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Recruiting NCT06286722

NCT06286722 Optimized Rehabilitation of Older Adults With Hip Fracture and Signs of Cognitive Impairment - Feasibility Study

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Clinical Trial Summary
NCT ID NCT06286722
Status Recruiting
Phase
Sponsor Lolland Community, Denmark
Condition Hip Fractures
Study Type INTERVENTIONAL
Enrollment 20 participants
Start Date 2024-02-08
Primary Completion 2025-12-31

Eligibility & Interventions

Sex All sexes
Min Age 65 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
Progressive, individualized and structured exercise program

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 20 participants in total. It began in 2024-02-08 with a primary completion date of 2025-12-31.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

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

Contact & Investigator

Central Contact

Jan Arnholtz Overgaard, MSc.

✉ jover@lolland.dk

📞 +4561121191

Principal Investigator

Trine Nordentoft

STUDY CHAIR

Vordingborg Municipality

Frequently Asked Questions

Who can join the NCT06286722 clinical trial?

This trial is open to participants of all sexes, aged 65 Years or older, studying Hip Fractures. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06286722 currently recruiting?

Yes, NCT06286722 is actively recruiting participants. Contact the research team at jover@lolland.dk for enrollment information.

Where is the NCT06286722 trial being conducted?

This trial is being conducted at Frederiksberg, Denmark, Hårlev, Denmark, Hørsholm, Denmark, Maribo, Denmark and 2 additional locations.

Who is sponsoring the NCT06286722 clinical trial?

NCT06286722 is sponsored by Lolland Community, Denmark. The principal investigator is Trine Nordentoft at Vordingborg Municipality. The trial plans to enroll 20 participants.

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