Cognitive Impairment, Hip Fractures
Conditions
Keywords
Outpatient, Rehabilitation, Progressive, structured exercise, Hip Fracture, Cognitive impairment, Older adults
Brief summary
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.
Detailed description
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).
Interventions
OTHERProgressive, individualized and structured exercise program
See description under Arms
Sponsors
Vordingborg Municipality
Stevns Municipality
Guldborgsund Municipality
Frederiksberg Municipality
Horsholm Municipality
Lolland Community, Denmark
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Feasibility study
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The New Mobility Score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Height | Baseline | To assess the participants height in meters |
| Weight | Baseline, 3 months, 6 months | To assess the participants weight in kilograms |
| Tandem balance test | Baseline, 3 months, 6 months | A static balance test scoring the participants ability to stand in 3 different positions (0-30 point, where 30 points indicating no balance problem to 0 points = having seriously balance problems) |
| The Barthel-20 | Baseline, 3 months, 6 months | To assess basic activities of daily living functions with the Barthel-20 test. Total possible scores range from 0-20, with lower scores indicating increased disability and higher score indicating independency. |
| 30 sec chair raise test | Baseline, 3 months, 6 months | This test examines the participants ability to raise up from a chair for as many times as possible within 30 seconds |
| Brief Assessment of Impaired Cognition Questionaire | Baseline, 3 months, 6 months | A test to evaluate the participants cognitive level with a score ranging from 0 (= serious cognitive problems) to 20 point (= no impaired cognition). |
| Mini Mental State Examination | Baseline and 6 months | A test to assess a participants cognitive level from a score from 0 to 30 points. A Mini-Mental State Examination can be used to check for cognitive impairment. The maximum score is 30 points. A score of 25 or higher is classed as normal. If the score is below 24, the result is usually considered to be abnormal, indicating possible cognitive impairment. |
| The Cumulated Ambulation Score | Baseline, 3 months, 6 months | This score describes the participants independence in three activities (getting in and out of bed, sit-to-stand-to-sit from a chair, and walking). Each activity is assessed from 0-2 (0 = Not able to, despite human assistance and verbal cueing, 1 = Able to, with human assistance and/or verbal cueing from one or more persons, 2 = Able to safely, without human assistance or verbal cueing, use of a walking aid allowed). Total score ranging from zero to six points |
| Four meter walk test | Baseline, 3 months, 6 months | To assess the participants gait speed over 4 meter walk. |
| Euroqol 5 dimensions | Baseline, 3 months, 6 months | The Euroqol 5 dimensions essentially consists of 2 overall items; a descriptive system and the Euroqol visual analogue scale. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The Euroqol visual analog scale records the patient's self-rated health on a vertical visual analogue scale ranging from 0 to 100 with endpoints labelled 'The best health you can image' (= 100) and 'The worst health you can image' (= 0). The visual analog scale can be used as a quantitative measure of health outcome that reflects the patient's own judgement. |
| Clinical Frailty Scale | Baseline, 3 months, 6 months | The Clinical Frailty Scale is a 9-point scale (ranging from 1 to 9) to summarize the overall level of fitness or frailty of an participant after they have been evaluated by a health care professional. The Clinical Frailty Scale is scored so that higher scores mean greater risk/frailty. |
| The Verbal Rating Scale | Baseline, 3 months, 6 months | To assess the level of hip fracture-related pain using a 5 point scale (0 = no pain, 1 = light pain, 2 = moderate pain, 3 = severe pain, 4 = intolerable pain) in participants with hip fracture. |
| Activity accelerometers | Baseline, 3 months, 6 months | To measure the amount of physical activity within 7 days. The two accelerometers (one placed on the wrist, the other on the thigh) will be monitor the participants activity level for 7 continous days (24 H a day). |
| Handgrip strength measurement | Baseline, 3 months, 6 months | An assessment of the participants handgrip strength with a handheld grip strength dynamometer. |
Countries
Denmark
Contacts
Primary ContactJan Arnholtz Overgaard, MSc.
Backup ContactSøren Thorgaard Skou, PhD
Outcome results
None listed