Obesity, Sarcopenic, Risk of Falls in Spanish Postmenopausal Women
2021년 9월 9일 업데이트: Agustín Aibar Almazán, University of Jaén
Effects of a Program of Pilates Exercises on Obesity, Sarcopenic, Risk of Falls and Health in Spanish Postmenopausal Women
To analyze the effects of a Pilates exercise program on obesity, sarcopenic, risk of falls and health in Spanish postmenopausal women.
연구 개요
상세 설명
This is a randomized clinical trial of single-blind with 2 arms (Control group and experimental group), in which a pre-treatment-postest design has been used.
The study will define two groups:
- A control group (CG) that will not be submitted to treatment, which will be evaluated in the pre and post phase of the study. Participants assigned to this group will receive general advice on the positive effects of regular physical activity and will be given a guide to recommendations for promoting physical activity.
- An experimental group (GE) that after an initial evaluation will undergo a physical training program based on Pilates exercises.
Once the intervention is finished, it will be submitted to a final evaluation to see if there is a difference or not with the results obtained at the beginning.
연구 유형
중재적
등록 (실제)
107
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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Jaén, 스페인, 23002
- Center of active participation of seniors of Jaén "Catedral"
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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
50년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
여성
설명
Inclusion Criteria:
- No menstrual activity for at least 12 months.
- Present obesity and / or sarcopenic.
- Do not participate in a weight loss program.
- Be able to understand the instructions, programs and protocols of this project.
Exclusion Criteria:
- Contraindications for conducting physical tests.
- Diseases that limit the static and dynamic balance and physical activity. -
- Central or peripheral vestibular or nerve alterations.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 필라테스 그룹
이 그룹은 필라테스 운동을 기반으로 체력 훈련을 받습니다.
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Training based on a basic level Pilates exercise program will be as follows: A duration of weeks with a frequency of 2 sessions a week and with a duration of 55 minutes each. The exercises to be performed will be divided into three distinct phases: warm-up, lasting 15 minutes; Main part with a duration of 30 minutes and the return to calm, based mostly on stretching and with a duration of 10 minutes. The repetitions of the exercises will be between 5 and 10 according to the difficulty. |
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간섭 없음: 중재 그룹 없음
이 그룹은 어떠한 치료도 받지 않습니다.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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골격근량(kg)
기간: 초기와 3개월
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거의 골격근으로 구성되어 있고 전체 골격근의 약 70%를 차지하는 팔다리의 근육량을 기준으로 산정
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초기와 3개월
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TUG(Timed Up and Go 테스트)
기간: 초기와 3개월
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사람의 이동성과 신체 기능을 평가하는 데 사용되는 간단한 테스트입니다.
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초기와 3개월
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X 평균
기간: 초기와 3개월
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압력 센터의 측면 진동의 평균값
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초기와 3개월
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Y 의미
기간: 초기와 3개월
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압력 센터의 전후방 진동의 평균값
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초기와 3개월
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Dynamometer
기간: At the beginning and at three months
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Dynamometer will be employed to assess hand grip stregth.
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At the beginning and at three months
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ABC-16 (Activities Specific Balance Confidence Scale)
기간: At the beginning and at three months
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Questionnaire that assesses balance confidence in performing activities of daily living.
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At the beginning and at three months
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FES-I (Falls Efficacy Scale-International)
기간: At the beginning and at three months
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Questionnaire that evaluates the fear of falling.
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At the beginning and at three months
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Barthel index
기간: At the beginning and at three months
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Measures disability or dependence in activities of daily living
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At the beginning and at three months
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KATZ INDEX
기간: At the beginning and at three months
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Is a widely used tool to assess the level of independency in older adults.
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At the beginning and at three months
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FSS (Fatigue Severity Scale)
기간: At the beginning and at three months
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A self-report scale describing the severity of fatigue and the impact of fatigue on activities of daily living.
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At the beginning and at three months
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PSQI (Pittsburgh Sleep Quality Index)
기간: At the beginning and at three months
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A simple and valid assessment of both sleep quality and disturbance that might affect sleep quality.
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At the beginning and at three months
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HADS (The Hospital Anxiety And Depression)
기간: At the beginning and at three months
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A reliable, valid and practical screening tool for identifying and quantifying anxiety and/or depression in non- patients.
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At the beginning and at three months
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SF-36 (The Short Form-36 Health Survey)
기간: At the beginning and at three months
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Used extensively for assessing health-related quality of life.
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At the beginning and at three months
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MRS (Menopause Rating Scale):
기간: At the beginning and at three months
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Assesses the severity of menopause-related complaints and the impact on health-related quality of life.
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At the beginning and at three months
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FSFI (Female Sexual Function Index)
기간: At the beginning and at three months
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Is a brief questionnaire that evaluates sexual functioning in women.
