- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07182812
- Original Trial
Effects of Blood Flow Restriction Exercises on Lumbar Muscle Endurance and Balance in Healthy Young Adults (BFR-LUMBEX)
Effects of Blood Flow Restriction Sit-to-Stand Exercises on Lumbar Extensor Muscle Endurance, Balance, and Physiological Parameters in Healthy Young Adults: A Randomized Controlled Trial
This study aims to examine the effects of blood flow restriction (BFR) exercises on back muscle endurance and balance in healthy young adults. BFR is a training method that involves applying controlled pressure to the limbs with a cuff while performing simple exercises. It has been shown to improve muscle strength and endurance even at low exercise loads, reducing stress on the joints.
In this study, participants aged 20 to 25 years will be randomly assigned to two groups. One group will perform sit-to-stand (STS) exercises combined with BFR, while the other group will perform the same exercises without BFR. The exercise program will last 6 weeks, with 2 sessions per week.
Before and after the program, participants will be assessed for:
Lumbar extensor muscle endurance (using the Biering-Sørensen test)
Balance performance (using a computerized balance platform)
Physiological responses such as oxygen saturation, heart rate, and blood pressure
The purpose of this research is to determine whether BFR exercises improve spinal muscle endurance and balance more effectively than standard sit-to-stand exercises. The results may provide new insights into the use of BFR training as a safe and practical strategy for improving posture, preventing back problems, and enhancing physical performance in young adults.
Study Overview
Status
Detailed Description
Detailed Description:
Low back muscle endurance and postural balance are essential components of physical health, functional capacity, and injury prevention. Weakness or fatigue in lumbar extensor muscles is associated with spinal instability, poor posture, and an increased risk of low back pain. Similarly, reduced balance control may impair daily activities and athletic performance. Sedentary lifestyles and prolonged sitting are known to negatively affect these functions in young adults.
Blood flow restriction (BFR) training is an innovative exercise method in which a cuff is applied to partially restrict blood flow in the exercising limb during low-load resistance or functional exercises. This technique has been shown to enhance muscle strength, hypertrophy, and endurance with relatively low mechanical stress, thereby reducing the potential risks associated with high-intensity training. While BFR has been studied extensively in the context of lower-limb strength training, its effects on spinal musculature and balance performance are not well understood.
The present randomized controlled trial is designed to investigate the effects of BFR applied during sit-to-stand (STS) exercises on lumbar extensor muscle endurance and balance performance in healthy young adults. Participants will be randomly assigned to one of two groups:
BFR Exercise Group: STS exercises performed with BFR applied to the thigh.
Control Group: STS exercises performed without BFR.
The intervention will last six weeks, with two supervised exercise sessions per week. The BFR cuff pressure will be set at 60-80% of the individual's systolic blood pressure and monitored to ensure participant safety.
Assessments will be conducted at baseline and after the six-week training program. The primary outcomes are lumbar extensor endurance, measured with the Biering-Sørensen test, and postural balance, assessed using a computerized balance platform. Secondary outcomes include oxygen saturation, heart rate, and blood pressure responses before and after exercise sessions.
The study hypothesizes that participants in the BFR exercise group will show greater improvements in lumbar muscle endurance and balance compared to the control group. Findings from this trial will help clarify whether BFR-based functional training can be considered a safe and effective method not only for enhancing muscle performance but also for improving postural stability in healthy individuals. This may have future applications in sports performance, preventive strategies for low back disorders, and rehabilitation programs for populations with musculoskeletal impairments.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mehmet Akif Güler, PhD, PT
- Phone Number: +90 542 464 42 09
- Email: makif.guler@selcuk.edu.tr
Study Locations
-
-
Konya
-
Konya, Konya, Turkey (Türkiye), 42130
- Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
-
Contact:
- Mehmet Akif Güler, PhD, PT
- Phone Number: +90 542 464 42 09
- Email: makif.guler@selcuk.edu.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age between 20 and 25 years
- Healthy, without musculoskeletal disorders
- No chronic neurological or systemic disease
- No regular exercise program in the last 3 months
- Voluntary participation with signed informed consent
Exclusion Criteria:
- History of musculoskeletal disease, injury, or chronic low back pain
- Neurological conditions or regular use of medications affecting balance or cardiovascular function
- Pregnancy
- Participation in regular lumbar or core exercise programs within the last 3 months
- Any symptoms during exercise (e.g., excessive fatigue, dizziness, abnormal blood pressure changes) that may pose health risks
- Withdrawal of consent or inability to comply with study protocol
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Blood Flow Restriction Exercise Group
Participants in this arm will perform sit-to-stand exercises combined with blood flow restriction (BFR) using a pneumatic cuff applied to the thigh.
The cuff pressure will be set to 60-80% of the participant's systolic blood pressure.
The program will be conducted for 6 weeks, with 2 sessions per week, supervised by a physiotherapist.
|
Participants perform sit-to-stand (STS) exercises with blood flow restriction applied using a pneumatic cuff placed on the thigh.
