- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07820436
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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-
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Taipei, Taïwan
- Wanfang Hospital
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
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A structured exercise program delivered and guided by an interactive robot (Kebbi), designed to help manage cancer-related fatigue.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Cancer-Related Fatigue Severity
Délai: 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.
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Baseline (prior to intervention) through completion of the intervention (up to 5 days), assessed up to three times daily during the intervention period
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Symptom Burden
Délai: Baseline (prior to intervention) and immediately after completion of the intervention (up to 5 days)
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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
Délai: 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.
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Immediately before and immediately after each exercise session, up to 4 sessions within the 5-day intervention period
|
|
Change in Respiratory Rate
Délai: Immediately before and immediately after each exercise session, up to 4 sessions within the 5-day intervention period
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Respiratory rate (breaths per minute) measured immediately before and immediately after each exercise session.
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Immediately before and immediately after each exercise session, up to 4 sessions within the 5-day intervention period
|
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Change in Systolic Blood Pressure
Délai: Immediately before and immediately after each exercise session, up to 4 sessions within the 5-day intervention period
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Systolic blood pressure (mmHg) measured immediately before and immediately after each exercise session.
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Immediately before and immediately after each exercise session, up to 4 sessions within the 5-day intervention period
|
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Change in Diastolic Blood Pressure
Délai: 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.
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Immediately before and immediately after each exercise session, up to 4 sessions within the 5-day intervention period
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- ROBOT_education_N202407020
- TMU-JIRB (Autre identifiant: TMU-JIRB)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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