Hip Fractures (ICD-10 72.01-72.2)NCT07027241
Frailty Intervention in Postoperative Hip Fracture Inpatients
A study testing Exercise Intervention and Nutritional Intervention in people with Hip Fractures (ICD-10 72.01-72.2) and Frailty at Older Adults, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fractures (ICD-10 72.01-72.2), Frailty at Older Adults, Strength Training
- What is being tested?
- Exercise Intervention and Nutritional Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIreland
- Study dates
- 1 Aug 2025to Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ireland1 site
University Hospital Waterford
Waterford, Waterford, X91ER8E
Niamh O'Regan, MB BCh BAO, B Med Sci, FRCPI, +35351848736, Niamh.ORegan5@hse.ie
Niamh O'Regan, MB BCh BAO, B Med Sci, FRCPI
About this study
Official title: Multicomponent Exercise and Nutrition Based Frailty Intervention in Postoperative Hip Fracture Inpatients
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.
Read more
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.
Read the 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.
- Conditions
- Hip Fractures (ICD-10 72.01-72.2), Frailty at Older Adults, Strength Training, Resistance Training, Exercise Training, Protein Supplementation
- Being tested
- Exercise Intervention, Usual Care, Nutritional Intervention
- Keywords
- Hip fracture, Exercise, Nutrition, Protein supplementation, Strength and resistance training, Frailty
- Medical subject headings
- Hip Fractures, Motor Activity, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise InterventionBehavioural
Also called Strength and Resistance Training, Aerobic Training
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 CareOther
Also called Usual Postoperative Hip Fracture 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 InterventionDietary supplement
Also called Protein Supplementation
The nutritional intervention will take the form of a protein fortified evening snack administered by nursing staff (additional 20g of protein).
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | 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. Receives: Other: Usual Care |
| Exercise and Nutritional Intervention | Experimental | 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.
The nutritional intervention will take the form of a protein fortified evening snack administered by nursing staff (additional 20g of protein).
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. Receives: Behavioral: Exercise Intervention; Dietary Supplement: Nutritional Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eligibility Rate
Patients eligible for inclusion/ total number of admissions
Measured: Through study completion, an average of 6 months
Recruitment Rate
Recruited patients/ Patients eligible for inclusion
Measured: Through study completion, an average of 6 months
Number of drop outs
Number of participant dropouts after recruitment into study
Measured: Through study completion, an average fo 6 months
Number of intervention related adverse events
Musculoskeletal injury/ pain, nausea, vomiting, aspiration, constipation etc.
Measured: Through study completion, an average of 6 months
Compliance to prescribed duration of exercise sessions
Percentage of sessions achieving 25 minutes of training
Measured: Through completion of intervention, an average of 3 weeks up to a maximum of 6 weeks
Patient Acceptability of Intervention
Survey utilising open ended questions and 5 point Likert Scales (Strongly Agree, Agree, Neither Agree nor Disagree, Disagree, Strongly Disagree) will be used to evaluate patient satisfaction of the intervention.
Measured: Through study completion, an average of 6 months
Nursing staff acceptability of intervention delivery
Survey utilising open ended questions and 5 point Likert Scales (Strongly Agree, Agree, Neither Agree nor Disagree, Disagree, Strongly Disagree) will be used to evaluate patient satisfaction of the intervention.
Measured: Through study completion, an average of 6 months
Compliance with prescribed intensity
Percentage of sessions completed at Borg Scale score 4-6
Measured: Through completion of intervention, an average of 3 weeks up to a maximum of 6 weeks
Attendance rate
Number of completed sessions/ number of planned sessions
Measured: Through completion of intervention, an average of 3 weeks up to a maximum of 6 weeks
Compliance rate to prescribed nutritional intervention
Number of supplements taken/ number prescribed
Measured: Through completion of intervention, an average of 3 weeks up to a maximum of 6 weeks
Secondary outcomes (11)
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.
Measured: At baseline and within 48 hours of discharge from hospital
Grip strength (Dominant hand)
Grip strength will be assessed using a handheld dynamometer. Measured in units of kg.
