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临床试验/NCT06513377
NCT06513377
已完成
不适用

Evaluating and Monitoring Physical Fatigue While Performing Functional Activities

Vrije Universiteit Brussel1 个研究点 分布在 1 个国家目标入组 40 人2025年3月20日

概览

阶段
不适用
干预措施
Performance test
疾病 / 适应症
Stroke
发起方
Vrije Universiteit Brussel
入组人数
40
试验地点
1
主要终点
Changes in the Ratings of Perceived Exertion throughout the protocol execution
状态
已完成
最后更新
3个月前

概览

简要总结

Fatigue is a critical health parameter in older adults and stroke patients and is associated with negative health outcomes. Current assessment tools predominantly focus on walking related fatigue, neglecting other activities of daily living (ADLs). This study aims to fill this gap by developing a standardized, laboratory-based fatigue protocol that includes a broader range of ADLs, providing a more comprehensive fatigue assessment that's in line with the WHO vision of healthy ageing.

The aim of this study is to evaluate a lab-based fatigue protocol and to unravel the relationship between physiological or movement data and perceived fatigue.

Participants will take part in three separate measurement moments, during which they will execute a performance task that induces fatigue. In addition, relevant sensors will be used to collect meaningful data.

注册库
clinicaltrials.gov
开始日期
2025年3月20日
结束日期
2025年10月15日
最后更新
3个月前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

David Beckwee

Principal Investigator

Vrije Universiteit Brussel

入排标准

入选标准

  • Stroke survivors:
  • Inclusion Criteria:
  • \> 18 years old
  • ≥ 3 months ago stroke diagnosis
  • FAC levels 3-5

排除标准

  • Severe problems with speech or memory which prevents the participant to understand or follow instruction
  • Co-morbidities that could influence the task execution and collected data
  • Older adults with sarcopenia:
  • \> 65 years old
  • Grip strength: \< 27 kg (man) or \< 16 kg (woman)
  • Be mobile independently
  • Severe problems with speech or memory which prevents the participant to understand or follow instruction
  • Co-morbidities that could influence the task execution and collected data
  • Healthy individuals:
  • \> 18 years old

研究组 & 干预措施

People post-stroke

The intervention includes a stress test that induces progressive feelings of fatigue.

干预措施: Performance test

Older adults with sarcopenia

The intervention includes a stress test that induces progressive feelings of fatigue.

干预措施: Performance test

Healthy individuals

The intervention includes a stress test that induces progressive feelings of fatigue.

干预措施: Performance test

结局指标

主要结局

Changes in the Ratings of Perceived Exertion throughout the protocol execution

时间窗: Collected during all measurement moments (2-12 weeks).

The subjective feelings of fatigue will be evaluated through the Ratings of Perceived Exertion. This will be expressed verbally by the participant throughout the execution of the protocol.

次要结局

  • Changes in muscle activity throughout the protocol execution(Collected during all measurement moments (2-12 weeks).)
  • Changes in skin temperature throughout the protocol execution(Collected during all measurement moments (2-12 weeks).)
  • Changes in muscle force myography throughout the protocol execution(Collected during all measurement moments (2-12 weeks).)
  • Changes in heart rate (variability) throughout the protocol execution(Collected during all measurement moments (2-12 weeks).)
  • Changes in plantar pressure throughout the protocol execution(Collected during all measurement moments (2-12 weeks).)
  • Changes in oxygen saturation throughout the protocol execution(Collected during all measurement moments (2-12 weeks).)
  • Changes in electrodermal activity throughout the protocol execution(Collected during all measurement moments (2-12 weeks).)
  • Changes in gaze patter throughout the protocol execution(Collected during all measurement moments (2-12 weeks).)
  • Changes in motion data throughout the protocol execution(Collected during all measurement moments (2-12 weeks).)
  • Changes in joint angles throughout the protocol execution(Collected during all measurement moments (2-12 weeks).)

研究点 (1)

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