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.
Condition or disease |
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Sarcopenia Spinal Disease |
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 Type : | Observational |
Estimated Enrollment : | 100 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Sarcopenia of Spine: a Prospective Cohort Study |
Estimated Study Start Date : | August 2019 |
Estimated Primary Completion Date : | July 2021 |
Estimated Study Completion Date : | July 2023 |
Ages Eligible for Study: | 65 Years and older (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
No Contacts or Locations Provided
Tracking Information | |||||
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First Submitted Date | May 21, 2019 | ||||
First Posted Date | May 24, 2019 | ||||
Last Update Posted Date | June 12, 2019 | ||||
Estimated Study Start Date | August 2019 | ||||
Estimated Primary Completion Date | July 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures |
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Change History | |||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Spinal Sarcopenia Cohort Study (SarcoSpine) | ||||
Official Title | Sarcopenia of Spine: a Prospective Cohort Study | ||||
Brief 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. 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. |
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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. |
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Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Probability Sample | ||||
Study Population | Healthy elderly population who are community ambulator. | ||||
Condition |
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Intervention | Not Provided | ||||
Study Groups/Cohorts | Not Provided | ||||
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. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Not yet recruiting | ||||
Estimated Enrollment |
100 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | July 2023 | ||||
Estimated Primary Completion Date | July 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 65 Years and older (Older Adult) | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts | |||||
Listed Location Countries | Not Provided | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03962530 | ||||
Other Study ID Numbers | 20-2019-19 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement | Not Provided | ||||
Responsible Party | Sang Yoon Lee, SMG-SNU Boramae Medical Center | ||||
Study Sponsor | Seoul National University Hospital | ||||
Collaborators | National Research Foundation of Korea | ||||
Investigators | Not Provided | ||||
PRS Account | Seoul National University Hospital | ||||
Verification Date | June 2019 |