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

Overview

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.

Interventions

• Other 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.
• 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.

Primary outcome measures

• Physical Functioning [Time frame: Physical performance measurements will be performed at baseline, after discharge from the rehabilitation centre (varies per participant, on average after 1 month), and after 3 months.]

Secondary outcome measures (10)

• Handgrip strength [Time frame: Handgrip strength will be measured at baseline, after discharge from the rehabilitation centre (varies per participant, on average after 1 month), and after 3 months.]
• Muscle mass [Time frame: The DEXA scans will be performed at baseline and after 3 months.]
• Bone Mineral Density [Time frame: The DEXA scans will be performed at baseline and after 3 months.]
• Bone Mineral Density [Time frame: The quantitative ultrasound measurements will be performed at baseline and after 3 months.]
• Quality of life [Time frame: Quality of life will be assessed at baseline, after discharge from the rehabilitation centre (varies per participant, on average after 1 month), and after 3 months.]
• Blood markers [Time frame: Blood markers will be measured at baseline, after discharge from the rehabilitation centre (varies per participant, on average after 1 month), and after 3 months.]
• Inpatient rehabilitation time [Time frame: Assessed at discharge from the rehabilitation centre (varies per participant, on average after 1 month).]
• Daily life functioning [Time frame: Daily life functioning will be assessed at baseline, after discharge from the rehabilitation centre (varies per participant, on average after 1 month), and after 3 months.]
• Nutritional Status [Time frame: This measurement will be performed at baseline, after discharge from the rehabilitation centre (varies per participant, on average after 1 month), and after 3 months.]
• Costs [Time frame: This will be assessed after 3 months.]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Netherlands · 2 centers

• Rijnstate Hospital — Arnhem
• Gelderse Vallei Hospital — Ede

Identifiers

NCT: NCT07036341 · NL68932.081.19

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