Hip FracturesLIFFNCT05039879
Life Improving Factors After a Hip Fracture
An observational study of Hip Fractures and Older Adults, run by Wageningen University at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Hip Fractures, Older Adults
- How many people
- 95 participants
- Where
- 1 siteNetherlands
- Study dates
- 6 Sep 2021to 15 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Older adult
Study population: Older adults aged 70 years or older recovering from an acute hip fracture
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Hip Fractures, Older Adults
- Medical subject headings
- Hip Fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: Three months
Procollagen type 1 N propeptide
Bone turnover marker, in serum
Measured: Baseline
Procollagen type 1 N propeptide
Bone turnover marker, in serum
Measured: Three months
C-terminal telopeptide of type I collagen
Bone turnover marker
Measured: Baseline
C-terminal telopeptide of type I collagen
Bone turnover marker
Measured: 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).
Measured: 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).
Measured: Three months
Insulin-like growth factor 1
In serum
Measured: Baseline
Insulin-like growth factor 1
In serum
Measured: Three months
Parathyroid hormone levels
In serum
Measured: Baseline
Parathyroid hormone levels
In serum
Measured: Three months
Handgrip strength
Using the Martin vigorimeter
Measured: Baseline
Handgrip strength
Using the Martin vigorimeter
Measured: Three months
Grip work
Using the Martin vigorimeter
Measured: Baseline
Grip work
Using the Martin vigorimeter
Measured: Three months
Secondary outcomes (10)
Appendicular skeletal muscle mass
Using bioimpedance spectroscopy
Measured: Baseline
Appendicular skeletal muscle mass
Using bioimpedance spectroscopy
Measured: 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.
Measured: 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.
Measured: 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'.
Measured: 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'.
Measured: Three months
Bodyweight
Bodyweight (kg) will be measured with a calibrated sitting weighing scale.
Measured: Baseline
Bodyweight
Bodyweight (kg) will be measured with a calibrated sitting weighing scale.
Measured: 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).
Measured: 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).
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
- Study start6 Sep 2021
- Primary completion29 Nov 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- Rijnstate Hospital
- Responsible party
- Principal investigator, Hugo Wijnen, Rijnstate Hospital
- Investigators
- Hugo Wijnen, Principal investigator, Hospital Rijnstate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05039879
- Sponsor's protocol ID
- 2021-1814
- Acronym
- LIFF
- Status last verified
- Feb 2023
- First submitted
- 21 Jul 2021
- Last updated
- 6 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Life Improving Factors After a Hip Fracture
- ClinicalTrials.gov ID
- NCT05039879
- Acronym / sponsor ID
- LIFF / 2021-1814
- Conditions
- Hip Fractures, Older Adults
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- Rijnstate Hospital
- Study start
- 6 Sep 2021 (actual)
- Primary completion
- 29 Nov 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 10 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- Older adults aged 70 years or older recovering from an acute hip fracture
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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).
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).
Procollagen type 1 N propeptide
Time frame: Baseline
Bone turnover marker, in serum
Procollagen type 1 N propeptide
Time frame: Three months
Bone turnover marker, in serum
C-terminal telopeptide of type I collagen
Time frame: Baseline
Bone turnover marker
C-terminal telopeptide of type I collagen
Time frame: Three months
Bone turnover marker
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).
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: Baseline
In serum
Insulin-like growth factor 1
Time frame: Three months
In serum
Parathyroid hormone levels
Time frame: Baseline
In serum
Parathyroid hormone levels
Time frame: Three months
In serum
Handgrip strength
Time frame: Baseline
Using the Martin vigorimeter
Handgrip strength
Time frame: Three months
Using the Martin vigorimeter
Grip work
Time frame: Baseline
Using the Martin vigorimeter
Grip work
Time frame: Three months
Using the Martin vigorimeter
10 secondary outcomes
Appendicular skeletal muscle mass
Time frame: Baseline
Appendicular skeletal muscle mass
Time frame: Three months
Mobility
Time frame: Baseline
Mobility
Time frame: Three months
Frailty
Time frame: Baseline
Frailty
Time frame: Three months
Bodyweight
Time frame: Baseline
Bodyweight
Time frame: Three months
Barthel Index
Time frame: Baseline
Barthel Index
Time frame: Three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Hip Fractures
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Lumbar-Sacral Plexus Block vs Fascia Iliaca Block Plus Low-Dose Spinal Anesthesia for Femoral Neck Fracture Surgery
Femoral Neck Fractures, Nerve Block
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Effect of Ondansetron on the Incidence of Spinal Anaesthesia-Induced Hypotension in Elderly Patients Undergoing Fracture Hip Surgery
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Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
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A Decision Support Tool for Common Surgical Fixations of Hip Fractures
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hugo Wijnen principal investigator
Hospital Rijnstate
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Fractures and Older Adults, run by Wageningen University at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protein intake (time frame: Baseline). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2023.