NCT03920020

Brief Summary

This study aims to compare the effects of concentric and eccentric isokinetic exercises on proprioception and muscle architecture in 42 patients with knee osteoarthritis enrolled the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Jan 2019

Longer than P75 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

January 28, 2019

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 18, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

April 28, 2023

Status Verified

April 1, 2023

Enrollment Period

2.9 years

First QC Date

February 20, 2019

Last Update Submit

April 27, 2023

Conditions

Knee Osteoarthritis

Keywords

ConcentricEccentricMuscle ArchitectureProprioception

Outcome Measures

Primary Outcomes (2)

  • Joint position sense

    Joint position sense will be evaluated with isokinetic dynamometer at predetermined angles.

    6 weeks

  • Ultrasonographic assessment of quadriceps and hamstring muscles

    Ultrasonographic evaluation is an outcome measure to evaluate muscle structure. In our study ultrasonographic evaluation will be performed to determine the muscle structure (muscle thickness(mm), fascicle length(mm), pennation angle(degree)) of quadriceps and hamstring muscles. Muscle thickness will be defined as the distance between the deeper and upper aponeurosis. The pennation angle will be calculated as the angle of insertion of muscle fascicles into the deep aponeurosis. Fascicle length will be defined as the length of the fascicular path between the superficial and deep aponeurosis.

    6 weeks

Secondary Outcomes (10)

  • WOMAC (Western Ontario & McMaster Universities Osteoarthritis Index)

    6 weeks

  • Range of motion

    6 weeks

  • Muscle strength assessment

    6 weeks

  • Shortness of muscles assessment

    6 weeks

  • Pain assessment: VAS (Visual analog scale)

    6 weeks

  • +5 more secondary outcomes

Study Arms (3)

the concentric isokinetic exercise group

OTHER

the concentric isokinetic exercise group will perform quadriceps and hamstring concentric isokinetic exercises in addition to the conventional physiotherapy and exercise program 3 times a week during 6 weeks.

Other: the concentric isokinetic exercise groupOther: the control group

the eccentric isokinetic exercise group

OTHER

the eccentric isokinetic exercise group will perform quadriceps and hamstring eccentric isokinetic exercises in addition to the conventional physiotherapy and exercise program 3 times a week during 6 weeks.

Other: the eccentric isokinetic exercise groupOther: the control group

the control group

OTHER

the control group will perform the standard exercise program predetermined by us consisting of stretching exercises and isometric strengthening (these exercises will be done at home, too) and the conventional physiotherapy program will be applied 3 times a week during 6 weeks.

Other: the control group

Interventions

the concentric isokinetic exercise groupOTHER

concentric isokinetic exercises

the concentric isokinetic exercise group
the eccentric isokinetic exercise groupOTHER

eccentric isokinetic exercises

the eccentric isokinetic exercise group
the control groupOTHER

conventional physiotherapy and standard therapeutic exercises predetermined by us

the concentric isokinetic exercise groupthe control groupthe eccentric isokinetic exercise group

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of primary knee osteoarthritis according to American College of Radiology
  • Being radiographically K-L grade 2-3
  • Presence of symptoms for at least 3 months
  • Patients who have been planned a conventional physiotherapy programme because of knee osteoarthritis
  • Presence of functional capacity for outpatient physical therapy

You may not qualify if:

  • Patients with seconder knee osteoarthritis
  • History of lower extremity or spine surgery
  • History of intraarticular injection in last 1 month
  • Patients with neurological disease that will affect muscle strength, balance and coordination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Health Sciences

Ankara, Altındağ, 06030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Aysun Baki, phd student

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

February 20, 2019

First Posted

April 18, 2019

Study Start

January 28, 2019

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

April 28, 2023

Record last verified: 2023-04

Locations

TU(1)