UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061231 |
|---|---|
| Receipt number | R000069985 |
| Scientific Title | Muscle activity during standing up and sitting down in older adults and its relationship with low back pain and pre frailty. |
| Date of disclosure of the study information | 2026/04/15 |
| Last modified on | 2026/04/14 08:47:12 |
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Basic information
Public title
Muscle activity during standing up and sitting down in older adults and its relationship with low back pain and pre frailty.
Acronym
Muscle activity during standing up and sitting down in older adults and its relationship with low back pain and pre frailty.
Scientific Title
Muscle activity during standing up and sitting down in older adults and its relationship with low back pain and pre frailty.
Scientific Title:Acronym
Muscle activity during standing up and sitting down in older adults and its relationship with low back pain and pre frailty.
Region
| Japan |
Condition
Condition
Chronic low back pain, Prefrailty
Classification by specialty
| Orthopedics | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to analyze the associations between nonspecific chronic low back pain and prefrailty and changes in lower limb and trunk muscle strength, muscle endurance, coordination, muscle synergies, and movement patterns, and to clarify their characteristics.
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle activity of lower limb and trunk muscles involved in the sit-to-stand movement, measured using surface electromyography
Key secondary outcomes
Joint angles of the trunk, hip, knee, and ankle measured using a three-dimensional motion analysis system.
Ground reaction forces at the buttocks and feet obtained using force plates.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Participants will include men and women aged 65 to 80 years residing in Toyama Prefecture who have chronic low back pain or prefrailty, as well as healthy men and women of the same age range residing in Toyama Prefecture who have neither condition.
Based on the definition of the Japanese Society for the Study of Low Back Pain and previous studies, chronic low back pain is defined as nonspecific low back pain persisting for at least 3 months, with either continuous pain during the past 3 months or recurrent episodes of exacerbation and remission within the past 6 months.
Prefrailty in this study will be defined using the revised Japanese version of the Cardiovascular Health Study (J-CHS) criteria (2020), with a focus on physical frailty. Participants meeting one or two of the following five criteria will be classified as prefrail: (1) unintentional weight loss of >=2 kg within the past 6 months; (2) grip strength <28 kg in men and <18 kg in women; (3) self-reported exhaustion within the past 2 weeks; (4) usual gait speed <1.0 m/s; and (5) no engagement in either light exercise or regular exercise/sports (defined as answering "not at all at least once per week" to both questions).
Key exclusion criteria
1) Individuals with acute low back pain
2) Individuals with an acute exacerbation of chronic low back pain
3) Individuals with low back pain accompanied by radiating pain to the lower limbs
4) Individuals with a history of spinal surgery
5) Individuals with ischemic heart disease or heart failure
6) Individuals who have been advised by a physician to refrain from lower limb exercise
7) Individuals with hearing or visual impairments severe enough to interfere with understanding the study explanation
8) Individuals with dementia or higher brain dysfunction that impairs comprehension of the study explanation
9) Individuals deemed unsuitable for participation by the principal investigator or co-investigators due to other health conditions or reasons
10) Individuals who are unable to perform the sit-to-stand movement independently or are judged to be at risk of falling
11) Individuals who do not provide informed consent
Additionally, individuals who take medications such as opioids, anticonvulsants, antidepressants, or nonsteroidal anti-inflammatory drugs (NSAIDs) on a daily basis will be excluded, as there is evidence that these medications may influence trunk motor control.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Noriaki |
| Middle name | |
| Last name | Hattori |
Organization
Toyama University Hospital
Division name
Department of Rehabilitation
Zip code
9300194
Address
2630, Sugitani, Toyama City, Toyama Prefecture, Japan
TEL
0764342315
rehab@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Shota |
| Middle name | |
| Last name | Niwa |
Organization
Toyama University Hospital
Division name
Department of Rehabilitation
Zip code
9300194
Address
2630, Sugitani, Toyama City, Toyama Prefecture, Japan
TEL
0764342315
Homepage URL
rehab@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
University of Toyama
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee for Clinical and Epidemiological Research of Toyama University
Address
2630, Sugitani, Toyama City, Toyama Prefecture, Japan
Tel
0764158857
kenrinri@adm.u-toyama.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 02 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2028 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Muscle activity of lower limb and trunk muscles involved in the sit-to-stand movement, measured using surface electromyography.
Joint angles of the trunk, hip, knee, and ankle measured using a three-dimensional motion analysis system.
Ground reaction forces at the buttocks and feet obtained using force plates.
Participants are users of the Kadokawa Care Prevention Center in Toyama City.
Management information
Registered date
| 2026 | Year | 04 | Month | 11 | Day |
Last modified on
| 2026 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069985
