- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Li-Chieh Kuo, Ph. D.
- 전화번호: 886-62353535 Ext. 5908
- 이메일: jkkuo@mail.ncku.edu.tw
연구 연락처 백업
- 이름: Chih-Chun Lin, Ph. D.
- 전화번호: 886-62757575 Ext. 58420
- 이메일: z9902026@email.ncku.edu.tw
연구 장소
-
-
Taiwan
-
Tainan, Taiwan, 대만, 701
- 모병
- National Cheng-Kung University
-
연락하다:
- Li-Chieh Kuo, Ph. D.
- 전화번호: 886-62353535 Ext. 5908
- 이메일: jkkuo@mail.ncku.edu.tw
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: 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.
|
|
실험적: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
TUG Manual
기간: 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
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
6분 걷기 테스트
기간: 기준선
|
6분 이내에 최대한 많이 걷고 이동한 총 거리를 측정합니다.
|
기준선
|
|
6분 걷기 테스트
기간: 12주 개입 후
|
6분 이내에 최대한 많이 걷고 이동한 총 거리를 측정합니다.
|
12주 개입 후
|
|
2분 걸음 테스트
기간: 기준선
|
2분 스텝 테스트는 2분 안에 단계를 완료하는 것입니다.
2분 안에 완료한 전체 걸음 수를 기록합니다.
|
기준선
|
|
2분 걸음 테스트
기간: 12주 개입 후
|
2분 스텝 테스트는 2분 안에 단계를 완료하는 것입니다.
2분 안에 완료한 전체 걸음 수를 기록합니다.
|
12주 개입 후
|
|
눈을 뜨고 한쪽 다리 균형 테스트
기간: 기준선
|
참가자에게 눈을 뜨고 한쪽 다리로 서도록 지시하고 초를 기록합니다.
|
기준선
|
|
눈을 뜨고 한쪽 다리 균형 테스트
기간: 12주 개입 후
|
참가자에게 눈을 뜨고 한쪽 다리로 서도록 지시하고 초를 기록합니다.
|
12주 개입 후
|
|
SOF(Study of Osteoporotic Fractures) 노쇠 지수(신체 기능 및 건강 상태에 대한 설문지)
기간: 기준선
|
골절 및 낙상에 대한 위험 요인과 성공적인 노화의 다양한 결정요인을 살펴보기 위해 성장했습니다.
나약함에 관한 세 가지 질문과 우울증에 관한 두 가지 질문.
|
기준선
|
|
SOF(Study of Osteoporotic Fractures) 노쇠 지수(신체 기능 및 건강 상태에 대한 설문지)
기간: 12주 개입 후
|
골절 및 낙상에 대한 위험 요인과 성공적인 노화의 다양한 결정요인을 살펴보기 위해 성장했습니다.
나약함에 관한 세 가지 질문과 우울증에 관한 두 가지 질문.
|
12주 개입 후
|
|
SARC-F
기간: 기준선
|
SARC-F 설문지는 SARCopenia에 대한 빠른 진단 테스트입니다.
설문지는 근력, 보행 보조, 의자에서 일어나기, 계단 오르기, 넘어짐의 5개 항목으로 구성되어 있습니다.
점수 범위는 0에서 10까지이며 각 구성 요소에 대해 0에서 2점입니다.
4 이상의 점수는 근감소증 및 불량한 결과를 예측합니다.
|
기준선
|
|
SARC-F
기간: 12주 개입 후
|
SARC-F 설문지는 SARCopenia에 대한 빠른 진단 테스트입니다.
설문지는 근력, 보행 보조, 의자에서 일어나기, 계단 오르기, 넘어짐의 5개 항목으로 구성되어 있습니다.
점수 범위는 0에서 10까지이며 각 구성 요소에 대해 0에서 2점입니다.
4 이상의 점수는 근감소증 및 불량한 결과를 예측합니다.
|
12주 개입 후
|
|
EQ-5D (EuroQol- 5 Dimensions)
기간: 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
기간: basline
|
Participants's weight in kilograms divided by the square of height in meters is recorded as Body Mass Index (BMI).
|
basline
|
|
BMI
기간: 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
기간: 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
기간: 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
기간: baseline
|
Number of full stands that can completed in 30 seconds with arms folded across chest.
|
baseline
|
|
30 second chair stand test
기간: after 12-week intervention
|
Number of full stands that can be completed 30 seconds with arms folded across chest.
|
after 12-week intervention
|
|
SMI
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: baseline
|
Hand grip strength test is performed by HandGRIP Dynamometer
|
baseline
|
|
Hand grip strength test
기간: after 12-week intervention
|
Hand grip strength test is performed by HandGRIP Dynamometer
|
after 12-week intervention
|
|
Extremity strength
기간: baseline
|
Extremity strength test is performed by handheld dynamometer
|
baseline
|
|
Extremity strength
기간: after 12-week intervention
|
Extremity strength test is performed by handheld dynamometer
|
after 12-week intervention
|
|
Soda pop coordination
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Li-Chieh Kuo, Ph. D., National Cheng-Kung University Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- B-BR-106-072B
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .