- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02936336
The Effect of Exercise Intervention on the Community's Older Adults
2018년 5월 11일 업데이트: Robert Wen-Wei Hsu, Chang Gung Memorial Hospital
The Effect of Exercise Intervention on the Physical Fitness, Bone Mineral Density and Health-related Quality of Life in the Community's Older Adults
Osteoporosis is a serious global health problem, second only to cardiovascular disease.
Osteoporosis is the most common metabolic bone disease in the elderly population, characterized by loss of bone mineral density (BMD) and continuous destruction of bone microstructure, especially in postmenopausal women.
It gives rise to bone fragility and fracture risk.
Moreover, as people grow older, falls frequently occur with high severity, and nearly 35% to 45% of persons aged 65 or older fall at least once a year.
Osteoporotic fractures increase mortality, morbidity, chronic pain, and the cost of social care and it decreases the quality of life.
Here, investigators plan to perform different exercise interventions such as circuit exercise, aerobic dance and Tai Chi on the community's older adults to evaluate whether exercise intervention could improve the bone mineral density, physical fitness, muscle strength or quality of life.
연구 개요
연구 유형
중재적
등록 (실제)
411
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Pizi, 대만, 613
- Sports Medicine Center, Chang Gung Memorial Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
45년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Being >45 years-of-age,
- Healthy and physically independent.
Exclusion Criteria:
- The exclusion criteria were individuals on hormone replacement therapy and those with cognitive impairment, progressive debilitating conditions, bone fractures, or any medical contraindications to administering the fitness assessment.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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간섭 없음: Control
without exercise intervention
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실험적: Exercise
Subjects with circuit exercise, aerobic dance, or Tai Chi exercise intervention.
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circuit exercise, aerobic dance and Tai Chi exercise
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change from baseline bone mineral density
기간: Pre-intervention, 3-month, 6-month, 9-month-follow-up
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Bone mineral density measurement is measured by dual-energy x-ray absorptiometry (DXA).
Measurements are made over the lumbar spine and over the upper part of the hip and the measurement is assessed at Pre-intervention, 3-month, 6-month, 9-month-follow-up.
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Pre-intervention, 3-month, 6-month, 9-month-follow-up
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change from baseline elbow muscle strength
기간: Pre-intervention, 3-month, 6-month, 9-month-follow-up
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Extension and flexion of elbow were tested by the HUMAC NORM system (CSMi, Stoughton, MA) with the eccentric/concentric contraction mode at an angular velocity of 60 degrees/s.Isokinetic tests were performed five times for each participant, and each test was separated by a rest period of 3 min.The Muscle strength was present as a peak torque which was normalized to body weight (Unit:Nm/kg).
The participants are assessed at Pre-intervention, 3-month, 6-month, 9-month-follow-up.
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Pre-intervention, 3-month, 6-month, 9-month-follow-up
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Change from baseline shoulder muscle strength
기간: Pre-intervention, 3-month, 6-month, 9-month-follow-up
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Extension and flexion of shoulder were tested by the HUMAC NORM system (CSMi, Stoughton, MA) with the eccentric/concentric contraction mode at an angular velocity of 60 degrees/s.Isokinetic tests were performed five times for each participant, and each test was separated by a rest period of 3 min.The Muscle strength was present as a peak torque which was normalized to body weight (Unit:Nm/kg).
The participants are assessed at Pre-intervention, 3-month, 6-month, 9-month-follow-up.
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Pre-intervention, 3-month, 6-month, 9-month-follow-up
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Change from baseline hip muscle strength
기간: Pre-intervention, 3-month, 6-month, 9-month-follow-up
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Extension and flexion of hip were tested by the HUMAC NORM system (CSMi, Stoughton, MA) with the eccentric/concentric contraction mode at an angular velocity of 60 degrees/s.Isokinetic tests were performed five times for each participant, and each test was separated by a rest period of 3 min.The Muscle strength was present as a peak torque which was normalized to body weight (Unit:Nm/kg).
