Functioning of Elder Muscle; Understanding Recovery

NCT04764617 | Completed

• 1 other identifier: 20/LO/0841
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

As people get older, the amount of skeletal muscle in the body can decrease. When the amount of this muscle in the body gets very low, there is an increased risk of falling, and not only is recovery to any injury slower, but more complications can be experienced following surgery, and patients may end up being more dependent on the help of others for meeting daily activities. However, it is not clear whether it is simply the amount of muscle that is in the body that is important for health, or whether it is the ability of muscle to function properly which is important. This research study is looking at the way muscles of frail older people function; not just how strong they are, but the amount of fats and protein that there are in muscle cells, and how the genes in the muscles are being expressed (genes being a collection of chemical information that carry the instructions for making the proteins a cell will need to function). We will also investigate whether recovery from hip fracture is impacted by the amount of muscle that there is in the body, and/or the functioning of this muscle.

Conditions

Frailty Syndrome

Outcome Measures

Primary Outcomes (1)

• Skeletal Muscle messenger ribonucleic acid (mRNA) expression (injured leg)

  mRNA expression of 384 gene targets spanning a number of cellular functions, in a vastus lateralis muscle biopsy taken from the injured leg

  On recruitment

Secondary Outcomes (23)

• Skeletal Muscle mRNA expression (un-injured leg)

  On recruitment

• Intramyocellular lipid density (injured leg)

  On recruitment

• Intramyocellular lipid density (uninjured leg)

  On recruitment

• Body weight

  on recruitment

• Grip Strength

  up to 3 days post surgery

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals \>65 years who have been admitted to Queens Medical Centre, Nottingham, UK for surgical repair of a hip fracture sustained following a low impact fall.

You may qualify if:

• Clinical Frailty Score (assessed as part of standard care) ≥ 4
• Fractured hip, sustained following a fall, that requires surgery
• Good understanding of spoken and written English language
• Able to give informed consent, or availability of a legally acceptable surrogate to provide consent

You may not qualify if:

• Those who fell and sustained their hip fracture greater than 12 hours prior to hospitalisation.
• Those who have fallen and sustained a hip fracture whilst an in-patient in hospital
• Those who sustained the hip fracture as a result of high impact trauma (e.g. road traffic accident)
• Surgery carried out later than 96 hrs after fall
• Chronic neurological, inflammatory or musculoskeletal disorders which result in muscle wasting, e.g. Multiple sclerosis, muscular dystrophy, rheumatoid arthritis
• Any co-morbidity which precludes hip surgery
• Those with a compromised swallowing reflex which would prevent the participant from taking fluids orally, will be excluded.
• Those taking diabetes medication

Sponsors & Collaborators

• University of Nottingham: lead
• Nottingham Biomedical Research Centre: collaborator

Study Sites (1)

Queens Medical Centre; Department of Orthopaedics

Nottingham, NG72UH, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Skeletal Muscle biopsy

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ben Ollivere, MBBS

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 21, 2021
• Study Start: January 4, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: April 1, 2026

Record last verified: 2025-08

Locations

GB (1)