Interactive Robot-Guided Exercise Program for Cancer-Related Fatigue
Using an Interactive Kebbi Robot to Develop an Exercise Program for Cancer-Related Fatigue: Assessing Its Effectiveness
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
-
Taipei, Taiwan
- Wanfang Hospital
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Robot-Guided Exercise Group
Cancer patients receiving the interactive robot (Kebbi)-guided exercise program.
Vital signs, fatigue, and symptom burden are assessed before and after sessions.
|
A structured exercise program delivered and guided by an interactive robot (Kebbi), designed to help manage cancer-related fatigue.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Cancer-Related Fatigue Severity
Prazo: 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.
|
Baseline (prior to intervention) through completion of the intervention (up to 5 days), assessed up to three times daily during the intervention period
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Symptom Burden
Prazo: Baseline (prior to intervention) and immediately after completion of the intervention (up to 5 days)
|
Symptom burden assessed using the Edmonton Symptom Assessment Scale (ESAS), which rates the severity of multiple symptoms (e.g., pain, tiredness, drowsiness, nausea, appetite) on a 0-10 scale.
Higher scores indicate greater symptom severity.
|
Baseline (prior to intervention) and immediately after completion of the intervention (up to 5 days)
|
|
Change in Heart Rate
Prazo: Immediately before and immediately after each exercise session, up to 4 sessions within the 5-day intervention period
|
Heart rate (beats per minute) measured immediately before and immediately after each exercise session.
|
Immediately before and immediately after each exercise session, up to 4 sessions within the 5-day intervention period
|
|
Change in Respiratory Rate
Prazo: Immediately before and immediately after each exercise session, up to 4 sessions within the 5-day intervention period
|
Respiratory rate (breaths per minute) measured immediately before and immediately after each exercise session.
|
Immediately before and immediately after each exercise session, up to 4 sessions within the 5-day intervention period
|
|
Change in Systolic Blood Pressure
Prazo: Immediately before and immediately after each exercise session, up to 4 sessions within the 5-day intervention period
|
Systolic blood pressure (mmHg) measured immediately before and immediately after each exercise session.
|
Immediately before and immediately after each exercise session, up to 4 sessions within the 5-day intervention period
|
|
Change in Diastolic Blood Pressure
Prazo: Immediately before and immediately after each exercise session, up to 4 sessions within the 5-day intervention period
|
Diastolic blood pressure (mmHg) measured immediately before and immediately after each exercise session.
|
Immediately before and immediately after each exercise session, up to 4 sessions within the 5-day intervention period
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- ROBOT_education_N202407020
- TMU-JIRB (Outro identificador: TMU-JIRB)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .