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- Essai clinique NCT07772726
The Effect of IoT-based Smart Exercises System in the Senior Adults: Coordination
Smart Health Care and Innovative Technology Service Model Plan: Development of Innovative Health Promotion System for Senior Adults
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Participants are divided into two groups: (1) the Control (Ctrl) group and (2) the Smart Exercise (SE) group. Participants in both groups are instructed to perform combined muscle strength and coordination exercises twice weekly for 12 weeks, with each session lasting approximately 30 minutes.
Participants in the Ctrl group perform combined muscle strength and coordination exercises twice weekly for 12 weeks, with each session lasting approximately 30 minutes, following an exercise guide recommended by a physical therapist.
Participants in the SE group perform muscle strength and coordination training using an upgraded smart exercise system. The smart exercise system consists of an upper-extremity cycle ergometer (UEE) and a lower-extremity cycle ergometer (LEE). Participants in the SE group complete one session using the UEE and one session using the LEE per week, with each session lasting approximately 30 minutes, for 12 weeks.
Physical fitness tests, coordination tests, and questionnaires are administered to participants in both groups before and after the 12-week exercise program. Changes in physical fitness, coordination, and questionnaire outcomes are compared between the two groups.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Li-Chieh Kuo, Ph. D.
- Numéro de téléphone: 886-62353535 Ext. 5908
- E-mail: jkkuo@mail.ncku.edu.tw
Sauvegarde des contacts de l'étude
- Nom: Chih-Chun Lin, Ph. D.
- Numéro de téléphone: 886-62757575 Ext. 58420
- E-mail: z9902026@email.ncku.edu.tw
Lieux d'étude
-
-
Taiwan
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Tainan, Taiwan, Taïwan, 701
- Recrutement
- National Cheng-Kung University
-
Contact:
- Li-Chieh Kuo, Ph. D.
- Numéro de téléphone: 886-62353535 Ext. 5908
- E-mail: jkkuo@mail.ncku.edu.tw
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Adult over 50 years old
- No significant limb disability or joint deformation
- No history of cardiovascular disease
- Never lost balance due to dizziness in the past 12 months
Exclusion Criteria:
- limb disability or joint deformation
- history of cardiovascular disease
- lost balance due to dizziness in the past 12 months
- cognitive deficits
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Control group
Participants in the Ctrl group perform combined muscle strength and coordination exercises twice weekly for 12 weeks, with each session lasting approximately 30 minutes, following an exercise guide recommended by a physical therapist.
|
Participants in the Ctrl group perform combined muscle strength and coordination exercises twice weekly for 12 weeks, with each session lasting approximately 30 minutes, following an exercise guide recommended by a physical therapist.
|
|
Expérimental: Smart Exercise group
Participants in the SE group perform muscle strength and coordination training using an upgraded smart exercise system.
The smart exercise system consists of an upper-extremity cycle ergometer (UEE) and a lower-extremity cycle ergometer (LEE).
Participants in the SE group complete one session using the UEE and one session using the LEE per week, with each session lasting approximately 30 minutes, for 12 weeks.
|
Participants in the SE group perform muscle strength and coordination training using an upgraded smart exercise system.
The smart exercise system consists of an upper-extremity cycle ergometer (UEE) and a lower-extremity cycle ergometer (LEE).
Participants in the SE group complete one session using the UEE and one session using the LEE per week, with each session lasting approximately 30 minutes, for 12 weeks.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
TUG Manual
Délai: baseline
|
The TUG Manual Test evaluates a senior's attentional control and dynamic balance under a motor dual-task condition.
Participants perform the standard Timed Up and Go task-standing, walking three meters, turning, and sitting-while carrying a full glass of water in one hand.
Instructors record the time, with scores over 14.5 seconds indicating a high risk of falling.
|
baseline
|
|
TUG Manual
Délai: after 12-week intervation
|
The TUG Manual Test evaluates a senior's attentional control and dynamic balance under a motor dual-task condition.
Participants perform the standard Timed Up and Go task-standing, walking three meters, turning, and sitting-while carrying a full glass of water in one hand.
Instructors record the time, with scores over 14.5 seconds indicating a high risk of falling.
|
after 12-week intervation
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Test de marche de six minutes
Délai: ligne de base
|
Marcher le plus possible en six minutes et mesurer la distance totale parcourue.
|
ligne de base
|
|
Test de marche de six minutes
Délai: après 12 semaines d'intervention
|
Marcher le plus possible en six minutes et mesurer la distance totale parcourue.
|
après 12 semaines d'intervention
|
|
Test par étape de 2 minutes
Délai: ligne de base
|
Le test par étapes de 2 minutes consiste à terminer les étapes en 2 minutes.
