跳至主要内容
临床试验/NCT06669598
NCT06669598已完成不适用

ENHANCING PHYSICAL and COGNITIVE EFFICIENCY in ELDERLY INDIVIDUALS AT RISK of DEMENTIA USING WHOLE-BODY ELECTROMYOSTIMULATION

University of Molise1 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2024年1月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
61
试验地点
1
主要终点
30-second arm curl test

研究概览

简要总结

This study aimed to evaluate the effectiveness of twelve weeks whole-body electrical muscle stimulation combined with aerobic exercises.

详细描述

This study aimed to evaluate the effectiveness of twelve weeks of WB-EMS (whole-body electrical muscle stimulation at 35Hz and 350 μs) combined with aerobic exercises on a treadmill and rowing machine, in improving physical and cognitive performance in older adults, both healthy and at risk of dementia. The results were compared with those obtained from the same training without WB-EMS.

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
Single (Participant)

入排标准

年龄范围
55 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •age from 55 to 85 years;
  • •no simultaneous participation in any type of supervised physical activity;
  • •Sedentary lifestyle

排除标准

  • •mini-mental state examination (MMSE) score of less than 24;
  • •inability to walk for 6 min without assistance;
  • •the presence of a medical condition influencing the cognitive and/or motor functions;
  • •the presence of any counter indication for the utilisation of EMS, such as cardiovascular diseases, stents, cardiac pacemakers, and diabetes mellitus, verified by medical certification.

研究组 & 干预措施

Experimental Training Group

Experimental

The ETG group underwent in two 20-minute training sessions per week, with 72 hours of rest between sessions. Each session included aerobic activities such as rowing and treadmill exercises, combined with supervised WB-EMS stimulation. This stimulation utilised a rectangular waveform at 35 Hz, 350 μs, with continuous pulse duration. The intensity of this training modality was set based on heart rate reserve (HRR), starting at 60% HRR in the first week and increasing by 5% every 3 weeks, reaching 80% HRR by the twelfth week.

干预措施: Whole Body Electromyostimulation (Other)

Control group

Active Comparator

The CON group underwent three weekly training sessions for twelve weeks, con-sisting of 20 minutes of aerobic activity, performed on a treadmill and rowing machine, without the WB-EMS superimposition.

干预措施: control group (Behavioral)

结局指标

主要结局

30-second arm curl test

时间窗: At the end of 12 weeks

30-second sit-to-stand test

时间窗: At the end of 12 weeks

hand grip strength test

时间窗: At the end of 12 weeks

6-minute walking test

时间窗: At the end of 12 weeks

8-foot up and go test

时间窗: At the end of 12 weeks

Chair Sit and Reach Test

时间窗: At the end of 12 weeks

Soda Pop Test

时间窗: At the end of 12 weeks

Tinetti Balance and Gait Test

时间窗: At the end of 12 weeks

Mini-Mental State Examination (MMSE)

时间窗: At the end of 12 weeks

Rey's Auditory Verbal Learning Test (RAVLT)

时间窗: At the end of 12 weeks

Stroop Colour and Word Interference Test (SCWT)

时间窗: At the end of 12 weeks

Trail Making Test (TMT)

时间窗: At the end of 12 weeks

Attentional Matrices Test

时间窗: At the end of 12 weeks

Prose recall test ( babcock)

时间窗: At the end of 12 weeks

Frontal Assessment battery (FAB)

时间窗: At the end of 12 weeks

次要结局

未报告次要终点

研究者

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

Giuseppe Calcagno

Dott. Prof.

University of Molise

研究点 (1)

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