An interventional study of Protein-enriched diet and Progressive resistance exercise in Hip Fractures, sponsored by Wageningen University. Recruiting at 2 sites in Netherlands. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by Wageningen University · Not applicable, Interventional, and Treatment
Hip fractures often lead to functional limitations, loss of independence, weight loss and decreased well-being. Only half of the patients regain their functional level and 24% die within the following year. Financial consequences are significant due to costly surgery and long-term care. Hip fracture incidence is expected to increase sharply due to the ageing population, reducing accessibility to and quality of rehabilitation care. Therefore, optimizing treatment is essential.
Previous protein and exercise studies showed improved muscle and bone health in healthy or frail community-dwelling older adults, but effects in older hip fracture patients are not known. Better rehabilitation may improve bone and muscle health, nutritional status, quality of life, lower costs and lower burden for healthcare.
The overall objective is to investigate the effectiveness, costs and cost-effectiveness of a protein-enriched diet and resistance exercise for 3 months compared to usual care on bone and muscle health, and quality of life in older adults recovering from an acute hip fracture.
842 studies on the registry are indexed under Hip Fractures; 165 are open to participants now.
This study's planned enrollment of 102 is above the median of 86 across 533 interventional studies indexed under Hip Fractures.
Browse Hip Fractures studies →Wageningen University is the lead sponsor of 153 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
A potential subject who meets any of the following criteria will be excluded from participation in this study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The intervention group receives a tailor-made protein-enriched diet and an extended progressive resistance training program.
Other: Protein-enriched diet · Other: Progressive resistance exercise
The control group receives usual care.
A protein intake of 1.5 g/kg bodyweight/day. This will be obtained by consuming protein-rich and protein-enriched foods.
The intervention group will perform resistance training during three non-consecutive days with a minimum of 48 hours between the sessions. Subjects will continue the resistance training after discharge for 2 times a week, also with a minimum of 48 hours between sessions until the study period of 3 months is completed. All sessions will be supervised by physiotherapists.
Physical Functioning
The short physical performance battery (SPPB) is used to assess physcial functioning. This test is a performance test assessing lower extremity function using measures of gait speed (over 4 meter), standing balance, and lower extremity strength.
Time frame: Physical performance measurements will be performed at baseline, after discharge from the rehabilitation centre (varies per participant, on average after 1 month), and after 3 months.
Handgrip strength
Handgrip strenght will be measured with a hand dynamometer (kg).
Time frame: Handgrip strength will be measured at baseline, after discharge from the rehabilitation centre (varies per participant, on average after 1 month), and after 3 months.
Muscle mass
Muscle mass will be quantified using dual-energy X-ray absorptiometry (DEXA).
Time frame: The DEXA scans will be performed at baseline and after 3 months.
Bone Mineral Density
BMD will be measured at baseline and after 3 months in the hospital. Total hip, femoral neck and total body BMD (g/cm2) will be measured using DEXA. The unfractured hip will be assessed.
Time frame: The DEXA scans will be performed at baseline and after 3 months.
Bone Mineral Density
Quantitative ultrasound (QUS) parameters of the calcaneus will be measured using the portable Achilles EXPII bone ultrasonometer.
Time frame: The quantitative ultrasound measurements will be performed at baseline and after 3 months.
Quality of life
Quality of life will be assessed with the EQ5D-5L questionnaire.
Time frame: Quality of life will be assessed at baseline, after discharge from the rehabilitation centre (varies per participant, on average after 1 month), and after 3 months.
Blood markers
Blood markers P1NP, IGF-1, PTH and vitamin D will be measured in serum.
Time frame: Blood markers will be measured at baseline, after discharge from the rehabilitation centre (varies per participant, on average after 1 month), and after 3 months.
Inpatient rehabilitation time
Number of days the patient stayed in the rehabilitation centre.
Time frame: Assessed at discharge from the rehabilitation centre (varies per participant, on average after 1 month).
Daily life functioning
The Barthel Index of Activities of Daily Living will be used to assess daily life functioning.
Time frame: Daily life functioning will be assessed at baseline, after discharge from the rehabilitation centre (varies per participant, on average after 1 month), and after 3 months.
Nutritional Status
The Mini Nutritional Assessment (MNA) will be used to evaluate nutritional status.
Time frame: This measurement will be performed at baseline, after discharge from the rehabilitation centre (varies per participant, on average after 1 month), and after 3 months.
Costs
Participants will use a cost diary to keep track of their health care use, out-of-pocket costs, and productivity losses. A health care use questionnaire based on the iMTA Medical Cost Questionnaire will be used, which includes cost categories that were deemed relevant for older adults (general practitioner, home care, informal care, dietitian, physiotherapist, occupational therapist, hospitalization, residential care, rehabilitation care, outpatient clinic, and medication use). Out-of-pocket costs includes sports club memberships, purchase of sport equipment, and other out-of-pocket payments related to the intervention. Productivity losses will be measured using questions from the Productivity Cost Questionnaire.
Time frame: This will be assessed after 3 months.
Dietary intake
The dietary intake will be observed and recorded over a period of three non-consecutive days.
Time frame: This measurement will be performed at baseline, after discharge from the rehabilitation centre (varies per participant, on average after 1 month), and after 3 months.
Frailty status
Frailty status is assessed with the Fried criteria.
Time frame: This measurement will be performed at baseline, after discharge from the rehabilitation centre (varies per participant, on average after 1 month), and after 3 months.
Body weight
Body weight in kg
Time frame: This measurement will be performed at baseline, after discharge from the rehabilitation centre (varies per participant, on average after 1 month), and after 3 months.
Blood markers
Levels of free vitamin D, folate, vitamin B12 and vitamin C are measured
Time frame: This measurement will be performed at baseline and after 3 months.
Physical Activity
The LASA Physical Activity Questionnaire (LAPAQ) is used to measure physical activity levels.
Time frame: This is assessed at baseline, after discharge from the rehabilitation centre (varies per participant, on average after 1 month), and after 3 months.
Appetite
The Simplified Nutritional Appetite Questionnaire (SNAQ) is used to assess appetite.
Time frame: This is assessed at baseline, after discharge from the rehabilitation centre (varies per participant, on average after 1 month), and after 3 months.
Fear of falling
Fear of falling will be assessed with the Falls Efficacy Scale International (FES-I).
Time frame: This will be assessed after 3 months.
Oral health
Questionnaire
Time frame: This measurement will be performed at baseline.
Number of and time to new falls and fragility fractures
Number of and time to new falls and fragility fractures is assessed with a questionnaire
Time frame: This is assessed after 3 months.
Started Sep 2024 (actual). Primary completion is estimated for Feb 2027, 29 months after the start.
Of 221 non-industry interventional studies with no phase under Hip Fractures, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 55. This study's planned 29 months is close to that.
Counting every sponsor, half of 237 studies reached it within 29 months; a quarter within 10 and three quarters within 57.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.