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临床试验/NL-OMON36063
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

发起方
TNO

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