- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03607136
Early Detection of Disability and Health Promotion for Community-dwelling Elderly
Department of Physical Therapy, Tzu Chi University
연구 개요
상세 설명
Physical inactivity can result in physical frailty and sarcopenia. Physical frailty and sarcopenia are two common and mostly overlapping geriatric conditions, which may cause negative consequences of aging, such as disability, hospitalization and mortality.
Regular physical activity has been suggested to maintain or improve functional capacity and body composition, as well as delay aging process. Nevertheless, inactivity prevalence still significantly increases among older adults, especially those with a disability. One of the probable reasons is that the use of physical activities or exercise interventions is not tailored to the needs and capabilities of the elderly.
연구 유형
등록 (예상)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- age greater than 50 years
- able to follow simple instructions
- willing to participate and sign consent form
Exclusion Criteria:
- unstable angina or epilepsy
- severe visual deficits
- cognitive dysfunction
- other musculoskeletal conditions that will limit mobility
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: exercise training
Participants in the exercise training group received a 12-week exercise training.
|
Aerobic exercises, strengthening exercises, flexibility training for 60min, twice a week for 12 weeks
|
|
간섭 없음: control
Participants in the control group did not receive any specific training programs instead of maintaining their usual activities of daily living.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Walking speed
기간: Change from baseline at 12 weeks
|
Participants are asked to walk along a 14 m hallway.
The time taken to the middle 10 m is recorded to calculate walking speed (m/s).
|
Change from baseline at 12 weeks
|
|
Muscle strength
기간: Change from baseline at 12 weeks
|
Muscle strength is assessed using hand-hold Dynamometers
|
Change from baseline at 12 weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Timed up and go test
기간: Change from baseline at 12 weeks
|
Participants are asked to stand up, walk 3 m, turn around a cone, and return to a sitting position
|
Change from baseline at 12 weeks
|
|
Walking endurance
기간: Change from baseline at 12 weeks
|
Participants are asked to walk back and forth along a 20-meter corridor and to cover the maximum distance possible in six minutes
|
Change from baseline at 12 weeks
|
|
Sit-to-stand test
기간: Change from baseline at 12 weeks
|
Participants are asked to stand up and sit down 5 times.
|
Change from baseline at 12 weeks
|
|
Berg balance scale
기간: Change from baseline at 12 weeks
|
It consists of 14 items, including sitting unsupported, standing unsupported, standing with eyes closed, standing with feet together, standing on one foot, turning to look behind, retrieving objective from floor, random standing, reaching forward with an outsrptretched arm, sit to stand, stand to sit, transfer, turning 360 degrees, stool stepping, scored from 0 to 4, "0" indicates the lowest level of function and "4" the highest level of function.
Total Score = 56.
|
Change from baseline at 12 weeks
|
|
Gait kinematics
기간: Change from baseline at 12 weeks
|
Gait kinematics are assessed by angular displacement of lower limbs using shoe-worn inertial measurement unit based device
|
Change from baseline at 12 weeks
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
기본 완료 (예상)
연구 완료 (예상)
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 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. .
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