SarcopeniaNCT04810312
Combined Exercise and Nutrition Intervention for Spinal Sarcopenia
A study testing Combined exercise and nutrition intervention in people with Sarcopenia, run by Seoul National University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 90 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Combined exercise and nutrition intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- May 2021to May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Older women (≥ 65 years old)
- Community-dwellers
- Able to walk with or without assistive devices for more than 100 meters
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Combined Exercise and Nutrition Intervention for Spinal Sarcopenia: a Pilot Study
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.
Read the 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.
- Conditions
- Sarcopenia
- Being tested
- Combined exercise and nutrition intervention
- Keywords
- Sarcopenia
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined exercise and nutrition interventionOther
Back extensor strengthening exercise and nutritional supplementation for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Back extensor strengthening with oral protein supplementation Receives: Other: Combined exercise and nutrition intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isometric back extensor strength
Isometric back muscle strength test using a handheld dynamometer (PowerTrack II; JTECH Medical, Salt Lake City, UT, USA)
Measured: 12 weeks after intervention
Secondary outcomes (8)
Isometric back extensor strength
Isometric back muscle strength test using a handheld dynamometer Shirley, NY, USA) to measure the torque of the back extensors
Measured: 24 weeks after intervention
Isokinetic back extensor strength
Isokinetic dynamometer (Biodex multi-joint system, Biodex Corporation, Shirley, NY, USA) to measure the torque of the back extensors
Measured: 12 weeks after intervention
Isokinetic back extensor strength
Isokinetic dynamometer (Biodex multi-joint system, Biodex Corporation, Shirley, NY, USA) to measure the torque of the back extensors
Measured: 24 weeks after intervention
Lumbar paraspinal muscle volume
Lumbar spine MRI will be performed using a 1.5-T scanner (Achieva 1.5 T; Philips Healthcare, Netherlands)
Measured: 12 weeks after intervention
Short physical performance battery (SPPB)
Physical performance test (0-12)
Measured: 12 weeks after intervention
Short physical performance battery (SPPB)
Physical performance test (0-12)
Measured: 24 weeks after intervention
Spinal sagittal balance parameters
Sagittal vertical axis (SVA) distance (mm)
Measured: 12 weeks after intervention
Spinal sagittal balance parameters
Sagittal vertical axis (SVA) distance (mm)
Measured: 24 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study startMay 2021 (estimated)
- Primary completionMar 2022 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang Yoon Lee, Seoul National University Hospital
- Investigators
- SANG YOON LEE, MD, PhD, Principal investigator, SMG-SNU Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04810312
- Sponsor's protocol ID
- 10-2021-27
- Status last verified
- Mar 2021
- First submitted
- 16 Mar 2021
- Last updated
- 22 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Exercise and Nutrition Intervention for Spinal Sarcopenia: a Pilot Study
- ClinicalTrials.gov ID
- NCT04810312
- Acronym / sponsor ID
- 10-2021-27
- Conditions
- Sarcopenia
- Keywords
- Sarcopenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- May 2021 (estimated)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 22 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Combined exercise and nutrition interventionBack extensor strengthening with oral protein supplementation |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Older women (≥ 65 years old)
- Community-dwellers
- Able to walk with or without assistive devices for more than 100 meters
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined exercise and nutrition interventionBack extensor strengthening exercise and nutritional supplementation for 12 weeks | Other | Intervention group |
Primary outcome
Isometric back extensor strength
Time frame: 12 weeks after intervention
Isometric back muscle strength test using a handheld dynamometer (PowerTrack II; JTECH Medical, Salt Lake City, UT, USA)
8 secondary outcomes
Isometric back extensor strength
Time frame: 24 weeks after intervention
Isokinetic back extensor strength
Time frame: 12 weeks after intervention
Isokinetic back extensor strength
Time frame: 24 weeks after intervention
Lumbar paraspinal muscle volume
Time frame: 12 weeks after intervention
Short physical performance battery (SPPB)
Time frame: 12 weeks after intervention
Short physical performance battery (SPPB)
Time frame: 24 weeks after intervention
Spinal sagittal balance parameters
Time frame: 12 weeks after intervention
Spinal sagittal balance parameters
Time frame: 24 weeks after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2021.
Related trials for Sarcopenia
Recruiting
Strength and Dual-Task on Sarcopenia in People With Parkinson's Disease
PARKINSON DISEASE (Disorder), Parkinsonism or Parkinson's Disease Nos
Not yet recruitingObservational study
Malnutrition and Sarcopenia in Adults With Chronic Kidney Disease in Tunisia
Malnutrition, Sarcopenia
RecruitingObservational study
Investigating the Link Between Advanced Glycation End Products (AGEs) and Muscle Wasting in Sarcobesity
Sarcopenia, Obesity
Enrolling by invitation
Physical Activity Interventions for Sleep Improvement and Sedative-Hypnotic Reduction in Middle-Aged and Older Adults: Investigating the Role of Sarcopenia
Insomnia Chronic, Hypnotics and Sedatives
Recruiting
Muscle Deterioration in Hospitalized Cancer Patient
Oncologic Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SANG YOON LEE, MD, PhD principal investigator
SMG-SNU Boramae Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Combined exercise and nutrition intervention in people with Sarcopenia, run by Seoul National University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SANG YOON LEE, MD, PhD (+82-2-870-2673, rehabilee@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isometric back extensor strength (time frame: 12 weeks after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2021.