Le nombre d'étapes complètes effectuées en 2 minutes est enregistré.
|
ligne de base
|
|
Test par étape de 2 minutes
Délai: après 12 semaines d'intervention
|
Le test par étapes de 2 minutes consiste à terminer les étapes en 2 minutes.
Le nombre d'étapes complètes effectuées en 2 minutes est enregistré.
|
après 12 semaines d'intervention
|
|
Test d'équilibre sur une jambe avec les yeux ouverts
Délai: ligne de base
|
Le participant est invité à se tenir debout sur une jambe avec les yeux ouverts, le nombre de secondes est enregistré.
|
ligne de base
|
|
Test d'équilibre sur une jambe avec les yeux ouverts
Délai: après 12 semaines d'intervention
|
Le participant est invité à se tenir debout sur une jambe avec les yeux ouverts, le nombre de secondes est enregistré.
|
après 12 semaines d'intervention
|
|
Indice de fragilité SOF (Study of Osteoporotic Fractures) (Questionnaire sur la fonction physique et l'état de santé)
Délai: ligne de base
|
Facteurs de risque de fractures et de chutes et s'est développé pour examiner divers déterminants d'un vieillissement réussi.
Trois questions sur la fragilité et deux questions sur la dépression.
|
ligne de base
|
|
Indice de fragilité SOF (Study of Osteoporotic Fractures) (Questionnaire sur la fonction physique et l'état de santé)
Délai: après 12 semaines d'intervention
|
Facteurs de risque de fractures et de chutes et s'est développé pour examiner divers déterminants d'un vieillissement réussi.
Trois questions sur la fragilité et deux questions sur la dépression.
|
après 12 semaines d'intervention
|
|
SARC-F
Délai: ligne de base
|
Le questionnaire SARC-F est un test de diagnostic rapide pour SARCopenia.
Le questionnaire contient cinq éléments, qui sont la force, l'aide à la marche, le lever d'une chaise, la montée des escaliers et les chutes.
Les scores vont de 0 à 10, avec 0 à 2 points pour chaque composante.
Un score égal ou supérieur à 4 est prédictif de sarcopénie et de mauvais pronostic.
|
ligne de base
|
|
SARC-F
Délai: après 12 semaines d'intervention
|
Le questionnaire SARC-F est un test de diagnostic rapide pour SARCopenia.
Le questionnaire contient cinq éléments, qui sont la force, l'aide à la marche, le lever d'une chaise, la montée des escaliers et les chutes.
Les scores vont de 0 à 10, avec 0 à 2 points pour chaque composante.
Un score égal ou supérieur à 4 est prédictif de sarcopénie et de mauvais pronostic.
|
après 12 semaines d'intervention
|
|
EQ-5D (EuroQol- 5 Dimensions)
Délai: baseline
|
EQ-5D is a standardized instrument with 5-item questionnaire for measuring generic health status.
EQ-5D was first introduced in 1990 by the EuroQol Group.
In which health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Rated level can be coded as a number 1, 2, or 3, which indicates having no problems for 1, having some problems for 2, and having extreme problems for 3.
As a result, a person's health status can be defined by a 5-digit number, ranging from 11111 (having no problems in all dimensions) to 33333(having extreme problems in all dimensions).
|
baseline
|
|
BMI
Délai: basline
|
Participants's weight in kilograms divided by the square of height in meters is recorded as Body Mass Index (BMI).
|
basline
|
|
BMI
Délai: after 12-week intervention
|
Participants's weight in kilograms divided by the square of height in meters is recorded as Body Mass Index (BMI).
|
after 12-week intervention
|
|
Up and Go test
Délai: baseline
|
Number of seconds required to get up from a seated position, walk 8 feet, turn, and return to seated position.
|
baseline
|
|
Up and Go test
Délai: after 12-week intervention
|
Number of seconds required to get up from a seated position, walk 8 feet, turn, and return to seated position.
|
after 12-week intervention
|
|
30 second chair stand test
Délai: baseline
|
Number of full stands that can completed in 30 seconds with arms folded across chest.
|
baseline
|
|
30 second chair stand test
Délai: after 12-week intervention
|
Number of full stands that can be completed 30 seconds with arms folded across chest.
|
after 12-week intervention
|
|
SMI
Délai: baseline
|
Skeletal muscle mass index (SMI), which is the sum of the muscle masses of the four limbs as appendicular skeletal mass (ASM) in kilograms divided by the square of height in meters, is detected by TANITA MC-780MA body composition analyzer.
|
baseline
|
|
SMI
Délai: after 12-week intervention
|
Skeletal muscle mass index (SMI), which is the sum of the muscle masses of the four limbs as appendicular skeletal mass (ASM) in kilograms divided by the square of height in meters, is detected by TANITA MC-780MA body composition analyzer.