Measured: At baseline and within 48 hours of discharge from hospital
Verbal Rating Scale for Pain (VRS)
Visual scale of 0-3, higher scores indicating more severe pain.
Measured: At baseline and within 48 hours of discharge from hospital
Functional Independence Measure (FIM)
This tool measures activities of daily living, scores range from 18-126, higher scores indicates higher level of independence.
Measured: At baseline and within 48 hours of discharge from hospital
Barthel Index
This tool measures activities of daily living, scored 0-20, higher scores indicates a higher level of independence
Measured: At baseline and within 48 hours of discharge from hospital
Length of Stay (LOS) in hospital
acute hospital stay + super-spell (LOS in acute rehabilitation units)
Measured: Through intervention completion, an average of 3 weeks up to a maximum of 6 weeks for prolonged stays
Discharge Destination
Discharge destination from hospital will be recorded
Measured: Through intervention completion, an average of 3 weeks up to a maximum of 6 weeks for prolonged stays
Health related quality of life (HRQoL)
- Using EuroQol 5-dimension 5-level (EQ-5D-5L) scale. Assesses mobility, self care, activities of daily living, pain, anxiety domains as well as general perception of health. Each dimension on the scale has five response options ranging from no problem to severe problems. The scale also consists of a visual analogue scale, higher values indicate better quality of life.
Measured: At baseline and 30 days post discharge
Upright and Sedentary Events
Measured using ActivPal Accelerometer
Measured: Throughout inpatient stay, average of 3 weeks up to a maximum of 6 weeks
Depression
Screened for using Geriatric Depression Scale (GDS). Screens for depression. Maximum score of 15 points. A score of 5 points or above indicates probable depression.
Measured: At baseline and within 48 hours of discharge from hospital
Fear of Falling
Measured Using the Falls Efficacy Scale- International (FES-I). Scored between 16-64, higher scores indicates increased concern for falling.
Measured: At baseline and within 48 hours of discharge from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start1 Aug 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Hip Fractures (ICD-10 72.01-72.2)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Model description
- Study will first be conducted in usual care group and subsequent progress to intervention group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal College of Surgeons, Ireland
- Sponsor type
- University, hospital or other
- Collaborators
- Health Service Executive, Ireland
- Responsible party
- Principal investigator, Arveen Jeyaseelan, Royal College of Surgeons, Ireland
- Investigators
- Niamh O'Regan, MB BCh BAO, B Med Sci, FRCPI, Principal investigator, University Hospital Waterford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07027241
- Sponsor's protocol ID
- 24225A007
- Status last verified
- Jun 2025
- First submitted
- 29 May 2025
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This will be stored in secure storage for the required duration after completion of study as specified by Good Clinical Practice, after which data will be destroyed.
Publications
Avenell A, Smith TO, Curtain JP, Mak JC, Myint PK. Nutritional supplementation for hip fracture aftercare in older people. Cochrane Database Syst Rev. 2016 Nov 30;11(11):CD001880. doi: 10.1002/14651858.CD001880.pub6.
PubMed 27898998Saunders J, Smith T. Malnutrition: causes and consequences. Clin Med (Lond). 2010 Dec;10(6):624-7. doi: 10.7861/clinmedicine.10-6-624. No abstract available.
PubMed 21413492Malafarina V, Reginster JY, Cabrerizo S, Bruyere O, Kanis JA, Martinez JA, Zulet MA. Nutritional Status and Nutritional Treatment Are Related to Outcomes and Mortality in Older Adults with Hip Fracture. Nutrients. 2018 Apr 30;10(5):555. doi: 10.3390/nu10050555.
PubMed 29710860Audit NOoC. Irish Hip Fracture Database National Report 2023. 2024.
Ftouh S, Morga A, Swift C; Guideline Development Group. Management of hip fracture in adults: summary of NICE guidance. BMJ. 2011 Jun 21;342:d3304. doi: 10.1136/bmj.d3304. No abstract available.
