NCT07482332

Brief Summary

Osteoarthritis (OA) is a non-inflammatory degenerative disease characterized by progressive deterioration of cartilage tissue, synovial membrane, and joint capsule, primarily affecting weight-bearing joints. Individuals with knee osteoarthritis exhibit weakness in the trunk and periarticular muscles. This loss of strength in the trunk and periarticular muscles increases the load on the joint, contributing to the development and progression of the disease. This study aimed to investigate the effects of core stabilization, applied in addition to knee muscle exercise programs, on clinical symptoms and functional capacity in individuals with knee osteoarthritis.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Jan 2026

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

Study Progress64%
Jan 2026Sep 2026

Study Start

First participant enrolled

January 5, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 19, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2026

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

8 months

First QC Date

March 16, 2026

Last Update Submit

March 16, 2026

Conditions

Keywords

Knee osteoarthritisCore stabilization exercisePhysiotherapyFunction

Outcome Measures

Primary Outcomes (3)

  • Sit Ups

    Participants are positioned supine with knees flexed and hands crossed over their shoulders. Their feet are held in place by the researcher, and the individual is asked to perform trunk flexion. The number of repetitions completed within 30 seconds is recorded.

    Baseline-6 weeks follow-up

  • Modified Push-Up

    Participants lie face down on an exercise mat with their knees flexed. They are asked to lift their head, torso, and hips off the ground, placing their hands on the floor and extending their elbows, so that they form a straight line. The number of complete repetitions the participant performs while maintaining this straight line within 30 seconds is recorded.

    Baseline-6 weeks follow-up

  • Core Endurance Tests

    Core endurance is determined by core endurance tests (right and left lateral bridge test, trunk extension test, trunk flexion test), as defined by McGgill, and the prone bridge test.

    Baseline-6 weeks follow-up

Secondary Outcomes (3)

  • 30-Second Sit-Stand Test

    Baseline-6 weeks follow-up

  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Baseline-6 weeks follow-up

  • Single Leg Balance Test

    Baseline-6 weeks follow-up

Study Arms (2)

Experimental Group

EXPERIMENTAL

This group will receive 10 days of conventional physiotherapy (Hot Pack, TENS, Ultrasound) and 6 weeks of routine knee exercises + 6 weeks of core stabilization exercises.

Other: 10 days of conventional physiotherapy (Hot Pack, TENS, Ultrasound) and 6 weeks of routine knee exercisesOther: Six weeks of core stabilization exercises.

Control Group

OTHER

This group will receive 10 days of conventional physiotherapy (Hot Pack, TENS, Ultrasound) and 6 weeks of routine knee exercises.

Other: 10 days of conventional physiotherapy (Hot Pack, TENS, Ultrasound) and 6 weeks of routine knee exercises

Interventions

For 10 days, conventional physical therapy consisting of Hot Pack, TENS, Ultrasound, and routine knee strengthening exercises was applied in the hospital. These knee exercises were continued for four weeks after the hospital treatment period.

Control GroupExperimental Group

For six weeks, Warner et al. A core stabilization exercise protocol, as defined by was provided. This protocol included neutral spine position in hook position, activation of deep abdominal muscles, supine bridge, ipsilateral and contralateral limb movements in hook position, abdominal curl (sit-up), bridge (double and single leg), plank on knees, side plank on knees, clam exercise (without resistance), and modified 100 exercises. The exercises were performed 3 days a week, with 10 repetitions each.

Experimental Group

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Kellgren-Lawrence 2-3 knee osteoarthritis
  • Female patient aged 40-65
  • Volunteer

You may not qualify if:

  • Having received physical therapy within the last month
  • Presence of neurological, cardiac, and respiratory problems
  • Less than 90 degrees of flexion in the knee and hip joints
  • Presence of any pathology in the lower extremity that may affect balance and function
  • History of lower extremity surgery
  • Severe visual, hearing, and speech impairment
  • Illiteracy in Turkish
  • Body mass index of 30 or higher

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sivas Cumhuriyet University

Sivas, 58140, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Transcutaneous Electric Nerve StimulationHigh-Energy Shock Waves

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and AnalgesiaUltrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Selvin Balki

    Cumhuriyet University

    STUDY CHAIR
  • Eda Yıldırım

    Cumhuriyet University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Selvin Balki, Associate Professor, Ph.D.

CONTACT

Eda Yıldırım, PT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Paralel Randomized
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor, Ph.D.

Study Record Dates

First Submitted

March 16, 2026

First Posted

March 19, 2026

Study Start

January 5, 2026

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

September 14, 2026

Last Updated

March 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations