Protein and resistance exercise to speed recovery after hip fracture
Rehabilitation After a Hip Fracture: the Effects of Dietary Protein and Exercise on Bone and Muscle Health and Quality of Life
This trial will test whether a protein-enriched diet plus three months of progressive resistance exercise helps people aged 65 and older recover bone and muscle health and improve quality of life after an acute hip fracture.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 102 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Wageningen University Academic / other |
| Locations | 2 sites (Arnhem and 1 other locations) |
| Trial ID | NCT07036341 on ClinicalTrials.gov |
What this trial studies
This interventional study compares a protein-enriched diet combined with progressive resistance exercise for three months to usual care in older adults recovering from an acute hip fracture. Participants are recruited at participating rehabilitation centers and must be aged 65 or older and able to give written informed consent. Outcomes include measures of bone and muscle health, nutritional status, quality of life, and health care costs, with cost-effectiveness analysis planned. Interventions are delivered during the rehabilitation admission and outcomes are followed after the three-month intervention period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 65 or older with an acute hip fracture admitted to a participating rehabilitation center who are mentally competent and able to provide written informed consent.
Not a fit: Patients with milk or lactose allergy/intolerance, significant renal or liver impairment, pathological or periprosthetic fractures, or those unwilling to stop most dietary supplements are excluded and unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the program could preserve bone and muscle, speed functional recovery, improve independence and quality of life, and lower long-term care costs for hip fracture patients.
How similar studies have performed: Previous trials combining protein supplementation and resistance exercise improved muscle and bone health in healthy or frail community-dwelling older adults, but the combined approach has not been proven in older hip fracture rehabilitation patients.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Arnhem and 1 other locations
- Rijnstate Hospital — Arnhem, Netherlands (Recruiting)
- Gelderse Vallei Hospital — Ede, Netherlands (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.