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Completed

NCT Number: NCT05039879

Life Improving Factors After a Hip Fracture

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.

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Key information

Conditions

Hip Fractures Femoral Fractures Fractures, Bone Hip Injuries Leg Injuries Older Adults Wounds and Injuries

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rijnstate Hospital

Arnhem, Netherlands

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Protein intake

    Time frame: Baseline

    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.

  2. 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.

  3. Nutritional status

    Time frame: Baseline

    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).

  4. 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).

  5. Procollagen type 1 N propeptide

    Time frame: Baseline

    Bone turnover marker, in serum

  6. Procollagen type 1 N propeptide

    Time frame: Three months

    Bone turnover marker, in serum

  7. C-terminal telopeptide of type I collagen

    Time frame: Baseline

    Bone turnover marker

  8. C-terminal telopeptide of type I collagen

    Time frame: Three months

    Bone turnover marker

  9. Calcaneus quantitative ultrasound parameters

    Time frame: Baseline

    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).

  10. 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).

  11. Insulin-like growth factor 1

    Time frame: Baseline

    In serum

  12. Insulin-like growth factor 1

    Time frame: Three months

    In serum

  13. Parathyroid hormone levels

    Time frame: Baseline

    In serum

  14. Parathyroid hormone levels

    Time frame: Three months

    In serum

  15. Handgrip strength

    Time frame: Baseline

    Using the Martin vigorimeter

  16. Handgrip strength

    Time frame: Three months

    Using the Martin vigorimeter

  17. Grip work

    Time frame: Baseline

    Using the Martin vigorimeter

  18. Grip work

    Time frame: Three months

    Using the Martin vigorimeter

Secondary outcomes

  1. Appendicular skeletal muscle mass

    Time frame: Baseline

    Using bioimpedance spectroscopy

  2. Appendicular skeletal muscle mass

    Time frame: Three months

    Using bioimpedance spectroscopy

  3. Mobility

    Time frame: Baseline

    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.

  4. Mobility

    Time frame: 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.

  5. Frailty

    Time frame: Baseline

    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'.

  6. Frailty

    Time frame: 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'.

  7. Bodyweight

    Time frame: Baseline

    Bodyweight (kg) will be measured with a calibrated sitting weighing scale.

  8. Bodyweight

    Time frame: Three months

    Bodyweight (kg) will be measured with a calibrated sitting weighing scale.

  9. Barthel Index

    Time frame: Baseline

    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).

  10. Barthel Index

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Wageningen University

Other

Collaborators

  • Rijnstate Hospital

Registry information

Acronym: LIFF

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 10, 2021
Registry last updated
Feb 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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