Optimized Rehabilitation of Older Adults With Hip Fracture and Signs of Cognitive Impairment - the ENHANCE Project - Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 12
- 主要终点
- The New Mobility Score
研究概览
简要总结
Older adults suffering from a hip fracture are a significant concern, with higher incidence rates among women. Mortality rates post-hip fracture are alarming, with up to 8-fold increased risk within 3 months and significant percentages within 30 days and 12 months. Older adults with hip fracture face challenges in regaining pre-fracture level of function, especially those with cognitive impairment, which affects 25% to 40% of cases and increases mortality risk. While interventions exist, such as progressive strength training and structured exercise programs, patients with hip fracture don't consistently restore pre-fracture function, particularly in cognitively impaired patients, who are often excluded from studies. Limited evidence exists on effective management for this subgroup, with a lack of clarity on community-based rehabilitation. Although guidelines suggest exercise interventions for patients with mild to moderate cognitive impairment, the specifics remain uncertain due to insufficient research focused solely on this population.
This feasibility study aims to assess the practicality and safety of implementing a 12-week individualized, progressive exercise program for older adults with hip fracture and cognitive impairment in an outpatient setting. Additionally, the investigators seek to gather qualitative insights through observations and interviews regarding participants' experiences and the perceived value of rehabilitation post-hip fracture, particularly focusing on the exercise intervention provided.
详细描述
Background and overall aim. Approximately 7,000 people suffer a hip fracture in Denmark each year. A hip fracture is a traumatic event with high mortality rates, and older adults with hip fractures experience significant pain, a general decline in functional ability, and difficulty regaining the same level of function (e.g., being able to move freely without walking aids) as before the fracture. Older adults with hip fracture and signs of cognitive impairment constitute a subgroup, accounting for 25-40% of the total group. Dementia increases the likelihood of sustaining a hip fracture nearly threefold and results in higher mortality rates compared to the rest of the patient group. Furthermore, many individuals do not receive the treatment/training they are entitled to, despite being initially worse off than those without signs of cognitive impairment. There is limited research in this area because older adults with signs of cognitive impairment are often excluded from research studies. The few studies available suggest that older adults with hip fracture and signs of cognitive impairment may benefit from the same interventions provided to older adults with hip fracture who do not have signs of cognitive impairment. However, no randomized controlled trials have been conducted to investigate whether a systematic, well-planned, and personalized home training program is superior to the standard training offered in municipalities for older adults with hip fracture and signs of cognitive impairment. With this feasibility study it is intended to assess the practicality and safety of a 12-week individualized, progressive exercise program for older adults with hip fracture and signs of cognitive impairment in a municipality-based setting shortly after discharge from hospital. Hopefully, and if there are positive results from this feasibility study the investigators will proceed with a randomized controlled trial (in another study).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Recently (within 3 weeks) underwent surgical repair of a hip fracture (femoral neck or trochanteric fracture)
- •Independent pre-fracture ambulatory function (≥2 on the New Mobility Score on indoor walking)
- •Having signs of cognitive impairment measured with the Mini-Mental Score Examination of <24 points, or a verified dementia diagnosis, or on information from the patient record
- •Living in their own home, nursing home, or assisted living facilities
- •Informed consent by patient
排除标准
- •Pathological hip fracture
- •Having signs of severe dementia measured with the Mini-Mental State Examination (<10 points)
- •Non-Danish speaking
- •Patients with an unstable health condition (e.g. not treated high blood pressure (>180 mm HG)) evaluated by medical consultant
- •"Safety concerns" (e.g. underlying comorbidities that might be associated with serious adverse events) - not safe to participate in the opinion of the investigator
- •Having behavioral or psychotic disorders
- •Alcohol or drug abuse
- •Unable to participate in the intervention (e.g. due to blindness, no language)
- •Patients with any weight-bearing restrictions after surgery
研究组 & 干预措施
Progressive, individualized and structured exercise program
Individualized, progressive, structured exercise program. Participants will receive 12-weeks of either home-based and/or at a healthcare center intervention.
The "at home" intervention will consist of 3 visits/sessions per week (approximately 30-60 min.) for 12 weeks (maximum of 36 sessions in total) delivered in the participants own home, temporary home (e.g. 24- hour rehabilitation facility), nursing home or assisted living facilities.
The "at a healthcare center" intervention will be suggested to the participant when the physiotherapist and the participant feel confident that the participant can handle the transportation to/from the healthcare center, and will benefit from the higher intensity of the "at a healthcare center" intervention. This intervention consists of 2 visits/sessions per week (approximately 45-60 min.) for 12 weeks (total maximum of 24 sessions).
干预措施: Progressive, individualized and structured exercise program (Other)
结局指标
主要结局
The New Mobility Score
时间窗: Baseline, 3 months, 6 months
The New Mobility Score is a composite score of the participant's ability to perform: indoor walking, outdoor walking and shopping, providing a score between zero and three (0: not at all, 1: with help from another person, 2: with an aid, 3: no difficulty) for each function, resulting in a total score from 0 to 9, with nine indicating a high functional level.
次要结局
- Mini Mental State Examination(Baseline and 6 months)
- Height(Baseline)
- Brief Assessment of Impaired Cognition Questionaire(Baseline, 3 months, 6 months)
- The Barthel-20(Baseline, 3 months, 6 months)
- 30 sec chair raise test(Baseline, 3 months, 6 months)
- Handgrip strength measurement(Baseline, 3 months, 6 months)
- The Cumulated Ambulation Score(Baseline, 3 months, 6 months)
- Four meter walk test(Baseline, 3 months, 6 months)
- Activity accelerometers(Baseline, 3 months, 6 months)
- Weight(Baseline, 3 months, 6 months)
- Tandem balance test(Baseline, 3 months, 6 months)
- Euroqol 5 dimensions(Baseline, 3 months, 6 months)
- Clinical Frailty Scale(Baseline, 3 months, 6 months)
- The Verbal Rating Scale(Baseline, 3 months, 6 months)
研究者
Mr. Jan Overgaard
Principal Investigator
Lolland Community, Denmark