NCT05970523

Brief Summary

There are very few studies on the effect of core stabilization exercises on balance, posture and trunk muscle endurance in healthy sedentary individuals in literature. The goal of the study is to investigate the effects of core stabilization exercises on balance, trunk muscle endurance and posture in healthy sedentary individuals. According to the results of International Physical Activity Questionnaire, the researcher includes sedentary individuals over the age of 18 in the study. The participants are divided into two groups as control (n=21) and exercise (n=21) groups. The outcome measures are The Stabilizer Pressure Biofeedback Unit, New York Posture Assesment Scale, Korebalance Balance System, trunk muscle endurance tests. Intervention includes core stabilization exercises 3 times a week and walking twice a week for 6 weeks. There is no treatment or intervention for the control group. The researcher evaluates both groups at the beginning and 6 weeks after the intervention.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
active not 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

Study Start

First participant enrolled

April 27, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

7 months

First QC Date

July 24, 2023

Last Update Submit

February 26, 2024

Conditions

Keywords

Trunk Muscle EnduranceBalancePosture

Outcome Measures

Primary Outcomes (4)

  • New York Posture Assessment Scale

    This test assesses alignment of various body parts of an individual in anatomical position. The New York Posture Rating Scale detects postural changes. There are 3 figure drawings for each of the 13 different body parts that provide general postural alignment. In the evaluation, five (5) points are given if the person's posture is correct, three (3) points if moderately impaired, and one (1) point if severely impaired. At the end of the evaluation, the total maximum score is 65 and the minimum is 13. Postural disturbances increase as the score decreases.

    6 weeks

  • KoreBalance Balance System

    The Korebalance Balance System is a computerized balance and exercise system. The software of the system assigns a score following static and dynamic balance evaluations. As stated in the device manual, a score of 700 and below was considered normal and above was considered risky for static balance and a score of 2000 and below was considered normal and above was considered risky for dynamic tests. A higher score is associated with more balance disorders.

    6 weeks

  • Trunk Muscle Endurance Tests

    The endurance of the trunk flexor, trunk extensor and lateral flexor muscles is evaluated by recording the maximum time that the person can maintain the test position. Measurements are made using a stopwatch and the result is recorded in seconds. The tests are repeated twice to save the best measurement value. Tests are terminated when the participant's position deteriorates or when the participant says cannot continue the test.

    6 weeks

  • International Physical Activity Questionnaire

    This survey lists activities and requests estimates of duration and frequency for each activity performed in the past week. The times are multiplied by the known Metabolic Equivalents (METs) per activity and the results for all items are summed, resulting in the overall physical activity score.

    Before Intervention (First Assesment)

Secondary Outcomes (1)

  • The Stabilizer Pressure Biofeedback Unite

    6 weeks

Study Arms (2)

Exercise Group

EXPERIMENTAL

Intervention includes core stabilization exercises for 45 minutes 3 times a week. Participants do exercise face to face under supervision of a physiotherapist and via an online application under the supervision of a physiotherapist once a week. Also participants do home exercise once a week. Exercise group walk for an hour in other two days.

Other: Core Stabilization Exercises

Control Group

NO INTERVENTION

There is no exercise or intervention for control group.

Interventions

Core stabilization exercises are known as a very effective exercise method based on the motor learning principle, performed with the individual's own body weight to strengthen the muscles, improve balance, posture, trunk muscle endurance and flexibility.Each exercise was performed for 7-8 seconds with 10 repetitions. Progression in the exercises was achieved by increasing the difficulty level of the exercises according to the participant's condition once every two weeks.

Exercise Group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Be voluntary to participate in the study
  • Being between the ages of 18-40
  • Being sedentary

You may not qualify if:

  • Not volunteering to participate in the study
  • Having a complaint of low back pain in the last two months
  • Being pregnant
  • Having chronic lower extremity pain
  • Having an orthopedic disease and undergoing a surgical operation
  • Having had abdominal surgery
  • Being a neurological disease pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beyza Nur Yumak

Istanbul, 34126, Turkey (Türkiye)

Location

Related Publications (6)

  • Sekendiz B, Cug M, Korkusuz F. Effects of Swiss-ball core strength training on strength, endurance, flexibility, and balance in sedentary women. J Strength Cond Res. 2010 Nov;24(11):3032-40. doi: 10.1519/JSC.0b013e3181d82e70.

  • Hung KC, Chung HW, Yu CC, Lai HC, Sun FH. Effects of 8-week core training on core endurance and running economy. PLoS One. 2019 Mar 8;14(3):e0213158. doi: 10.1371/journal.pone.0213158. eCollection 2019.

  • von Garnier K, Koveker K, Rackwitz B, Kober U, Wilke S, Ewert T, Stucki G. Reliability of a test measuring transversus abdominis muscle recruitment with a pressure biofeedback unit. Physiotherapy. 2009 Mar;95(1):8-14. doi: 10.1016/j.physio.2008.10.003. Epub 2009 Jan 22.

  • Dogruoz Karatekin B, Yasin S, Yumusakhuylu Y, Bayram F, Icagasioglu A. Validity of the Korebalance(R) Balance System in Patients with Postmenopausal Osteoporosis. Medeni Med J. 2020;35(2):79-84. doi: 10.5222/MMJ.2020.18828. Epub 2020 Jun 30.

  • Evans K, Refshauge KM, Adams R. Trunk muscle endurance tests: reliability, and gender differences in athletes. J Sci Med Sport. 2007 Dec;10(6):447-55. doi: 10.1016/j.jsams.2006.09.003. Epub 2006 Dec 1.

  • Saglam M, Arikan H, Savci S, Inal-Ince D, Bosnak-Guclu M, Karabulut E, Tokgozoglu L. International physical activity questionnaire: reliability and validity of the Turkish version. Percept Mot Skills. 2010 Aug;111(1):278-84. doi: 10.2466/06.08.PMS.111.4.278-284.

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Ayşe Nur Tunali, Professor

    Medipol University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: I applied exercise intervention for the intervention group. I will not apply any intervention for the control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 24, 2023

First Posted

August 1, 2023

Study Start

April 27, 2023

Primary Completion

November 30, 2023

Study Completion

May 1, 2024

Last Updated

February 28, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations