SarcopeniaNCT05894213
Prevalence and Factors Associated With Sarcopenia in Pre-retirement Aged Adults With Chronic Non-specific Lower Back Pain
An observational study of Sarcopenia and Chronic Lower Back Pain, run by Mahidol University at 1 site in Thailand.
Trial summary
To study the prevalence of sarcopenia in a pre-retirement group with chronic lower back pain and factors associated between sarcopenia and chronic lower back pain in the pre-retirement group. Read more about this study
- Who is it for?
- Ages 50 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Chronic Lower Back Pain
- How many people
- 164 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jul 2019to 30 Mar 2020
- 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 50 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The population included 164 people aged 50 - 59 years.
Who may be able to join
- Be a person between the ages of 50 - 59 years with or without chronic lower back pain longer than 3 months, but without any dangerous signs of lower back pain, sciatica pain, and neurological disorder.
- Be able to walk continuously for at least 10 minutes.
- Give written consent to join the research project.
Who cannot join
- Have a history of spinal fracture, spondylolisthesis, scoliosis, or osteomyelitis.
- Have a neurological disorder or myasthenia gravis.
- Have a congenital disease such as acute coronary syndrome, cancer, or severe muscular or joint disease that affects the ability to walk continuously for at least 10 meters.
- Be implanted with a pacemaker or electrical device.
- Refuse or withdraw from the study.
Trial locations and contacts
1 site in 1 country.
About this study
To study the prevalence of sarcopenia in a pre-retirement group with chronic lower back pain and factors associated between sarcopenia and chronic lower back pain in the pre-retirement group.
- Conditions
- Sarcopenia, Chronic Lower Back Pain
- Medical subject headings
- Sarcopenia
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of sarcopenia
participants with or without chronic lower back pain,
Measured: December2019
Secondary outcomes (8)
The associated factors 1
age
Measured: December2019
The associated factors 2
body mass index
Measured: December2019
The associated factors 3
IPAQ
Measured: December2019
The associated factors 4
EQ-5D-5L
Measured: December2019
The associated factors 5
Congential diseases
Measured: December2019
The associated factors 6
Alcohol drinking
Measured: December2019
The associated factors 7
Cigarette smoking
Measured: December2019
The associated factors 8
Body muscular mass
Measured: December2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start1 Jul 2019
- Primary completion1 Dec 2019
- Study completion30 Mar 2020
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 Mahidol UniversityThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Songsuda Roongsaiwatana, Mahidol University
- Investigators
- Songsuda Roongsaiwatana, MD, Study director, Ramathibodi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05894213
- Sponsor's protocol ID
- COA.MURA2019/733
- Status last verified
- Jun 2023
- First submitted
- 7 Apr 2023
- Last updated
- 8 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu WT, Lee TM, Han DS, Chang KV. The Prevalence of Sarcopenia and Its Impact on Clinical Outcomes in Lumbar Degenerative Spine Disease-A Systematic Review and Meta-Analysis. J Clin Med. 2021 Feb 15;10(4):773. doi: 10.3390/jcm10040773.
PubMed 33671958
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Factors Associated With Sarcopenia in Pre-retirement Aged Adults With Chronic Non-specific Lower Back Pain
- ClinicalTrials.gov ID
- NCT05894213
- Acronym / sponsor ID
- COA.MURA2019/733
- Conditions
- Sarcopenia, Chronic Lower Back Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 8 Jun 2023 (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.
To study the prevalence of sarcopenia in a pre-retirement group with chronic lower back pain and factors associated between sarcopenia and chronic lower back pain in the pre-retirement group.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 50 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The population included 164 people aged 50 - 59 years.
Key inclusion criteria (3 listed)
- Be a person between the ages of 50 - 59 years with or without chronic lower back pain longer than 3 months, but without any dangerous signs of lower back pain, sciatica pain, and neurological disorder.
- Be able to walk continuously for at least 10 minutes.
- Give written consent to join the research project.
Key exclusion criteria (5 listed)
- Have a history of spinal fracture, spondylolisthesis, scoliosis, or osteomyelitis.
- Have a neurological disorder or myasthenia gravis.
- Have a congenital disease such as acute coronary syndrome, cancer, or severe muscular or joint disease that affects the ability to walk continuously for at least 10 meters.
- Be implanted with a pacemaker or electrical device.
- Refuse or withdraw from the study.
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
The prevalence of sarcopenia
Time frame: December2019
participants with or without chronic lower back pain,
8 secondary outcomes
The associated factors 1
Time frame: December2019
The associated factors 2
Time frame: December2019
The associated factors 3
Time frame: December2019
The associated factors 4
Time frame: December2019
The associated factors 5
Time frame: December2019
The associated factors 6
Time frame: December2019
The associated factors 7
Time frame: December2019
The associated factors 8
Time frame: December2019
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
- Background: PubMed 33671958Wu WT, Lee TM, Han DS, Chang KV. The Prevalence of Sarcopenia and Its Impact on Clinical Outcomes in Lumbar Degenerative Spine Disease-A Systematic Review and Meta-Analysis. J Clin Med. 2021 Feb 15;10(4):773. doi: 10.3390/jcm10040773.
- Individual participant dataSharing planned: No
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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.
Songsuda Roongsaiwatana, MD study director
Ramathibodi Hospital
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 and Chronic Lower Back Pain, run by Mahidol University at 1 site in Thailand.
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 5 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: finished, as of the sponsor's last update on 8 Jun 2023. 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 Thailand. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The prevalence of sarcopenia (time frame: December2019). 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 NCT05894213, 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 8 Jun 2023.