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NCT Number: NCT07036341

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

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.

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Key information

Conditions

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

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rijnstate Hospital, Arnhem, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

    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

  1. 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.

    Handgrip strenght will be measured with a hand dynamometer (kg).

  2. Muscle mass

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

    Muscle mass will be quantified using dual-energy X-ray absorptiometry (DEXA).

  3. Bone Mineral Density

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

    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.

  4. Bone Mineral Density

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

    Quantitative ultrasound (QUS) parameters of the calcaneus will be measured using the portable Achilles EXPII bone ultrasonometer.

  5. 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.

    Quality of life will be assessed with the EQ5D-5L questionnaire.

  6. 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.

    Blood markers P1NP, IGF-1, PTH and vitamin D will be measured in serum.

  7. Inpatient rehabilitation time

    Time frame: Assessed at discharge from the rehabilitation centre (varies per participant, on average after 1 month).

    Number of days the patient stayed in the rehabilitation centre.

  8. 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.

    The Barthel Index of Activities of Daily Living will be used to assess daily life functioning.

  9. 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.

    The Mini Nutritional Assessment (MNA) will be used to evaluate nutritional status.

  10. Costs

    Time frame: This will be assessed after 3 months.

    Participants will use a cost diary to keep track of their health care use, out-of-pocket costs, and productivity losses. A health care use questionnaire based on the iMTA Medical Cost Questionnaire will be used, which includes cost categories that were deemed relevant for older adults (general practitioner, home care, informal care, dietitian, physiotherapist, occupational therapist, hospitalization, residential care, rehabilitation care, outpatient clinic, and medication use). Out-of-pocket costs includes sports club memberships, purchase of sport equipment, and other out-of-pocket payments related to the intervention. Productivity losses will be measured using questions from the Productivity Cost Questionnaire.

Other outcomes

  1. Dietary intake

    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.

    The dietary intake will be observed and recorded over a period of three non-consecutive days.

  2. Frailty 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.

    Frailty status is assessed with the Fried criteria.

  3. Body weight

    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.

    Body weight in kg

  4. Blood markers

    Time frame: This measurement will be performed at baseline and after 3 months.

    Levels of free vitamin D, folate, vitamin B12 and vitamin C are measured

  5. Physical Activity

    Time frame: This is assessed at baseline, after discharge from the rehabilitation centre (varies per participant, on average after 1 month), and after 3 months.

    The LASA Physical Activity Questionnaire (LAPAQ) is used to measure physical activity levels.

  6. Appetite

    Time frame: This is assessed at baseline, after discharge from the rehabilitation centre (varies per participant, on average after 1 month), and after 3 months.

    The Simplified Nutritional Appetite Questionnaire (SNAQ) is used to assess appetite.

  7. Fear of falling

    Time frame: This will be assessed after 3 months.

    Fear of falling will be assessed with the Falls Efficacy Scale International (FES-I).

  8. Oral health

    Time frame: This measurement will be performed at baseline.

    Questionnaire

  9. Number of and time to new falls and fragility fractures

    Time frame: This is assessed after 3 months.

    Number of and time to new falls and fragility fractures is assessed with a questionnaire

Sponsors and collaborators

Lead sponsor

Wageningen University

Other

Collaborators

  • Alliantie Voeding in de Zorg
  • Attent Zorg en Behandeling
  • Gelderse Vallei Hospital
  • HAN University of Applied Sciences
  • Liemerije Revalidatiezorg
  • Opella Revalidatiezorg
  • Osteoporosis Association
  • Pleyade Revalidatiezorg
  • Rijnstate Hospital

Registry information

Acronym: ProBUS

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 25, 2025
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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