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

NCT07036341 | Recruiting

• 1 other identifier: NL68932.081.19
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 2

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

Keywords

Hip fracture patients; Protein; Resistance Exercise; Bone health; Muscle health

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (10)

• Handgrip strength

  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

  The DEXA scans will be performed at baseline and after 3 months.

• Bone Mineral Density

  The DEXA scans will be performed at baseline and after 3 months.

• Bone Mineral Density

  The quantitative ultrasound measurements will be performed at baseline and after 3 months.

• Quality of life

  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.

Other Outcomes (9)

• Dietary intake

  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.

• Frailty status

  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.

• Body weight

  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.

Study Arms (2)

Intervention

EXPERIMENTAL

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

Other: Protein-enriched diet; Other: Progressive resistance exercise

Control

NO INTERVENTION

The control group receives usual care.

Interventions

Protein-enriched diet OTHER

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

Intervention

Progressive resistance exercise 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.

Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Wageningen University: lead
• 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

Study Sites (2)

Rijnstate Hospital

Arnhem, 6851AD, Netherlands

RECRUITING

Gelderse Vallei Hospital

Ede, 6716RP, Netherlands

RECRUITING

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof.dr.ir.

Model Details: A randomized controlled two-arm parallel trial

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: June 25, 2025
• Study Start: September 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: June 25, 2025

Record last verified: 2025-04

Locations

NL (2)