NCT04186143

Brief Summary

Osteoarthritis (OA) is a heterogeneous pathology characterized by focal cartilage degeneration and the formation of new bone around the subchondral bone and joint, which is the disruption of balance between the processes of destruction and repair in subchondral area. Knee OA is a considerable cause of disability and is present in 2-3% of all disability causes. Exercises are more noticeable than other methods because they are an easy method, low cost and long-lasting. To the best of our knowledge, the studies based on this topic are scarce. Therefore, the aim of this study was to compare the effects of open and closed kinetic chain exercises on pain, functional level, quality of life and muscle strength in patients with knee osteoarthritis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable

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

November 20, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2018

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 4, 2019

Completed
Last Updated

June 29, 2020

Status Verified

June 1, 2020

Enrollment Period

7 months

First QC Date

November 30, 2019

Last Update Submit

June 25, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Visual analogue scale (Pain)

    The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain. The 11-point numeric scale ranges from '0' representing no pain to '10' representing pain as bad as you can imagine or worst pain imaginable.

    12 weeks

Secondary Outcomes (5)

  • The WOMAC Index (Functional Level)

    12 weeks

  • Biodex System Pro 4 Isokinetic Strength Dynamometer (Muscle Strength)

    12 weeks

  • Biodex System Pro 4 Isokinetic Strength Dynamometer (Muscle Strength)

    12 weeks

  • Biodex System Pro 4 Isokinetic Strength Dynamometer (Muscle Strength)

    12 weeks

  • 36-Item Short Form Survey (SF-36) (Quality of Life)

    12 weeks

Study Arms (3)

Experimental-Study Group

EXPERIMENTAL

In addition to the conservative treatment of the control group, closed cinetic chain exercises were applied for 12 weeks.

Other: Closed Cinetic Chain Exercises

Active Comparator

ACTIVE COMPARATOR

In addition to the conservative treatment of the control group, opened cinetic chain exercises were applied for 12 weeks.

Other: Open Kinetic Chain Exercises

Control Group

OTHER

Conservative treatment was applied for 12 weeks.

Other: Control Group

Interventions

Sit to stand, mini squat, anterior lunge, step up exercises are performed as Closed Cinetic Chain Exercises.

Experimental-Study Group

Isometric quadriceps, isotonic quadriceps, hip extension and hip adduction exercises are performed as Open Kinetic Chain Exercises.

Active Comparator

Control Group was followed up by conservative treatment and home program for 12 weeks and they were asked to apply the home program three days in a week. Exercise brochure was handed out for home program. Quadriceps strength and harmstring stretch exercises were applied.

Control Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • the presence of knee osteoarthritis Grade 2 and Grade 3 based on Kellgren Lawrence Classification,
  • volunteering to participate in the study.

You may not qualify if:

  • the presence of active synovitis,
  • participation physiotherapy program in the last 6 months,
  • systemic and cardiovascular diseases,
  • neurological and orthopedic problems affecting walking and standing,
  • lower extremity surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Caner KARARTI

Kırşehir, 40100, Turkey (Türkiye)

Location

Related Publications (3)

  • Heywood S, McClelland J, Geigle P, Rahmann A, Villalta E, Mentiplay B, Clark R. Force during functional exercises on land and in water in older adults with and without knee osteoarthritis: Implications for rehabilitation. Knee. 2019 Jan;26(1):61-72. doi: 10.1016/j.knee.2018.11.003. Epub 2019 Jan 2.

  • Olagbegi OM, Adegoke BO, Odole AC. Effectiveness of three modes of kinetic-chain exercises on quadriceps muscle strength and thigh girth among individuals with knee osteoarthritis. Arch Physiother. 2017 Jul 19;7:9. doi: 10.1186/s40945-017-0036-6. eCollection 2017.

  • Resende RA, Kirkwood RN, Deluzio KJ, Morton AM, Fonseca ST. Mild leg length discrepancy affects lower limbs, pelvis and trunk biomechanics of individuals with knee osteoarthritis during gait. Clin Biomech (Bristol). 2016 Oct;38:1-7. doi: 10.1016/j.clinbiomech.2016.08.001. Epub 2016 Aug 3.

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
Single blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 30, 2019

First Posted

December 4, 2019

Study Start

November 20, 2017

Primary Completion

June 20, 2018

Study Completion

July 20, 2018

Last Updated

June 29, 2020

Record last verified: 2020-06

Locations