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临床试验/NCT06621368
NCT06621368招募中不适用

Effect of Two Years of Resistance Training on Muscular Strength, Body Composition, Functional Fitness, Metabolic Biomarkers, Cognition, and Cardiac Parameters in Postmenopausal Women: Longitudinal Study Active Aging

Universidade Estadual de Londrina2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年11月23日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
2
主要终点
Body Fat

研究概览

简要总结

Aging is a natural process of the life cycle that can result in morphological, neuromuscular, metabolic, physiological, cognitive and behavioral changes that can compromise quality of life, autonomy, self-esteem, health and life expectancy, especially in the elderly. On the other hand, resistance training (RT) has been widely recommended for the elderly population, due to the numerous health benefits it brings, such as increased strength and muscle mass, reduced body fat, increased bone mineral content and density, and improved cardiometabolic profile, among others. However, the effectiveness of RT in attenuating or reversing the deleterious effects of aging has been analyzed by studies conducted, in most cases, over relatively short periods, i.e., eight to 24 weeks. Considering that recent investigations have demonstrated a wide variation in the adaptive responses to RT in this population, it is likely that many of these responses are time-dependent. Additionally, the influence of important mediators and moderators in this process, especially training intensity and volume, dietary habits, the presence or absence of diseases and degenerative processes that cause disability, and the use of polypharmaceuticals, has not yet been well established. Therefore, based on the Active Aging Longitudinal Study, a research project initiated in 2012, it is intend to analyze whether or not RT practice can produce positive and lasting adaptive responses on muscle strength, body composition, functional fitness, cognition, cardiometabolic biomarkers, and cardiac function in postmenopausal women, based on a randomized controlled clinical trial over a long period of time (two years). In addition, mediation and moderation analyses will be used to understand the real impact of RT on the outcomes to be analyzed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • 60 years of age or older;
  • physically independent;
  • not have cardiovascular, musculoskeletal or metabolic limitations that prevent the practice of physical exercises or the execution of motor tests;
  • not being on hormone replacement therapy;
  • not being involved in physical exercise more than once a week, over the six months prior to the start of the study.

排除标准

  • not participating in at least 85% of the training and not attending the assessments.

结局指标

主要结局

Body Fat

时间窗: from begining (November 2023) to the end 48 weeks of resistance training (November 2026)

Dual-energy x-ray absorptiometry examinations were performed in a Lunar Prodigy device, model NRL 41990 (General Electric, Madison, WI), to determine the total, regional lean soft tissue (LST), appendicular LST (ALST), and the total body, trunk, gynoid, and android fat masses (all these outcomes are presented in kilograms). Participants were instructed to remove all metal objects before scanning to minimize possible estimation errors. Scans were performed with participants lying in the supine position along the table's longitudinal centerline axis. Feet were secured together at the toes to immobilize the legs while the hands were maintained in a pronated position within the scanning region. A skilled researcher carried out both calibration and analysis, following the manufacturer's recommendations. The software generated standard lines that separated the limbs from the trunk and head.

Muscle mass

时间窗: from begining (November 2023) to the end 48 weeks of resistance training (November 2026)

Dual-energy x-ray absorptiometry examinations were performed in a Lunar Prodigy device, model NRL 41990 (General Electric, Madison, WI), to determine the total, regional lean soft tissue (LST), appendicular LST (ALST), and the total body, trunk, gynoid, and android fat masses (all these outcomes are presented in kilograms). Participants were instructed to remove all metal objects before scanning to minimize possible estimation errors. Scans were performed with participants lying in the supine position along the table's longitudinal centerline axis. Feet were secured together at the toes to immobilize the legs while the hands were maintained in a pronated position within the scanning region. A skilled researcher carried out both calibration and analysis, following the manufacturer's recommendations. The software generated standard lines that separated the limbs from the trunk and head.

次要结局

  • Cardiovascular risk factors(from begining (November 2023) to the end 48 weeks of resistance training (November 2026))
  • Set shifting(from begining (November 2023) to the end 48 weeks of resistance training (November 2026))
  • Cardiac function(from begining (November 2023) to the end 48 weeks of resistance training (November 2026))
  • MoCA(from begining (November 2023) to the end 48 weeks of resistance training (November 2026))
  • Stroop test(from begining (November 2023) to the end 48 weeks of resistance training (November 2026))
  • Verbal fluency tasks(from begining (November 2023) to the end 48 weeks of resistance training (November 2026))
  • Depressive symptoms(from begining (November 2023) to the end 48 weeks of resistance training (November 2026))
  • Anxiety symptoms(from begining (November 2023) to the end 48 weeks of resistance training (November 2026))
  • Bone(from begining (November 2023) to the end 48 weeks of resistance training (November 2026))

研究者

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

Edilson Serpeloni Cyrino

Principal investigator, PhD

Universidade Estadual de Londrina

研究点 (2)

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