Tokyo, April 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061231) titled 'Muscle activity during standing up and sitting down in older adults and its relationship with low back pain and pre frailty' on April 15.

Study Type: Observational

Primary Sponsor: Institute - University of Toyama

Condition: Condition - Chronic low back pain, Prefrailty Classification by malignancy - Others Genomic information - NO

Objective: 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

Eligibility: Age-lower limit - 65 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 Size - 45

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069985

Disclaimer: Curated by HT Syndication.