NCT06621784

Brief Summary

Exercise plays a key role in the treatment of knee osteoarthritis, but there is no clear evidence on which type of exercise is most effective. Recent studies highlight the benefits of core stabilization exercises for improving knee stability. This study aims to demonstrate the effects of adding core stabilization exercises to conventional exercise therapy for patients with knee osteoarthritis.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 23, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 1, 2024

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 9, 2024

Completed
Last Updated

October 4, 2024

Status Verified

September 1, 2024

Enrollment Period

1 year

First QC Date

September 26, 2024

Last Update Submit

October 2, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Knee Injury and Osteoarthritis Outcome Score total and subscale scores after a 6-week exercise program

    The Knee Injury and Osteoarthritis Outcome Score is scored on a scale from 0 to 100, where 0 represents extreme knee problems and 100 indicates no knee problems. Higher scores indicate a better outcome, reflecting less pain and better function.

    Baseline and 1 week after the 6-week exercise program

Secondary Outcomes (3)

  • Change in single-leg stance test durations after a 6-week exercise program

    Baseline and 1 week after the 6-week exercise program

  • Change in quadriceps femoris muscle thickness after a 6-week exercise program

    Baseline and 1 week after the 6-week exercise program

  • Change in Visual Analog Scale at rest and during activity after a 6-week exercise program

    Baseline and 1 week after the 6-week exercise program

Study Arms (2)

Traditional exercise (control) group

ACTIVE COMPARATOR

The first group followed a standard home exercise program for three times per week for six weeks

Other: Classical exercise therapy

core exercise group

ACTIVE COMPARATOR

The second group followed a standard home exercise program and core stabilization exercises for three times per week for six weeks

Other: Core stabilization exercisesOther: Classical exercise therapy

Interventions

In most studies, exercises focused on the extremities have been researched. We believe that the positive effects of the core region on walking and postural stability will play a significant role in the treatment of knee osteoarthritis.

core exercise group

In the first group of our study, we prescribed exercises that have been proven effective in many studies, are frequently prescribed, and focus on joint range of motion and quadriceps strengthening

Traditional exercise (control) groupcore exercise group

Eligibility Criteria

Age50 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of bilateral stage II or III knee osteoarthritis according to the Kellgren and Lawrence grading system
  • Aged between 50 and 65 years
  • Having a complaint of knee pain for at least 6 months
  • No systemic diseases that may hinder exercise (such as uncontrolled hypertension, cardiac arrhythmia, heart failure, neurological sequelae, joint deformities, malignancy, etc.)

You may not qualify if:

  • Having received physical therapy in the last 6 months
  • Having undergone knee injection in the last 6 months
  • Having had knee surgery
  • Morbid obesity
  • Presence or history of malignancy
  • Individuals with severe visual impairment
  • Individuals with a history of neurological or vestibular diseases that could cause balance problems, or patients using medications that may affect balance
  • Individuals with serious cardiac, respiratory, or uncontrolled metabolic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Istanbul, Bahçelievler, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • İrem Setenay ÖZKAN

    Istanbul Physical Medicine Rehabilitation Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

September 26, 2024

First Posted

October 1, 2024

Study Start

June 23, 2023

Primary Completion

June 23, 2024

Study Completion

October 9, 2024

Last Updated

October 4, 2024

Record last verified: 2024-09

Locations