Life Improving Factors After a Hip Fracture (LIFF)

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.

Study Overview

• Status: Completed
• Conditions: Hip Fractures; Older Adults

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 Type: Observational
• Enrollment (Actual): 95

Contacts and Locations

Study Locations

• Netherlands
  • Arnhem, Netherlands
    • Rijnstate Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Older adults aged 70 years or older recovering from an acute hip fracture

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Protein intake	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.	Baseline
Protein intake	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.	Three months
Nutritional status	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).	Baseline
Nutritional status	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).	Three months
Procollagen type 1 N propeptide	Bone turnover marker, in serum	Baseline
Procollagen type 1 N propeptide	Bone turnover marker, in serum	Three months
C-terminal telopeptide of type I collagen	Bone turnover marker	Baseline
C-terminal telopeptide of type I collagen	Bone turnover marker	Three months
Calcaneus quantitative ultrasound parameters	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).	Baseline
Calcaneus quantitative ultrasound parameters	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).	Three months
Insulin-like growth factor 1	In serum	Baseline
Insulin-like growth factor 1	In serum	Three months
Parathyroid hormone levels	In serum	Baseline
Parathyroid hormone levels	In serum	Three months
Handgrip strength	Using the Martin vigorimeter	Baseline
Handgrip strength	Using the Martin vigorimeter	Three months
Grip work	Using the Martin vigorimeter	Baseline
Grip work	Using the Martin vigorimeter	Three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Appendicular skeletal muscle mass	Using bioimpedance spectroscopy	Baseline
Appendicular skeletal muscle mass	Using bioimpedance spectroscopy	Three months
Mobility	Pre-fracture mobility will be assessed with the pre-fracture mobility scale (PMS). The PMS classifies the patient as independent walker, walk with rollator, in a wheelchair or bedridden.	Baseline
Mobility	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.	Three months
Frailty	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'.	Baseline
Frailty	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'.	Three months
Bodyweight	Bodyweight (kg) will be measured with a calibrated sitting weighing scale.	Baseline
Bodyweight	Bodyweight (kg) will be measured with a calibrated sitting weighing scale.	Three months
Barthel Index	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).	Baseline
Barthel Index	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).	Three months

Collaborators and Investigators

• Sponsor: Wageningen University
• Collaborators: Rijnstate Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 6, 2021
• Primary Completion (ACTUAL): November 29, 2022
• Study Completion (ACTUAL): December 15, 2022

Study Registration Dates

• First Submitted: July 21, 2021
• First Submitted That Met QC Criteria: September 1, 2021
• First Posted (ACTUAL): September 10, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 6, 2023
• Last Update Submitted That Met QC Criteria: February 1, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: 2021-1814

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No