Clinical trial NCT05039879: Life Improving Factors After a Hip Fracture
Official title: Life Improving Factors After a Hip Fracture
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Fractures
Older Adults
Lead sponsor: Wageningen University
Sponsor class: OTHER
Collaborators: name: Rijnstate Hospital
First posted: 2021-09-10
Enrollment: 95
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Older adults aged 70 years or older recovering from an acute hip fracture

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.

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

Primary outcomes:
measure: Protein intake
timeFrame: Baseline
measure: Protein intake
timeFrame: Three months
measure: Nutritional status
timeFrame: Baseline
measure: Nutritional status
timeFrame: Three months
measure: Procollagen type 1 N propeptide
timeFrame: Baseline
measure: Procollagen type 1 N propeptide
timeFrame: Three months
measure: C-terminal telopeptide of type I collagen
timeFrame: Baseline
measure: C-terminal telopeptide of type I collagen
timeFrame: Three months
measure: Calcaneus quantitative ultrasound parameters
timeFrame: Baseline
measure: Calcaneus quantitative ultrasound parameters
timeFrame: Three months
measure: Insulin-like growth factor 1
timeFrame: Baseline
measure: Insulin-like growth factor 1
timeFrame: Three months
measure: Parathyroid hormone levels
timeFrame: Baseline
measure: Parathyroid hormone levels
timeFrame: Three months
measure: Handgrip strength
timeFrame: Baseline
measure: Handgrip strength
timeFrame: Three months
measure: Grip work
timeFrame: Baseline
measure: Grip work
timeFrame: Three months
Secondary outcomes:
measure: Appendicular skeletal muscle mass
timeFrame: Baseline
measure: Appendicular skeletal muscle mass
timeFrame: Three months
measure: Mobility
timeFrame: Baseline
measure: Mobility
timeFrame: Three months
measure: Frailty
timeFrame: Baseline
measure: Frailty
timeFrame: Three months
measure: Bodyweight
timeFrame: Baseline
measure: Bodyweight
timeFrame: Three months
measure: Barthel Index
timeFrame: Baseline
measure: Barthel Index
timeFrame: Three months
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
Study officials:
affiliation: Hospital Rijnstate
name: Hugo Wijnen
role: PRINCIPAL_INVESTIGATOR
References: