Muscle Ageing Sarcopenia Study Lifecourse (MASS Lifecourse)

NCT04239495 | Unknown

• 1 other identifier: 8734
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Sarcopenia is the loss of muscle mass and function with age. It has been recognised as an important health problem because it is common in older adults and associated with decline in physical function as well as a reduced quality of life. Sarcopenia can also lead to serious health consequences in terms of increased disability and the need for increased health and social care. There is considerable interest in understanding what causes sarcopenia in order to develop new approaches to prevention, diagnosis and treatment. To gain a detailed understanding of sarcopenia across a range of ages, we have designed the Muscle Ageing Sarcopenia Study (MASS\_Lifecourse) in collaboration with members of the public and patients.

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (4)

• Sarcopenia phenotype- grip strength

  Maximum grip strength (Kg)

  Baseline

• Sarcopenia phenotype- chair rise time

  Time to complete 5 chair rises (seconds)

  Baseline

• Sarcopenia phenotype- appendicular lean mass

  Appendicular lean mass from DXA Scan (Kg)

  Baseline

• Sarcopenia phenotype- walking speed

  Usual walking speed (m/s)

  Baseline

Secondary Outcomes (6)

• Presence of Frailty

  Baseline

• Presence of Frailty

  Baseline

• Cognitive and Psychosocial Function

  Baseline

• Cognitive and Psychosocial Function

  Baseline

• Geriatric Depression Scale

  Baseline

Interventions

Observational study: range of clinical and lifestyle factors OTHER

Medical conditions and medications. Educational and occupational history. 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).

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will aim to recruit 160 participants (approximately 80 women and 80 men) aged 45 to 85 years of age to participate in this study, divided into four ten-year age groups of equal size (45-54, 55-64, 65-74 and 75-85 years old, with 20 men and 20 women in each age group). Region: Geographical area North East UK.

You may qualify if:

• Primary care source:
• \- Registered patient with one of the GP (General Practice) surgeries identified as PIC (Participant Identification Centre) via North East and North Cumbria Clinical Research Network.
• Secondary care source:
• \- Attending a NuTH (Newcastle upon Tyne Hospitals NHS Foundation Trust) 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:
• Has capacity to consent.
• Within the study age range (45-85 years).

You may not qualify if:

• \- Inability to give informed consent.
• \- As the study involves biopsy of skeletal muscle, individuals who are taking medications that increase bleeding risk are excluded, specifically: i. anti-coagulant medication: warfarin, injected low-molecular weight heparins such as dalteparin, and direct oral anticoagulant drugs such as rivaroxaban and apixaban.
• ii. 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.
• Individuals known to have diabetes mellitus, due to the increased risk of infection at the biopsy sites.
• 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.
• Pregnancy, due to the exposure to small amount of ionising radiation during the DXA scan.
• 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.
• 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.

Sponsors & Collaborators

• Newcastle-upon-Tyne Hospitals NHS Trust: lead

Study Sites (1)

Clinical Ageing Research Unit

Newcastle upon Tyne, Tyne and Wear, NE4 5PL, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples (including for DNA and RNA) and a biopsy of the vastus lateralis muscle of the thigh will be collected.

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Richard M Dodds, MBBS PhD

  Newcastle University

  PRINCIPAL INVESTIGATOR

• Avan A Sayer, PhD FRCP

  Newcastle University

  STUDY CHAIR

Central Study Contacts

Richard M Dodds, MBBS PhD

CONTACT

+44 (0) 1912081319; richard.dodds@ncl.ac.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 1, 2019
• First Posted: January 27, 2020
• Study Start: October 9, 2018
• Primary Completion: October 1, 2020
• Study Completion: March 31, 2021
• Last Updated: January 27, 2020

Record last verified: 2020-01

Locations

GB (1)