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临床试验/NCT05484661
NCT05484661已完成不适用

Mechanisms to Reduce Mental and Physical Fatigue Following Exercise Training in Older Adults

The University of Texas Health Science Center at San Antonio2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年12月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Fatigue

研究概览

简要总结

Fatigue is a strong predictor of negative health outcomes in older adults. The research in this study will compared the effects of 8-weeks of branched chain amino acids (BCAAs: dietary supplements commonly taken to improve muscle growth and exercise performance) added to exercise on fatigue compared to exercise with a placebo (an inactive, harmless substance). BCAAs could have an impact on improving fatigue common in older adults, especially when exercising.

详细描述

Thirty participants will be asked to participate in this research study. They will be randomized (like a flip of a coin) to exercise + a placebo or exercise + BCAAs for 8 weeks. We would like to examine the effects of the 8-week exercise + dietary supplement program on body composition (fat and muscle), physical activity habits, fatigue, and physical performance (such as walking and strength). We would also like to assess whether these outcomes are controlled by changes in markers (kynurenine metabolites) in the skeletal muscle and blood.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
60 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Fatigue (participants reporting ≥3 on a 1-10 scale)
  • Lack of menses for at least one year for women
  • BMI 20-50 kg/m2
  • Untrained with regard to structured exercise training (is not currently training more than 2x/week)

排除标准

  • Taking an anticoagulant medication that is unable to be discontinued before biopsies
  • Allergic to lidocaine
  • Neurologic, musculoskeletal, or other condition that limits subject's ability to complete study physical assessments or training
  • Hepatic (LFTs >2.5xWNL), renal (eGFR<45), , and uncontrolled psychiatric disease
  • Cognitive impairment
  • Uncontrolled depression
  • Any disease or condition considered to be exclusionary based on the clinical opinion and discretion of the principal investigator

结局指标

主要结局

Fatigue

时间窗: change from baseline to 8 weeks

Participants will complete the Fatigue Assessment Scale questionnaire (Total scores can range from 10, indicating the lowest level of fatigue, to 50, denoting the highest)

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

Monica Serra

Associate Professor

The University of Texas Health Science Center at San Antonio

研究点 (2)

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