- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Li-Chieh Kuo, Ph. D.
- Numero di telefono: 886-62353535 Ext. 5908
- Email: jkkuo@mail.ncku.edu.tw
Backup dei contatti dello studio
- Nome: Chih-Chun Lin, Ph. D.
- Numero di telefono: 886-62757575 Ext. 58420
- Email: z9902026@email.ncku.edu.tw
Luoghi di studio
-
-
Taiwan
-
Tainan, Taiwan, Taiwan, 701
- Reclutamento
- National Cheng-Kung University
-
Contatto:
- Li-Chieh Kuo, Ph. D.
- Numero di telefono: 886-62353535 Ext. 5908
- Email: jkkuo@mail.ncku.edu.tw
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: 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.
|
|
Sperimentale: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
TUG Manual
Lasso di tempo: 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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Test del cammino di sei minuti
Lasso di tempo: linea di base
|
Camminare il più possibile entro sei minuti e misurare la distanza totale percorsa.
|
linea di base
|
|
Test del cammino di sei minuti
Lasso di tempo: dopo 12 settimane di intervento
|
Camminare il più possibile entro sei minuti e misurare la distanza totale percorsa.
|
dopo 12 settimane di intervento
|
|
Test del passo di 2 minuti
Lasso di tempo: linea di base
|
Il test del passo di 2 minuti consiste nel completare i passaggi in 2 minuti.
Viene registrato il numero di passi completi completati in 2 minuti.
|
linea di base
|
|
Test del passo di 2 minuti
Lasso di tempo: dopo 12 settimane di intervento
|
Il test del passo di 2 minuti consiste nel completare i passaggi in 2 minuti.
Viene registrato il numero di passi completi completati in 2 minuti.
|
dopo 12 settimane di intervento
|
|
Equilibrio su una gamba sola con test ad occhi aperti
Lasso di tempo: linea di base
|
Al partecipante viene chiesto di stare in piedi su una gamba con gli occhi aperti, viene registrato il numero di secondi.
|
linea di base
|
|
Equilibrio su una gamba sola con test ad occhi aperti
Lasso di tempo: dopo 12 settimane di intervento
|
Al partecipante viene chiesto di stare in piedi su una gamba con gli occhi aperti, viene registrato il numero di secondi.
|
dopo 12 settimane di intervento
|
|
Indice di fragilità SOF (Study of Osteoporotic Fractures) (Questionario per la funzione fisica e lo stato di salute)
Lasso di tempo: linea di base
|
Fattori di rischio per fratture e cadute ed è cresciuto fino a considerare vari fattori determinanti dell'invecchiamento di successo.
Tre domande sulla fragilità e due domande sulla depressione.
|
linea di base
|
|
Indice di fragilità SOF (Study of Osteoporotic Fractures) (Questionario per la funzione fisica e lo stato di salute)
Lasso di tempo: dopo 12 settimane di intervento
|
Fattori di rischio per fratture e cadute ed è cresciuto fino a considerare vari fattori determinanti dell'invecchiamento di successo.
Tre domande sulla fragilità e due domande sulla depressione.
|
dopo 12 settimane di intervento
|
|
SARC-F
Lasso di tempo: linea di base
|
Il questionario SARC-F è un test diagnostico rapido per la SARCopenia.
Il questionario contiene cinque elementi, che sono Forza, Assistenza nel camminare, Alzarsi da una sedia, Salire le scale e Cadere.
I punteggi vanno da 0 a 10, con da 0 a 2 punti per ogni componente.
Un punteggio uguale o superiore a 4 è predittivo di sarcopenia e scarsi risultati.
|
linea di base
|
|
SARC-F
Lasso di tempo: dopo 12 settimane di intervento
|
Il questionario SARC-F è un test diagnostico rapido per la SARCopenia.
Il questionario contiene cinque elementi, che sono Forza, Assistenza nel camminare, Alzarsi da una sedia, Salire le scale e Cadere.
I punteggi vanno da 0 a 10, con da 0 a 2 punti per ogni componente.
Un punteggio uguale o superiore a 4 è predittivo di sarcopenia e scarsi risultati.
|
dopo 12 settimane di intervento
|
|
EQ-5D (EuroQol- 5 Dimensions)
Lasso di tempo: 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
Lasso di tempo: basline
|
Participants's weight in kilograms divided by the square of height in meters is recorded as Body Mass Index (BMI).
|
basline
|
|
BMI
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: baseline
|
Number of full stands that can completed in 30 seconds with arms folded across chest.
|
baseline
|
|
30 second chair stand test
Lasso di tempo: after 12-week intervention
|
Number of full stands that can be completed 30 seconds with arms folded across chest.
|
after 12-week intervention
|
|
SMI
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: baseline
|
Hand grip strength test is performed by HandGRIP Dynamometer
|
baseline
|
|
Hand grip strength test
Lasso di tempo: after 12-week intervention
|
Hand grip strength test is performed by HandGRIP Dynamometer
|
after 12-week intervention
|
|
Extremity strength
Lasso di tempo: baseline
|
Extremity strength test is performed by handheld dynamometer
|
baseline
|
|
Extremity strength
Lasso di tempo: after 12-week intervention
|
Extremity strength test is performed by handheld dynamometer
|
after 12-week intervention
|
|
Soda pop coordination
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
|
Collaboratori e investigatori
Investigatori
- Direttore dello studio: Li-Chieh Kuo, Ph. D., National Cheng-Kung University Hospital
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- B-BR-106-072B
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