About this trial
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
This trial does not accept healthy volunteersQualifiers
Age ≥ 65 years
Acute hip fracture
Able to give written informed consent
Mentally competent, as judged by the treating physician
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Protein-enriched diet
Other interventionA protein intake of 1.5 g/kg bodyweight/day. This will be obtained by consuming protein-rich and protein-enriched foods.
Progressive resistance exercise
Other interventionThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Physical Functioning
The short physical performance battery (SPPB) is used to assess physcial functioning. This test is a performance test assessing lower extremity function using measures of gait speed (over 4 meter), standing balance, and lower extremity strength.
Secondary outcomes
Handgrip strength
Handgrip strenght will be measured with a hand dynamometer (kg).
Muscle mass
Muscle mass will be quantified using dual-energy X-ray absorptiometry (DEXA).
Bone Mineral Density
BMD will be measured at baseline and after 3 months in the hospital. Total hip, femoral neck and total body BMD (g/cm2) will be measured using DEXA. The unfractured hip will be assessed.
Bone Mineral Density
Quantitative ultrasound (QUS) parameters of the calcaneus will be measured using the portable Achilles EXPII bone ultrasonometer.
Other outcomes
Dietary intake
The dietary intake will be observed and recorded over a period of three non-consecutive days.
Frailty status
Frailty status is assessed with the Fried criteria.
Body weight
Body weight in kg
Blood markers
Levels of free vitamin D, folate, vitamin B12 and vitamin C are measured
Sponsors and contacts
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Wageningen University
Lead sponsor
Rijnstate Hospital
Collaborator
Gelderse Vallei Hospital
Collaborator
HAN University of Applied Sciences
Collaborator
Liemerije Revalidatiezorg
Collaborator
Opella Revalidatiezorg
Collaborator
Pleyade Revalidatiezorg
Collaborator
Attent Zorg en Behandeling
Collaborator
Alliantie Voeding in de Zorg
Collaborator
Osteoporosis Association
Collaborator