Life Improving Factors After a Hip Fracture

Completed

• Conditions: Hip Fractures; Older Adults

• Registration Number: NCT05039879
• Lead Sponsor: Wageningen University

Brief Summary

The primary objective of the proposed research is to investigate the association between protein intake and nutritional status with bone health and physical functioning in older hip fracture patients. In addition, it will be investigated which patient characteristics and modifiable factors can predict mobility, clinical frailty, living situation and mortality. This study will be a 3-month prospective cohort study in adults aged 70 years and older with an acute hip fracture. This study will lead to knowledge about how protein intake and nutritional status in combination with patient characteristics can predict the degree of recovery (bone health and physical functioning) 3 months after the hip fracture. Knowledge on factors related to recovery can contribute to an improved and shorter rehabilitation in the future, which results in a reduction of health care costs.

Detailed Description

Only half of the patients with an acute hip fracture regain their pre-fracture functional level and 24% dies within the following year. Identifying and targeting modifiable risk factors for optimal recovery after a hip fracture is therefore essential. These factors include protein intake and nutritional status, which may affect markers of bone health and physical functioning and thereby influence recovery.

Measurements will be performed at baseline (within 5 days after the hip surgery) and after 3 months during an outpatient clinic visit for the evaluation of the hip fracture surgery. A total of 95 older adults (aged 70 years or older) recovering from an acute hip fracture will be recruited from Rijnstate hospital.

Study Timeline

• Study First Submitted: 2021-07-21
• Study First Submitted QC: 2021-09-01
• Study Start: 2021-09-06
• Study First Posted: 2021-09-10
• Primary Completion: 2022-11-29
• Study Completion: 2022-12-15
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-01
• Last Update Posted: 2023-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

• Age ≥ 70 years
• Community-dwelling
• Proximal femur fracture: femoral neck fracture/ pertrochanteric fracture, subtrochanteric fracture
• Able to give informed consent
• Pre-fracture Clinical Frailty Scale 3-6

Exclusion Criteria

• Pathological fracture or periprosthetic fracture
• Current participation in scientific research that interferes with the proposed study
• History of dementia
• No permission to request information from the general practitioner/ treating specialist(s) about medical history, medication use, liver and kidney values, and details about the broken hip

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Protein intake	Three months	Dietary protein intake will be recorded using a protein screener which gives an indication of protein intake in g/d. Based on the past 4 weeks.
Procollagen type 1 N propeptide	Three months	Bone turnover marker, in serum
Nutritional status	Three months	Using the Mini Nutritional Assessment Short Form. Subjects will be classified as having a normal nutritional status (12-14 points), having a risk of malnutrition (8-11 points), or being undernourished (0-7 points).
C-terminal telopeptide of type I collagen	Three months	Bone turnover marker
Calcaneus quantitative ultrasound parameters	Three months	Ultrasound of the calcaneus which gives an indication of the bone density. Device yields the following two parameters: speed of sound (SOS) and broadband ultrasound attenuation (BUA), which can be combined to get the Stiffness Index (SI).
Insulin-like growth factor 1	Three months	In serum
Parathyroid hormone levels	Three months	In serum
Grip work	Three months	Using the Martin vigorimeter
Handgrip strength	Three months	Using the Martin vigorimeter

Secondary Outcome Measures

Name	Time	Method
Mobility	Three months	Mobility at 3 months will be assessed with the Functional Ambulation Categories (FAC). The FAC is scaled from 0 to 5, in which zero means that patient cannot walk or need at least two persons to help and five means independent walker.
Appendicular skeletal muscle mass	Three months	Using bioimpedance spectroscopy
Frailty	Three months	Frailty will be assessed with the Clinical Frailty Scale. This scale is graded from 1 to 9 in which level 1 represents 'very fit' and level 9 'terminally ill'.
Bodyweight	Three months	Bodyweight (kg) will be measured with a calibrated sitting weighing scale.
Barthel Index	Three months	This questionnaire determines the degree of (physical or verbal) help a person needs to perform general daily activities. It is graded from 0 (person is completely dependent on others) to 20 (person is completely independent).

Trial Locations

Locations (1)

Rijnstate Hospital; 🇳🇱 Arnhem, Netherlands