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Clinical Trials/NCT05039879
NCT05039879
Completed
Not Applicable

Life Improving Factors After a Hip Fracture

Wageningen University1 site in 1 country95 target enrollmentSeptember 6, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hip Fractures
Sponsor
Wageningen University
Enrollment
95
Locations
1
Primary Endpoint
Protein intake
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 6, 2021
End Date
December 15, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hugo Wijnen

Drs.

Rijnstate Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Protein intake

Time Frame: 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

Time Frame: Three months

Bone turnover marker, in serum

Nutritional status

Time Frame: 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

Time Frame: Three months

Bone turnover marker

Calcaneus quantitative ultrasound parameters

Time Frame: 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

Time Frame: Three months

In serum

Parathyroid hormone levels

Time Frame: Three months

In serum

Grip work

Time Frame: Three months

Using the Martin vigorimeter

Handgrip strength

Time Frame: Three months

Using the Martin vigorimeter

Secondary Outcomes

  • Bodyweight(Three months)
  • Mobility(Three months)
  • Frailty(Three months)
  • Appendicular skeletal muscle mass(Three months)
  • Barthel Index(Three months)

Study Sites (1)

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