Effects of Whole Body Vibration Therapy on Cognitive Function, Balance, and Quality of Life in Older Adults With Mild Cognitive Impairment: A Randomized, Double-Blind, Placebo-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 180
- 主要终点
- Montreal Cognitive Assessment (MoCA) for Cognitive Function
研究概览
简要总结
This is a double-blind, randomized controlled trial comparing WBV therapy with a placebo intervention and standard care. A total of 150 participants will be recruited and investigated from Prince Mutib Hospital. Participants will be randomly allocated to one of three groups: WBV therapy, placebo (non-vibrating platform), or control (standard care). The study duration will be 12 weeks, with assessments conducted at baseline, post-intervention (12 weeks), and at a 6-month follow-up.
Protocol Parameters Summary
- Session Frequency: 3 times per week.
- Session Duration: 25 minutes per session.
- Vibration Frequency: 30 Hz.
- Amplitude: 1-2 mm.
- Program Duration: 12 weeks.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 60 years and older.
- •Diagnosed with mild cognitive impairment (Montreal Cognitive Assessment (MoCA) score of 18-25). One point is added if years of education are less than 12 years[2].
- •Able to stand independently or with minimal assistance.
- •No contraindications for WBV therapy or exercise.
排除标准
- •Diagnosis of dementia.
- •Severe musculoskeletal or neurological disorders.
- •Implanted electronic medical devices (e.g., pacemaker).
- •Inability to comprehend study instructions.
结局指标
主要结局
Montreal Cognitive Assessment (MoCA) for Cognitive Function
时间窗: 6 months
Assessed using the standard Arabic version of the Montreal Cognitive Assessment (MoCA) at baseline, 12 weeks, and 6 months. The tool is a reliable and valid instrument to detect MCI among the elderly. The maximum score is 0-30, with higher scores indicating better cognitive functioning. A score below 26 typically suggests cognitive impairment. These tests evaluate changes in executive function, attention, and overall cognitive ability. The investigator will use the standard Arabic version used among community dwelling Saudi Arabians population with changes in some word to make it suitable for the Arabic speaking Saudi Arabian population
次要结局
- Berg Balance Scale(6 months)
- • Quality of Life(12 weeks)
- Timed up and go test(6 month)
研究者
Fahad Alanazi
Assistant professor
Jouf University