Activating Older People After a Hip Fracture
试验速览
- 阶段
- 不适用
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Short Physical Performance Battery (SPPB)
研究概览
简要总结
The main aim of this study is to determine if the ActiveHip tele-rehabilitation mobile application improves the functional level and the quality of life of patients who undergone hip surgery after a fracture.
The second aim is to determine if the ActiveHip intervention reduce the anxiety, stress and burden of the caregivers.
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
- 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
- 否
入选标准
- •Have hip fracture surgery
- •Age equal to or greater than 65 years
- •Are allowed weight-bearing at 48 hours after surgery
- •Had a high pre-fracture functional level the week before the fracture (Functional Independence Measure [FIM] index scored more than 90 points)
- •Have an informal or family caregiver who has the ability to access the Internet to use the app ActiveHip+
- •Basic management of the mobile phone
- •Have signed an informed consent.
排除标准
- •Presence of low cognitive level (Pfeiffer test score lower than 4 points)
- •Being dependent on the activities of daily living before the hip (Functional Independence Measure [FIM] index scored less than 60 points)
- •Being institutionalized
- •Post-surgery complications
- •Terminal disease
- •Age under 65 years
结局指标
主要结局
Short Physical Performance Battery (SPPB)
时间窗: The primary outcome will be followed over 12 weeks.
The SPPB is one of the most commonly used instruments for measuring physical performance in population studies. The SPPB assessment has previously been used to evaluate the mobility of older people and patients with a hip fracture. The performance battery consists of three tasks: balance, walking, and chair stands. The SPPB tests of balance, including time to walk 4 meters and time required to stand from a chair 5 times. The score ranges from 0 to 12 points, with higher scores indicating better mobility. Low scores on the SPPB have a high predictive value for a wide range of health consequences including disability in Activities of Daily Living, loss of mobility, disability, hospitalization duration of stay in the hospital, admission to nursing facilities, and death. Internal consistency is high, with Cronbach's α = 0.87.
次要结局
- Visual Analogue Scale for Pain (VAS Pain)(12 weeks)
- EuroQoL 5D Quality of Life questionnaire(12 weeks)
- Functional Independence Measure(12 weeks)
- New Mobility Score (NMS)(12 weeks)
- Short Falls Efficacy Scale-International (SFES-I)(12 weeks)
- International Fitness Scale (IFIS)(12 weeks)
- The Short Portable Mental State Questionnaire (SPMSQ) of Pfeiffer(12 weeks)
- The Hospital Anxiety and Depression Scale (HADS)(12 weeks)
- Zarit Burden Interview(12 weeks)
- The Low Back Pain Disability Scale (Oswestry)(12 weeks)
研究者
Patrocinio Ariza Vega
Principal investigator
Universidad de Granada