Optimized Rehabilitation of Older Adults With Hip Fracture and Signs of Cognitive Impairment - Feasibility Study

NCT ID: NCT06286722

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-08
• Study Completion Date: 2026-06-30

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).

Conditions

Hip Fractures; Cognitive Impairment

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Progressive, individualized and structured exercise program

Intervention Type: OTHER

See description under Arms

Interventions

Progressive, individualized and structured exercise program

See description under Arms

Intervention Type: OTHER

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vordingborg Municipality

UNKNOWN

Sponsor Role: collaborator

Stevns Municipality

UNKNOWN

Sponsor Role: collaborator

Guldborgsund Municipality

UNKNOWN

Sponsor Role: collaborator

Frederiksberg Municipality

UNKNOWN

Sponsor Role: collaborator

Horsholm Municipality

OTHER

Sponsor Role: collaborator

Lolland Community, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Mr. Jan Overgaard

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Trine Nordentoft

Role: STUDY_CHAIR

Vordingborg Municipality

Halil Baldan

Role: STUDY_CHAIR

Guldborgsund Municipality

Lotte Bylov

Role: STUDY_CHAIR

Stevns Municipality

Gwen Tremmel

Role: STUDY_CHAIR

Lolland Municipality

Locations

Frederiksberg Healthcare center and 24-hour rehabilitation

Frederiksberg, , Denmark

Site Status: RECRUITING

Stevns Healthcare Center, Stevns Municipality

Hårlev, , Denmark

Site Status: RECRUITING

Hørsholm Health and Rehabilitation Center

Hørsholm, , Denmark

Site Status: RECRUITING

Maribo Health Center, Lolland Municipality

Maribo, , Denmark

Site Status: RECRUITING

Guldborgsund Healthcare Center, Guldborgsund Municipality

Nykøbing Falster, , Denmark

Site Status: RECRUITING

Vordingborg Healthcare Center, Vordingborg Municipality

Vordingborg, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Jan Arnholtz Overgaard, MSc.

Role: CONTACT

jover@lolland.dk

+4561121191

Søren Thorgaard Skou, PhD

Role: CONTACT

stskou@health.sdu.dk

004523708640

Facility Contacts

Nanna Aue Sobol, PT, PhD

Role: primary

jover@lolland.dk

Lotte Bylov

Role: primary

jover@lolland.dk

Niklas Grundt Hansen, PT, MSc.

Role: primary

jover@lolland.dk

Jan Arnholtz Overgaard, MSc.

Role: primary

jover@lolland.dk

+4554677700

Gwen Tremmel

Role: backup

gptr@lolland.dk

+4554677700

Jakob Jensen, PT

Role: primary

jover@lolland.dk

Line Flemmer, Bachelor

Role: primary

jover@lolland.dk

Other Identifiers

LollandCD

Identifier Type: -

Identifier Source: org_study_id