Rehabilitation After a Hip Fracture: the Effects of Dietary Protein and Exercise on Bone and Muscle Health and Quality of Life (ProBUS)

Wageningen University

Status

Enrolling

Conditions

Hip Fractures

Treatments

Other: Progressive resistance exercise

Other: Protein-enriched diet

Study type

Interventional

Funder types

Other

Identifiers

NCT07036341

NL68932.081.19

Details and patient eligibility

About

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.

Enrollment

102 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

Inclusion and 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