The Effectiveness of Remote Fall Prevention Program vs. Face-to-Face in Low-medium Risk Elderly- A Cross Over Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 3
- 主要终点
- Number of falls during the study period
研究概览
简要总结
Falls are a serious problem in the elderly leading to injuries, morbidity, and consequently a heavy impact on the individual suffering, and society at large.
This study aims to investigate the effectiveness of a remote fall prevention program in comparison with a similar face-to-face program. This study design is a randomized control trial (RCT) with a cross-over in group allocation. The population will include 106 home-dwelling elderly, aged 65 years or more, with low to moderate risk of fall. Participants will be randomized to start intervention in the remote or face-to-face group. Training will be twice weekly for 3 months, after which there will be two weeks of washout, followed by a cross-over between groups. Outcome measures will include fall rate over a year (primary measure), balance, functional testing, subjective measures of fear of falls, quality of life, satisfaction from intervention, adherence, and compliance.
详细描述
The aim of the proposed study is to investigate the effectiveness of a remote fall prevention training program. The proposed intervention program includes an Otago-based fall prevention training program to improve lower extremity strength, balance, and walking, directed by physical therapists, over 6 months. The remote group will train at home, using video communication software, while the face-to-face group will train at a local community center.
The proposed study will be designed as a randomized control trial (RCT) with a cross-over design. The population will include 106 home-dwelling elderly, aged 65 years or more, walking independently, that will be identified at low to moderate risk of fall. Candidates with unbalanced systemic disease or disorders, cognitive and physical Impairments that will prevent participation in the program, will not be included. A full description of the inclusion and exclusion criteria is provided below in the Eligibility section.
Participants will be randomized into two groups that will receive similar Otago-based fall prevention group training, either remotely or face-to-face.
The training sessions: The training starts with five minutes of gentle warm-up with the same five flexibility exercises, followed by structured lower limb muscles strengthening, balance exercises, and instruction for independent walking for up to 30 minutes at least twice a week. The training will be delivered to groups of ten participants. The duration of each session will be one hour, twice a week for three months. After three months of training, there will be a two weeks break, serving as a washout period, after which the groups will switch, for another three months. At the end of the intervention period (6.5 months), each participant will be trained by both remote and face-to-face programs. Assessments will be conducted at 4-time points: baseline, 3 months after completion of the first-ordered training, 6.5 months after completion of both trainings, and 12 months follow up.
The primary outcome measure is the number of falls during a year. secondary outcome measures include Objective measures as balance, Walking speed, lower extremities functional strength, adherence, and compliance to the training program. The subjective outcome measure will include participant Satisfaction from the program, Fear of falls, and Quality of life. More details regarding outcome measures are provided below in the outcome measure section.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Functional and balance tests will be performed by a skilled physiotherapist, blind to the participant's group affiliation
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •home-dwelling elderly, aged 65 years or more
- •Identified to be at low to moderate risk of falling
- •Risk of falling will be assessed according to a combination of subjective and objective evaluation. Subjective questions from the STEADI (stopping elderly accidents death, and injuries), an algorithm for fall risk screening, assessment, and intervention, developed by the American Center for Disease Control and Prevention, relate to (1) Feels unsteady when standing/walking, (2) Worries about falling, and (3) Has fallen no more than 3 times in the past year.
- •An additional inclusion criterion is scoring 21 or more in the Mini-Best test (a balance test).
排除标准
- •Subjects suffering from severe musculoskeletal pain or disorders that will limit completion of the assessment procedure such as pain limiting weight-bearing for no longer than a few minutes
- •Unstable cardiovascular/pulmonary disease
- •Unbalanced diabetes
- •Neurological diseases such as stroke, Parkinson's, or multiple sclerosis
- •Use of a walking aid (except for a cane)
- •visual or hearing impairment that will not allow the use of technology for remote practice
- •A score lower than 21/30 on the Montreal Cognitive Assessment score (MoCA),
- •High risk of falling on the balance test (Mini-BESTest ≤ 20)
- •Comment: exclusion criteria will be based on self-report and completed at the initial baseline assessment
结局指标
主要结局
Number of falls during the study period
时间窗: Falls will be monitored for one year
Subjects will self-report falls weekly in a personal fall diary. This will be supported by a telephone call from one of the investigators once a month.
次要结局
- Time-Up and Go Test(Change from baseline at 3, 6 and 12 months)
- Walking speed(Change from baseline at 3, 6 and 12 months)
- Satisfaction from program(Twice- after each program session (after 3 and 6 months).)
- 12-Item Short Form Survey (SF-12) Quality of life questionnaire(Change from baseline at 3, 6 and 12 months)
- Berg Balance Scale(Change from baseline at 3, 6 and 12 months)
- Attendance(Will be monitored and record in any session time, for 6 months)
- Four Stage Balance Test(Change from baseline at 3, 6 and 12 months)
- Mini Balance Evaluation Systems Tests(Change from baseline at 3, 6 and 12 months)
- Completion (retention)(Will be monitored and record in any session time, for 6 months)
- Fear of falls(Change from baseline at 3, 6 and 12 months)
- Lower extremities functional strength(Change from baseline at 3, 6 and 12 months)