The participants are assessed at Pre-intervention, 3-month, 6-month, 9-month-follow-up.
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Pre-intervention, 3-month, 6-month, 9-month-follow-up
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Change from baseline knee muscle strength
기간: Pre-intervention, 3-month, 6-month, 9-month-follow-up
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Extension and flexion of knee were tested by the HUMAC NORM system (CSMi, Stoughton, MA) with the eccentric/concentric contraction mode at an angular velocity of 60 degrees/s.Isokinetic tests were performed five times for each participant, and each test was separated by a rest period of 3 min.The Muscle strength was present as a peak torque which was normalized to body weight (Unit:Nm/kg).
The participants are assessed at Pre-intervention, 3-month, 6-month, 9-month-follow-up.
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Pre-intervention, 3-month, 6-month, 9-month-follow-up
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Change from baseline SF-36 questionnaire assessment
기간: Pre-intervention, 3-month, 6-month, 9-month-follow-up
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SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section.
Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
The lower score the more disability.
The higher the score the less disability.
Eight sections including physical function, role limitation due to physical problems, bodily pain, general health, vitality, social functioning, role limitation due to emotional problems, and mental health.
Additionally, the eight health domains can be used to provide a physical component summary and mental component summary score.
The outcome measurement is assessed at Pre-intervention, 3-month, 6-month, 9-month-follow-up.
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Pre-intervention, 3-month, 6-month, 9-month-follow-up
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High-density lipoprotein from blood sample
기간: Pre-intervention, 3-month, 6-month, 9-month-follow-up
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High-density lipoprotein are measured at Pre-intervention, 3-month, 6-month, 9-month-follow-up.
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Pre-intervention, 3-month, 6-month, 9-month-follow-up
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Triglyceride from blood sample
기간: Pre-intervention, 3-month, 6-month, 9-month-follow-up
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Triglyceride are measured at Pre-intervention, 3-month, 6-month, 9-month-follow-up.
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Pre-intervention, 3-month, 6-month, 9-month-follow-up
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Fasting blood glucose from blood sample
기간: Pre-intervention, 3-month, 6-month, 9-month-follow-up
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Fasting blood glucose are measured at Pre-intervention, 3-month, 6-month, 9-month-follow-up.
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Pre-intervention, 3-month, 6-month, 9-month-follow-up
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Blood pressure
기간: Pre-intervention, 3-month, 6-month, 9-month-follow-up
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Diastolic and systolic blood pressure are measured at Pre-intervention, 3-month, 6-month, 9-month-follow-up.
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Pre-intervention, 3-month, 6-month, 9-month-follow-up
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Weight parameters of the subjects
기간: Pre-intervention, 3-month, 6-month, 9-month-follow-up
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Weight (kg) are measured at Pre-intervention, 3-month, 6-month, 9-month-follow-up.
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Pre-intervention, 3-month, 6-month, 9-month-follow-up
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Height parameters of the subjects
기간: Pre-intervention, 3-month, 6-month, 9-month-follow-up
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Height (cm) are measured at Pre-intervention, 3-month, 6-month, 9-month-follow-up.
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Pre-intervention, 3-month, 6-month, 9-month-follow-up
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Waistline parameters of the subjects
기간: Pre-intervention, 3-month, 6-month, 9-month-follow-up
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Waistline (cm) are measured at Pre-intervention, 3-month, 6-month, 9-month-follow-up.
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Pre-intervention, 3-month, 6-month, 9-month-follow-up
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Robert Wen-Wei HSU, MD, Sports Medicine Center, Chang Gung Memorial Hospital, Chiayi
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2009년 11월 1일
기본 완료 (실제)
2013년 12월 1일
연구 완료 (실제)
2013년 12월 1일
연구 등록 날짜
최초 제출
2016년 10월 13일
QC 기준을 충족하는 최초 제출
2016년 10월 14일
처음 게시됨 (추정)
2016년 10월 18일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 5월 14일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 5월 11일
마지막으로 확인됨
2018년 5월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CMRPG690111-3;CMRPG6A0421-22
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
미정
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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