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| ID | Type | Description | Link |
|---|---|---|---|
| 116235/12-11-2025 | Other Identifier | Ethics Committee, University of West Attica |
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This pilot randomized controlled trial will examine the effects of a four-week lumbar spine stabilization exercise program on motor control, dynamic balance, and quality of life in healthy sedentary adults. Prolonged sedentary behavior has been associated with impaired neuromuscular function and increased risk of musculoskeletal disorders, even in asymptomatic individuals.
Forty sedentary adults will be randomly assigned to either an intervention group, which will follow a structured lumbar stabilization exercise program, or to a control group, which will receive ergonomic and stretching guidelines.
Outcomes will be assessed before and after the intervention using the SF-12v2 quality of life questionnaire, the Functional Movement Screen (FMS) and the Y-Balance Test. Physical activity levels will be monitored using the IPAQ-SF. The study aims to determine whether lumbar stabilization exercises improve health-related quality of life, motor control and dynamic balance in sedentary adults.
This study will employ a two-arm parallel randomized controlled design to examine the effectiveness of a four-week lumbar stabilization intervention in sedentary adults. Participants will be randomly allocated in a 1:1 ratio to either an exercise intervention group or a control group.
To enhance measurement reliability, two baseline assessments will be conducted prior to the intervention and two post-intervention assessments will be performed after completion of the program, with a three-day interval between repeated measurements.
The stabilization program will focus on activation and progressive strengthening of the deep trunk musculature, with particular emphasis on transversus abdominis and multifidus activation. Special attention will be given to the acquisition of diaphragmatic breathing patterns to facilitate neuromuscular control. Exercises will be performed in multiple positions, including supine, side-lying, prone, and quadruped positions. The level of difficulty will be progressively increased throughout the four-week intervention period.
The control group will receive written ergonomic education and general stretching instructions without supervised exercise.
Assessments will be conducted using standardized and validated instruments to evaluate motor control, dynamic balance, and health-related quality of life. Statistical analysis will be performed using repeated-measures analysis of variance to assess within-group and between-group differences over time, with a predefined level of statistical significance set at 0.05.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lumbar Stabilization Exercise Group | Experimental | Structured lumbar stabilization exercise program . |
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| Control Group | Active Comparator | Ergonomic advice and general stretching exercise instructions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ergonomic and Stretching Instructions | Other | Educational booklet including ergonomic recommendations and general stretching exercises without supervised stabilization training. |
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| Measure | Description | Time Frame |
|---|---|---|
| Short Form-12 Health Survey (SF-12v2) Scores | Health-related quality of life will be assessed using the SF-12v2 questionnaire. The eight domain scores (Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, and Mental Health) as well as the Physical Component Summary (PCS) and Mental Component Summary (MCS) scores will be calculated. Domain scores will be transformed to a 0-100 scale, with higher scores indicating better perceived health status. PCS and MCS will be computed using norm-based scoring (mean = 50, SD = 10), where higher values reflect better overall physical and mental health. | Baseline and 4 weeks (post-intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Y-Balance Test Composite Score | Dynamic balance will be assessed using the Y-balance test. The composite approach distance for each lower limb will be calculated as: (ANT + PM + PL approach distance) / (3 × limb length) × 100. The composite score is expressed as a percentage of limb length. Minimum value: 0%. Maximum value: 100% (theoretically may exceed 100% in high-performing individuals). Higher values indicate better dynamic balance. [Time frame: Baseline and 4 weeks (after intervention)] Asymmetry will be calculated as the absolute difference between right and left normalized reach distances (% of limb length). Minimum value: 0%. No fixed maximum value. Higher values indicate greater asymmetry. |
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Inclusion Criteria:
Healthy adults with a sedentary lifestyle (no regular structured exercise in the past 2-3 months)
Exclusion Criteria:
Regular participation in structured exercise programs within the previous 2-3 months
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dimitra Korda, PT | Contact | +306938441422 | dimitracorda@gmail.com | |
| Georgios Koumantakis, PhD | Contact | gkoumantakis@uniwa.gr |
| Name | Affiliation | Role |
|---|---|---|
| Georgios Koumantakis, PhD | University of West Attica | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of West Attica | Aigáleo | Attica | 12243 | Greece |
De-identified individual participant data related to study outcomes and basic demographic characteristics will be made available upon reasonable request and subject to institutional approval.
Data will be available upon reasonable request after publication of the study results, subject to institutional approval and data protection regulations.
Data will be shared with qualified researchers upon reasonable request, following review and approval by the principal investigator and in accordance with applicable data protection regulations.
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| ID | Term |
|---|---|
| D057185 | Sedentary Behavior |
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D006804 | Ergonomics |
| ID | Term |
|---|---|
| D004738 | Engineering |
| D013676 | Technology, Industry, and Agriculture |
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Two-arm parallel randomized controlled trial. Participants will be randomly assigned in a 1:1 ratio to either a lumbar stabilization exercise group or a control group receiving ergonomic and stretching instructions. Assessments will be conducted at baseline and post-intervention.
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| Lumbar Stabilization Exercise Program | Behavioral | A structured four-week lumbar stabilization exercise program targeting deep trunk musculature in healthy sedentary adults. The program will emphasize activation of the transversus abdominis, incorporation of diaphragmatic breathing, and progressive increase in exercise difficulty. Exercises will be performed under supervision in supine, prone, side-lying, and quadruped positions under structured guidance. |
|
| Baseline and 4 weeks (post-intervention) |
| Functional Movement Screen (FMS) Total Score | Motor control will be assessed using the Functional Movement Screen (FMS). Higher scores indicate better motor control and movement quality. The total score ranges from 0 to 21 for the 7 functional test. | Baseline and 4 weeks (post-intervention) |
| D013568 |
| Pathological Conditions, Signs and Symptoms |