NL-OMON36063已完成不适用
Heat acclimation in elderly - Heat acclimation in elderly
TNO0 个研究点目标入组 24 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99(—)
入选标准
- •1. Having no contra-indications to exercise testing as judged by the screening physician based on assessment of:
- •- medical history
- •- physical examination
- •- results of the 12-lead ECG examination
- •2. Females aged 20 to 30 years or aged over75 years at day 01 of the study
- •3. Normal weight and BMI (between 18 and 28)
- •4. Voluntary participation
- •5. Having given written informed consent
- •6. Willing to comply with the study procedures
- •7. Willing to accept use of all nameless data, including publication, and the confidential
- •use and storage of all data for at least 15 years
- •8. Willing to accept the disclosure of the financial benefit of participation in the study to the
- •authorities concerned.
排除标准
- •Exclusion criteria (adapted from ACSM 2000):
- •- Acute or chronic infection
- •- Unstable metabolic disorder
- •- Significant locomotor disturbance
- •- Neuromuscular, musculoskeletal, or rheumatic disorders that are exacerbated by exercise
- •- Uncontrolled systemic hypertension; systolic blood pressure at rest over 180 mmHg, diastolic over 100 mmHg
- •- Any evidence of cardiovascular disease on medical history, physical examination, electrocardiography, treadmill exercise testing, or echocardiography
- •- Unstable respiratory/pulmonary disorders
- •- Pulmonary hypertension
- •- Medication known to interfere with study variables
- •- Electrolyte abnormalities
- •- Severe anemia (Hb <6 mmol/l)
- •- Severe psychological, or psychiatric disturbance
- •- Severe insomnia
- •- History of clinical signs of heat intolerance
- •- Contra-indications to ingest temperature capsule
- •- Any other condition considered by the screening physician as a contra-indication to exercise testing;Indications for terminating exercise (stop criteria)
- •(adapted from ACSM 2000)
- •- Drop (>= 10 mmHg) in systolic blood pressure (SBP) or no increase of SBP despite an increase in exercise load
- •- Blunted heart rate response to increasing exercise load
- •- Chest pain (angina)
- •- Near syncope, or syncope
- •- Increasing nervous system symptoms (ataxia, dizziness, vertigo)
- •- Signs of poor perfusion: pallor, cyanosis, cold and clammy skin
- •- SBP rise over 260 mmHg, diastolic over 115 mmHg
- •- Cardiac rhythm disturbances
- •- ST segment abnormalities on ECG
- •- Technical difficulties in monitoring ECG or blood pressure
- •- Subject*s wish to terminate exercise;Contra-indications for subsequent exercise challenge
- •- ST segment depression or elevation during recovery
- •- Cardiac arrhythmia during recovery
- •- Insufficient heart rate recovery;Signs and symptoms indicating excessive effort
- •(when observing these signs, the project leader should consider to stop further exercise challenges)
- •- Angina pectoris
- •- Cardiac arrhythmia
- •- Inappropriate bradycardia
- •- Inappropriate tachycardia
- •- Ataxia, light headedness, confusion
- •- Claudication
- •- Pallor, cyanosis
- •- Inappropriate dyspnoea
- •- Prolonged fatigue
- •- Unusual insomnia
- •- Weight gain due to fluid retention (edema in the legs)
- •- Musculoskeletal pain
- •- Pregnancy or lactation
研究者
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