Muscle Ageing Sarcopenia Study Lifecourse (MASS Lifecourse) (MASS_LC)

Muscle Ageing Sarcopenia Study_Lifecourse (MASS_Lifecourse): Establishing a Life Course Cohort for Advances in the Prevention, Diagnosis and Treatment of Sarcopenia

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.

Study Overview

• Status: Unknown
• Conditions: Sarcopenia
• Intervention / Treatment: Other: Observational study: range of clinical and lifestyle factors

Detailed Description

We aim to recruit 160 participants from Newcastle upon Tyne across an age range of 45-85 years from primary care, secondary care and the NIHR (National Institute for Health Research) Bioresource. Participants will receive a home visit from a researcher to complete a detailed health profile. Participants will then be invited to attend a clinical visit at Newcastle's Campus for Ageing and Vitality for imaging and muscle biopsy. A subsequent clinical visit will involve a fasting blood test, follow-up of the biopsy site and gather participants' views about taking part in the study.

The aims of the study:

1. To determine if it is acceptable and feasible to recruit adults across a range of ages to undergo detailed studies of skeletal muscle including biopsy
2. To understand how lifestyle is related to the characteristics of muscle
3. To use advances in technology (an omics approach) to identify mechanisms of sarcopenia and biomarkers for early diagnosis
4. To use findings from 2 and 3 to develop new approaches to treatment and also to invite participants to relevant trials
5. To secure funding for maintaining and expanding the cohort

• Study Type: Observational
• Enrollment (Anticipated): 160

Contacts and Locations

Study Locations

• United Kingdom
  • Tyne And Wear
    • Newcastle upon Tyne, Tyne And Wear, United Kingdom, NE4 5PL
      • Recruiting
      • Clinical Ageing research Unit
      • Contact: Richard Dodds; Phone Number: 019120181319; Email: richard.dodds@ncl.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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).
• 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:

- 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of Frailty	Fried frailty Score	Baseline
Presence of Frailty	Electronic frailty index (EFI) Score	Baseline
Cognitive and Psychosocial Function	Montreal Cognitive Assessment (MoCA) Score	Baseline
Cognitive and Psychosocial Function	Standardised mini-mental state examination (SMMSE) Score	Baseline
Geriatric Depression Scale	Geriatric Depression Scale Score	Baseline
Patient-reported survey of patient health	Short Form 36 (SF-36)	Baseline

Collaborators and Investigators

• Sponsor: Newcastle-upon-Tyne Hospitals NHS Trust
• Investigators: Principal Investigator: Richard M Dodds, MBBS PhD, Newcastle University; Study Chair: Avan A Sayer, PhD FRCP, Newcastle University

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2018
• Primary Completion (Anticipated): October 1, 2020
• Study Completion (Anticipated): March 31, 2021

Study Registration Dates

• First Submitted: October 1, 2019
• First Submitted That Met QC Criteria: January 20, 2020
• First Posted (Actual): January 27, 2020

Study Record Updates

• Last Update Posted (Actual): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 20, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: 8734

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No