Measuring the Effect of Using the Arabic Otago Exercise Program on Falls and Falls-related Outcomes in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Incidence of falls
研究概览
简要总结
Falls are common in older adults and may lead to disability or even death. Therefore, exercise programs that focus on preventing falls by improving strength and balance are important to investigate in older adults. One of the home-based exercise programs that was found effective in reducing the risk of falling and the rate of subsequent falls in older adults is the Otago exercise program (OEP). The OEP is an individualized home based retraining program that works mainly on balance and lower extremity strength through several progressive resistive exercises.
Therefore, this study aims to assess the effectiveness of this program on falls prevention and falls-related outcomes using a Randomized Controlled Trial in a sample of Jordanian older adults.
详细描述
❖ Research ethics: This study got the ethics approval from the IRB at Jordan University Hospital at University of Jordan. A consent form that contains the study procedures will be prepared and signed from all participants. To insure the privacy of participants, every older adult will be assigned a study identification number. All results will be stored in a locked cabinet/computer only accessible by the researchers.
❖ Participants: Data will be collected prospectively from older adults in Jordan. Older adults will be approached to complete the program via Jordan University Hospital, community based organizations (e.g. Help-Age International Jordan) and social media platforms such as Facebook and WhatsApp.
❖ Design:
● This will be a single blinded randomized controlled trial study with 2 groups: treatment group who will receive the OEP plus health awareness videos every 2 weeks and a control group who will receive the same health awareness videos only every 2 weeks.
- Eligible older adults will be recruited for the RCT.
- Baseline assessment will be conducted by a blind assessor.
- Participant will be randomized using a computer-based randomization tool into either the treatment (OEP) or the control group (awareness videos). The treatment group will receive the OEP for 8 weeks plus health awareness videos. The control group will receive the same health awareness videos every 2 weeks for 8 weeks. The treatment group will be trained by a researcher different from the one conducting the assessments.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults who are 60 years of age and older.
- •Who can read and write in Arabic language.
- •Who are able to walk outdoors with no more support than a single point cane.
排除标准
- •Who have a serious orthopedic condition (e.g., recent lower limb surgery, severe arthritis of a lower limb) or major neurological disorder (e.g., stroke with unilateral or bilateral paresis, Parkinson disease or multiple sclerosis) that could restrict functional mobility.
- •Who are unable to comprehend study information and consent processes due to any illness including dementia.
结局指标
主要结局
Incidence of falls
时间窗: 12 months post intervention.
The effect of the intervention on the incidence of falls.
次要结局
- Muscle strength (Hand grip and Quadriceps muscle strength using a dynamometer)(2 months post intervention.)
- The Quality of sleep (Using Pittsburgh Sleep Quality Index)(2 months post intervention.)
- The Quality of Life (using Medical Outcomes Study Short Form 12)(2 months post intervention.)
- Pain (using pain rating scale)(2 months post intervention.)
- Mobility (using Timed-Up and go)(2 months post intervention.)
- Cognitive ability (using Montreal Cognitive Assessment)(2 months post intervention.)
- Sarcopenia (using the bio-impedance analysis)(2 months post intervention.)
- Fear of Falling (using the Falls Efficacy Scale-International)(2 months post intervention.)
- Balance (using Chair balance test and Four test balance scale)(2 months post intervention.)
- Activities of daily living (using Katz index of daily living)(2 months post intervention.)
- the severity of Anxiety and Depression (using Hospital Anxiety and Depression Scale)(2 months post intervention.)
研究者
Alia A. Alghwiri
Professor
University of Jordan