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

NCT06286722 | Recruiting DMC

• 1 other identifier: LollandCD
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 6

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.

Conditions

Hip Fractures; Cognitive Impairment

Keywords

Outpatient; Rehabilitation; Progressive; structured exercise; Hip Fracture; Cognitive impairment; Older adults

Outcome Measures

Primary Outcomes (1)

• The New Mobility Score

  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.

  Baseline, 3 months, 6 months

Secondary Outcomes (14)

• Mini Mental State Examination

  Baseline and 6 months

• Height

  Baseline

• Weight

  Baseline, 3 months, 6 months

• Tandem balance test

  Baseline, 3 months, 6 months

• The Barthel-20

  Baseline, 3 months, 6 months

Study Arms (1)

Progressive, individualized and structured exercise program

EXPERIMENTAL

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).

Other: Progressive, individualized and structured exercise program

Interventions

Progressive, individualized and structured exercise program OTHER

See description under Arms

Progressive, individualized and structured exercise program

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lolland Community, Denmark: lead
• Vordingborg Municipality: collaborator
• Stevns Municipality: collaborator
• Guldborgsund Municipality: collaborator
• Frederiksberg Municipality: collaborator
• Horsholm Municipality: collaborator

Study Sites (6)

Frederiksberg Healthcare center and 24-hour rehabilitation

Frederiksberg, 2000, Denmark

RECRUITING

Stevns Healthcare Center, Stevns Municipality

Hårlev, 4652, Denmark

RECRUITING

Hørsholm Health and Rehabilitation Center

Hørsholm, 2970, Denmark

RECRUITING

Maribo Health Center, Lolland Municipality

Maribo, 4930, Denmark

RECRUITING

Guldborgsund Healthcare Center, Guldborgsund Municipality

Nykøbing Falster, 4800, Denmark

RECRUITING

Vordingborg Healthcare Center, Vordingborg Municipality

Vordingborg, 4760, Denmark

RECRUITING

MeSH Terms

Conditions

Hip Fractures; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Trine Nordentoft

  Vordingborg Municipality

  STUDY CHAIR

• Halil Baldan

  Guldborgsund Municipality

  STUDY CHAIR

• Lotte Bylov

  Stevns Municipality

  STUDY CHAIR

• Gwen Tremmel

  Lolland Municipality

  STUDY CHAIR

Central Study Contacts

Jan Arnholtz Overgaard, MSc.

CONTACT

+4561121191; jover@lolland.dk

Søren Thorgaard Skou, PhD

CONTACT

004523708640; stskou@health.sdu.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Feasibility study

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: February 29, 2024
• Study Start: February 8, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 12, 2025

Record last verified: 2025-02

Locations

DK (6)