Clinical trial NCT06286722: Optimized Rehabilitation of Older Adults With Hip Fracture and Signs of Cognitive Impairment - Feasibility Study
Official title: Optimized Rehabilitation of Older Adults With Hip Fracture and Signs of Cognitive Impairment - the ENHANCE Project - Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hip Fractures
Cognitive Impairment
Keywords: Outpatient
Rehabilitation
Progressive
structured exercise
Hip Fracture
Cognitive impairment
Older adults
Lead sponsor: Lolland Community, Denmark
Sponsor class: OTHER
Collaborators: name: Vordingborg Municipality
name: Stevns Municipality
name: Guldborgsund Municipality
name: Frederiksberg Municipality
name: Horsholm Municipality
First posted: 2024-02-29
Enrollment: 20
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Feasibility study
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: The New Mobility Score
timeFrame: Baseline, 3 months, 6 months
Secondary outcomes:
measure: Mini Mental State Examination
timeFrame: Baseline and 6 months
measure: Height
timeFrame: Baseline
measure: Weight
timeFrame: Baseline, 3 months, 6 months
measure: Tandem balance test
timeFrame: Baseline, 3 months, 6 months
measure: The Barthel-20
timeFrame: Baseline, 3 months, 6 months
measure: 30 sec chair raise test
timeFrame: Baseline, 3 months, 6 months
measure: Brief Assessment of Impaired Cognition Questionaire
timeFrame: Baseline, 3 months, 6 months
measure: Handgrip strength measurement
timeFrame: Baseline, 3 months, 6 months
measure: The Cumulated Ambulation Score
timeFrame: Baseline, 3 months, 6 months
measure: Four meter walk test
timeFrame: Baseline, 3 months, 6 months
measure: Euroqol 5 dimensions
timeFrame: Baseline, 3 months, 6 months
measure: Clinical Frailty Scale
timeFrame: Baseline, 3 months, 6 months
measure: The Verbal Rating Scale
timeFrame: Baseline, 3 months, 6 months
measure: Activity accelerometers
timeFrame: Baseline, 3 months, 6 months
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: Frederiksberg Healthcare center and 24-hour rehabilitation
city: Hårlev
country: Denmark
facility: Stevns Healthcare Center, Stevns Municipality
city: Hørsholm
country: Denmark
facility: Hørsholm Health and Rehabilitation Center
city: Maribo
country: Denmark
facility: Maribo Health Center, Lolland Municipality
city: Nykøbing Falster
country: Denmark
facility: Guldborgsund Healthcare Center, Guldborgsund Municipality
city: Vordingborg
country: Denmark
facility: Vordingborg Healthcare Center, Vordingborg Municipality
Study officials:
affiliation: Vordingborg Municipality
name: Trine Nordentoft
role: STUDY_CHAIR
affiliation: Guldborgsund Municipality
name: Halil Baldan
role: STUDY_CHAIR
affiliation: Stevns Municipality
name: Lotte Bylov
role: STUDY_CHAIR
affiliation: Lolland Municipality
name: Gwen Tremmel
role: STUDY_CHAIR
References: