Frailty Intervention in Postoperative Hip Fracture Inpatients

NCT07027241 | Not Yet Recruiting DMC

• 1 other identifier: 24225A007
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (10)

• Eligibility Rate

  Patients eligible for inclusion/ total number of admissions

  Through study completion, an average of 6 months

• Recruitment Rate

  Recruited patients/ Patients eligible for inclusion

  Through study completion, an average of 6 months

• Number of drop outs

  Number of participant dropouts after recruitment into study

  Through study completion, an average fo 6 months

• Number of intervention related adverse events

  Musculoskeletal injury/ pain, nausea, vomiting, aspiration, constipation etc.

  Through study completion, an average of 6 months

• Compliance to prescribed duration of exercise sessions

  Percentage of sessions achieving 25 minutes of training

  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.

  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.

  Through study completion, an average of 6 months

• Compliance with prescribed intensity

  Percentage of sessions completed at Borg Scale score 4-6

  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

  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

  Through completion of intervention, an average of 3 weeks up to a maximum of 6 weeks

Secondary Outcomes (11)

• Cumulative Ambulation Score (CAS)

  At baseline and within 48 hours of discharge from hospital

• Grip strength (Dominant hand)

  At baseline and within 48 hours of discharge from hospital

• Verbal Rating Scale for Pain (VRS)

  At baseline and within 48 hours of discharge from hospital

• Functional Independence Measure (FIM)

  At baseline and within 48 hours of discharge from hospital

• Barthel Index

  At baseline and within 48 hours of discharge from hospital

Study Arms (2)

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.

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.

Behavioral: Exercise Intervention; Dietary Supplement: Nutritional Intervention

Interventions

Exercise Intervention BEHAVIORAL

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.

Also known as: Strength and Resistance Training, Aerobic Training

Exercise and Nutritional Intervention

Usual Care OTHER

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.

Also known as: Usual Postoperative Hip Fracture Care

Usual Care

Nutritional Intervention DIETARY_SUPPLEMENT

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

Also known as: Protein Supplementation

Exercise and Nutritional Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Royal College of Surgeons, Ireland: lead
• Health Service Executive, Ireland: collaborator

Study Sites (1)

University Hospital Waterford

Waterford, Waterford, X91ER8E, Ireland

Location

Related Publications (32)

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MeSH Terms

Conditions

Hip Fractures; Motor Activity; Frailty

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Niamh O'Regan, MB BCh BAO, B Med Sci, FRCPI

  University Hospital Waterford

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arveen Jeyaseelan, MB BCh BAO

CONTACT

+35351847557; arveenjeyaseelan20@rcsi.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Investigator

Model Details: Study will first be conducted in usual care group and subsequent progress to intervention group

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 18, 2025
• Study Start: August 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: February 1, 2026
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)