Prevalence and Factors Associated With Sarcopenia in Pre-... | NCT05894213

Studies
Prevalence and Factors Associated With Sarcopenia in Pre-retirement Aged Adults With Chronic Non-specific Lower Back Pain

NCT05894213

Sponsor

Mahidol University

Status

Completed

Last Update Posted

Jun 8, 2023Actual

Enrollment

164Actual

Phase

Not provided

Conditions

Sarcopenia
Chronic Lower Back Pain

Interventions

Not provided

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2019Actual

Primary Completion Date

Dec 1, 2019Actual

Completion Date

Mar 30, 2020Actual

First Submitted Date

Apr 7, 2023

First Submission Date that Met QC Criteria

Jun 6, 2023

First Posted Date

Jun 8, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 6, 2023

Last Update Posted Date

Jun 8, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

164Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The prevalence of sarcopenia	participants with or without chronic lower back pain,	December2019

Secondary Outcomes

Measure	Description	Time Frame
The associated factors 1	age	December2019
The associated factors 2	body mass index	December2019

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

59 Years

Standard Ages

Adult

Study Population

The population included 164 people aged 50 - 59 years.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Songsuda Roongsaiwatana, MD	Ramathibodi Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Physical medicine and rehabilitation		Bangkok		10400	Thailand

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33671958	Background	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.

ID	Term
D009133	Muscular Atrophy
D020879	Neuromuscular Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases