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临床试验/NCT03448276
NCT03448276已完成不适用

Immediate Effect Of Whole-Body Vibration And Walk Over Muscle Strength, Balance And Functional Performance In Elderly People With Osteoporosis And Osteopenia: Clinical Randomized Controlled Trial

Universidade Federal de Pernambuco1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2018年2月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
1
主要终点
Functional performance

研究概览

简要总结

Introduction: Osteoporosis and Osteopenia are common bone disorders, characterized by low bone mass, signs of bone deterioration and are responsible for typical bone fragility. Physical activity is certainly a valid prevention tool because it contributes to a healthy energy balance, increasing muscle mass and providing beneficial effects in bone metabolism. Stress induced by more vigorous activities such as weight lifting, increases the risk of injury, particularly in the elderly. Therefore, alternative strategies with lower risk of injury are indicated such as whole body vibration and walk.

Objective: Compare the effect whole body vibration and walking on muscular strength, balance and functional performance in the elderly with Osteoporosis and Osteopenia

Methods: It is a clinical trial study, controlled, parallel, randomized and blind, which will follow the guidelines established in the Consolidated Standards of Reporting Trials (CONSORT). Participants will be randomly distributed in 2 groups: the experimental group (GI) that will hold the training in the vibrating platform and the control group (GC) that will perform the walk, settling 1 treatment session. All participants will be subjected to the initial and final assessment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

盲法说明

Triple: a researcher shall be exclusively responsible for the evaluations and reevaluations not having knowledge of what intervention group the patient will enter. The patient will be allocated among three groups. After the final evaluations, all data will be analyzed by another researcher directed solely to that purpose. Therefore, there will be a triple blinding (researcher, patient and statistician).

入排标准

年龄范围
60 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Confirmed diagnosis of osteoporosis or osteopenia examination of bone densitometry;
  • Patients without severe neurological disease, vascular disorders, labyrinthitis and blindness;
  • No use of gait auxiliaries;
  • No history of fractures of the lower limbs in the last year;
  • Do not be an alcoholic inactive (0 to 5 points) or less active (6 to 11 points) accordance with the usual physical activity questionnaire (QAFH).

排除标准

  • Patients who submit to hypertensive peak, nausea and dizziness during the training program.

研究组 & 干预措施

Training in the vibrating platform

Experimental

20-minute workout will be held, which will include: heating (5 minutes and stretching for the muscles quadriceps and sural triceps), 10 and 5 min of cooling.

干预措施: Training in the vibrating platform (Other)

Walk

Active Comparator

Will be held 30 minutes of training, which will include the heating (5 minutes of stretching for the muscles quadriceps and sural triceps), 10 and 5 min of cooling.

干预措施: Walk (Other)

结局指标

主要结局

Functional performance

时间窗: 20 minutes

Timed Up and Go test (TUG)

Muscular strength

时间窗: 20 minutes

Test of 1 repetition maximum (1RM)

Balance

时间窗: 20 minutes

Berg Balance scale (BBS). Minimum score 0 and maximum 56, the lower the score the greater the risk of falls.

次要结局

  • Plantar pressure distribution(20 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maria das Graças Rodrigues de Araújo

Professor, PhD

Universidade Federal de Pernambuco

研究点 (1)

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