Cuff pressure is set at 60-80% of the participant's systolic blood pressure.
Sessions are supervised by a physiotherapist twice per week for six weeks.
|
|
Active Comparator: Control Exercise Group
Participants in this arm will perform the same sit-to-stand exercise protocol as the experimental group, but without blood flow restriction.
Sessions will also be supervised twice weekly for 6 weeks, and assessments will be performed before and after the intervention.
|
Participants perform the same sit-to-stand (STS) exercise protocol as the experimental group, but without blood flow restriction.
Sessions are supervised twice weekly for six weeks, and outcomes are assessed before and after the program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lumbar Extensor Muscle Endurance
Time Frame: Baseline and after 6 weeks of intervention
|
Endurance of the lumbar extensor muscles will be assessed using the Biering-Sørensen Test.
Participants maintain the upper body in a horizontal position while lying prone with the pelvis stabilized.
The test duration (in seconds) until trunk decline >5-10° will be recorded.
|
Baseline and after 6 weeks of intervention
|
|
Postural Balance Performance
Time Frame: Baseline and after 6 weeks of intervention
|
Balance performance will be evaluated using a computerized balance platform (TechnoBody™ Pro-Kin).
Both static and dynamic balance parameters will be recorded.
Outcome measures include sway area (cm²), sway velocity (cm/s), and postural stability index.
|
Baseline and after 6 weeks of intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Oxygen Saturation
Time Frame: Baseline and immediately after exercise sessions (pre- and post-intervention at 6 weeks)
|
Peripheral oxygen saturation (SpO₂, %) will be measured using a pulse oximeter placed on the finger.
Measurements will be taken before and after exercise sessions, and changes from baseline to week 6 will be recorded.
|
Baseline and immediately after exercise sessions (pre- and post-intervention at 6 weeks)
|
|
Change in Blood Pressure
Time Frame: Baseline and immediately after exercise sessions (pre- and post-intervention at 6 weeks)
|
Systolic and diastolic blood pressure will be measured using a validated digital sphygmomanometer.
Measurements will be taken at rest before and after exercise sessions.
The change from baseline to week 6 will be compared between groups.
|
Baseline and immediately after exercise sessions (pre- and post-intervention at 6 weeks)
|
|
Change in Body Mass Index (BMI)
Time Frame: Baseline and after 6 weeks of intervention
|
Body mass index (kg/m²) will be calculated from height and weight measured with a digital body composition analyzer (Tanita device).
Changes from baseline to week 6 will be analyzed.
|
Baseline and after 6 weeks of intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mehmet Akif Güler, PhD, PT, Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
Publications and helpful links
General Publications
- Loenneke JP, Wilson JM, Marin PJ, Zourdos MC, Bemben MG. Low intensity blood flow restriction training: a meta-analysis. Eur J Appl Physiol. 2012 May;112(5):1849-59. doi: 10.1007/s00421-011-2167-x. Epub 2011 Sep 16.
- Demoulin C, Vanderthommen M, Duysens C, Crielaard JM. Spinal muscle evaluation using the Sorensen test: a critical appraisal of the literature. Joint Bone Spine. 2006 Jan;73(1):43-50. doi: 10.1016/j.jbspin.2004.08.002.
- Madarame H, Neya M, Ochi E, Nakazato K, Sato Y, Ishii N. Cross-transfer effects of resistance training with blood flow restriction. Med Sci Sports Exerc. 2008 Feb;40(2):258-63. doi: 10.1249/mss.0b013e31815c6d7e.
- Gogna K. Quality assurance: Hodgkin's disease and beyond. Australas Radiol. 2000 Nov;44(4):367-8. doi: 10.1046/j.1440-1673.2000.00839.x. No abstract available.
- Meiners KM, Loudon JK. Dynamic and Static Assessment of Single-Leg Postural Control in Female Soccer Players. J Sport Rehabil. 2020 Feb 1;29(2):174-178. doi: 10.1123/jsr.2018-0072.
- Lee KH, Chon SC. Enhanced Pain Relief and Muscle Growth in Individuals with Low Back Instability: The Impact of Blood Flow Restriction Exercise during Sit to Stand Movements. Med Sci Monit. 2024 Jan 25;30:e942508. doi: 10.12659/MSM.942508.
- Amano S, Ludin AF, Clift R, Nakazawa M, Law TD, Rush LJ, Manini TM, Thomas JS, Russ DW, Clark BC. Effectiveness of blood flow restricted exercise compared with standard exercise in patients with recurrent low back pain: study protocol for a randomized controlled trial. Trials. 2016 Feb 12;17:81. doi: 10.1186/s13063-016-1214-7.
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 (Estimated)
Study Record Updates
Last Update Posted (Estimated)
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
- 1919B012413960 (Other Grant/Funding Number: TUBİTAK)
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
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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