PubMed 21693526Oberstar JS, Bakker CJ, Sorich M, McCarthy T. What Postoperative Nutritional Interventions Lead to Better Outcomes in Fragility Hip Fractures? A Systematic Review. Geriatr Orthop Surg Rehabil. 2023 Feb 15;14:21514593231155828. doi: 10.1177/21514593231155828. eCollection 2023.
PubMed 36817328Phang JK, Lim ZY, Yee WQ, Tan CYF, Kwan YH, Low LL. Post-surgery interventions for hip fracture: a systematic review of randomized controlled trials. BMC Musculoskelet Disord. 2023 May 25;24(1):417. doi: 10.1186/s12891-023-06512-9.
PubMed 37231406Cadel L, Kuluski K, Wodchis WP, Thavorn K, Guilcher SJT. Rehabilitation interventions for persons with hip fracture and cognitive impairment: A scoping review. PLoS One. 2022 Aug 15;17(8):e0273038. doi: 10.1371/journal.pone.0273038. eCollection 2022.
PubMed 35969624Avola M, Mangano GRA, Testa G, Mangano S, Vescio A, Pavone V, Vecchio M. Rehabilitation Strategies for Patients with Femoral Neck Fractures in Sarcopenia: A Narrative Review. J Clin Med. 2020 Sep 26;9(10):3115. doi: 10.3390/jcm9103115.
PubMed 32993140Halter M, Jarman H, Moss P, Kulnik ST, Baramova D, Gavalova L, Cole E, Crouch R, Baxter M. Configurations and outcomes of acute hospital care for frail and older patients with moderate to major trauma: a systematic review. BMJ Open. 2023 Feb 21;13(2):e066329. doi: 10.1136/bmjopen-2022-066329.
PubMed 36810176Wang YC, Liang CK, Chou MH, Chiu CF, Lin HC, Hsu YH, Liao MC, Yin CH, Chou MY, Lin YT. The Effectiveness of Frailty Intervention for Older Patients with Frailty during Hospitalization. J Nutr Health Aging. 2023;27(6):413-420. doi: 10.1007/s12603-023-1924-y.
PubMed 37357324Puts MTE, Toubasi S, Andrew MK, Ashe MC, Ploeg J, Atkinson E, Ayala AP, Roy A, Rodriguez Monforte M, Bergman H, McGilton K. Interventions to prevent or reduce the level of frailty in community-dwelling older adults: a scoping review of the literature and international policies. Age Ageing. 2017 May 1;46(3):383-392. doi: 10.1093/ageing/afw247.
PubMed 28064173Dedeyne L, Deschodt M, Verschueren S, Tournoy J, Gielen E. Effects of multi-domain interventions in (pre)frail elderly on frailty, functional, and cognitive status: a systematic review. Clin Interv Aging. 2017 May 24;12:873-896. doi: 10.2147/CIA.S130794. eCollection 2017.
PubMed 28579766Kidd T, Mold F, Jones C, Ream E, Grosvenor W, Sund-Levander M, Tingstrom P, Carey N. What are the most effective interventions to improve physical performance in pre-frail and frail adults? A systematic review of randomised control trials. BMC Geriatr. 2019 Jul 11;19(1):184. doi: 10.1186/s12877-019-1196-x.
PubMed 31291884Travers J, Romero-Ortuno R, Bailey J, Cooney MT. Delaying and reversing frailty: a systematic review of primary care interventions. Br J Gen Pract. 2019 Jan;69(678):e61-e69. doi: 10.3399/bjgp18X700241. Epub 2018 Dec 3.
