatine phosphokinase (CPK)
时间窗: 6 experiment days for each participant
CPK is a marker for muscle damage assessed in blood test. blood sample will be taken before and after step test, anaerobic test and time to exhaustion test.
次要结局
- renal function (composite)(6 experiment days for each participant)
- lactic acid(6 experiment days for each participant)
- oxygen consumption (VO2)(6 experiment days for each participant)
- heart rate variability (HRV)(6 experiment days for each participant)
- blood count(6 experiment days for each participant)
- apolipoprotein A1 (APO-A1) levels(6 experiment days for each participant)
- heart rate(6 experiment days for each participant)
- inflammation (composite)(6 experiment days for each participant)