Ignite Creation Date:
2024-05-06 @ 3:56 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04810312
Status:
UNKNOWN
Last Update Posted:
2021-03-22
First Post:
2021-03-16
Brief Title:
Combined Exercise and Nutrition Intervention for Spinal Sarcopenia
Sponsor:
Seoul National University Hospital
Organization:
Seoul National University Hospital
Study Overview
Official Title:
Combined Exercise and Nutrition Intervention for Spinal Sarcopenia a Pilot Study
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Sarcopenia in the lumbar paraspinal muscles is receiving renewed attention as a cause of spinal degeneration However there were few studies on the precise concept and diagnostic criteria for spinal sarcopenia We have already developed the concept of spinal sarcopenia in community-dwelling older adults and investigated the association between conventional sarcopenic indices and spinal sarcopenia However intervention studies on spinal sarcopenia have not been conducted until now Here we aim a pilot study to evaluate the effectiveness of the combined exercise and nutrition intervention for spinal sarcopenia
This is a prospective study with 35 community-dwelling older women who were diagnosed as spinal sarcopenia in our previous cohort study Combined intervention will consist of back extensor strengthening exercise and nutritional supplementation for 12 weeks The primary outcome of this study is isometric back extensor strength after 12 weeks intervention All functional outcomes will be measured at 0 12 and 24 weeks after intervention The data will be analysed using the intention-to-treat principle
This is a prospective study with 35 community-dwelling older women who were diagnosed as spinal sarcopenia in our previous cohort study Combined intervention will consist of back extensor strengthening exercise and nutritional supplementation for 12 weeks The primary outcome of this study is isometric back extensor strength after 12 weeks intervention All functional outcomes will be measured at 0 12 and 24 weeks after intervention The data will be analysed using the intention-to-treat principle
Detailed Description:
Both the atrophy and fatty change of paraspinal muscles originated from sarcopenia on lumbar paraspinal are also known to be associated with functional disorders and chronic back pain We want to suggest classifying this phenomenon as spinal sarcopenia While feasible inexpensive and less radiation-exposed tools such as dual energy X-ray absorptiometry have been used to measure appendicular skeletal muscle mass paraspinal muscle assessment is still needed using spinal CT or MRI In addition spinal extensor strength measurement is necessary to confirm the function of lumbar paraspinal muscle but isokinetic exercise equipment for accurate measurement is not as feasible as a dynamometer for hand grip strength to evaluate sarcopenia Furthermore many elderly people may experience pain during the measurement of spinal extension strength Therefore it is necessary to develop a simple accessible and clinically meaningful measurement index to confirm the myofunction of spinal extension The main two axes of treatment and prevention of conventional sarcopenia are muscle strengthening exercises and high protein nutritional supplements Therefore it is necessary to confirm the clinical effect by intervention for spinal extension exercise and nutritional supplementation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None