PubMed 30510094
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicomponent Exercise and Nutrition Based Frailty Intervention in Postoperative Hip Fracture Inpatients
- ClinicalTrials.gov ID
- NCT07027241
- Acronym / sponsor ID
- 24225A007
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Royal College of Surgeons, IrelandUniversity, hospital or other
- Collaborators
- Health Service Executive, Ireland
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 18 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Study will first be conducted in usual care group and subsequent progress to intervention group
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Other: Usual CareThis 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. |
| Exercise and Nutritional Intervention | Experimental | Behavioral: Exercise Intervention, Dietary Supplement: Nutritional InterventionThis 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. The nutritional intervention will take the form of a protein fortified evening snack administered by nursing staff (additional 20g of protein). 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise InterventionAlso: Strength and Resistance Training, Aerobic TrainingThis 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. | Behavioural | Exercise and Nutritional Intervention |
| Usual CareAlso: Usual Postoperative Hip Fracture CareThis 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. | Other | Usual Care |
| Nutritional InterventionAlso: Protein SupplementationThe nutritional intervention will take the form of a protein fortified evening snack administered by nursing staff (additional 20g of protein). | Dietary supplement | Exercise and Nutritional Intervention |
Primary outcome
Eligibility Rate
Time frame: Through study completion, an average of 6 months
Patients eligible for inclusion/ total number of admissions
Recruitment Rate
Time frame: Through study completion, an average of 6 months
Recruited patients/ Patients eligible for inclusion
Number of drop outs
Time frame: Through study completion, an average fo 6 months
Number of participant dropouts after recruitment into study
Number of intervention related adverse events
Time frame: Through study completion, an average of 6 months
Musculoskeletal injury/ pain, nausea, vomiting, aspiration, constipation etc.
Compliance to prescribed duration of exercise sessions
Time frame: Through completion of intervention, an average of 3 weeks up to a maximum of 6 weeks
Percentage of sessions achieving 25 minutes of training
Patient Acceptability of Intervention
Time frame: Through study completion, an average of 6 months
Survey utilising open ended questions and 5 point Likert Scales (Strongly Agree, Agree, Neither Agree nor Disagree, Disagree, Strongly Disagree) will be used to evaluate patient satisfaction of the intervention.
Nursing staff acceptability of intervention delivery
Time frame: Through study completion, an average of 6 months
Survey utilising open ended questions and 5 point Likert Scales (Strongly Agree, Agree, Neither Agree nor Disagree, Disagree, Strongly Disagree) will be used to evaluate patient satisfaction of the intervention.
Compliance with prescribed intensity
Time frame: Through completion of intervention, an average of 3 weeks up to a maximum of 6 weeks
Percentage of sessions completed at Borg Scale score 4-6
Attendance rate
Time frame: Through completion of intervention, an average of 3 weeks up to a maximum of 6 weeks
Number of completed sessions/ number of planned sessions
Compliance rate to prescribed nutritional intervention
Time frame: Through completion of intervention, an average of 3 weeks up to a maximum of 6 weeks
Number of supplements taken/ number prescribed
11 secondary outcomes
Cumulative Ambulation Score (CAS)
Time frame: At baseline and within 48 hours of discharge from hospital
Grip strength (Dominant hand)
Time frame: At baseline and within 48 hours of discharge from hospital
Verbal Rating Scale for Pain (VRS)
Time frame: At baseline and within 48 hours of discharge from hospital
Functional Independence Measure (FIM)
Time frame: At baseline and within 48 hours of discharge from hospital
Barthel Index
Time frame: At baseline and within 48 hours of discharge from hospital
Length of Stay (LOS) in hospital
Time frame: Through intervention completion, an average of 3 weeks up to a maximum of 6 weeks for prolonged stays
Discharge Destination
Time frame: Through intervention completion, an average of 3 weeks up to a maximum of 6 weeks for prolonged stays
Health related quality of life (HRQoL)
Time frame: At baseline and 30 days post discharge
Upright and Sedentary Events
Time frame: Throughout inpatient stay, average of 3 weeks up to a maximum of 6 weeks
Depression
Time frame: At baseline and within 48 hours of discharge from hospital
Fear of Falling
Time frame: At baseline and within 48 hours of discharge from hospital
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Background: PubMed 27898998Avenell A, Smith TO, Curtain JP, Mak JC, Myint PK. Nutritional supplementation for hip fracture aftercare in older people. Cochrane Database Syst Rev. 2016 Nov 30;11(11):CD001880. doi: 10.1002/14651858.CD001880.pub6.
- Background: PubMed 21413492Saunders J, Smith T. Malnutrition: causes and consequences. Clin Med (Lond). 2010 Dec;10(6):624-7. doi: 10.7861/clinmedicine.10-6-624. No abstract available.
