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临床试验/NCT07093216
NCT07093216尚未招募不适用

Understanding Response Variability to Optimize Exercise Efficacy for Improving Health Among Older Adults

University of Alabama at Birmingham0 个研究点目标入组 304 人开始时间: 2028年12月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
304
主要终点
Intrinsic Capacity

研究概览

简要总结

here is enormous variation in how individuals respond to exercise and understanding the factors that drive this variation will guide individualized exercise prescriptions to improve or maintain health into older age. This study will help to elucidate reasons for the variation in the responses to exercise in older adults.

详细描述

here is enormous variation in how individuals respond to exercise and understanding the factors that drive this variation will guide individualized exercise prescriptions to improve or maintain health into older age. Our multidisciplinary team will apply Multiphase Optimization Strategy Framework (MOST) principles to addresses the impacts of exercise intervention components (e.g. exercise timing, aerobic exercise intensity levels, resistance exercise intensity levels, and training volume levels), as well as participant-specific factors (e.g. age, sex, race, BMI, and medication use), on health domains of Intrinsic Capacity (locomotion, vitality, sensory, psychological, and cognition) among older adults in response to six months of supervised, center-based exercise training. This approach - unprecedented in the fields of exercise and aging - will provide comprehensive evidence to more fully understand the variation in the responses to exercise in older adults.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Basic Science
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Written informed consent prior to any study procedure
  • 60+ years of age
  • <120 min/wk of self-reported moderate physical activity as assessed by Community Health Activities Model Program for Seniors (CHAMPS) physical activity questionnaire13
  • Evidence of impairment in one or more Intrinsic Capacity domains (see section 3.2)
  • Passage of a physical exam and diagnostic, graded exercise test with 12-lead ECG reviewed by a cardiologist or otherwise credentialed clinician.

排除标准

  • End-stage disease and/or a life expectancy less than one year
  • Resistant hypertension, defined as BP > 140/90, despite the use of three or more anti-hypertensive drugs
  • Chronic kidney disease
  • Serum creatinine >2.5 mg/dL in men or >2.0 mg/dL in women
  • Serum potassium >5.0 mEq/L
  • Urinary protein > 1 on dipstick
  • Abnormal liver enzymes (AST, ALT, or alkaline phosphatase > 2.5 times the upper limit of normal)
  • Severe cardiac disease, including NYHA Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina
  • Acute myocardial infarction identified by ECG
  • Current treatment for malignancy
  • Known diagnosis of dementia
  • Any other disease or condition that would preclude completion of all testing and exercise training
  • Any other condition that would interfere with testing or increase risk of complications during exercise
  • Any other condition or events considered exclusionary by the PIs and/or study clinicians.

研究组 & 干预措施

Mode

Experimental

Resistance vs Aerobic

干预措施: Exercise (Behavioral)

Volume

Experimental

Amount of Exercise Performed

干预措施: Exercise (Behavioral)

Time of Day

Experimental

Time of Day Exercise Performed

干预措施: Exercise (Behavioral)

Dose

Experimental

Testing Dose of Exercise

干预措施: Exercise (Behavioral)

Intensity

Experimental

Testing Intensity of Effort

干预措施: Exercise (Behavioral)

结局指标

主要结局

Intrinsic Capacity

时间窗: 6 months

Single composite score of results of multiple tests across five domains: 1) Locomotion, 2) Vitality, 3) Sensory, 4) Psychological, and 5) Cognition

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Thomas W. Buford

Professor

University of Alabama at Birmingham

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