SarcopeniaMASS_LCNCT04239495
Muscle Ageing Sarcopenia Study Lifecourse (MASS Lifecourse)
An observational study of Sarcopenia, run by Newcastle-upon-Tyne Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Observational study: range of clinical and lifestyle factors
- How many people
- 160 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Oct 2018to 31 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Clinical Ageing Research Unit
Newcastle upon Tyne, Tyne and Wear, NE4 5PL
Richard Dodds, 019120181319, richard.dodds@ncl.ac.uk
About this study
Official title: 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.
Read the 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:
- 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
- To understand how lifestyle is related to the characteristics of muscle
- To use advances in technology (an omics approach) to identify mechanisms of sarcopenia and biomarkers for early diagnosis
- To use findings from 2 and 3 to develop new approaches to treatment and also to invite participants to relevant trials
- To secure funding for maintaining and expanding the cohort
- Conditions
- Sarcopenia
- Being tested
- Observational study: range of clinical and lifestyle factors
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational study: range of clinical and lifestyle factorsOther
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
Sarcopenia phenotype- grip strength
Maximum grip strength (Kg)
Measured: Baseline
Sarcopenia phenotype- chair rise time
Time to complete 5 chair rises (seconds)
Measured: Baseline
Sarcopenia phenotype- appendicular lean mass
Appendicular lean mass from DXA Scan (Kg)
Measured: Baseline
Sarcopenia phenotype- walking speed
Usual walking speed (m/s)
Measured: Baseline
Secondary outcomes (6)
Presence of Frailty
Fried frailty Score
Measured: Baseline
Presence of Frailty
Electronic frailty index (EFI) Score
Measured: Baseline
Cognitive and Psychosocial Function
Montreal Cognitive Assessment (MoCA) Score
Measured: Baseline
Cognitive and Psychosocial Function
Standardised mini-mental state examination (SMMSE) Score
Measured: Baseline
Geriatric Depression Scale
Geriatric Depression Scale Score
Measured: Baseline
Patient-reported survey of patient health
Short Form 36 (SF-36)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start9 Oct 2018
- Primary completion1 Oct 2020 (estimated)
- Study completion31 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Newcastle-upon-Tyne Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard M Dodds, MBBS PhD, Principal investigator, Newcastle UniversityAvan A Sayer, PhD FRCP, Study chair, Newcastle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04239495
- Sponsor's protocol ID
- 8734
- Acronym
- MASS_LC
- Status last verified
- Jan 2020
- First submitted
- 1 Oct 2019
- Last updated
- 27 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Ageing Sarcopenia Study_Lifecourse (MASS_Lifecourse): Establishing a Life Course Cohort for Advances in the Prevention, Diagnosis and Treatment of Sarcopenia
- ClinicalTrials.gov ID
- NCT04239495
- Acronym / sponsor ID
- MASS_LC / 8734
- Conditions
- Sarcopenia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Newcastle-upon-Tyne Hospitals NHS TrustUniversity, hospital or other
- Study start
- 9 Oct 2018 (actual)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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
- To understand how lifestyle is related to the characteristics of muscle
- To use advances in technology (an omics approach) to identify mechanisms of sarcopenia and biomarkers for early diagnosis
- To use findings from 2 and 3 to develop new approaches to treatment and also to invite participants to relevant trials
- To secure funding for maintaining and expanding the cohort
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- 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.
- Attending a NuTH (Newcastle upon Tyne Hospitals NHS Foundation Trust) clinical area.
- 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.
- Has capacity to consent.
- Within the study age range (45-85 years).
Key exclusion criteria (8 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational study: range of clinical and lifestyle factorsMedical 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). | Other | – |
Primary outcome
Sarcopenia phenotype- grip strength
Time frame: Baseline
Maximum grip strength (Kg)
Sarcopenia phenotype- chair rise time
Time frame: Baseline
Time to complete 5 chair rises (seconds)
Sarcopenia phenotype- appendicular lean mass
Time frame: Baseline
Appendicular lean mass from DXA Scan (Kg)
Sarcopenia phenotype- walking speed
Time frame: Baseline
Usual walking speed (m/s)
6 secondary outcomes
Presence of Frailty
Time frame: Baseline
Presence of Frailty
Time frame: Baseline
Cognitive and Psychosocial Function
Time frame: Baseline
Cognitive and Psychosocial Function
Time frame: Baseline
Geriatric Depression Scale
Time frame: Baseline
Patient-reported survey of patient health
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard M Dodds, MBBS PhD principal investigator
Newcastle University
Avan A Sayer, PhD FRCP study chair
Newcastle University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia, run by Newcastle-upon-Tyne Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Richard M Dodds, MBBS PhD (+44 (0) 1912081319, richard.dodds@ncl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sarcopenia phenotype- grip strength (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.