Combined Exercise and Nutrition Intervention for Spinal Sarcopenia

NCT04810312 | Unknown DMC

• 1 other identifier: 10-2021-27
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sarcopenia

Keywords

Sarcopenia

Outcome Measures

Primary Outcomes (1)

• Isometric back extensor strength

  Isometric back muscle strength test using a handheld dynamometer (PowerTrack II; JTECH Medical, Salt Lake City, UT, USA)

  12 weeks after intervention

Secondary Outcomes (8)

• Isometric back extensor strength

  24 weeks after intervention

• Isokinetic back extensor strength

  12 weeks after intervention

• Isokinetic back extensor strength

  24 weeks after intervention

• Lumbar paraspinal muscle volume

  12 weeks after intervention

• Short physical performance battery (SPPB)

  12 weeks after intervention

Study Arms (1)

Intervention group

EXPERIMENTAL

Back extensor strengthening with oral protein supplementation

Other: Combined exercise and nutrition intervention

Interventions

Combined exercise and nutrition intervention OTHER

Back extensor strengthening exercise and nutritional supplementation for 12 weeks

Intervention group

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

MeSH Terms

Conditions

Sarcopenia

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• SANG YOON LEE, MD, PhD

  SMG-SNU Boramae Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SANG YOON LEE, MD, PhD

CONTACT

+82-2-870-2673; rehabilee@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 22, 2021
• Study Start: May 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: May 1, 2022
• Last Updated: March 22, 2021

Record last verified: 2021-03