Characterising Frailty Using Magnetic Resonance Imaging

NCT04612686 | Unknown

• 1 other identifier: 20039
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

Ageing is associated with the development of various negative conditions, such as frailty. Defined as a decreased ability to combat negative stressors (e.g. injury and illness), frailty is highly prevalent in elderly adults and significantly increases an individual's risk of adverse events such as falls, illness and death. The underlying physical characteristics of frailty are currently incompletely understood, with many previous studies focusing on one tissue (e.g. the brain) in isolation. However, frailty is known to affect many tissues simultaneously, and to further our insight into the biological basis of frailty and how to treat it, we must determine how different organs are affected at the same time. The study will look at the physical characteristics of non-frail and frail elderly females (aged 65 years and over), who are attending geriatric clinics across the Nottingham University Hospitals NHS Trust. We will aim to recruit 51 participants with this cohort broken down into non-frail (n=17), pre-frail (n=17) and frail (n=17) subgroups. Participants will be allocated to these groups based on their Electronic Frailty Index, Clinical Frailty Scale and Fried frailty phenotype scores. All participants will undergo basic muscle function tests (grip strength, leg strength and muscle activity) and questionnaires on their first visit to University of Nottingham laboratories. At a second visit, they will then undergo one Magnetic Resonance Imaging (MRI) scanning session, at the Sir Peter Mansfield Imaging Centre within the University, to gather information about the structure and function of their heart, brain and skeletal muscle. MRI scan protocols will take approximately 45-60 mins. Data gathered from MRI scanning will be compared across non-frail, pre-frail and frail groups to investigate differences across frailty states, with the aim of highlighting the defining physical characteristics of the frail state which may help to develop future treatment interventions to combat the condition. We hypothesise that frail females will present with common physical characteristics, the clustering of which will be indicative of frailty severity. We also hypothesise that certain physical traits present in the frail will not be present in the non-frail.

Conditions

Frailty; Frailty Syndrome; Frail Elderly Syndrome

Keywords

Phenotype; Magnetic resonance imaging; MRI; Phenotyping; Elderly; Frail; Frailty; Fried; Physiological; Physiology; Female; Heart; Brain; Muscle; Strength; Power output; Fatigability; Cognition; Older persons; Pre-frail; Non-frail

Outcome Measures

Primary Outcomes (1)

• Hand grip strength

  Hand grip strength measured by a handheld dynamometer

  Baseline (During visit to University physiology laboratory)

Secondary Outcomes (17)

• Whole body skeletal muscle volume

  Baseline (During visit to Sir Peter Mansfield Imaging Centre - University of Nottingham)

• Volumes of individual muscles in the lower limbs

  Baseline (During visit to Sir Peter Mansfield Imaging Centre - University of Nottingham)

• White/grey matter volumes of the brain

  Baseline (During visit to Sir Peter Mansfield Imaging Centre - University of Nottingham)

• Cerebral perfusion

  Baseline (During visit to Sir Peter Mansfield Imaging Centre - University of Nottingham)

• Motor unit size and recruitment in thigh muscle

  Baseline (During visit to University physiology laboratory)

Study Arms (3)

Frail

At screening participants will be classed as frail if their Electronic Frailty Index score is \>0.24 and if their Clinical Frailty Scale score is 6. This will be confirmed following the Fried frailty phenotype assessment made during the first visit to the University laboratory. Participants exhibiting 3 or more frailty components (slowness, weakness, weight loss, exhaustion, low physical activity) will be classed as frail. All participants will receive the same assessment procedures.

Pre-frail

At the point of screening, participants will be classed as pre-frail if their Electronic Frailty Index score is 0.13-0.24 and if their Clinical Frailty Scale score is 4-5. This will be confirmed following the Fried frailty phenotype assessment made during the first visit to the University laboratory. Participants exhibiting 1 or 2 frailty components (slowness, weakness, weight loss, exhaustion, low physical activity) will be classed as pre-frail. All participants will receive the same assessment procedures.

Non-frail

At the point of screening, participants will be classed as non-frail if their Electronic Frailty Index score is 0-0.12 and if their Clinical Frailty Scale score is 1-2. This will be confirmed following the Fried frailty phenotype assessment made during the first visit to the University laboratory. Participants exhibiting no frailty components (slowness, weakness, weight loss, exhaustion, low physical activity) will be classed as non-frail. All participants will receive the same assessment procedures.

Eligibility Criteria

• Age: 65 Years+
• Gender Eligibility Details: female sex
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be identified from hospital clinics for older people, many of whom will be frail. Participants will be female, aged over 65 years and outpatients attending these clinics.

You may qualify if:

• Females aged over 65 years of age attending Nottingham University Hospitals NHS Trust 'falls and bone health' and general geriatric clinics;
• Able to provide informed consent;
• Once 17 participants have been recruited to any of the three study groups (non-frail, pre-frail, frail) the study will be restricted to people in the remaining groups only;
• Good understanding of written and spoken English.

You may not qualify if:

• Metal within the body which could be affected by MRI;
• Any other contraindications for MRI scan (e.g. brain aneurysm clips, permanent pacemaker);
• Over 190.5 cm in height
• Inability to lie on back within the MRI scanner
• Mobility limitations which would prevent the individual transferring onto equipment
• Unable to speak or understand English;
• In receipt of end of life care;
• Lacking the mental capacity to understand the requirements of study participation and provide consent.

Sponsors & Collaborators

• University of Nottingham: lead
• Medical Research Council: collaborator
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

Queen's Medical Centre

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

RECRUITING

Related Publications (2)

• Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.

  PMID: 11253156 BACKGROUND

• Fried LP, Xue QL, Cappola AR, Ferrucci L, Chaves P, Varadhan R, Guralnik JM, Leng SX, Semba RD, Walston JD, Blaum CS, Bandeen-Roche K. Nonlinear multisystem physiological dysregulation associated with frailty in older women: implications for etiology and treatment. J Gerontol A Biol Sci Med Sci. 2009 Oct;64(10):1049-57. doi: 10.1093/gerona/glp076. Epub 2009 Jun 30.

  PMID: 19567825 BACKGROUND

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Joseph Taylor, PhD student

  University of Nottingham

  PRINCIPAL INVESTIGATOR

• Tahir Masud, Professor

  Nottingham University Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

• Paul Greenhaff, Professor

  University of Nottingham

  PRINCIPAL INVESTIGATOR

• Susan Francis, Professor

  University of Nottingham

  PRINCIPAL INVESTIGATOR

• John Gladman, Professor

  University of Nottingham

  STUDY CHAIR

Central Study Contacts

John Gladman, Professor

CONTACT

01158230242; john.gladman@nottingham.ac.uk

Tahir Masud, Professor

CONTACT

01158402697; Tahir.Masud@nuh.nhs.uk

Study Design

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

Study Record Dates

• First Submitted: October 28, 2020
• First Posted: November 3, 2020
• Study Start: July 5, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: May 18, 2022

Record last verified: 2022-05

Locations

GB (1)