跳至主要内容
临床试验/NCT07698912
NCT07698912已完成不适用

AIoT-Based Ergometer for Early Rehabilitation in Geriatric Wards: Supporting Physical Recovery in Frail Older Adult

National Cheng Kung University1 个研究点 分布在 1 个国家目标入组 376 人开始时间: 2020年5月1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
入组人数
376
试验地点
1
主要终点
Muscle strength of knee extensors

研究概览

简要总结

This clinical trial aims to evaluate the effectiveness of an Artificial Intelligence of Things (AIoT)-based feedback assistive strengthening ergometer (AIFASE) exercise system on frail older adults in geriatric wards. Baseline assessments will include physical fitness, functional performance, and frailty severity. Muscle strength of the major muscle groups in the upper and lower extremities will be evaluated at both baseline and post-intervention. Throughout the intervention, exercise-related data, including exercise duration, workload, heart rate, rate of perceived exertion (RPE), and blood oxygen saturation (SpO2) will be continuously and simultaneously collected for analysis.

详细描述

At baseline, participants will undergo a personal health assessment and physical fitness evaluation. The personal health assessment includes collection of demographic information, past medical history, general health status, and clinical frailty scale. Physical fitness assessment consists of handgrip strength, Timed Up and Go test and 4-meter walk test. These baseline assessments will be used to individualize and guide the AIFASE exercise program.

Following the baseline assessment, the intervention group will undergo training using an AIFASE exercise system. Muscle strength of the major muscle groups in the upper and lower extremities (elbow flexors, elbow extensors, knee flexors, and knee extensors) will be evaluated at both baseline and post-intervention.

During the exercise sessions, exercise-related metrics, including workload, cadence (revolutions per minute, RPM), exercise duration, heart rate, and rate of perceived exertion (RPE), and blood oxygen saturation (SpO2) will be continuously recorded in real time.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

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

入选标准

  • Adult over 65 years old
  • The Clinical Frailty Scale (CFS) score of 3 to 7 (hospitalized patients)

排除标准

  • Limb disability or joint deformation
  • Admission to the intensive care unit, scheduled surgery, anticipated discharge within three days, medical contraindications to physical activity, or enrollment in hospice care.

研究组 & 干预措施

Frail older adults

Experimental

Participants will undergo AIoT-based feedback assistive strengthening ergometer exercise program.

干预措施: AIoT-based Feedback Assistive Strengthening Ergometer (Device)

结局指标

主要结局

Muscle strength of knee extensors

时间窗: baseline

Muscle strength of knee extensors is assessed using a MicroFET2 handheld dynamometer.

Muscle strength of knee extensors

时间窗: through study completion, an average of 13 days

Muscle strength of knee extensors is assessed using a MicroFET2 handheld dynamometer.

次要结局

  • Timed Up and Go test (TUG)(basline)
  • Gait speed (4-meter walk test)(baseline)
  • Clinical Frailty Scale (CFS)(baseline)
  • Short Portable Mental Status Questionnaire (SPMSQ)(baseline)
  • Geriatric Depression Scale (GDS-5)(baseline)
  • Activities of Daily Living (ADLs)(baseline)
  • Activities of Daily Living (ADLs)(through study completion, an average of 13 days)
  • EQ-5D (EuroQol- 5 Dimensions)(baseline)
  • Mini Nutritional Assessment-Short Form (MNA-SF)(baseline)
  • Muscle strength of elbow flexors(baseline)
  • Muscle strength of elbow flexors(through study completion, an average of 13 days)
  • Muscle strength of elbow extensors(baseline)
  • Muscle strength of elbow extensors(through study completion, an average of 13 days)
  • Muscle strength of knee flexors(baseline)
  • Muscle strength of knee flexors(through study completion, an average of 13 days)

研究者

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

Chia-Ming Chang

MD

National Cheng Kung University

研究点 (1)

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