- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05649150
Influence of Physical Activity Level on Lumbar Movement Control
The Influence of Physical Activity Level on Lumbar Movement Control and Standing Balance in Adults With and Without Low Back Pain.
Study Overview
Status
Conditions
Detailed Description
Low back pain (LBP) is a leading cause of disability that results in significant health and socioeconomic problems. Most of the LBP is non-specific and altered motor control is one of the possible causes. Motor control exercise (MCE) thus has been recently developed as a non-operative intervention for LBP. Recently, a series of lumbar movement control (LMC) tests have been advocated to evaluate impaired motor control of lumbar. To perform a coordinated movement pattern, normal proprioception (part of neural system) is thought to be essential. Poor proprioception related to delayed muscle response and altered motor control which possibly leading to deficits in postural control and balance in LBP population. Study showed standing balance was related to higher physical activity (PA) which has been promoted in all adults and proper amount is at least 150 to 300 minutes of moderate-intensity aerobic physical activity; or at least 75 to 150 minutes of vigorous-intensity aerobic physical activity per week for substantial health benefits. As we know, there is no specific research about the relationship among PA, LMC and standing balance. Therefore, the purposes of the study are to investigate (1) the influence of different level of PA on LMC tests; (2) the influence of PA on standing balance; (3) the relationship of battery of LMC tests and standing balance in adults with and without LBP.
It is expected to recruit total 160 participants with and without LBP. The inclusion criteria for adults with LBP are: (1) aged from 20 to 65 years old, (2) persistent LBP for more than 3 months. For adults without LBP are: (1) aged from 20 to 65 years old, (2) no specific low back pain in the past 6 months. All the participants will fill in International PA Questionnaire (IPAQ), Short form Taiwan Version, perform proprioception test for the lumbar spine, LMC tests, timed one-leg standing balance, and Y-balance test for the lower quarter (YBT-LQ). After finishing the examination, all the data will be analyzed by mix analysis of variance (ANOVA) and Chi-square analysis. Bonferroni post-hoc tests will be used to identify the significance within each analysis. Level of statistical significance was set at p<0.05.
Keywords: Physical activity, motor control exercise, lumbar movement control, standing balance, proprioception
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Tainan, Taiwan, 30013
- National Cheng Kung University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- For adults with LBP are: (1) aged from 20 to 65 years old, (2) persistent LBP for more than 3 months.
- For adults without LBP are: (1) aged from 20 to 65 years old, (2) no specific low back pain in the past 6 months.
Exclusion Criteria: (for both groups)
- Musculoskeletal symptoms of lower extremity in the past 6 months
- History of surgeries, fractures, or ruptures to the musculoskeletal structures on the lower limbs and spine
- Congenital spinal pathologies and deformities
- Sensory and neurological deficits
- Pregnancy
- Body mass indexes (BMI) >30 kg/m2
- Self-reported symptoms of dizziness
- Visual, vestibular or balance problems
- Other conditions affecting balance (eg, drug or alcohol consumption)
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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Healthy group
For healthy group A.K.As adults without LBP are: (1) aged from 20 to 65 years old, (2) no specific low back pain in the past 6 months.
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LBP group
The inclusion criteria for adults with LBP are: (1) aged from 20 to 65 years old, (2) persistent LBP for more than 3 months.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Lumbar proprioception (joint repositioning error of lumbar spine)
Time Frame: One day
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Joint repositioning error of lumbar spine will be measured by the difference between starting to the finishing position.
Five trials will be tested and the average of the difference will be recored for analysis.
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One day
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Lumbar movement control ability
Time Frame: One day
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Lumbar motor control is a self-made battery according to the previous studies.
The lumbar movement control tests included 10 items.
And the passed number of tests will be recorded for analysis.
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One day
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One-leg standing balance
Time Frame: One day
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Timed balance tests will be exanimated for static one-leg standing balance in four conditions.
The subjects will be instructed to one leg standing in barefoot, arm folded across the chest, on solid surface or foam surface with eyes opened and closed.
3 trial for each conditions and the average of the 3 trials will be recored into analysis
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One day
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Dynamic standing balance
Time Frame: One day
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Y-balance test- lower quarter (YBT-LQ) will be used for assessing dynamic standing balance.
Participants stand on one leg in the center of the YBT-LQ and reaching the gesture leg into three different directions (anterior, posterio-lateral, posterior-medial).
The reaching distance will be recored in centimeters.
Three for each direction, the average will be normalized by leg length and be recorded into analysis.
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One day
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Oswestry Disability Index
Time Frame: One day
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Oswestry Disability Index is a self-reported questionnaire for assessing disability of LBP group.
The sum score of the Oswestry Disability Index will transformed into percentage for analysis.
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One day
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International PA Questionnaire (IPAQ)
Time Frame: One day
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IPAQ is a self-reported questionnaire for assessing physical activity.
The total MET-mins/week will be recorded for analysis.
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One day
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Fear-Avoidance Beliefs Questionnaire (FABQ)
Time Frame: One day
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FABQ is an self-reported questionnaire for assessing the fear-avoidance in low back pain group.
The sum of the score of the 16 questions will be transformed into percentage for analysis.
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One day
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Yi-Ju Tsai, National Cheng Kung University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCKU-2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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