- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07447167
Lumbar Stabilization Exercises in Sedentary Adults
The Effect of a Lumbar Stabilization Exercise Program on Quality of Life and Motor Control in Sedentary Adults
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dimitra Korda, PT
- Phone Number: +306938441422
- Email: dimitracorda@gmail.com
Study Contact Backup
- Name: Georgios Koumantakis, PhD
- Email: gkoumantakis@uniwa.gr
Study Locations
-
-
Attica
-
Aigáleo, Attica, Greece, 12243
- University of West Attica
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Healthy adults with a sedentary lifestyle (no regular structured exercise in the past 2-3 months)
- Ability to participate in a moderate-intensity exercise program
- Ability to understand instructions and complete assessment questionnaires
Exclusion Criteria:
Regular participation in structured exercise programs within the previous 2-3 months
- Diagnosed lumbar disc herniation with neurological deficits
- History of spinal or lower limb surgery within the past year
- Acute musculoskeletal injury or exacerbation of low back pain within the past 4 weeks
- Neurological or neuromuscular disorders
- Active inflammatory rheumatic disease
- Cardiopulmonary contraindications to moderate-intensity exercise
- Pregnancy or postpartum period
- Use of medications significantly affecting balance or physical performance
- Inability to understand study instructions or comply with study procedures
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Lumbar Stabilization Exercise Group
Structured lumbar stabilization exercise program .
|
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.
|
|
Active Comparator: Control Group
Ergonomic advice and general stretching exercise instructions.
|
Educational booklet including ergonomic recommendations and general stretching exercises without supervised stabilization training.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Short Form-12 Health Survey (SF-12v2) Scores
Time Frame: Baseline and 4 weeks (post-intervention)
|
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)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional Movement Screen (FMS) Total Score
Time Frame: Baseline and 4 weeks (post-intervention)
|
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)
|
|
Y-Balance Test Composite Score
Time Frame: Baseline and 4 weeks (post-intervention)
|
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. |
Baseline and 4 weeks (post-intervention)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Georgios Koumantakis, PhD, University of West Attica
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- UWestAttica-LSE-116235
- 116235/12-11-2025 (Other Identifier: Ethics Committee, University of West Attica)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
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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