NCT07182812

Brief Summary

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.

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
70

participants targeted

Target at P75+ for not_applicable healthy-volunteers

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable healthy-volunteers

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 19, 2025

Completed
10 days until next milestone

Study Start

First participant enrolled

September 29, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

2 months

First QC Date

September 14, 2025

Last Update Submit

September 14, 2025

Conditions

Keywords

Blood Flow Restriction ExerciseSit-to-Stand ExerciseLumbar Extensor MusclesMuscle EndurancePostural BalancePhysiological Parameters (Oxygen Saturation, Heart Rate, Blood Pressure)Young AdultsRandomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

  • Lumbar Extensor Muscle Endurance

    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

    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 Outcomes (3)

  • Change in Oxygen Saturation

    Baseline and immediately after exercise sessions (pre- and post-intervention at 6 weeks)

  • Change in Blood Pressure

    Baseline and immediately after exercise sessions (pre- and post-intervention at 6 weeks)

  • Change in Body Mass Index (BMI)

    Baseline and after 6 weeks of intervention

Study Arms (2)

Blood Flow Restriction Exercise Group

EXPERIMENTAL

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.

Behavioral: Blood Flow Restriction Sit-to-Stand Exercise

Control Exercise Group

ACTIVE COMPARATOR

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.

Behavioral: Sit-to-Stand Exercise without Blood Flow Restriction

Interventions

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.

Blood Flow Restriction Exercise Group

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.

Control Exercise Group

Eligibility Criteria

Age20 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Selçuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

Konya, Konya, 42130, Turkey (Türkiye)

Location

Related Publications (7)

  • 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.

    PMID: 11103532BACKGROUND
  • 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.

    PMID: 30526247BACKGROUND
  • 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.

    PMID: 18202577BACKGROUND
  • 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.

    PMID: 38268184BACKGROUND
  • 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.

    PMID: 21922259BACKGROUND
  • 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.

    PMID: 16461206BACKGROUND
  • 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.

    PMID: 26867541BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mehmet Akif Güler, PhD, PT

    Selçuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mehmet Akif Güler, PhD, PT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessors will be blinded to group allocation. Participants and care providers cannot be blinded due to the nature of the intervention (blood flow restriction vs. no restriction). Randomization will be concealed until outcome data collection is completed.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: This randomized controlled trial uses a parallel assignment design. Healthy young adults will be randomly allocated into two groups: (1) an experimental group performing sit-to-stand exercises with blood flow restriction (BFR), and (2) a control group performing the same exercises without BFR. Both groups will follow the intervention for six weeks, with two sessions per week. Pre- and post-intervention assessments will be conducted to compare outcomes between groups.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD, PT

Study Record Dates

First Submitted

September 14, 2025

First Posted

September 19, 2025

Study Start

September 29, 2025

Primary Completion

November 30, 2025

Study Completion

November 30, 2025

Last Updated

September 19, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

De-identified individual participant data (IPD) related to primary and secondary outcomes will be available upon reasonable request from qualified researchers after publication of study results. Data will be shared through secure institutional repositories in compliance with Selçuk University ethical guidelines.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
De-identified individual participant data (IPD) and supporting documents will be available beginning 6 months after publication of the primary results and will be accessible for a period of 5 years thereafter.
Access Criteria
IPD will be available to qualified researchers affiliated with academic or healthcare institutions upon reasonable request. Requests will be reviewed by the principal investigator and Selçuk University Ethics Committee. Approved researchers will gain access through a secure institutional repository with appropriate data use agreements to ensure participant confidentiality.

Locations