🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in Ireland / NCT07027241
Starting soon Not applicable

Frailty Intervention in Postoperative Hip Fracture Inpatients

NCT07027241 · tracked via the Priya Life Science Ireland tracker
Sponsor
Royal College of Surgeons, Ireland
Phase
Not applicable
Started
2025-08-01
Last updated
2025-06-18

Condition(s) studied

Hip Fractures (ICD-10 72.01-72.2)Frailty at Older AdultsStrength TrainingResistance TrainingExercise TrainingProtein Supplementation

Investigational drug(s) / intervention(s)

Exercise InterventionUsual CareNutritional Intervention

Exercise Intervention: This arm will include and exercise and nutritional intervention in addition to usual postoperative hip fracture care. The exercise program will be delivered 3-5 times per week, each session lasting between 20-30 minutes depending on patient tolerance. The program will be progressed gradually between sessions and be guided by patient tolerance. The program will involve bed/ chair-based aerobic and resistance training (using an arm crank ergometer, resistance bands and ankle weights). The program will be delivered over the entire length of a patient's hospital stay up to a duration of 6 weeks for prolonged stays. All patients will undergo baseline assessments including assessment of level of frailty, pre-fracture level of mobility \& function, postoperative mobility, nutritional status/ screening, grip strength and level of pain.

Usual Care: This arm will assess all aspects of usual postoperative hip fracture care which will include multidisciplinary team assessment which include physiotherapists, occupational therapists, dieticians as well as specialist nurses and doctors working as part of the orthogeriatric team (falls and bone health assessment). They will receive daily physiotherapy training starting on the first postoperative day which will include mobility, balance, strength and gait training. This group will also receive additional protein supplementation in the form of a nutritional supplement twice daily as part of usual postoperative hip fracture care. All patients will undergo baseline assessments including assessment of level of frailty, pre-fracture level of mobility \& function, postoperative mobility, nutritional status/ screening, grip strength and level of pain. All patients will be asked to maintain a three-day food diary to monitor their protein intake.

Nutritional Intervention: The nutritional intervention will take the form of a protein fortified evening snack administered by nursing staff (additional 20g of protein).

Study summary

Hip fracture is a big health concern in older adults, and can lead to increased risk of death, reduced level of independence \& mobility, reduced quality of life, and higher likelihood of admission to nursing homes. Frailty is a medical condition associated with ageing that results in a reduced ability to do daily tasks. A frail older adult is also less able to recover well from conditions that may affect their wellbeing (for example, infections, falls resulting in injuries or hospital admissions). Frailty is common in older adults with hip fractures.

There has been increasing research showing that frailty can be slowed down and improved by a combination of nutritional supplementation and exercise. However, most of the research in this area has been in frail older adults living at home or in nursing homes. The exercise or nutritional programs in these studies tend to be carried out over weeks or months. There are very few studies looking at older adults in hospital and how exercise and nutrition help with frailty over shorter periods of time, even more so in patients who have sustained an injury.

There is, however, very little research in hospital based frailty programs in older patients who have suffered major trauma. It is well known that standing up and starting to walk soon after a hip fracture improves time to recovery, reduces hospital length of stay and death. Hence, physiotherapy on the first day after hip fracture surgery is now recommended. However, there needs to be more research to aid in developing physiotherapy and exercise programs that are safe and doable in the care of hip fracture patients despite limited resources in our healthcare system.

Similarly, although malnutrition is common in frail older adults with hip fractures, the benefits of nutritional supplementation in these patients is not fully understood. It is known that having a hip fracture puts a person at risk of muscle breakdown and increasing protein intake is recommended to help reduce this risk. Research on exercise and nutrition based frailty programs specific to hip fracture patients is strongly needed, specifically the development of that are doable and safe in the hospital setting that can help improve outcomes in hip fracture patients after surgery.

The investigators believe that a multicomponent exercise and nutrition based frailty program will be safe, doable and acceptable in frail older adults after hip fracture surgery.

Eligibility

Sex
ALL
Min age
65 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Older adults \>/= 65 * Clinical Frailty Score 4-6 (This includes patients with very mild, mild and moderate frailty. This would be in keeping with literature quoting frailty interventions where patients who are 'pre-frail' and frail are included) * Post fragility hip fracture (including subtrochanteric fracture) * Post hip fracture surgery (all types including total hip replacement, hemiarthroplasty, IM nailing) * Medically stable postoperatively * No weightbearing restriction * Mobile pre-admission (including aids and max assist of 1 person) Exclusion Criteria: * Medically unstable (NEWS \>3, unless a higher cutoff is stipulated by the primary medical researcher) * Non fragility hip fracture (fracture from non osteoporotic aetiology, pathologic fracture) * Hip surgery for other aetiology (prosthetic joint infection, arthritis, implant loosening, avascular necrosis, periprosthetic fracture) * Polytrauma * Delirium or severe cognitive impairment (as defined by inability to follow instructions and unable to provide informed consent) * Pre-existing neurologic or cardiovascular disorders that would affect participation/ compliance with exercise intervention * Open hip fracture * Other lower limb orthopaedic disorders that affect participation/ compliance with exercise intervention * Terminal illness with \</= 6 months to live * Active treatment for cancer (systemic chemotherapy or radiotherapy, patients on oral chemotherapeutic agents/ checkpoint inhibitors will be eligible for inclusion) * Nursing Home Resident * Severe lower limb pain post-op * Severe skin issues/ ulcers in non-operated lower limb that would preclude utilisation of ankle weights * Swallowing disorders/ difficulty * Renal impairment with eGFR \<30 * Hepatic failure * Patients with a dairy/ soy allergy

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
University Hospital Waterford Waterford Waterford
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07027241 on ClinicalTrials.gov ↗ ← All trials in Ireland