- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03986840
Multicomponent Exercise Training in Frail Elderly
Effectiveness of the Multicomponent Exercise Training in Frail Elderly
The aim of the present study will be to assess the effectiveness of the multicomponent exercise training in frail for the physical function, frailty and performance.
All the individuals will be assessed two times.
연구 개요
상세 설명
This will be a experimental, randomized controlled intervention study in frail. Subjects will be recruited at the Albertia Care Center, Madrid. The exercise training group will developed a concurrent training 3 days per week during 6 weeks. The control group will follow an usual care also for 6 weeks.
The main variables will be as follows:
- Ultrasound imaging measurements for the lower limb: core muscles, vastus medialis, rectus femoris, vastus intermedius, gastrocnemius, soleus. We will employed a General Electric (GE) Ultrasound device in B mode to assess the thickness of the muscles.
- Heart rate variability with a Suunto smart bell.
- Activities of daily living with the Bartel index.
- Force-velocity profile and muscle power.
- Frailty with the Linda´s frailty criteria.
The exercise program was applied for 6 weeks. A total of 18 sessions were distributed in 3 weekly sessions. The participants performed a resistance exercises: leg press at an intensity of 40%-60% with 10 repetitions, 12 repetitions of steps with their bodyweight and a plantar flexion followed by a cardiovascular high intensity interval training (HIIT) exercise walking on a treadmill.
One measurements will be taken (pre), the second (post) measurements will be performed at 6 weeks.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Madrid, 스페인
- Albertia Elderly Care Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Men and women aged 75 years or more,
- 2 or more points in the Short Physical Performance Battery (SPPB)
- Capability of walking (alone or assisted)
Exclusion Criteria:
- Severity cognitive alterations
- Severe disability on the Barthel score
- Surgeries in the previous 6 months
- Other any disorder that exclude for the exercise group.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Exercise program
The exercise program was applied for 6 weeks.
A total of 18 sessions were distributed in 3 weekly sessions.
The participants performed a resistance exercises: leg press at an intensity of 40%-60% with 10 repetitions, 12 repetitions of steps with their bodyweight and a plantar flexion followed by a cardiovascular HIIT exercise walking on a treadmill.
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A multicomponent exercise program
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활성 비교기: Daily activities
The patients who belongs to this group will continue to perform their daily routines.
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A multicomponent exercise program
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Thickness of the core and quadriceps muscles
기간: Change from baseline muscle thickness at 6 weeks
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Thickness assessment by ultrasound imaging
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Change from baseline muscle thickness at 6 weeks
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Heart rate variability
기간: Change from baseline heart rate variability at 6 weeks
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Heart rate variability by Suunto smart bell device
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Change from baseline heart rate variability at 6 weeks
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Daily life activities
기간: Change from baseline daily life activities at 6 weeks
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Bartel index questionnaire
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Change from baseline daily life activities at 6 weeks
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Muscle power
기간: Change from baseline muscle power at 6 weeks
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Force-velocity profile for the lower limb muscle power
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Change from baseline muscle power at 6 weeks
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Frailty
기간: Change from baseline frailty at 6 weeks
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Frailty with the Linda´s frailty criteria
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Change from baseline frailty at 6 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Sergio López, MsC, Universidad Europea de Madrid
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
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