- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef 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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Li-Chieh Kuo, Ph. D.
- Telefoonnummer: 886-62353535 Ext. 5908
- E-mail: jkkuo@mail.ncku.edu.tw
Studie Contact Back-up
- Naam: Chih-Chun Lin, Ph. D.
- Telefoonnummer: 886-62757575 Ext. 58420
- E-mail: z9902026@email.ncku.edu.tw
Studie Locaties
-
-
Taiwan
-
Tainan, Taiwan, Taiwan, 701
- Werving
- National Cheng-Kung University
-
Contact:
- Li-Chieh Kuo, Ph. D.
- Telefoonnummer: 886-62353535 Ext. 5908
- E-mail: jkkuo@mail.ncku.edu.tw
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: 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.
|
|
Experimenteel: 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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
TUG Manual
Tijdsspanne: 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
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Looptest van zes minuten
Tijdsspanne: basislijn
|
Zoveel mogelijk binnen zes minuten lopen en de totale afgelegde afstand meten.
|
basislijn
|
|
Looptest van zes minuten
Tijdsspanne: na 12 weken interventie
|
Zoveel mogelijk binnen zes minuten lopen en de totale afgelegde afstand meten.
|
na 12 weken interventie
|
|
Stappentest van 2 minuten
Tijdsspanne: basislijn
|
Stappentest van 2 minuten is om stappen in 2 minuten te voltooien.
Het aantal volledige stappen dat in 2 minuten is voltooid, wordt geregistreerd.
|
basislijn
|
|
Stappentest van 2 minuten
Tijdsspanne: na 12 weken interventie
|
Stappentest van 2 minuten is om stappen in 2 minuten te voltooien.
Het aantal volledige stappen dat in 2 minuten is voltooid, wordt geregistreerd.
|
na 12 weken interventie
|
|
Evenwicht op één been met ogen open test
Tijdsspanne: basislijn
|
De deelnemer krijgt de instructie om op één been te gaan staan met het oog open, het aantal seconden wordt geregistreerd.
|
basislijn
|
|
Evenwicht op één been met ogen open test
Tijdsspanne: na 12 weken interventie
|
De deelnemer krijgt de instructie om op één been te gaan staan met het oog open, het aantal seconden wordt geregistreerd.
|
na 12 weken interventie
|
|
SOF (Studie van Osteoporotische Fracturen) kwetsbaarheidsindex (Vragenlijst voor lichamelijk functioneren en gezondheidstoestand)
Tijdsspanne: basislijn
|
Risicofactoren voor fracturen en vallen zijn uitgegroeid tot verschillende determinanten van succesvol ouder worden.
Drie vragen over kwetsbaarheid en twee vragen over depressie.
|
basislijn
|
|
SOF (Studie van Osteoporotische Fracturen) kwetsbaarheidsindex (Vragenlijst voor lichamelijk functioneren en gezondheidstoestand)
Tijdsspanne: na 12 weken interventie
|
Risicofactoren voor fracturen en vallen zijn uitgegroeid tot verschillende determinanten van succesvol ouder worden.
Drie vragen over kwetsbaarheid en twee vragen over depressie.
|
na 12 weken interventie
|
|
SARC-F
Tijdsspanne: basislijn
|
De SARC-F-vragenlijst is een snelle diagnostische test voor SARCopenie.
De vragenlijst bevat vijf items, te weten Kracht, Hulp bij lopen, Opstaan uit een stoel, Traplopen en Vallen.
De scores lopen van 0 tot 10, met 0 tot 2 punten voor elk onderdeel.
Score gelijk aan of groter dan 4 is voorspellend voor sarcopenie en slechte resultaten.
|
basislijn
|
|
SARC-F
Tijdsspanne: na 12 weken interventie
|
De SARC-F-vragenlijst is een snelle diagnostische test voor SARCopenie.
De vragenlijst bevat vijf items, te weten Kracht, Hulp bij lopen, Opstaan uit een stoel, Traplopen en Vallen.
De scores lopen van 0 tot 10, met 0 tot 2 punten voor elk onderdeel.
Score gelijk aan of groter dan 4 is voorspellend voor sarcopenie en slechte resultaten.
|
na 12 weken interventie
|
|
EQ-5D (EuroQol- 5 Dimensions)
Tijdsspanne: 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
Tijdsspanne: basline
|
Participants's weight in kilograms divided by the square of height in meters is recorded as Body Mass Index (BMI).
|
basline
|
|
BMI
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: baseline
|
Number of full stands that can completed in 30 seconds with arms folded across chest.
|
baseline
|
|
30 second chair stand test
Tijdsspanne: after 12-week intervention
|
Number of full stands that can be completed 30 seconds with arms folded across chest.
|
after 12-week intervention
|
|
SMI
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: baseline
|
Hand grip strength test is performed by HandGRIP Dynamometer
|
baseline
|
|
Hand grip strength test
Tijdsspanne: after 12-week intervention
|
Hand grip strength test is performed by HandGRIP Dynamometer
|
after 12-week intervention
|
|
Extremity strength
Tijdsspanne: baseline
|
Extremity strength test is performed by handheld dynamometer
|
baseline
|
|
Extremity strength
Tijdsspanne: after 12-week intervention
|
Extremity strength test is performed by handheld dynamometer
|
after 12-week intervention
|
|
Soda pop coordination
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Onderzoekers
- Studie directeur: Li-Chieh Kuo, Ph. D., National Cheng-Kung University Hospital
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- B-BR-106-072B
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .