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临床试验/NCT03918291
NCT03918291已完成不适用

Whole-body Vibration Training on Muscle Strength and Brain-derived Neurotrophic Factor Levels in Elderly Woman With Knee Osteoarthritis: a Randomized Clinical Trial Study.

Federal University of the Valleys of Jequitinhonha and Mucuri0 个研究点目标入组 15 人开始时间: 2008年10月28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
发起方
入组人数
15
主要终点
Change in isometric quadriceps muscle strength

研究概览

简要总结

The present study evaluated the effects of adding whole body vibration to squat training on the isometric quadriceps muscle strength, the plasma concentration of brain-derived neurotrophic factor at rest in elderly woman with osteoarthritis of the knee. The eligible patients were fifteen elderly women ≥ 60 years of age who had been diagnosed with osteoarthritis of the knee. The intervention consisted of uninterrupted squatting exercises for 12 weeks, a 3x/week. The exercise protocol was similar in both groups differed only in the presence of vibration.

详细描述

Ethical statement: This study was carried out in accordance with the recommendations of the ethical principles for research involving humans (Resolution 196-96 of the National Health Council of the Brazilian Ministry of Health) and Federal University of Jequitinhonha and Mucuri Valleys Ethics Committee. All subjects gave written informed consent in accordance with the Declaration of Helsinki. The protocol was approved by the Federal University of Jequitinhonha and Mucuri Valleys Ethics Committee (protocol No. 046.08).

Design: This is a randomized, controlled trial in which the variables were assessed 24 h before and 24 h after a 12-week training program. For the allocation of participants, a 1:1 ratio randomization was performed using opaque envelopes for allocation concealment. To minimize the chance of bias, The investigators used the following methods: a) opaque, sealed and serial-numbered envelopes; b) the envelopes were opened sequentially after the participant name and details were written on the envelope; c) the envelopes were kept in a locked and secure place. The allocation sequence was concealed from the researcher enrolling and assessing participants. Only one researcher performing the randomization was aware of the group assignment.

Subjects: The particpants were recruited through the physiotherapy clinic and through medical referrals. To participate in the study, participants were required to meet the following inclusion criteria: females older than 65 years of age; not using hormone replacement therapy; diagnosed with OA in at least one knee in accordance with of the American College of Rheumatology. The severity of the kOA was classified radiographically according to the Kellgren and Lawrence scale (grades 0-4, with 0 being normal and 4 representing severe OA). A Grade 2 classification (definite osteophytes and possible narrowing of joint space) was used as a cutoff to determine knee OA. Further inclusion criteria included the following: no recent knee injury; no walking aid requirement; and no rehabilitation procedures in the previous three months. Participants were excluded if they had any orthopedic, neurological, respiratory or acute cardiac diseases or if had any cognitive deficit as determined by the Mini-Mental State Examination.

Of the 125 elderly people screened for eligibility, 15 elderly women fulfilled the criteria, had blood sampling collected at rest (8:00 a.m.) and then participated in the IQMS test. Thereafter, the participants were allocated to one of two groups: 1) the vibration group, in which participants performed squat exercise training in association with WBV (VG; n=7); or 2) the exercise group, in which participants performed squat exercise training without vibration (EG; n=8).

Procedures: The clinical and demographic data were collected from the participants using an evaluation chart. Prior to the initiation of the 12-week intervention program, a blood sample was collected at 8:00 a.m. from the volunteers of all groups followed by the isometric quadriceps muscle strength (IQMS) evaluation. At 24 h after the intervention period, the volunteers of both groups were reassessed. These procedures were performed to avoid any circadian rhythm effects on hormonal status and the performance of IQMS. The tests were performed by an experienced examiner who was blind to the group allocation.

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
Single (Outcomes Assessor)

盲法说明

The tests were performed by an experienced examiner who was blind to the group allocation.

入排标准

年龄范围
65 Years 至 85 Years(Older Adult)
性别
Female
接受健康志愿者

入选标准

  • females older than 65 years of age
  • not using hormone replacement therapy
  • diagnosed with OA in at least one knee in accordance with of the American College of Rheumatology

排除标准

  • no recent knee injury
  • no walking aid requirement
  • no rehabilitation procedures in the previous three months
  • any orthopedic, neurological, respiratory or acute cardiac diseases
  • any cognitive deficit as determined by the Mini-Mental State Examination

研究组 & 干预措施

Addition of whole-body vibration to squat training

Experimental

The addition of whole-body vibration to squat training (for 12 weeks, 3x/week). The mechanical stimulation parameters of the vibration consisted of the following: frequency of 35 to 40 Hz, amplitude of 4 mm and acceleration that ranged from 2.78 to 3.26 G

干预措施: Addition of whole-body vibration to squat training (Other)

Squat training

Other

Squatting exercises for 12 weeks, 3x/week

干预措施: Squat training (Other)

结局指标

主要结局

Change in isometric quadriceps muscle strength

时间窗: 24 hours before and 24 hours after a 12-week training program

The maximal voluntary isometric contraction of knee extensors measured using the load cell

次要结局

  • Change in plasma concentration of neurotrophin 40/5000 Plasma neurotrophin concentration(24 hours before and 24 hours after a 12-week training program)

研究者

发起方
Federal University of the Valleys of Jequitinhonha and Mucuri
申办方类型
Other
责任方
Sponsor

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