관절 운동성에 대한 식물 추출물 조합(BSL_EP028)의 평가
식물추출물 복합제(BSL_EP028) 섭취가 관절 운동성, 신체 기능 및 활력에 미치는 영향을 평가하기 위한 파일럿 연구
The aim of this trial is to study the effect of the combination of plant extracts (BSL_EP028) on joint mobility, physical performance and vitality in a group of healthy older adults who remit some joint discomfort. This is a preliminary study whose purpose is to gather information for future studies.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
The natural aging process involves several body changes that can affect to the mobility of subjects. Among them, those that affect the joints may have the greatest impact on mobility. With age, there is a progressive loss of the cartilage that covers the joints, as well as the synovial fluid, which in turn increases the stiffness of the ligaments and tendons that allow joint mobility, which implies a reduction in muscle tone and bone strength. This joint degeneration produces pain and discomfort, which leads to stiffness and restriction of movement. Therefore, and as a consequence of this loss of mobility, subjects decrease their physical performance, which can affect their mood and vitality. All of these may lead to a loss of quality of life and to an increase of the risk of future adverse health events, such as disability, institutionalization, hospitalization and the need for home medical care.
For all these reasons, and considering the increase in the ageing population worldwide, it seems relevant to develop new strategies to improve joint mobility, physical performance and vitality that are safe for the consumer, affordable and not associated with undesirable side effects. In this regard, natural plant extracts have been widely used as a traditional remedy to reduce joint pain, reduce fatigue and improve mood and physical performance.
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 2 단계
- 1단계
연락처 및 위치
연구 장소
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Madrid
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Villaviciosa de Odón, Madrid, 스페인, 28670
- Universidad Europea de Madrid
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Healthy men and women that have joint discomfort (WOMAC score >20)
Exclusion Criteria:
- Consumption of pharmacological treatments on an ongoing basis that may affect joint mobility (chondroprotectors, corticoids and/or interarticular therapy or infiltrations).
- Having undergone surgery for osteoarthritis and/or having a diagnosis of degenerative osteoarthritis made by a rheumatologist/traumatologist
- Consuming nutritional supplements containing antioxidant substances
- Consumption of analgesics and/or anti-inflammatory drugs on a continuous and/or scheduled basis and will continue to do so during the study, even if they do not have pain.
- Being unable to perform the physical tests required in the study.
- Have an allergy to some component of the study product.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: Combination of Plant Extracts (BSL_EP028)
Volunteers will take twice at day for 8 weeks a capsule containing the combination of a plant extracts (BSL_EP028) |
Each participant will consume 2 capsules daily, in the morning and at night without any restriction in the diet nor in their habits of life. |
|
위약 비교기: Placebo
Volunteers will take twice at day for 8 weeks a capsule containing maltodextrin. |
Each participant will consume 2 capsules daily, in the morning and at night without any restriction in the diet nor in their habits of life. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Total Score of the WOMAC (Western Ontario and McMaster. Universities Osteoarthritis index) test
기간: 8 weeks
|
It is a questionnaire consisting of 24 items divided into 3 subscales:
|
8 weeks
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
SF-36 Vitality score
기간: 8 weeks
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Vitality score measured by the The Short Form (36) Health Survey (0-100 scale, the higher score the higher vitality) |
8 weeks
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Physical activity measurement
기간: 8 weeks
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Physical activity level will measure by the International Physical Activity Questionnaire (IPAQ). Results will be reported as MET minutes a week |
8 weeks
|
기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Evaluation of Knee Pain
기간: 8 weeks
|
Knee pain will evaluate by a Visual Analogue Scale (VAS), range 0 to 10, being 0 no pain and 10 the maximun pain |
8 weeks
|
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Evaluation of Hip Pain
기간: 8 weeks
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Hip pain will evaluate by a Visual Analogue Scale (VAS), range 0 to 10, being 0 no pain and 10 the maximun pain |
8 weeks
|
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Timed Up and Go test
기간: 8 weeks
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This test evaluates mobility and balance by measuring the time it takes a person to get up from a chair, walk three meters, turn around, walk to the chair, and sit. |
8 weeks
|
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30 sec Chair Stand test
기간: 8 weeks
|
This test evaluates the strength and endurance of the lower limbs by measuring the number of times a person can get up from a chair, with arms crossed at the chest, for 30 seconds. |
8 weeks
|
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Manual Dynamometry
기간: 8 weeks
|
Evaluates the grip strength of both hands |
8 weeks
|
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Evaluation of Muscular power and fatigue of the lower limbs
기간: 8 weeks
|
We evaluate the strength-velocity profile that the person has in the lower limbs through a linear encoder. It measures the speed of execution of a squat (extension of hips and knees) with three different loads. |
8 weeks
|
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Goniometric study
기간: 8 weeks
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Evaluates the angles and ranges of movement of the hip joint (flexo-extension, abduction-adduction, internal-external rotation) and the femorotibial (flexo-extension). |
8 weeks
|
공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: Helios Pareja Galeano, Universidad Europea de Madrid
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (실제)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- C028
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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