A Personalized Video-based Exercise Program for Fall Prevention in Frail and Pre-frail Older Adult
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Objective 1
研究概览
简要总结
This is a randomized interventional clinical trial, whereby 100 participants will be randomized to either follow the SAFE exercise program (experimental group) or not (control group). At the end of the intervention, the experimental group will be encouraged to continue doing the exercises, and the control group will have the opportunity to participate in the SAFE exercises. 12 weeks post-intervention, the investigators will follow up with participants by telephone to follow up whether they are still following the SAFE program or not.
详细描述
For this study, the investigators will recruit 100 frail men and women aged 75 and over from the greater Montreal area. Enrolled participants will have 4 visits at their residence. The first visit, is a screening visit, the second is a pre-intervention assessment of cognition and functional abilities and explanation of the exercise program. The third visit will be a virtual visit, by phone call, and the final visit will be a post-intervention assessment of cognition and functional abilities.
Participants in the experimental group will engage in the SAFE exercises three times a week for 12 weeks at home while continuing their activities of daily living (ADLs) without any changes. Participants in the control group will not engage in the SAFE exercises but will be asked to maintain their ADLs without any changes. Before and after the 12-week intervention, all participants will complete a comprehensive battery of assessments to evaluate changes in their muscular strength, functional capacities, cognitive abilities and quality of life. At the end of the intervention, the experimental group will be encouraged to continue doing the exercises, and the control group will have the opportunity to participate in the SAFE exercises. 12 weeks post-intervention, the investigators will follow up with participants by telephone to follow up whether they are still following the SAFE program or not.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Considered Frail or Pre frail according to Fried's criteria
排除标准
- •Smoked within 6 months prior to study enrollment,
- •dementia diagnosos,
- •Abused drugs, medication or alcohol within up to 30 days prior to the start of the study.
- •drug or alcohol-addiction,
- •Heart disease, history of heart attacks or electrocardiogram abnormalities
- •Any family history of thrombosis, thrombosis risk,
- •hypocalcaemia,
- •uric acidemia,
- •orthostatic intolerance,
- •vestibular disorders,
- •considerable musculoskeletal issues,
- •chronic back pain,
- •head trauma,
- •seizures,
- •renal stones,
- •gastro-esophageal reflux disease,
- •renal function disorder,
- •hiatus hernia,
- •migraines,
- •mental illness diagnosis
- •prescribed medication that may interfere with the interpretation of the results
研究组 & 干预措施
SAFE program
Participants will be asked to carry out the SAFE program with the help of a caregiver. Our healthcare professionals will visit them during the first week to explain to them and their caregivers how to perform the exercises correctly while using our website. All exercises will be performed using video capsules available on our website (https://safe-seniors.com/fr). The exercises are divided into 4 levels of difficulty: level 1 (light); level 2 (moderate); level 3 (moderate to vigorous); and level 4 (vigorous). Each level lasts 25 to 30 minutes and includes 5 exercise categories split into 5 videos: warm-up, strength, balance, flexibility, and endurance. The exercise intervention will include 3 sessions per week over 12 weeks.
干预措施: SAFE program (exercise intervention) (Other)
Control group
Participants will be asked to continue their activities of daily living without making any changes.
结局指标
主要结局
Objective 1
时间窗: 12 weeks
Number of participants that displayed changes on their functional testing (SPPB) in comparison with their baseline and the control group after having participated in the SAFE program, following the 12 week intervention.
Objective 2
时间窗: 12 weeks
Number of participants that displayed changes on their cognitive (STROOP) in comparison with their baseline and the control group after having participated in the SAFE program, following the 12 week intervention.
次要结局
- Objective 4(12 weeks)
研究者
Jose Morais
Medical director
McGill University Health Centre/Research Institute of the McGill University Health Centre