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

Overview

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

• Other Progressive, individualized and structured exercise program
  See description under Arms

Primary outcome measures

• The New Mobility Score [Time frame: Baseline, 3 months, 6 months]

Secondary outcome measures (12)

• Mini Mental State Examination [Time frame: Baseline and 6 months]
• Height [Time frame: Baseline]
• Weight [Time frame: Baseline, 3 months, 6 months]
• Tandem balance test [Time frame: Baseline, 3 months, 6 months]
• The Barthel-20 [Time frame: Baseline, 3 months, 6 months]
• 30 sec chair raise test [Time frame: Baseline, 3 months, 6 months]
• Brief Assessment of Impaired Cognition Questionaire [Time frame: Baseline, 3 months, 6 months]
• Handgrip strength measurement [Time frame: Baseline, 3 months, 6 months]
• The Cumulated Ambulation Score [Time frame: Baseline, 3 months, 6 months]
• Four meter walk test [Time frame: Baseline, 3 months, 6 months]
• Euroqol 5 dimensions [Time frame: Baseline, 3 months, 6 months]
• Clinical Frailty Scale [Time frame: Baseline, 3 months, 6 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Denmark · 6 centers

• Frederiksberg Healthcare center and 24-hour rehabilitation — Frederiksberg
• Stevns Healthcare Center, Stevns Municipality — Hårlev
• Hørsholm Health and Rehabilitation Center — Hørsholm
• Maribo Health Center, Lolland Municipality — Maribo
• Guldborgsund Healthcare Center, Guldborgsund Municipality — Nykøbing Falster
• Vordingborg Healthcare Center, Vordingborg Municipality — Vordingborg

Identifiers

NCT: NCT06286722 · LollandCD

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