Hip FracturesProBUSNCT07036341
Rehabilitation After a Hip Fracture: the Effects of Dietary Protein and Exercise on Bone and Muscle Health and Quality of Life
A study testing Protein-enriched diet and Progressive resistance exercise in people with Hip Fractures, run by Wageningen University at 2 sites in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fractures
- What is being tested?
- Protein-enriched diet and Progressive resistance exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 2 sitesNetherlands
- Study dates
- 1 Sep 2024to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Age ≥ 65 years
- Acute hip fracture
- Able to give written informed consent
- Mentally competent, as judged by the treating physician
- Admission to a rehabilitation centre that participates in this research
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Allergic, intolerant or hypersensitive to milk/lactose (self-reported)
- Not willing to stop using dietary supplements with exception of calcium and vitamin D
- Pathological fracture or periprosthetic fracture
- Abnormal hepatic or renal laboratory parameters, such as estimated glomerular filtration rate (eGFR) <30 ml/min/1,73 m2 (data from hospital)
- Diagnosis of disorders/diseases where a high protein intake can be harmful, such as renal impairment or failure, or liver disease (geriatric care physician has the decisive voice)
- Diagnosis of bone metabolic disorders such as primary hyperparathyroidism, Paget's disease, or myeloma.
- Taking medication other than bisphosphonates known to strongly alter bone, calcium or muscle metabolism, such as oestrogen, hormone replacement therapy, corticosteroids, anabolic agents, or calcitonin.
- Disorders/diseases which may affect ability to follow study protocol and which cannot be overcome with help of a caregiver
- Current participation in other scientific research
- 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
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands2 sites, 2 recruiting
- Recruiting
Rijnstate Hospital
Arnhem, 6851AD
Hugo H Wijnen, MD, 0031 88 005 7397, hwijnen@rijnstate.nl
- Recruiting
Gelderse Vallei Hospital
Ede, 6716RP
Nienke Golüke, MD, 0031 318 43 5938, ngoluke@zgv.nl
About this study
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.
- Conditions
- Hip Fractures
- Being tested
- Protein-enriched diet, Progressive resistance exercise
- Keywords
- Hip fracture patients, Protein, Resistance Exercise, Bone health, Muscle health
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein-enriched dietOther
A protein intake of 1.5 g/kg bodyweight/day. This will be obtained by consuming protein-rich and protein-enriched foods.
Progressive resistance exerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention group receives a tailor-made protein-enriched diet and an extended progressive resistance training program. Receives: Other: Protein-enriched diet; Other: Progressive resistance exercise |
| Control | No intervention | The control group receives usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Secondary outcomes (10)
Handgrip strength
Handgrip strenght will be measured with a hand dynamometer (kg).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: This will be assessed after 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start1 Sep 2024
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled two-arm parallel trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- Rijnstate Hospital, Gelderse Vallei Hospital, HAN University of Applied Sciences, Liemerije Revalidatiezorg, Opella Revalidatiezorg, Pleyade Revalidatiezorg, Attent Zorg en Behandeling, Alliantie Voeding in de Zorg, Osteoporosis Association
- Responsible party
- Principal investigator, Lisette de Groot, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07036341
- Sponsor's protocol ID
- NL68932.081.19
- Acronym
- ProBUS
- Status last verified
- Aug 2026
- First submitted
- 9 May 2025
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation After a Hip Fracture: the Effects of Dietary Protein and Exercise on Bone and Muscle Health and Quality of Life
- ClinicalTrials.gov ID
- NCT07036341
- Acronym / sponsor ID
- ProBUS / NL68932.081.19
- Conditions
- Hip Fractures
- Keywords
- Hip fracture patients, Protein, Resistance Exercise, Bone health, Muscle health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- Rijnstate Hospital, Gelderse Vallei Hospital, HAN University of Applied Sciences, Liemerije Revalidatiezorg, Opella Revalidatiezorg, Pleyade Revalidatiezorg, Attent Zorg en Behandeling, Alliantie Voeding in de Zorg, Osteoporosis Association
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 25 Jun 2025 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized controlled two-arm parallel trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Protein-enriched diet, Other: Progressive resistance exerciseThe intervention group receives a tailor-made protein-enriched diet and an extended progressive resistance training program. |
| Control | No intervention | –The control group receives usual care. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protein-enriched dietA protein intake of 1.5 g/kg bodyweight/day. This will be obtained by consuming protein-rich and protein-enriched foods. | Other | Intervention |
| Progressive resistance exerciseThe 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. | Other | Intervention |
Primary outcome
Physical Functioning
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.
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.
10 secondary outcomes
Handgrip strength
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
Time frame: The DEXA scans will be performed at baseline and after 3 months.
Bone Mineral Density
Time frame: The DEXA scans will be performed at baseline and after 3 months.
Bone Mineral Density
Time frame: The quantitative ultrasound measurements will be performed at baseline and after 3 months.
Quality of life
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
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
Time frame: Assessed at discharge from the rehabilitation centre (varies per participant, on average after 1 month).
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
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
Time frame: This will be assessed after 3 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein-enriched diet and Progressive resistance exercise in people with Hip Fractures, run by Wageningen University at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Functioning (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.). 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 18 Aug 2026.