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

ConditionHip Fractures
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorWageningen University

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 volunteers

Qualifiers

Age ≥ 65 years

Acute hip fracture

Able to give written informed consent

Mentally competent, as judged by the treating physician

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Protein-enriched diet

    Other intervention

    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 intervention

    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.

Treatment groups

102 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 2 interventions
Group B: ControlNo intervention 0 interventions

Trial outcomes

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.

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 outcomes

1

Handgrip strength

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

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.
2

Muscle mass

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

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

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.

Time frame
The DEXA scans will be performed at baseline and after 3 months.
4

Bone Mineral Density

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

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

Other outcomes

1

Dietary intake

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

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.
2

Frailty status

Frailty status is assessed with the Fried criteria.

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.
3

Body weight

Body weight in kg

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.
4

Blood markers

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

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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