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Combined Exercise and Nutrition Intervention for Spinal Sarcopenia

Combined Exercise and Nutrition Intervention for Spinal Sarcopenia: a Pilot Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04810312
Enrollment
35
Registered
2021-03-22
Start date
2021-05-31
Completion date
2022-05-31
Last updated
2021-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcopenia

Keywords

Sarcopenia

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.

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.

Interventions

Back extensor strengthening exercise and nutritional supplementation for 12 weeks

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
65 Years to 90 Years
Healthy volunteers
Yes

Inclusion criteria

* Older women (≥ 65 years old) * Community-dwellers * Able to walk with or without assistive devices for more than 100 meters

Exclusion criteria

* 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) * Communication disorder (such as severe hearing loss) * 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 * Other medical conditions which need active treatment * Subjects who refuse to participate in a study

Design outcomes

Primary

MeasureTime frameDescription
Isometric back extensor strength12 weeks after interventionIsometric back muscle strength test using a handheld dynamometer (PowerTrack II; JTECH Medical, Salt Lake City, UT, USA)

Secondary

MeasureTime frameDescription
Isometric back extensor strength24 weeks after interventionIsometric back muscle strength test using a handheld dynamometer Shirley, NY, USA) to measure the torque of the back extensors
Isokinetic back extensor strength12 weeks after interventionIsokinetic dynamometer (Biodex multi-joint system, Biodex Corporation, Shirley, NY, USA) to measure the torque of the back extensors
Lumbar paraspinal muscle volume12 weeks after interventionLumbar spine MRI will be performed using a 1.5-T scanner (Achieva 1.5 T; Philips Healthcare, Netherlands)
Short physical performance battery (SPPB)12 weeks after interventionPhysical performance test (0-12)
Spinal sagittal balance parameters12 weeks after interventionSagittal vertical axis (SVA) distance (mm)

Contacts

Primary ContactSANG YOON LEE, MD, PhD
rehabilee@gmail.com+82-2-870-2673

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026