Clinical trial NCT07027241: Frailty Intervention in Postoperative Hip Fracture Inpatients
Official title: Multicomponent Exercise and Nutrition Based Frailty Intervention in Postoperative Hip Fracture Inpatients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hip Fractures (ICD-10 72.01-72.2)
Frailty at Older Adults
Strength Training
Resistance Training
Exercise Training
Protein Supplementation
Keywords: Hip fracture
Exercise
Nutrition
Protein supplementation
Strength and resistance training
Frailty
Lead sponsor: Royal College of Surgeons, Ireland
Sponsor class: OTHER
Collaborators: name: Health Service Executive, Ireland
First posted: 2025-06-18
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Study will first be conducted in usual care group and subsequent progress to intervention group
Primary purpose: TREATMENT

Brief 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.

Detailed description: Hip fractures are often the result of falls in the frail older population and result in subsequent poor quality of life and mortality.Over a third of older adults die in the first year after having sustained a hip fracture, suggesting that this may be a result of frailty and the beginning of a decline towards end of life. The incidence of patients presenting with hip fractures is predicted to rise to 11.9% in 2030 compared to 2010. Hip fracture care contributes to a significant burden towards healthcare systems, costing approximately £25,000 per episode and almost £1 billion per annum in the United Kingdom. This likely stems from the likelihood of its association with longer hospital length of stays, multimorbidity and readmissions. Frailty, an age related impairment of physical reserves and resilience, is common in hip fracture patients, and plays a significant role in determining outcomes in this cohort.

Current recommendations suggest early mobilisation post hip fracture to facilitate return to pre-fracture mobility and independence. Intensive in-hospital rehabilitation of post hip fracture patients have been shown to impart greater improvements in physical function and activities of daily living. Hence, physiotherapy on the first day postoperatively is now a recognized quality standard. To supplement this, it is recommended that rehabilitation be provided by multidisciplinary healthcare teams to maximize potential for return to pre-fracture level of function.

The prevalence of malnutrition in hip fracture patients is often high. The management of this problem, particularly in hip fracture patients is challenging. Reduced oral intake in older inpatients are often multifactorial. Studies involving monomodal nutritional interventions in hip fracture patients have shown mixed results. It has been shown that early nutritional intervention led by dieticians was associated with lower prevalence of malnutrition and incidence of pressure ulcers. There was also an association with reduced subacute length of stay. Another study demonstrated that combined nutritional counselling and intensive nutritional intervention led by a dietician reduced malnutrition and improved dietary intake, but only for the duration of the intervention. However, a Cochrane review concluded that nutritional supplementation in the aftercare of hip fracture patients had unclear benefit on outcomes and more randomised trials with robust methodology are required.

There is now an established body of evidence that frailty is modifiable through a combination of nutrition and exercise. However, most of the studies to date have examined interventions delivered over longer periods (e.g. months); and in the community setting. There is however, emerging evidence of in-hospital multicomponent interventions targeting physical and non-physical components of frailty. A recent study showed that a multicomponent intervention in frail and pre-frail adults with cardiovascular disease was safe and feasible in the acute setting. This encompassed additional encouragement to mobilize between usual physiotherapy visits and eat during meals. Additional cognitive stimulation activities and screening and addressing iron deficiency anaemia were also performed bi-daily. It has been shown that an in-hospital multidomain intervention that included nutrition and frailty education and advice, an exercise intervention and cognitive stimulation activities improved frailty and activities of daily living at time of discharge as well as reduced length of stay and subsequent healthcare utilisation.

There is still a relative paucity of research in frailty interventions in older patients who sustained major trauma, and in particular in multi-modal interventions. Studies to date in this population have explored interventions aiming to enhance recovery post-hip fracture for frail patients, however specifically looked at mono-modal interventions, included outpatient interventions in the analyses or only addressed specific components of frailty separately such as cognitive impairment or sarcopenia in the evaluation of rehabilitation strategies in this cohort.

The objective of this study is to assess the feasibility of this intervention in the acute postoperative aftercare of frail older inpatients with hip fracture.

Eligibility criteria: 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 outcomes:
measure: Eligibility Rate
timeFrame: Through study completion, an average of 6 months
measure: Recruitment Rate
timeFrame: Through study completion, an average of 6 months
measure: Number of drop outs
timeFrame: Through study completion, an average fo 6 months
measure: Number of intervention related adverse events
timeFrame: Through study completion, an average of 6 months
measure: Compliance to prescribed duration of exercise sessions
timeFrame: Through completion of intervention, an average of 3 weeks up to a maximum of 6 weeks
measure: Patient Acceptability of Intervention
timeFrame: Through study completion, an average of 6 months
measure: Nursing staff acceptability of intervention delivery
timeFrame: Through study completion, an average of 6 months
measure: Compliance with prescribed intensity
timeFrame: Through completion of intervention, an average of 3 weeks up to a maximum of 6 weeks
measure: Attendance rate
timeFrame: Through completion of intervention, an average of 3 weeks up to a maximum of 6 weeks
measure: Compliance rate to prescribed nutritional intervention
timeFrame: Through completion of intervention, an average of 3 weeks up to a maximum of 6 weeks
Secondary outcomes:
measure: Cumulative Ambulation Score (CAS)
timeFrame: At baseline and within 48 hours of discharge from hospital
measure: Grip strength (Dominant hand)
timeFrame: At baseline and within 48 hours of discharge from hospital
measure: Verbal Rating Scale for Pain (VRS)
timeFrame: At baseline and within 48 hours of discharge from hospital
measure: Functional Independence Measure (FIM)
timeFrame: At baseline and within 48 hours of discharge from hospital
measure: Barthel Index
timeFrame: At baseline and within 48 hours of discharge from hospital
measure: Length of Stay (LOS) in hospital
timeFrame: Through intervention completion, an average of 3 weeks up to a maximum of 6 weeks for prolonged stays
measure: Discharge Destination
timeFrame: Through intervention completion, an average of 3 weeks up to a maximum of 6 weeks for prolonged stays
measure: Health related quality of life (HRQoL)
timeFrame: At baseline and 30 days post discharge
measure: Upright and Sedentary Events
timeFrame: Throughout inpatient stay, average of 3 weeks up to a maximum of 6 weeks
measure: Depression
timeFrame: At baseline and within 48 hours of discharge from hospital
measure: Fear of Falling
timeFrame: At baseline and within 48 hours of discharge from hospital
Other outcomes:
Locations:
city: Waterford
country: Ireland
facility: University Hospital Waterford
Study officials:
affiliation: University Hospital Waterford
name: Niamh O'Regan, MB BCh BAO, B Med Sci, FRCPI
role: PRINCIPAL_INVESTIGATOR
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