NCT05054686

Brief Summary

This study will include 3 different groups of intervention. First group of knee osteoarthritis patients will be applied both strengthening and 30 minutes bicycle exercises in the same session, 2 days strecthing exercises and 30 minutes walking will be given in seperate days as home program, Second group of knee osteoarthritis patients will be applied both stretching and 30 minutes bicycle exercises in the same session, strengthening exercises and 30 minutes walking will be given in seperate days as home program.Third group of knee osteoarthritis patients will be applied all stretching, strengthening and 30 minutes bicycle exercises in the same session, only 30 minutes walking will be given as home program. The primary outcome measures include the pain, function and the secondary outcome measures include the joint proprioception. The aim of this study is to investigate the effects on outcome measures increasing number of exercises in one session and to determine which exercise types are more suitable to prescribe as a home program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Jul 2019

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

July 1, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 23, 2021

Completed
Last Updated

February 4, 2026

Status Verified

February 1, 2026

Enrollment Period

1.8 years

First QC Date

September 12, 2021

Last Update Submit

February 2, 2026

Conditions

Keywords

ostearthritispainproprioceptionresistance trainingexercise

Outcome Measures

Primary Outcomes (3)

  • The Western Ontario and McMaster Universities Arthritis Index

    The Western Ontario and McMaster Universities Arthritis Index is a questionnaire consisting of 24 items divided into 3 subscales: Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items): after first waking and later in the day Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties. The increasing scores reflect improvement of the function.

    Change of The Western Ontario and McMaster Universities Arthritis Index scores from the beginning to the end of study (8 weeks)

  • Numeric Pain Rating Scale

    The Numeric Pain Rating Scale is a segmented numeric version of the visual analog scale in which a respondent selects a whole number (0-10 likert type integers) that best reflects the intensity of his/her pain.The levels of pain felt at rest / activity / night will be evaluated. The increase in pain scores demonstrate that the health status get worse.

    Change of Numeric Pain Rating Scale scores from the beginning to the end of study (8 weeks)

  • Pain Pressure Treshold (PPT)

    Pain Pressure Treshold is evaluated via algometric measurement that were taken from 4 point including the mid portion of patella, 3 cm medial to patellar midline, 3 cm lateral to patellar midline, 2 cm above to patellar upper boundary.The increase in algometric measurement demonstrate the development in the pain sensitivity.

    Change of Pain Pressure Treshold measurements from the beginning to the end of study (8 weeks)

Secondary Outcomes (2)

  • Proprioception

    Change of Inclinometric measurements from the beginning to the end of study (8 weeks).

  • Knee Muscle Strength

    Change of muscle strength measurements from the beginning to the end of study (8 weeks)

Study Arms (3)

Combination of Stretching and Aerobic Exercises at Clinic

EXPERIMENTAL

Combination of Stretching and Aerobic Exercises at Clinic and Strengthening and Aerobic Exercises at Home

Other: Stretching and Aerobic Exercise at Clinic

Combination of Strengthening and Aerobic Exercises at Clinic

ACTIVE COMPARATOR

Combination of Strengthening and Aerobic Exercises at Clinic and Stretching and Aerobic Exercises at Home

Other: Strenghthening and Aerobic Exercise

Combination of Strengthening, Stretching and Aerobic Exercises at Clinic

ACTIVE COMPARATOR

Combination of Strengthening, Stretching and Aerobic Exercises at Clinic and Aerobic Exercises at Home

Other: Strengthening, Stretching and Aerobic Exercises at clinic

Interventions

In this group of knee osteoarthritis patients will be applied both stretching and 30 minutes bicycle exercises in the same session, strengthening exercises and 30 minutes walking will be given in seperate days as home program.

Combination of Stretching and Aerobic Exercises at Clinic

In this group of knee osteoarthritis patients will be applied both strengthening and 30 minutes bicycle exercises in the same session, 2 days strecthing exercises and 30 minutes walking will be given in seperate days as home program.

Combination of Strengthening and Aerobic Exercises at Clinic

In this group of knee osteoarthritis patients will be applied all stretching, strengthening and 30 minutes bicycle exercises in the same session, only 30 minutes walking will be given as home program.

Combination of Strengthening, Stretching and Aerobic Exercises at Clinic

Eligibility Criteria

Age45 Years - 73 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being diagnosed as knee osteoarthritis
  • Being between the ages 45-74
  • Being at stage 2-3 according to Kellegren Lawrence Classification
  • Having body mass index lower than 30
  • Being volunteer for participation to this study

You may not qualify if:

  • Refusing to participation to study
  • Having another orthopeadic problem ralated to lower extremity
  • Having uncontrollable hypertension
  • Having arterial and venous disease
  • Having neurological disease
  • Having perceptual problem
  • Having cardiac pacemaker
  • Participation to physiotherapy program in the last 6 months for the same extremity
  • Taking injection from the same extremity in the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seda Baktır

Küçükçekmece, Alkent 2000, Büyükçekmece/İstanbul, 34307, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, KneePainMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Seda BAKTIR, MSc.PT.

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Double Blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective Randomized Controlled Parallel Group Study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 12, 2021

First Posted

September 23, 2021

Study Start

July 1, 2019

Primary Completion

April 30, 2021

Study Completion

May 30, 2021

Last Updated

February 4, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

We planned not to make group' data available to other researchers.

Locations