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Combined Exercise and Nutrition Intervention for Spinal Sarcopenia

Primary Purpose

Sarcopenia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Combined exercise and nutrition intervention
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcopenia focused on measuring Sarcopenia

Eligibility Criteria

65 Years - 90 Years (Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Intervention group

    Arm Description

    Back extensor strengthening with oral protein supplementation

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Isometric back extensor strength
    Isometric back muscle strength test using a handheld dynamometer Shirley, NY, USA) to measure the torque of the back extensors
    Isokinetic back extensor strength
    Isokinetic dynamometer (Biodex multi-joint system, Biodex Corporation, Shirley, NY, USA) to measure the torque of the back extensors
    Isokinetic back extensor strength
    Isokinetic dynamometer (Biodex multi-joint system, Biodex Corporation, Shirley, NY, USA) to measure the torque of the back extensors
    Lumbar paraspinal muscle volume
    Lumbar spine MRI will be performed using a 1.5-T scanner (Achieva 1.5 T; Philips Healthcare, Netherlands)
    Short physical performance battery (SPPB)
    Physical performance test (0-12)
    Short physical performance battery (SPPB)
    Physical performance test (0-12)
    Spinal sagittal balance parameters
    Sagittal vertical axis (SVA) distance (mm)
    Spinal sagittal balance parameters
    Sagittal vertical axis (SVA) distance (mm)

    Full Information

    First Posted
    March 16, 2021
    Last Updated
    March 19, 2021
    Sponsor
    Seoul National University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04810312
    Brief Title
    Combined Exercise and Nutrition Intervention for Spinal Sarcopenia
    Official Title
    Combined Exercise and Nutrition Intervention for Spinal Sarcopenia: a Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2021 (Anticipated)
    Primary Completion Date
    March 2022 (Anticipated)
    Study Completion Date
    May 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Seoul National University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sarcopenia
    Keywords
    Sarcopenia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    35 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention group
    Arm Type
    Experimental
    Arm Description
    Back extensor strengthening with oral protein supplementation
    Intervention Type
    Other
    Intervention Name(s)
    Combined exercise and nutrition intervention
    Intervention Description
    Back extensor strengthening exercise and nutritional supplementation for 12 weeks
    Primary Outcome Measure Information:
    Title
    Isometric back extensor strength
    Description
    Isometric back muscle strength test using a handheld dynamometer (PowerTrack II; JTECH Medical, Salt Lake City, UT, USA)
    Time Frame
    12 weeks after intervention
    Secondary Outcome Measure Information:
    Title
    Isometric back extensor strength
    Description
    Isometric back muscle strength test using a handheld dynamometer Shirley, NY, USA) to measure the torque of the back extensors
    Time Frame
    24 weeks after intervention
    Title
    Isokinetic back extensor strength
    Description
    Isokinetic dynamometer (Biodex multi-joint system, Biodex Corporation, Shirley, NY, USA) to measure the torque of the back extensors
    Time Frame
    12 weeks after intervention
    Title
    Isokinetic back extensor strength
    Description
    Isokinetic dynamometer (Biodex multi-joint system, Biodex Corporation, Shirley, NY, USA) to measure the torque of the back extensors
    Time Frame
    24 weeks after intervention
    Title
    Lumbar paraspinal muscle volume
    Description
    Lumbar spine MRI will be performed using a 1.5-T scanner (Achieva 1.5 T; Philips Healthcare, Netherlands)
    Time Frame
    12 weeks after intervention
    Title
    Short physical performance battery (SPPB)
    Description
    Physical performance test (0-12)
    Time Frame
    12 weeks after intervention
    Title
    Short physical performance battery (SPPB)
    Description
    Physical performance test (0-12)
    Time Frame
    24 weeks after intervention
    Title
    Spinal sagittal balance parameters
    Description
    Sagittal vertical axis (SVA) distance (mm)
    Time Frame
    12 weeks after intervention
    Title
    Spinal sagittal balance parameters
    Description
    Sagittal vertical axis (SVA) distance (mm)
    Time Frame
    24 weeks after intervention

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    65 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    SANG YOON LEE, MD, PhD
    Phone
    +82-2-870-2673
    Email
    rehabilee@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    SANG YOON LEE, MD, PhD
    Organizational Affiliation
    SMG-SNU Boramae Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Combined Exercise and Nutrition Intervention for Spinal Sarcopenia

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