Protein and resistance exercise to speed recovery after hip fracture

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Rijnstate Hospital
  Arnhem, Netherlands Recruiting
• Gelderse Vallei Hospital
  Ede, Netherlands Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.