|
after 12-week intervention
|
|
Back scratch
Délai: baseline
|
Back scratch with one hand reaching over shoulder and one up the middle of the back, the distance (cm) between extended middle fingers is recorded.
|
baseline
|
|
Back scratch
Délai: after 12-week intervention
|
Back scratch with one hand reaching over shoulder and one up the middle of the back, the distance (cm) between extended middle fingers is recorded.
|
after 12-week intervention
|
|
Chair sit-&-reach test
Délai: baseline
|
From a sitting position at front of chair, with leg extended and hands reaching toward toes, the distance (cm) between extended fingers and tip of toe is recorded.
|
baseline
|
|
Chair sit-&-reach test
Délai: after 12-week intervention
|
From a sitting position at front of chair, with leg extended and hands reaching toward toes, the distance (cm) between extended fingers and tip of toe is recorded.
|
after 12-week intervention
|
|
Hand grip strength test
Délai: baseline
|
Hand grip strength test is performed by HandGRIP Dynamometer
|
baseline
|
|
Hand grip strength test
Délai: after 12-week intervention
|
Hand grip strength test is performed by HandGRIP Dynamometer
|
after 12-week intervention
|
|
Extremity strength
Délai: baseline
|
Extremity strength test is performed by handheld dynamometer
|
baseline
|
|
Extremity strength
Délai: after 12-week intervention
|
Extremity strength test is performed by handheld dynamometer
|
after 12-week intervention
|
|
Soda pop coordination
Délai: baseline
|
The Soda Pop Coordination Test assesses manual dexterity and hand-eye coordination.
Participants use their dominant hand to flip and reposition three soda cans across six marked points as quickly as possible.
Completion time is recorded.
|
baseline
|
|
Soda pop coordination
Délai: after 12-week intervention
|
The Soda Pop Coordination Test assesses manual dexterity and hand-eye coordination.
Participants use their dominant hand to flip and reposition three soda cans across six marked points as quickly as possible.
Completion time is recorded.
|
after 12-week intervention
|
|
Ruler drop test
Délai: baseline
|
The Ruler Drop Test assesses visual reaction time and hand-eye coordination.
Participants catch a ruler dropped without warning using their dominant hand.
The falling distance is recorded to calculate reaction time in milliseconds.
|
baseline
|
|
Ruler drop test
Délai: after 12-week intervation
|
The Ruler Drop Test assesses visual reaction time and hand-eye coordination.
Participants catch a ruler dropped without warning using their dominant hand.
The falling distance is recorded to calculate reaction time in milliseconds.
|
after 12-week intervation
|
|
Box and blocks test
Délai: baseline
|
The Box and Block Test assesses gross manual dexterity and upper-extremity function.
Participants transfer blocks across a partition using one hand at a time.
The number of blocks transferred within one minute is recorded.
|
baseline
|
|
Box and blocks test
Délai: after 12-week intervation
|
The Box and Block Test assesses gross manual dexterity and upper-extremity function.
Participants transfer blocks across a partition using one hand at a time.
The number of blocks transferred within one minute is recorded.
|
after 12-week intervation
|
|
EQ-5D (EuroQol- 5 Dimensions)
Délai: after 12-week intervention
|
EQ-5D is a standardized instrument with 5-item questionnaire for measuring generic health status.
EQ-5D was first introduced in 1990 by the EuroQol Group.
In which health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Rated level can be coded as a number 1, 2, or 3, which indicates having no problems for 1, having some problems for 2, and having extreme problems for 3.
As a result, a person's health status can be defined by a 5-digit number, ranging from 11111 (having no problems in all dimensions) to 33333(having extreme problems in all dimensions).
|
after 12-week intervention
|
|
QUEST (Questionnaire for satisfaction)
Délai: after 12-week intervention
|
The 8 items of the questionnaire included Dimensions, Weight, Ease in Adjusting, Safety and Security, Durability, Ease of Use, Comfortable, and Effectiveness.
Each item employed a 5-point scale, with 1-point representing not satisfied at all, and 5-point representing very satisfied.
Evaluation of Satisfaction with Assistive Technology.
|
after 12-week intervention
|
|
System Usability Scale (SUS)
Délai: after 12-week intervention
|
The System Usability Scale (SUS) is a reliable, 10-item Likert-scale questionnaire utilized to provide a global evaluation of a system's usability and user-friendliness.
Each item is scored from 1 (strongly disagree) to 5 (strongly agree).
Higher scores indicate better system usability.
|
after 12-week intervention
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Li-Chieh Kuo, Ph. D., National Cheng-Kung University Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- B-BR-106-072B
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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