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

NCT ID: NCT07036341

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2026-08-31

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.

Conditions

Hip Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention

The intervention group receives a tailor-made protein-enriched diet and an extended progressive resistance training program.

Group Type: EXPERIMENTAL

Protein-enriched diet

Intervention Type: OTHER

A protein intake of 1.5 g/kg bodyweight/day. This will be obtained by consuming protein-rich and protein-enriched foods.

Progressive resistance exercise

Intervention Type: OTHER

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.

Control

The control group receives usual care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Protein-enriched diet

A protein intake of 1.5 g/kg bodyweight/day. This will be obtained by consuming protein-rich and protein-enriched foods.

Intervention Type: OTHER

Progressive resistance exercise

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rijnstate Hospital

OTHER

Sponsor Role: collaborator

Gelderse Vallei Hospital

OTHER

Sponsor Role: collaborator

HAN University of Applied Sciences

OTHER

Sponsor Role: collaborator

Liemerije Revalidatiezorg

UNKNOWN

Sponsor Role: collaborator

Opella Revalidatiezorg

UNKNOWN

Sponsor Role: collaborator

Pleyade Revalidatiezorg

UNKNOWN

Sponsor Role: collaborator

Attent Zorg en Behandeling

UNKNOWN

Sponsor Role: collaborator

Alliantie Voeding in de Zorg

UNKNOWN

Sponsor Role: collaborator

Osteoporosis Association

UNKNOWN

Sponsor Role: collaborator

Wageningen University

OTHER

Sponsor Role: lead

Responsible Party

Lisette de Groot

prof.dr.ir.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Rijnstate Hospital

Arnhem, , Netherlands

Site Status: RECRUITING

Gelderse Vallei Hospital

Ede, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Facility Contacts

Hugo H Wijnen, MD

Role: primary

hwijnen@rijnstate.nl

0031 88 005 7397

Nienke Golüke, MD

Role: primary

ngoluke@zgv.nl

0031 318 43 5938

Other Identifiers

NL68932.081.19

Identifier Type: -

Identifier Source: org_study_id