NCT06034665

Brief Summary

Background: The effect of exercise on knee osteoarthritis (OA) is often evaluated with patient-reported scales. The Minimal Clinically Important Difference (MCID) values of these scales are needed to understand the change in patients after treatment and to manage the treatment. It is also one of the most important data in calculating the MCID sample size. Aim: In the literature, MCID studies for exercise applied to knee OA are limited especially for those who did not undergo surgery. Thus new studies are needed. Method: 100 patients who were diagnosed with knee osteoarthritis will be recruited for the study. Participants will be included in an exercise program tailored to their needs for 15 sessions. WOMAC, OKS, LEFS scales will be used also knee range of motion will be assessed in the baseline, after treatments and in the 4th month follow up.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Feb 2022

Typical duration for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

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

February 1, 2022

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 22, 2023

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2023

Completed
Last Updated

January 9, 2024

Status Verified

January 1, 2024

Enrollment Period

1.3 years

First QC Date

May 22, 2023

Last Update Submit

January 7, 2024

Conditions

Knee Osteoarthritis

Keywords

knee osteoarthritismcidexerciserehabilitation

Outcome Measures

Primary Outcomes (4)

  • WOMAC

    Western Ontario and McMaster Universities Osteoarthritis Index

    Baseline, after 15 session and 4 months follow up

  • KOOS

    Knee Injury and Osteoarthritis Outcome Score

    Baseline, after 15 session and 4 months follow up

  • LEFS

    Lower Extremity Functional Scale

    Baseline, after 15 session and 4 months follow up

  • Knee Range of Motion

    Range of motion assessment with goniometer

    Baseline, after 15 session and 4 months follow up

Secondary Outcomes (1)

  • 30s sit to stand test

    Baseline, after 15 session and 4 months follow up

Study Arms (1)

Exercise

OTHER

All patients will receive an exercise rehabilitation program tailored to their needs.

Other: Exercise

Interventions

ExerciseOTHER

All patients will be included in the exercise program for their symptoms regarding knee osteoarthritis for 15 sessions.

Exercise

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To be diagnosed with knee OA according to the criteria of the American Society of Rheumatology (ACR) (Diagnosis of primary knee OA)
  • Stage 2 or 3 according to Kellgren Lawrence radiological staging criteria
  • Participants with age between 50 and 70 years old
  • Being able to walk without using an assistive device
  • Having a body mass index of less than 30 kg/m²
  • Pain severity is between 3 and 7 according to the Numerical Pain Rating Scale

You may not qualify if:

  • Patients who received physical therapy or intra-articular injections in the last 6 months
  • Receiving an indication for surgery
  • Have severe hearing, vision and speech impairment
  • Having serious systemic and cardiovascular diseases that interfere with exercise
  • Having a lower extremity deformity
  • Patients with acute inflammation of the knee

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istinye University Physiotherapy and Rehabilitation Application and Research Center

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, KneeMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 22, 2023

First Posted

September 13, 2023

Study Start

February 1, 2022

Primary Completion

June 4, 2023

Study Completion

December 5, 2023

Last Updated

January 9, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)