Life Improving Factors After a Hip Fracture

Hip Fractures Clinical Trial

— LIFF  

Official title:

Life Improving Factors After a Hip Fracture

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05039879
• Other study ID #: 2021-1814
• Status: Completed
• Start date: September 6, 2021
• Est. completion date: December 15, 2022

Study information

• Verified date: February 2023
• Source: Wageningen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: December 15, 2022
• Est. primary completion date: November 29, 2022
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures
• Older Adults

Locations

Country	Name	City	State
Netherlands	Rijnstate Hospital	Arnhem

Sponsors (2)

Lead Sponsor	Collaborator
Wageningen University	Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Procollagen type 1 N propeptide	Bone turnover marker, in serum	Baseline
Primary	Procollagen type 1 N propeptide	Bone turnover marker, in serum	Three months
Primary	C-terminal telopeptide of type I collagen	Bone turnover marker	Baseline
Primary	C-terminal telopeptide of type I collagen	Bone turnover marker	Three months
Primary	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
Primary	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
Primary	Insulin-like growth factor 1	In serum	Baseline
Primary	Insulin-like growth factor 1	In serum	Three months
Primary	Parathyroid hormone levels	In serum	Baseline
Primary	Parathyroid hormone levels	In serum	Three months
Primary	Handgrip strength	Using the Martin vigorimeter	Baseline
Primary	Handgrip strength	Using the Martin vigorimeter	Three months
Primary	Grip work	Using the Martin vigorimeter	Baseline
Primary	Grip work	Using the Martin vigorimeter	Three months
Secondary	Appendicular skeletal muscle mass	Using bioimpedance spectroscopy	Baseline
Secondary	Appendicular skeletal muscle mass	Using bioimpedance spectroscopy	Three months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Bodyweight	Bodyweight (kg) will be measured with a calibrated sitting weighing scale.	Baseline
Secondary	Bodyweight	Bodyweight (kg) will be measured with a calibrated sitting weighing scale.	Three months
Secondary	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
Secondary	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