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
About this trial
This is an interventional treatment trial for Sarcopenia focused on measuring Sarcopenia
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
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
NCT ID
NCT04810312
First Posted
March 16, 2021
Last Updated
March 19, 2021
Sponsor
Seoul National University Hospital
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
We'll reach out to this number within 24 hrs