NCT06943898

Brief Summary

This study is designed as a single-blind randomized controlled trial. Male and female patients aged 18-65 years with complaints of non-specific low back pain (NSLBP) lasting longer than 12 weeks will be included in the study. Participants will be randomly assigned into two parallel groups: control and intervention. The control group will perform core stabilization exercises five days a week for three weeks. In the intervention group, core stabilization exercises will be combined with 360-degree breathing exercises. To our knowledge, there is no randomized controlled trial investigating the effect of combining core stabilization with 360-degree breathing in individuals with NSLBP. The aim of this study is to examine the acute effects of combining 360-degree breathing techniques with core stabilization exercises on balance and proprioception in individuals with NSLBP.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
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

First Submitted

Initial submission to the registry

April 17, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 24, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

July 30, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

August 6, 2025

Status Verified

August 1, 2025

Enrollment Period

4 months

First QC Date

April 17, 2025

Last Update Submit

August 1, 2025

Conditions

Keywords

core stability exerciselow back painexercise

Outcome Measures

Primary Outcomes (2)

  • • Proprioception Assessment

    Proprioception will be evaluated using an inclinometric method. An inclinometer is usually placed and fixed at the L3-L4 segment of the lumbar spine. The patient will be asked to achieve and then reproduce a target position. The difference between the reference angle and the reproduced angle (position error) will be recorded as a measure of proprioceptive perception.

    3 week

  • Y Balance Test (YBT)

    The Y Balance Test (YBT) will be used to assess balance. Patients will remove their shoes and place the stance foot on the center footplate of the YBT platform. They will attempt to reach maximally with the opposite leg in three directions (anterior, posteromedial, and posterolateral), maintaining balance on the stance leg. Maximum reach distances will be recorded.

    3 week

Secondary Outcomes (2)

  • Core Muscle Endurance Assessment:

    3 week

  • Visual Analog Scale (VAS)

    3 week

Study Arms (2)

Control Group (Core Exercises)

OTHER

Core Exercises Group

Other: Core Egzercise

Intervention Group (Core Exercises + Breathing Exercises):

OTHER

Core Exercises + Breathing Exercises

Other: Core Exercises + Breathing Exercises

Interventions

The core exercise group will perform core stabilization exercises for a total of 15 sessions, five days a week for three weeks. Exercises will include pelvic tilt, bridge, dead bug, bird dog, mini squats on a balance board, and wall planks. The number of repetitions will be increased from 10 to 20, and plank duration will be increased from 30 seconds to 45 seconds. A 5-minute warm-up and cool-down session will be included.

Control Group (Core Exercises)

This group will perform core stabilization exercises combined with the 360-degree breathing technique, for a total of 15 sessions over three weeks (five days a week). "360-degree breathing" is a novel breathing method targeting deep and controlled inhalations into various regions of the body. Unlike traditional breathing exercises, 360-degree breathing ensures that all directions of the lungs are equally ventilated.

Intervention Group (Core Exercises + Breathing Exercises):

Eligibility Criteria

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

You may qualify if:

  • Low back pain persisting for at least 3 months
  • No neurological, rheumatological, or musculoskeletal system problems

You may not qualify if:

  • Individuals with neurological, vestibular, or serious orthopedic conditions that may cause physical disability
  • Patients with back-leg or dorsolumbar pain due to lumbar disc protrusion or fracture
  • Cancer patients
  • Individuals with acute infections
  • Individuals with respiratory system diseases
  • Individuals with any mental disorder that would prevent participation in the study assessment
  • Pregnant individuals

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sivas Cumhuriyet University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation

Sivas, Merkez, 58000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Low Back PainMotor Activity

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Balki, PhD

    Sivas Cumhuriyet University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation

    STUDY DIRECTOR

Central Study Contacts

Study Coordinator, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: two groups with a conventional therapy control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

April 17, 2025

First Posted

April 24, 2025

Study Start

July 30, 2025

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

August 6, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations