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临床试验/NCT07820436
NCT07820436已完成不适用

Using an Interactive Kebbi Robot to Develop an Exercise Program for Cancer-Related Fatigue: Assessing Its Effectiveness

Taipei Medical University1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2024年8月13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
46
试验地点
1
主要终点
Change in Cancer-Related Fatigue Severity

研究概览

简要总结

The goal of this study is to learn whether an exercise program guided by an interactive robot can help reduce tiredness in people with cancer. This kind of tiredness, called cancer-related fatigue, is common during cancer treatment and can make everyday activities harder.

People who take part in the exercise program will do sessions guided by the robot. Before and after each session, the study team checks things like heart rate, breathing rate, and blood pressure, and asks about tiredness and other symptoms.

Family members and nurses who help patients use the robot are also asked to share their views on how well the robot's teaching materials hold their attention and help them feel confident and satisfied.

Everyone who joins the exercise part of the study receives the same robot-guided program. There is no separate group that skips the robot program.

详细描述

Cancer-related fatigue is one of the most common and distressing symptoms experienced by patients undergoing cancer treatment, often persisting despite rest and negatively affecting daily function and quality of life. Exercise is a recommended non-pharmacological strategy to help manage this symptom, but adherence to conventional exercise programs among cancer patients is often limited.

This study develops and evaluates an exercise teaching program delivered through an interactive robot (Kebbi) for cancer patients treated at Taipei Medical University-affiliated Wanfang Hospital. The robot guides participants through a structured exercise routine. Physiological parameters (heart rate, respiratory rate, systolic and diastolic blood pressure) are recorded immediately before and after exercise sessions, and patient-reported fatigue and symptom burden are assessed repeatedly over the course of the intervention period.

In addition to the patient cohort, family caregivers and nursing staff who interact with the robot-based teaching materials are invited to evaluate the instructional design of the materials, focusing on their ability to engage attention, demonstrate relevance, build confidence, and achieve satisfaction.

This is a single-group study; all enrolled patients receive the robot-guided exercise program, and outcomes are compared within participants before versus after the intervention. No randomization or control group is used.

研究设计

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

入排标准

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

入选标准

  • Age 20 years or older
  • Confirmed diagnosis of cancer, currently receiving anticancer treatment at Taipei Municipal Wanfang Hospital
  • Presence of cancer-related fatigue (self-reported or clinically assessed)
  • Sufficient cognitive and physical function to participate in a robot-guided, low-to-moderate intensity exercise program
  • Willing and able to provide informed consent

排除标准

  • Severe cognitive impairment or communication barriers preventing comprehension of study instructions
  • Unstable cardiopulmonary or hemodynamic status contraindicating exercise
  • Bedridden or physical performance status precluding participation in basic exercise movements

研究组 & 干预措施

Robot-Guided Exercise Group

Experimental

Cancer patients receiving the interactive robot (Kebbi)-guided exercise program. Vital signs, fatigue, and symptom burden are assessed before and after sessions.

干预措施: Interactive Robot (Kebbi)-Guided Exercise Program (Behavioral)

结局指标

主要结局

Change in Cancer-Related Fatigue Severity

时间窗: Baseline (prior to intervention) through completion of the intervention (up to 5 days), assessed up to three times daily during the intervention period

Fatigue severity assessed using the Brief Fatigue Inventory (BFI), a self-reported measure with items rated from 0 (no fatigue) to 10 (fatigue as bad as you can imagine). Higher scores indicate greater fatigue severity.

次要结局

  • Change in Symptom Burden(Baseline (prior to intervention) and immediately after completion of the intervention (up to 5 days))
  • Change in Heart Rate(Immediately before and immediately after each exercise session, up to 4 sessions within the 5-day intervention period)
  • Change in Respiratory Rate(Immediately before and immediately after each exercise session, up to 4 sessions within the 5-day intervention period)
  • Change in Systolic Blood Pressure(Immediately before and immediately after each exercise session, up to 4 sessions within the 5-day intervention period)
  • Change in Diastolic Blood Pressure(Immediately before and immediately after each exercise session, up to 4 sessions within the 5-day intervention period)

研究者

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

Tsai-Wei Huang

Principal Investigator

Taipei Medical University

研究点 (1)

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