NCT07036341 Rehabilitation After a Hip Fracture: the Effects of Dietary Protein and Exercise on Bone and Muscle Health and Quality of Life
| NCT ID | NCT07036341 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Wageningen University |
| Condition | Hip Fractures |
| Study Type | INTERVENTIONAL |
| Enrollment | 102 participants |
| Start Date | 2024-09-01 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 102 participants in total. It began in 2024-09-01 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
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
Frequently Asked Questions
Who can join the NCT07036341 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Hip Fractures. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07036341 currently recruiting?
Yes, NCT07036341 is actively recruiting participants. Visit ClinicalTrials.gov or contact Wageningen University to inquire about joining.
Where is the NCT07036341 trial being conducted?
This trial is being conducted at Arnhem, Netherlands, Ede, Netherlands.
Who is sponsoring the NCT07036341 clinical trial?
NCT07036341 is sponsored by Wageningen University. The trial plans to enroll 102 participants.