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临床试验/NCT06185010
NCT06185010招募中不适用

Effects of Different Resistance Training Volumes on Cognitive Function, Oxidative Stress, Immunological Response, Lipid Profile, Glycemic Status, Liver Function, Muscle Function, Hemodynamic Response, and Physical Performance in Individuals With Mild Cognitive Impairment

University of Beira Interior2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
80
试验地点
2
主要终点
Short Physical Performance Battery (SPPB)

研究概览

简要总结

This research project aims to analyze the effects of different resistance training volumes on cognitive function, oxidative stress, immunological response, lipid profile, glycemic status, liver function, muscle function, hemodynamic response, and physical performance in individuals with mild cognitive impairment. First the investigators will analyze the effects of a single resistance training session (acute effects) with one and three sets on hemodynamic and physical performance in individuals with mild cognitive impairment. After, the investigators will analyze the effects of an 8-week resistance training program with one or three sets on cognitive function, oxidative stress, immunological response, lipid profile, glycemic status, liver function, muscle function, hemodynamic response, and physical performance in individuals with mild cognitive impairment. The investigators hypothesize that a single resistance training session of one or three sets will increase the acute hemodynamic and physical performance stress in individuals with mild cognitive impairment, although with a higher magnitude in the session with three sets. Furthermore, we hypothesize that eight weeks of resistance training with one or three sets will induce similar improvements in cognitive function, oxidative stress, immunological response, lipid profile, glycemic status, liver function, muscle function, hemodynamic response, and physical performance in individuals with mild cognitive impairment.

详细描述

Following specific inclusion and exclusion criteria (see Eligibility Criteria), participants will be recruited from residential care facilities or day centers. For the acute effects study (cross-over study), participants will randomly perform two resistance training sessions separated by one week of rest: i) one session with one set and ii) another session of three sets. The intensity of the exercises, number of repetitions, type and order of exercises, movement velocity, and rest time between exercises will be the same in both groups. Before, immediately after, and 72 hours after the sessions, a battery of tests will be applied to evaluate the changes in blood pressure, heart rate, tympanic temperature, medicine ball throw distance, five-repetition sit-to-stand time, and handgrip strength. Afterward, participants will be randomly assigned into a one-set or three-set group to perform an eight-week resistance training intervention. As for the acute effects study, the prescription of the other acute training variables will be the same for both groups. A control group (without any form of physical exercise), recruited at the beginning of the research project, will also be part of the study. Before and after the intervention, a battery of tests will be applied to determine the training program's impact on cognitive function, oxidative stress, immunological response, lipid profile, glycemic status, liver function, muscle function, hemodynamic response, and physical performance in individuals with mild cognitive impairment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Clinical diagnosis of mild cognitive impairment
  • SPPB score ≥ 3 points
  • Willingness to participate in the interventions and collaborate with the research team
  • Must be able to provide informed consent (oral or written)

排除标准

  • Severe dementia
  • Severe comorbidity that negatively influences participation in the intervention
  • Color blindness
  • Fractures in the last three months

结局指标

主要结局

Short Physical Performance Battery (SPPB)

时间窗: Change from baseline until week 8

In the eight-week study, the SPPB will determine the overall level of functional performance through three tests: balance (feet side by side, semi tandem, tandem), 4-meter walking, and 5-repetition sit-to-stand.

Systolic blood pressure (SBP)

时间窗: Change from baseline to 0 minutes and 72 hours after the sessions

In the cross-over study (acute effects), the SBP will be assessed through a blood pressure device.

Handgrip strength (HGS)

时间窗: Change from baseline to 0 minutes and 72 hours after the sessions

In the cross-over study (acute effects), the HGS will be assessed through an analogic dynamometer.

Dementia Rating Scale-2 (DRS-2)

时间窗: Change from baseline to week 8

In the eight-week study, the DRS-2 questionnaire will be applied to analyze the overall level of cognitive function through five subscales: attention, initiation/perseveration, construction, conceptualization, and memory.

Brain-Derived Neurotrophic Factor (BDNF)

时间窗: Change from baseline to week 8

In the eight-week study, the BDNF protein levels will be analyzed through specific blood testing kits.

次要结局

  • Five-repetition sit-to-stand (5STS)(Change from baseline to 0 minutes and 72 hours after the sessions)
  • Oxidative stress(Change from baseline to week 8)
  • Lipid Profile(Change from baseline to week 8)
  • Load-velocity profiles(Change from baseline to week 8)
  • Diastolic blood pressure (DBP)(Change from baseline to 0 minutes and 72 hours after the sessions)
  • Heart rate (HR)(Change from baseline to 0 minutes and 72 hours after the sessions)
  • Tympanic temperature (TT)(Change from baseline to 0 minutes and 72 hours after the sessions)
  • 1-kg Medicine Ball Throw (MBT)(Change from baseline to week 8)
  • Inflammatory markers(Change from baseline to week 8)
  • HbA1c(Change from baseline to week 8)
  • Ten-meters walking(Change from baseline to week 8)
  • Muscle Damage(Change from baseline to week 8)
  • One-repetition maximum (1RM)(Change from baseline to week 8)
  • Handgrip strength (HGS)(Change from baseline to week 8)
  • 6-Minute Walk Test (6MWT)(Change from baseline to week 8)

研究者

发起方
University of Beira Interior
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nuno Miguel Pintassilgo da Silva Fonseca

Researcher

University of Beira Interior

研究点 (2)

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