About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Factorial
Treatments tested in this trial
Exercise Intervention
BehavioralThis 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
Other interventionThis 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
Dietary supplementThe nutritional intervention will take the form of a protein fortified evening snack administered by nursing staff (additional 20g of protein).
Treatment groups
Trial outcomes
Primary outcomes
Eligibility Rate
Patients eligible for inclusion/ total number of admissions
Recruitment Rate
Recruited patients/ Patients eligible for inclusion
Number of drop outs
Number of participant dropouts after recruitment into study
Number of intervention related adverse events
Musculoskeletal injury/ pain, nausea, vomiting, aspiration, constipation etc.
Secondary outcomes
Cumulative Ambulation Score (CAS)
Daily score will be 0-6, higher score indicates higher level of independence. Cumulative score over 3 days results in a score of 0-18.
Grip strength (Dominant hand)
Grip strength will be assessed using a handheld dynamometer. Measured in units of kg.
Verbal Rating Scale for Pain (VRS)
Visual scale of 0-3, higher scores indicating more severe pain.
Functional Independence Measure (FIM)
This tool measures activities of daily living, scores range from 18-126, higher scores indicates higher level of independence.
Sponsors and contacts
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Royal College of Surgeons, Ireland
Lead sponsor
Health Service Executive, Ireland
Collaborator
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