SarcopeniaSarcoSpineNCT03962530
Spinal Sarcopenia Cohort Study (SarcoSpine)
An observational study of Sarcopenia and Spinal Disease, run by Seoul National University Hospital.
Trial summary
Sarcopenia on lumbar paraspinal muscles is receiving renewed attention as a cause of spinal degeneration. However, there are few studies on the precise concept and diagnostic criteria for spinal sarcopenia. Here, we develop the concept of spinal sarcopenia in community-dwelling healthy elderly people. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Spinal Disease
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Aug 2019to Jul 2023
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Healthy elderly population who are community ambulator.
Who may be able to join
- Elderly people aged 65 and over;
- Community dweller;
- Ambulator with or without an assistive device.
Who cannot join
- low back pain with moderate severity (numeric rating scale 5 and over);
- history of any types of lumbar spine surgery;
- history of hip fracture surgery and arthroplasty of hip or knee;
- contraindications for MRI (such as cardiac pacemaker, implanted metallic objects, and claustrophobia);
- disorders in central nervous system (such as stroke, parkinsonism, spinal cord injury);
- cognitive dysfunction (Mini Mental State Examination score < 24);
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- communication disorder (such as severe hearing loss);
- severe cardiopulmonary disease (such as heart failure with New York Heart Association Class III or IV);
- uncontrolled chronic disease (such as hypertension with systolic blood pressure >165 and diastolic blood pressure >95);
- musculoskeletal condition affecting physical function (such as amputation of limb);
- long term use of corticosteroids due to inflammatory disease;
- malignancy requiring treatment within 5 years; and
- other medical conditions which needs active treatment; patients who refuse to participate in a study will also be excluded.
About this study
Official title: Sarcopenia of Spine: a Prospective Cohort Study
Sarcopenia on lumbar paraspinal muscles is receiving renewed attention as a cause of spinal degeneration. However, there are few studies on the precise concept and diagnostic criteria for spinal sarcopenia. Here, we develop the concept of spinal sarcopenia in community-dwelling healthy elderly people. In addition, we aim to observe the natural aging course of paraspinal muscle and back muscle strength, and investigate the association between conventional sarcopenic indices and spinal sarcopenia.
This is a prospective observational cohort study with 120 healthy community-dwelling elderly people for 4 years. All subjects will be recruited according to no sarcopenia, possible sarcopenia, sarcopenia, and severe sarcopenia groups. The primary outcomes of this study are isokinetic back muscle strength and lumbar paraspinal muscle quantity and quality using lumbar spine MRI. Conventional sarcopenic indices and spine specific outcomes such as spinal sagittal balance, back performance scale, and Sorenson test will be also assessed. The data will be analysed using the intention-to-treat principle.
Read the detailed description
This is a prospective observational cohort study with 120 healthy community-dwelling elderly people in a single center (SMG-SNU Boramae Medical Center). Individual follow-up will last 4 years. Elderly people (≥ 65 years old) who are community-dwellers and able to walk with or without assistive devices) will be included. Sarcopenia can be divided by two stages: 1) possible sarcopenia (PS) defined by low handgrip strength and/or low gait speed and 2) sarcopenia (SA) confirmed by low handgrip strength and/or low gait speed and low muscle mass by the consensus report of the Asian working group for sarcopenia. No sarcopenia (NS) group is added to this classification, and the study participants are classified into three groups (NS, PS, and SA) after the screening tests. All outcome variables will be collected at baseline, 2 and 4 years. However, L-S spine MRI for lumbar paraspinal muscle quantity and quality will be performed only at baseline.
Data will be collected using a standardised data entry form and entered into the data management system. The intention-to-treat principle will be used for data analysis. Participant characteristics will be described using means and standard deviations for continuous data and frequencies and percentages for categorical data. The three groups will be compared using an analysis of variance (ANOVA) or the non-parametric equivalence Kruskal-Wallis test if required. To compare paired data (intra-group) between two different points, we will use repeated-measures ANOVA and Friedman tests for continuous and non-parametric data, respectively.
- Conditions
- Sarcopenia, Spinal Disease
- Medical subject headings
- Sarcopenia, Spinal Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of isokinetic back muscle strength
Isokinetic back extensor strength using Biodex
Measured: Baseline, 24 months, and 48 months
Lumbar paraspinal muscle quantity and quality
Lumbar paraspinal muscle examination using L-S spine MRI
Measured: Baseline
Secondary outcomes (5)
Change of appendicular limb mass
Appendicular limb mass measure using wholebody DEXA and BIA
Measured: Baseline, 24 months, and 48 months
Change of short physical performance battery
Physical performance measure by walking speed, balance test, and chair standing
Measured: Baseline, 24 months, and 48 months
Laboratory test with biomarker
Serum IL-6 level
Measured: Baseline, 24 months, and 48 months
Change of spinal sagittal balance
Spinopelvic parameters using simple whole spine X-ray
Measured: Baseline, 24 months, and 48 months
Change of back performance scale
Sock Test, the Pick-up Test, the Roll-up Test, the Fingertip-to-Floor Test, and the Lift Test.
