Effect of an Individualized Combined Intervention (Vivifrail-Cogn) on the Rate of Falling of Frail Older Adults at Risk of Falling Living in the Community: a Multicenter Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 310
- 试验地点
- 1
- 主要终点
- One year fall-related fracture
研究概览
简要总结
Randomized clinical trial of 310 older adults over 75 years old recruited from the Falls Units of Geriatric Departments in 4 three University Hospitals in Spain (Pamplona, San Sebastián, Albacete and Barcelona). Participants who met inclusion criteria will be randomized to the usual care group (Otago exercise program) or the Vivifrail-Cog Intervention (a combination of physical exercise Vivifrail program and cognitive training). The main objective of the present randomized clinical trial is to investigate the effect of the combined intervention (exercise and cognitive intervention) in frail older participants living in the community and at risk of falling. The main endpoint will be the rate of falling in the following year. Secondary endpoints include physical performance, muscle strength, cognitive performance, hospitalizations, institutionalization, depression and quality of life.
详细描述
Usual care: subjects randomized to the usual care group will receive an evidence-based multidisciplinary intervention tailored at reducing the fall risk (polypharmacy, environmental intervention, physical exercise). Importantly, the Otago exercise program (considered the standard physical exercise intervention) will be prescribed in this group.
Intervention group: subjects assigned to this intervention will engage in a multicomponent intervention combining an exercise program, Vivifrail (A practical guide for prescribing a Multicomponent Physical Training Program to prevent weakness and falls in people over 70, more information at www.vivifrail.com) and a cognitive training. Vivifrail exercise program combines resistance, endurance, balance and flexibility exercise tailored to the functional level of the subjects, guaranteeing an individualized approach. Exercises progress in terms of intensity and difficulty as the subject adapts to exercise. The cognitive stimulation program combines exercises to work on different cognitive functions, mainly addressing executive functions (attentional system, processing speed, perceptual organization, working memory and cognitive flexibility, verbal comprehension, abstraction and reasoning, planning, execution and problem solving ).
It lasts 12 weeks, two weekly sessions. It is divided into 4 levels in order to adapt the intervention to participant's individual capacity, and the level can be adjusted throughout the intervention.
Correct execution will be monitored by constant contact with relatives in charge of supervising the exercise program, who will be familiarized with the intervention prior to participation.
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
- None
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 75 years or older
- •Referral to the Falls Unit
- •Ability to ambulate independently with or without technical aids
- •Barthel Index ≥ 60
- •Pre-frailty (1-2 criteria) or Frailty according to the Frailty Phenotype by Fried et al
- •Risk of falling according to following criteria:
- •Gait disorders captured through physical performance measures (Time Up and Go Test ≥ 20 s and/or Gait Speed ≥0,8 m/s
- •≥2 self-reported falls in the previous year
- •≥1 self-reported falls requiring medical assistance
- •Relative/caregiver willingness to supervise the exercise/cognitive stimulation sessions
- •Capability and willingness to provide informed consent
排除标准
- •Unwillingness to either complete the study requirements or to be randomized into the control or the intervention group
- •Life expectancy ≤ 3 months
- •Terminal illness
- •No possibility of follow-up
- •Institutionalization or awaiting institutionalization
- •Major cognitive impairment DSM-V moderate or severe (CDR 2-3 /GDS 5-7)
- •No ability to read and write
- •Severe visual and hearing deficit
- •Any contraindications for physical exercise or testing procedures, including but not limited to:
- •myocardial infarction in the past 3 months
- •unstable angina pectoris
- •uncontrolled arrhythmia
- •unstable cardiovascular disease or other unstable medical condition
- •uncontrolled arterial hypertension
- •recent pulmonary thromboembolism
- •upper or lower extremity fracture in the past 3 months
研究组 & 干预措施
Combined multicomponent physical exercise and cognitive stimulation (Vivfrail-Cog)
The supervised multicomponent exercise training program (resistance, endurance, balance and flexibility) will be comprised of upper and lower body exercises tailored to the individual's functional capacity. Subjects will be encouraged at performing strength and endurance exercise at a moderate intensity. Exercise will progress in terms of intensity and difficulty upon individual adaptation.
The cognitive intervention will include the performance of different exercises with pencil and paper in order to train different cognitive areas, especially the executive functions.
干预措施: Vivfrail-Cog combined multicomponent physical exercise and cognitive stimulation. (Other)
Usual care
The usual care group will receive normal outpatient care (including the evidence-based Otago exercise program).
结局指标
主要结局
One year fall-related fracture
时间窗: during one year
Number of fall-related fracture (radiologically confirmed)
One year fall-related death
时间窗: during one year
Number of fall-related death
One year falls rate
时间窗: during one year
Fall: an unexpected event in which the participants come to rest on the ground, floor, or lower level.Subjects will be contacted by phone in a monthly basis after completing the 3-months lasting intervention and inform the research team about the incidence of falls.
One year fall-related hospitalizations
时间窗: during one year
Number of fall-related hospitalizations
次要结局
- Barthel(At baseline, 6-week, 12-week and 24-week and 1-year.)
- Musculoskeletal echography(At baseline, 6 weeks and 3 months)
- MOCA (Montreal Cognitive Assessment) test(At baseline, 6 weeks and 3 months)
- 1-Repetition Maximum (RM) Maximal dynamic strength test(At baseline, 6 weeks and 3 months)
- Geriatric Depression Scale (GDS) Yesavage abbreviated scale(At baseline, 6 weeks and 3 months)
- Psychotropic and hypotensive drugs registration(At baseline and 3 months)
- Garvan Fracture Risk(At baseline and 12-week)
- Short Physical Performance Battery (SPPB)(At baseline,1 and 3 months.)
- Fried's Frailty Phenotype (FP)(At baseline and 3 months)
- SARC-F (Screening of Sarcopenia Among Older Adults)(At baseline,1 and 3 months.)
- Handgrip Strength in both hands(At baseline, 6-week, 12-week)
- 4-metre gait velocity test (GVT)(At baseline, 6 week and 3 months.)
- Presence of 5 or more drugs ( Polypharmacy ) registration(At baseline and 3 months)
- Dual task gait (verbal) 6 m velocity test(At baseline, 6-week and 3 months)
- EuroQol-5D (EQ-5D) Quality of life assessment test(At baseline and 3 months)
- Trail Making Test part A ( TMT-A)(At baseline, 6 weeks and 3 months)
- Falls-related psychological consequences(At baseline, 12 week, 24 week and 1 year.)
- Repetitions at maximal velocity at intensities of 50% of 1RM test(At baseline, 6 weeks and 3 months)
- Mortality(At baseline, 6 weeks and 3 months)
- Admissions to the hospital(At baseline, 6 weeks and 3 months)
- Number of total Drugs(At baseline and 3 months)
- Dual task gait ( arithmetic) 6 m velocity test(At baseline, week 6 and 3 months)
- - Registration of other geriatric syndromes (visual and hear impairment, urinary and fecal incontinence, delirium , dysphagia, constipation , pressure ulcers )(At baseline and 3 months)
- Incidence of institutionalization to nursing homes(At baseline, 6 weeks and 3 months)
- Visit to emergency room(At baseline, 6 weeks and 3 months)
- Drug Burden Index(At baseline, 3, 6, 9 and 12 months)