- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06943898
Investigation of the Acute Effects of Core Stabilization and 360-Degree Breathing Exercises on Balance and Proprioception in Individuals With Non-Specific Low Back Pain (360° Breath)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Study Coordinator, PhD
- Phone Number: +905065945067
- Email: sbalki@cumhuriyet.edu.tr
Study Locations
-
-
Merkez
-
Sivas, Merkez, Turkey, 58000
- Recruiting
- Sivas Cumhuriyet University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation
-
Contact:
- Selvin Balki
- Phone Number: +905065945067
- Email: sbalki@cumhuriyet.edu.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Low back pain persisting for at least 3 months
- No neurological, rheumatological, or musculoskeletal system problems
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Control Group (Core Exercises)
Core Exercises Group
|
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.
|
|
Other: Intervention Group (Core Exercises + Breathing Exercises):
Core Exercises + Breathing 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
• Proprioception Assessment
Time Frame: 3 week
|
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)
Time Frame: 3 week
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Core Muscle Endurance Assessment:
Time Frame: 3 week
|
Core endurance will be assessed using McGill's protocol, including trunk extension, trunk flexion, lateral bridge, and prone bridge tests.
The patient lies in a side-lying position with the lower arm flexed at 90° and forearm on the table. The upper arm is crossed over the chest. Lower extremities are extended |
3 week
|
|
Visual Analog Scale (VAS)
Time Frame: 3 week
|
Pain levels will be evaluated using the Visual Analog Scale (VAS), ranging from 0 to 10.
A score of 0 indicates no pain; 1-4 indicates mild pain; 5-6 indicates moderate pain; 7-10 indicates severe pain.
|
3 week
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Balki, PhD, Sivas Cumhuriyet University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation
Study record dates
Study Major Dates
Study Start (Actual)
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
- SCU-FTR-SB-01
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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