NCT06940037招募中不适用
The Impact of Biological Mechanisms of Aging on Response Variability to Resistance Training in Older Adults (BRIO): A Randomized, Placebo-controlled Trial of Progressive Resistance Training in Older Adults.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 300
- 试验地点
- 4
- 主要终点
- Precisely define the variability in changes in physical function
研究概览
简要总结
To critically examine biological, clinical, and behavioral modulators of progressive resistance training-associated exercise response heterogeneity in physical function and whole-body metabolism in older adults.
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 (Investigator, Outcomes Assessor)
盲法说明
Data analysis team
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged greater than or equal to 65 years
- •sedentary (Community Healthy Activities Model Program for Seniors physical activity questionnaire to identify and exclude persons engaged in regular (125 min/week or more) moderate intensity physical activity
- •at risk for mobility disability score of less than or equal to 10 (but greater than 3) on the SPPB
- •willing to be randomized into HE or PRT
- •willing to be transported or transport themselves to the clinical sites for the intervention and assessments
排除标准
- •unwillingness to provide informed consent
- •participation in lifestyle or pharmacologic intervention trial or structured program of exercise training in the past 6 months
- •an SPPB score of less than or equal to 3
- •osteoarthritis or condition with joint pain limiting daily life activities
- •significant weight loss or gain (7.5% of body weight) in past six months
- •current anti-coagulant or anti-platelet therapy (Coumadin, Eliquis, Pradaxa, Xarelto, heparin, Lovenox, Plavix)
- •clinically significant abnormality in any of the screening laboratory values, including those identified as outside of the "normal limits', that are deemed to be of concern for participation in the study by the study physician
- •acute or terminal illness
- •Mini Mental State Exam (MMSE) <23
- •myocardial infarction in the previous 6 months or other symptomatic coronary artery disease
- •New York Heart Association Class III or IV congestive heart failure
- •serious conduction disorder (e.g., 3rd degree heart block), uncontrolled arrhythmia, or new Q waves or ST-segment depressions (>3 mm) on ECG
- •chronic obstructive pulmonary disease requiring oxygen therapy
- •upper or lower extremity fracture in the previous 6 months
- •uncontrolled hypertension (150/90 mm Hg)
- •neuromuscular diseases and/or drugs which affect neuromuscular function
- •current use of anabolic steroids, growth hormone, replacement androgen therapy, anti-androgen therapy
- •allergy to lidocaine
- •presence of significant liver or renal disease (eGFR < 45 mL/min)
- •diagnosis of type I diabetes mellitus or insulin requiring type 2 diabetes mellitus
- •HbA1c > 7%
- •BMI <21 or >35 for men or >40 for women
- •excessive alcohol intake (>14 alcoholic beverages per wk.)
- •current tobacco use
- •current participation in any interventional clinical trial
- •current use of weight loss medications
研究组 & 干预措施
Progressive Resistance Training
Other
participants will attend exercise session 3 times per week.
干预措施: Progressive Resistance Training (Other)
Health Education
Other
participants will attend health educations classed 1 time per week.
干预措施: Health Education (Other)
结局指标
主要结局
Precisely define the variability in changes in physical function
时间窗: baseline, 6 months
Measured by the Short Physical Performance Battery (SPPB), a 0-12 categorical scale of walking speed, standing balance, and repeated sit-to-stand time, with higher scores reflecting better physical function.
Precisely define the variability in changes in blood glucose concentrations in response to a meal tolerance test
时间窗: baseline, 6 months
Blood glucose concentrations (millimoles/liter) will be measured in response to a physiologically relevant meal challenge. Lower values are indicative of better metabolic health.
次要结局
- Precisely define the variability in changes in six-minute walk distance.(baseline, 6 months)
- Precisely define the variability in changes in skeletal muscle size.(baseline, 6 months)
- Precisely define the variability in changes in skeletal muscle strength.(baseline, 6 months)
- Precisely define the variability in insulin secretion in response to a mixed meal tolerance test.(baseline, 6 months)
- Precisely define the variability in changes in the percentage of glycated hemoglobin in the blood.(baseline, 6 months)
- Precisely define the variability in changes in blood lipids.(baseline, 6 months)
- Precisely define the variability in changes in waist-to-hip ratio.(baseline, 6 months)
研究者
Nathan K. LeBrasseur
Principal Investigator
Mayo Clinic
研究点 (4)
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