Measured: Baseline, 24 months, and 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2019
- Study startAug 2019 (estimated)
- Primary completionJul 2021 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Foundation of Korea
- Responsible party
- Principal investigator, Sang Yoon Lee, SMG-SNU Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03962530
- Sponsor's protocol ID
- 20-2019-19
- Acronym
- SarcoSpine
- Status last verified
- Jun 2019
- First submitted
- 21 May 2019
- Last updated
- 12 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kim JC, Lee SU, Jung SH, Lim JY, Kim DH, Lee SY. Natural aging course of paraspinal muscle and back extensor strength in community-dwelling older adults (sarcopenia of spine, SarcoSpine): a prospective cohort study protocol. BMJ Open. 2019 Sep 5;9(9):e032443. doi: 10.1136/bmjopen-2019-032443.
PubMed 31492798
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sarcopenia of Spine: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03962530
- Acronym / sponsor ID
- SarcoSpine / 20-2019-19
- Conditions
- Sarcopenia, Spinal Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- National Research Foundation of Korea
- Study start
- Aug 2019 (estimated)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 24 May 2019 (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 on lumbar paraspinal muscles is receiving renewed attention as a cause of spinal degeneration. However, there are few studies on the precise concept and diagnostic criteria for spinal sarcopenia. Here, we develop the concept of spinal sarcopenia in community-dwelling healthy elderly people. In addition, we aim to observe the natural aging course of paraspinal muscle and back muscle strength, and investigate the association between conventional sarcopenic indices and spinal sarcopenia.
This is a prospective observational cohort study with 120 healthy community-dwelling elderly people for 4 years. All subjects will be recruited according to no sarcopenia, possible sarcopenia, sarcopenia, and severe sarcopenia groups. The primary outcomes of this study are isokinetic back muscle strength and lumbar paraspinal muscle quantity and quality using lumbar spine MRI. Conventional sarcopenic indices and spine specific outcomes such as spinal sagittal balance, back performance scale, and Sorenson test will be also assessed. The data will be analysed using the intention-to-treat principle.
Detailed description
This is a prospective observational cohort study with 120 healthy community-dwelling elderly people in a single center (SMG-SNU Boramae Medical Center). Individual follow-up will last 4 years. Elderly people (≥ 65 years old) who are community-dwellers and able to walk with or without assistive devices) will be included. Sarcopenia can be divided by two stages: 1) possible sarcopenia (PS) defined by low handgrip strength and/or low gait speed and 2) sarcopenia (SA) confirmed by low handgrip strength and/or low gait speed and low muscle mass by the consensus report of the Asian working group for sarcopenia. No sarcopenia (NS) group is added to this classification, and the study participants are classified into three groups (NS, PS, and SA) after the screening tests. All outcome variables will be collected at baseline, 2 and 4 years. However, L-S spine MRI for lumbar paraspinal muscle quantity and quality will be performed only at baseline.
Data will be collected using a standardised data entry form and entered into the data management system. The intention-to-treat principle will be used for data analysis. Participant characteristics will be described using means and standard deviations for continuous data and frequencies and percentages for categorical data. The three groups will be compared using an analysis of variance (ANOVA) or the non-parametric equivalence Kruskal-Wallis test if required. To compare paired data (intra-group) between two different points, we will use repeated-measures ANOVA and Friedman tests for continuous and non-parametric data, respectively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Healthy elderly population who are community ambulator.
Key inclusion criteria (3 listed)
- Elderly people aged 65 and over;
- Community dweller;
- Ambulator with or without an assistive device.
Key exclusion criteria (13 listed)
- low back pain with moderate severity (numeric rating scale 5 and over);
- history of any types of lumbar spine surgery;
- history of hip fracture surgery and arthroplasty of hip or knee;
- contraindications for MRI (such as cardiac pacemaker, implanted metallic objects, and claustrophobia);
- disorders in central nervous system (such as stroke, parkinsonism, spinal cord injury);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change of isokinetic back muscle strength
Time frame: Baseline, 24 months, and 48 months
Isokinetic back extensor strength using Biodex
Lumbar paraspinal muscle quantity and quality
Time frame: Baseline
Lumbar paraspinal muscle examination using L-S spine MRI
5 secondary outcomes
Change of appendicular limb mass
Time frame: Baseline, 24 months, and 48 months
Change of short physical performance battery
Time frame: Baseline, 24 months, and 48 months
Laboratory test with biomarker
Time frame: Baseline, 24 months, and 48 months
Change of spinal sagittal balance
Time frame: Baseline, 24 months, and 48 months
Change of back performance scale
Time frame: Baseline, 24 months, and 48 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2019.
- Derived from this study: PubMed 31492798Kim JC, Lee SU, Jung SH, Lim JY, Kim DH, Lee SY. Natural aging course of paraspinal muscle and back extensor strength in community-dwelling older adults (sarcopenia of spine, SarcoSpine): a prospective cohort study protocol. BMJ Open. 2019 Sep 5;9(9):e032443. doi: 10.1136/bmjopen-2019-032443.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia and Spinal Disease, run by Seoul National University Hospital.
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 3 inclusion and 13 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 12 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of isokinetic back muscle strength (time frame: Baseline, 24 months, and 48 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03962530, which also lists 1 linked publication.
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 12 Jun 2019.