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At the beginning and at three months
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INBODY
기간: At the beginning and at three months
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Valid and reliable tool to quantify and measure the 4 major components of body composition: Water, Protein, Minerals and Fat.
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At the beginning and at three months
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Bone Mineral Content (BMC)
기간: At the beginning and at three months
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Is mineral mass in bone.
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At the beginning and at three months
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Body Weight
기간: At the beginning and at three months
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Is the sum of Body Fat and Fat Free Mass.
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At the beginning and at three months
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Lean Body Mass
기간: At the beginning and at three months
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The amount of lean body mass.
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At the beginning and at three months
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Body Fat Mass
기간: At the beginning and at three months
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The standard range of Body Fat Mass is ascertained by calculating an examinee Body Fat Mass as compared to the standard weight and standard Body Fat Mass.
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At the beginning and at three months
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Percent of Body Fat (%)
기간: At the beginning and at three months
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Indicates the percentage of body fat to body weight.
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At the beginning and at three months
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BMI (Body Mass Index)
기간: At the beginning and at three months
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Is calculated from the formula, Weight (kg) / Height2 (m2), whose unit is kg/m2.
It is a rough indicator of total body fat.
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At the beginning and at three months
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Segmental Analysis
기간: At the beginning and at three months
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Is the technology that assumes the body as five cylinders of four limbs and trunk and measures the impedance of these parts separately.
Segmental body composition analysis provides segmental measurement of body water, muscle mass, and fat free mass.
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At the beginning and at three months
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OPTOGAIT
기간: At the beginning and at three months
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Is an innovative system for movement analysis and functional assessment of patients with normal or pathological conditions.
REACTION TEST: This test detects the time between one optical/acoustic impulse and the patient's movement.
It can be used to measure simple reactions or more complex movements
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At the beginning and at three months
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CT10P
기간: At the beginning and at three months
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Test that evaluates the balance by walking along a straight line.
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At the beginning and at three months
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STABILOMETRIC PLATFORM
기간: At the beginning and at three months
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Instrument composed of resistive pressure sensors, used to measure the static or postural balance.
The test was performed under both eyes-open and eyes-closed conditions.
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At the beginning and at three months
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RMS X
기간: At the beginning and at three months
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Mean position of the center of pressure in the mediolateral plane.
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At the beginning and at three months
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RMS Y
기간: At the beginning and at three months
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Mean position of the center of pressure in the anteroposterior plane
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At the beginning and at three months
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Length
기간: At the beginning and at three months
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Length of the path described by the center of pressure.
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At the beginning and at three months
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Area
기간: At the beginning and at three months
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Area of the path described by the center of pressure.
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At the beginning and at three months
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Velocity
기간: At the beginning and at three months
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Is an estimate of the average velocity of displacement of the center of pressures of the subject during the whole test.
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At the beginning and at three months
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Isaac test
기간: At the beginning and at three months
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Questionnaire that measures verbal fluency.
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At the beginning and at three months
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trail making test part a y b
기간: At the beginning and at three months
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Neuropsychological test of visual attention and task switching.
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At the beginning and at three months
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mmse (mini-mental state examination)
기간: At the beginning and at three months
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A tool that can be used to systematically and thoroughly assess mental status.
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At the beginning and at three months
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chair sit and reach test
기간: At the beginning and at three months
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To test low back and hamstring flexibility.
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At the beginning and at three months
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back scratch test
기간: At the beginning and at three months
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To measure general shoulder range of motion.
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At the beginning and at three months
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30-second chair stand test
기간: At the beginning and at three months
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To test leg strength and endurance.
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At the beginning and at three months
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height
기간: At the beginning and at three months
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The distance between the lowest and highest points of a person standing upright.
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At the beginning and at three months
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waist circumference
기간: At the beginning and at three months
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Is used to assess central fat distribution and degree of abdominal obesity.
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At the beginning and at three months
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hip circumference
기간: At the beginning and at three months
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It is the greatest circumference of hip
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At the beginning and at three months
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waist-to-hip ratio
기간: At the beginning and at three months
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Is the dimensionless ratio of the circumference of the waist to that of the hips.
This is calculated as waist measurement divided by hip measurement.
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At the beginning and at three months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 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 (실제)
2017년 8월 1일
기본 완료 (실제)
2017년 11월 1일
연구 완료 (실제)
2018년 2월 27일
연구 등록 날짜
최초 제출
2017년 6월 22일
QC 기준을 충족하는 최초 제출
2017년 6월 23일
처음 게시됨 (실제)
2017년 6월 28일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 9월 16일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 9월 9일
마지막으로 확인됨
2021년 9월 1일
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. .