- Background: PubMed 29710860Malafarina V, Reginster JY, Cabrerizo S, Bruyere O, Kanis JA, Martinez JA, Zulet MA. Nutritional Status and Nutritional Treatment Are Related to Outcomes and Mortality in Older Adults with Hip Fracture. Nutrients. 2018 Apr 30;10(5):555. doi: 10.3390/nu10050555.
- BackgroundAudit NOoC. Irish Hip Fracture Database National Report 2023. 2024.
- Background: PubMed 21693526Ftouh S, Morga A, Swift C; Guideline Development Group. Management of hip fracture in adults: summary of NICE guidance. BMJ. 2011 Jun 21;342:d3304. doi: 10.1136/bmj.d3304. No abstract available.
- Background: PubMed 36817328Oberstar JS, Bakker CJ, Sorich M, McCarthy T. What Postoperative Nutritional Interventions Lead to Better Outcomes in Fragility Hip Fractures? A Systematic Review. Geriatr Orthop Surg Rehabil. 2023 Feb 15;14:21514593231155828. doi: 10.1177/21514593231155828. eCollection 2023.
- Background: PubMed 37231406Phang JK, Lim ZY, Yee WQ, Tan CYF, Kwan YH, Low LL. Post-surgery interventions for hip fracture: a systematic review of randomized controlled trials. BMC Musculoskelet Disord. 2023 May 25;24(1):417. doi: 10.1186/s12891-023-06512-9.
- Background: PubMed 35969624Cadel L, Kuluski K, Wodchis WP, Thavorn K, Guilcher SJT. Rehabilitation interventions for persons with hip fracture and cognitive impairment: A scoping review. PLoS One. 2022 Aug 15;17(8):e0273038. doi: 10.1371/journal.pone.0273038. eCollection 2022.
- Background: PubMed 32993140Avola M, Mangano GRA, Testa G, Mangano S, Vescio A, Pavone V, Vecchio M. Rehabilitation Strategies for Patients with Femoral Neck Fractures in Sarcopenia: A Narrative Review. J Clin Med. 2020 Sep 26;9(10):3115. doi: 10.3390/jcm9103115.
- Background: PubMed 36810176Halter M, Jarman H, Moss P, Kulnik ST, Baramova D, Gavalova L, Cole E, Crouch R, Baxter M. Configurations and outcomes of acute hospital care for frail and older patients with moderate to major trauma: a systematic review. BMJ Open. 2023 Feb 21;13(2):e066329. doi: 10.1136/bmjopen-2022-066329.
- Background: PubMed 37357324Wang YC, Liang CK, Chou MH, Chiu CF, Lin HC, Hsu YH, Liao MC, Yin CH, Chou MY, Lin YT. The Effectiveness of Frailty Intervention for Older Patients with Frailty during Hospitalization. J Nutr Health Aging. 2023;27(6):413-420. doi: 10.1007/s12603-023-1924-y.
- Background: PubMed 28064173Puts MTE, Toubasi S, Andrew MK, Ashe MC, Ploeg J, Atkinson E, Ayala AP, Roy A, Rodriguez Monforte M, Bergman H, McGilton K. Interventions to prevent or reduce the level of frailty in community-dwelling older adults: a scoping review of the literature and international policies. Age Ageing. 2017 May 1;46(3):383-392. doi: 10.1093/ageing/afw247.
- Individual participant dataSharing planned: No. This will be stored in secure storage for the required duration after completion of study as specified by Good Clinical Practice, after which data will be destroyed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Niamh O'Regan, MB BCh BAO, B Med Sci, FRCPI principal investigator
University Hospital Waterford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Intervention and Nutritional Intervention in people with Hip Fractures (ICD-10 72.01-72.2) and Frailty at Older Adults, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arveen Jeyaseelan, MB BCh BAO (+35351847557, arveenjeyaseelan20@rcsi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eligibility Rate (time frame: Through study completion, an average of 6 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07027241, which also lists 32 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025.