Effectiveness of Fall-Preventive Home Exercise Programs in Patients With Parkinson Disease: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Falls Efficacy Scale
研究概览
简要总结
Falls are common in patients with Parkinson disease and may lead to reduced mobility, fear of falling, loss of independence, and injury. Exercise-based rehabilitation programs may help improve balance, gait, and physical performance in this population.
This randomized controlled trial aims to compare the effectiveness of two home-based exercise programs in patients with Parkinson disease: the Otago Exercise Program and a structured home exercise program. Participants will be randomly assigned to one of two groups. Both groups will receive exercise education and will perform their assigned home exercise program for 6 weeks.
Participants will be evaluated at baseline, at week 3, and at the end of week 6. The study will assess fall-related outcomes, freezing of gait, functional mobility, gait parameters, postural control, and physical performance. The results may help determine which home-based exercise approach is more effective for reducing fall risk and improving functional outcomes in patients with Parkinson disease.
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)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Parkinson disease confirmed by a neurologist
- •Hoehn and Yahr stage 3 or 4 Parkinson disease
- •Diagnosis of Parkinson disease for at least 5 years
- •Willingness to participate in the study and provide written informed consent
- •Ability to walk independently or with minimal assistance
- •Mini-Mental State Examination score >24
排除标准
- •Balance or gait impairment due to causes other than Parkinson disease, such as severe orthopedic problems or another neurological disease
- •Red flags suggestive of Parkinson-plus syndromes, such as symmetric onset, early falls, early-onset dementia, or gaze palsy
- •History of serious fall-related injury or surgery within the last 6 months
- •Any additional health condition that would prevent participation in the exercise program during the study period
研究组 & 干预措施
Structured Home Exercise Program
Participants in this arm will receive a structured home exercise program. The program includes spinal stabilization exercises and stretching and strengthening exercises targeting the ankle plantar flexor and dorsiflexor muscles, quadriceps, lumbar extensor muscles, pectoral muscles, and hamstring muscles. Participants will perform the exercises 3 times per week for 6 weeks, with each session lasting approximately 40 minutes. The exercise program will be reviewed and progressed at week 3 according to the participant's functional status.
干预措施: Structured Home Exercise Program (Behavioral)
Otago Home Exercise Program
Participants in this arm will receive the Otago Home Exercise Program. The program includes home-based strengthening, static balance, and dynamic balance exercises designed to improve lower extremity muscle strength, balance, functional mobility, and fall-related outcomes. Participants will perform the exercises 3 times per week for 6 weeks, with each session lasting approximately 40 minutes. The exercise program will be reviewed and progressed at week 3 according to the participant's functional status.
干预措施: Otago Home Exercise Program (Behavioral)
结局指标
主要结局
Falls Efficacy Scale
时间窗: Baseline, week 3, and week 6
Fall-related self-efficacy and fear of falling will be assessed using the Falls Efficacy Scale. The scale evaluates the participant's confidence in performing daily activities without falling. Scores range from 10 to 100, with lower scores indicating greater fear of falling and higher scores indicating lower fear of falling.
Freezing of Gait Questionnaire (FOGQ)
时间窗: Baseline, week 3, and week 6
Freezing of gait will be assessed using the Freezing of Gait Questionnaire (FOGQ). The FOGQ evaluates the severity of freezing episodes and their impact on walking performance in patients with Parkinson disease. The total score ranges from 0 to 24. Higher scores indicate more severe freezing of gait and worse walking performance.
次要结局
- Freezing of Gait Questionnaire (FOGQ)(Baseline, week 3, and week 6)
- Gait Speed(Baseline, week 3, and week 6)
- Timed Up and Go Test(Baseline, week 3, and week 6)
- Functional Reach Test(Baseline, week 3, and week 6)
- Sit-to-Stand Test(Baseline, week 3, and week 6)
- Gait Initiation Time(Baseline, week 3, and week 6)
- Falls Efficacy Scale(Baseline, week 3, and week 6)
研究者
Selim Mahmut GÜNAY
Asst. Prof.
Mustafa Kemal University