Sarcopenia Musculoskeletal Diseases
Conditions
Interventions
Current interventions as of 02/05/2025:
1. Sample and recruitment
The aim was to recruit 260 participants (with a roughly even split between women and men) aged 18 to 85 years of age. Participants w
Sponsors
Newcastle upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 02/05/2025: Primary care source: Registered patient with one of the participating GP surgeries identified as PIC via North East and North Cumbria Clinical Research Network Secondary care source: Attending a NuTH clinical area NIHR Bioresource: Participants identified by the NIHR Bioresource Centre Newcastle as being eligible for the study and who have not previously expressed a wish to no longer be contacted about further studies For all recruitment sources: 1. Has capacity to consent 2. Within the study age range (18-85 years) 3. Not taking any anticoagulant or antiplatelet medications (see below under exclusion criteria), with the exception of aspirin bei _____ Previous inclusion criteria: Primary care source: Registered patient with one of the participating GP surgeries identified as PIC via North East and North Cumbria Clinical Research Network Secondary care source: Attending a NuTH clinical area NIHR Bioresource: Participants identified by the NIHR Bioresource Centre Newcastle as being eligible for the study and who have not previously expressed a wish to no longer be contacted about further studies For all recruitment sources: 1. Has capacity to consent 2. Within the study age range (45-85 years) 3. Not taking any anticoagulant or antiplatelet medications (see below under exclusion criteria), with the exception of aspirin being taken for primary prevention (i.e. where there is no diagnosis of cardiovascular disease)
Exclusion criteria
Exclusion criteria: 1. Inability to give informed consent 2. As the study involves muscle biopsy, individuals who are taking medications that increase bleeding risk are excluded, specifically: 2.1. Anti-coagulant medication: warfarin, injected low-molecular weight heparins such as dalteparin, and direct oral anticoagulant drugs such as rivoxaban and apiaxaban 2.2. Anti-platelet medication such as clopidogrel or prasugrel. This also includes aspirin where an individual has a known history of cardiovascular disease. Aspirin being taken where there is no history of cardiovascular disease is acceptable, as we would consider there to be minimal risk of stopping the aspirin for 14 days prior to biopsies 3. Individuals known to have diabetes mellitus, due to the increased risk of infection at the biopsy sites 4. Individuals currently taking medication that suppresses the immune system (such as prednisolone or methotrexate), due to the increased risk of infection or poor healing of the biopsy sites 5. We appreciate it is unlikely in the age range of the participants, but nevertheless we would exclude anyone who was pregnant, due to the exposure to small amount of ionising radiation during the DEXA scan 6. Individuals who use a wheelchair or who are unable to walk without assistance, as we would anticipate that the muscle biopsy procedure would not be feasible in these groups 7. An individual who the NuTH clinician/GP feels it is inappropriate for the researchers to approach - the NuTH clinician/GP may consider an individual unsuitable for approach for reasons such as end stage terminal disease or safety risk
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sarcopenia phenotype assessed using walking speed, grip strength, chair rise time, tests of standing balance and measurement muscle mass (using appendicular lean mass from DXA scan) at baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Physical and mental health assessed at baseline: 1. Presence of frailty, assessed using the Fried frailty and the electronic frailty index (EFI) 2. Cognitive and psychosocial function, assessed using standardised mini-mental state examination (SMMSE), Montreal Cognitive Assessment (MoCA), Geriatric Depression Scale (GDS) and Short Form 36 (SF-36) Health Survey Questionnaire 3. Lifestyle exposures, assessed using reduced Food Frequency Questionnaire, Rapid Assessment of Physical Activity questionnaire and objectively-measured physical activity levels over 7 days using a GeneActiv wrist-worn accelerometer (Activinsights, Cambridge, UK) 4. Endocrine markers (TFTs, IGF-1 and cortisol) assessed from blood sample 5. Muscle transcriptome assessed by RNA sequencing of biopsy sample of vastus lateralis muscle using a deep-phenotyping/omics approach | — |
Countries
England, United Kingdom
Contacts
Public ContactMiles Witham
Outcome results
None listed