NCT07447167

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2026

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

February 25, 2026

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2026

Completed
Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

28 days

First QC Date

February 25, 2026

Last Update Submit

March 2, 2026

Conditions

Keywords

preventionback painlumbar spine stabilization exercisessedentary behaviorsedentary worklack of physical activity

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (2)

  • Y-Balance Test Composite Score

    Baseline and 4 weeks (post-intervention)

  • Functional Movement Screen (FMS) Total Score

    Baseline and 4 weeks (post-intervention)

Study Arms (2)

Lumbar Stabilization Exercise Group

EXPERIMENTAL

Structured lumbar stabilization exercise program .

Behavioral: Lumbar Stabilization Exercise Program

Control Group

ACTIVE COMPARATOR

Ergonomic advice and general stretching exercise instructions.

Other: Ergonomic and Stretching Instructions

Interventions

Educational booklet including ergonomic recommendations and general stretching exercises without supervised stabilization training.

Control Group

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.

Lumbar Stabilization Exercise Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of West Attica

Aigáleo, Attica, 12243, Greece

Location

MeSH Terms

Conditions

Sedentary BehaviorBack Pain

Interventions

Ergonomics

Condition Hierarchy (Ancestors)

BehaviorPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EngineeringTechnology, Industry, and Agriculture

Study Officials

  • Georgios Koumantakis, PhD

    University of West Attica

    STUDY CHAIR

Central Study Contacts

Dimitra Korda, PT

CONTACT

Georgios Koumantakis, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc Student

Study Record Dates

First Submitted

February 25, 2026

First Posted

March 3, 2026

Study Start

February 1, 2026

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

March 4, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data will be available upon reasonable request after publication of the study results, subject to institutional approval and data protection regulations.
Access Criteria
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.
More information

Locations