Relationship Between the Risk of Falls and Frailty, and the Effect of a Physical Exercise Program on These Conditions in the Elderly: a Randomized Crossover Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Fried frailty criteria
研究概览
简要总结
The goal of this randomized crossover clinical trial is to examine the effectiveness of a new therapeutic exercise program in elderly patients with risk of falls and physical fragility. The main questions it aims to answer are:
- If the therapeutic exercise program proposed is a successful treatment for this kind of patients
- If patients at risk of falls also suffer from pre-frailty or frailty, and if they can be treated together with the proposed therapy.
Participants will follow a program consisting of exercises to correct posture, gain strength and contribute to greater balance.
Researchers will compare the therapy and control groups to see if the program increases the percentage of muscle mass of participants, their mobility, balance, quality of life and if they reduce their Fried´s frailty criteria, fear of falling and falls compared to their usual physical activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •Community dwelling older adults.
- •Independent for ambulation.
- •With a cognitive state that do not prevent understand the researcher indications.
- •Not performing regular physical exercise (only basic activities of daily living, but no other type of intervention).
排除标准
- •Contraindication of physical exercise.
- •Evident impaired cognitive state.
- •Vestibular or central nervous system affection.
- •Can´t speak and understand spanish correctly.
研究组 & 干预措施
Exercise group
干预措施: Therapeutic exercise program (Other)
Control group
结局指标
主要结局
Fried frailty criteria
时间窗: Assessed after 3 months from the previous assessement.
The Fried frailty criteria are five: unintentional weight loss, muscular weakness, low resistance or tiredness, slow gait and low level of physical activity.
Timed Up and Go (TUG)
时间窗: Assessed after 3 months from the previous assessement.
Timed Up and Go (TUG)
时间窗: Assessed before the first intervention (baseline).
Timed Up and Go (TUG)
时间窗: Assessed after the first intervention (3 months later).
Timed Up and Go (TUG)
时间窗: Assessed after the second intervention (3 months after the previous assessement).
Fried frailty criteria
时间窗: Assessed before the first intervention (baseline).
The Fried frailty criteria are five: unintentional weight loss, muscular weakness, low resistance or tiredness, slow gait and low level of physical activity.
Fried frailty criteria
时间窗: Assessed after the first intervention (3 months later).
The Fried frailty criteria are five: unintentional weight loss, muscular weakness, low resistance or tiredness, slow gait and low level of physical activity.
Fried frailty criteria
时间窗: Assessed after the second intervention (3 months after the previous assessement).
The Fried frailty criteria are five: unintentional weight loss, muscular weakness, low resistance or tiredness, slow gait and low level of physical activity.
次要结局
- Berg Balance Scale (BBS)(Assessed after 3 months from the previous assessement.)
- Falls and their consequences(Every two weeks from date of the first assessement until the date of the study completion, an average of 1 year.)
- Falls Efficacy Scale-International (FES-I)(Assessed after 3 months from the previous assessement.)
- European Quality of Life-5 Dimensions (EuroQol-5D)(Assessed after 3 months from the previous assessement.)
- Muscle mass(Assessed after 3 months from the previous assessement.)
- Falls and their consequences(Assessed before the first intervention (baseline).)
- Berg Balance Scale (BBS)(Assessed before the first intervention (baseline).)
- Berg Balance Scale (BBS)(Assessed after the first intervention (3 months later).)
- Berg Balance Scale (BBS)(Assessed after the second intervention (3 months after the previous assessement).)
- Falls Efficacy Scale-International (FES-I)(Assessed before the first intervention (baseline).)
- Falls Efficacy Scale-International (FES-I)(Assessed after the first intervention (3 months later).)
- Falls Efficacy Scale-International (FES-I)(Assessed after the second intervention (3 months after the previous assessement).)
- European Quality of Life-5 Dimensions (EuroQol-5D)(Assessed before the first intervention (baseline).)
- European Quality of Life-5 Dimensions (EuroQol-5D)(Assessed after the first intervention (3 months later).)
- European Quality of Life-5 Dimensions (EuroQol-5D)(Assessed after the second intervention (3 months after the previous assessement).)
- Muscle mass(Assessed before the first intervention (baseline).)
- Muscle mass(Assessed after the first intervention (3 months later).)
- Muscle mass(Assessed after the second intervention (3 months after the previous assessement).)