NCT04227860

Brief Summary

The aim of this study is to assess the effect of balance exercise on dynamic balance and physical function in 80 patients with different grades of primary knee osteoarthritis (KOA).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Jan 2020

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 14, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

January 20, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

May 26, 2022

Status Verified

May 1, 2022

Enrollment Period

1.4 years

First QC Date

January 9, 2020

Last Update Submit

May 25, 2022

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (3)

  • Assessment of pain

    Using the Western Ontario and McMaster University Osteoarthritis Index (WOMAC), which contains pain sub-score and a overall total score. The higher the score the worst the pain.

    2-6 weeks

  • Assessment of stiffness

    Using the Western Ontario and McMaster University Osteoarthritis Index (WOMAC), which contains stiffness sub-score and a overall total score. The higher the score the worst the stiffness.

    2-6 weeks

  • Assessment of physical function

    Using the time up and go test, where the patient is seated and asked to get up walk a distance turn around and return to chair and sit again. It is measured using a timer, the longer the patient takes the worst the physical function of the patient.

    2-6 weeks

Secondary Outcomes (1)

  • Dynamic Balance

    2-6 weeks

Study Arms (4)

Group 1: G I primary KOA

ACTIVE COMPARATOR

Exercise and balance training

Other: Balance exercise programOther: Strengthening exercise program

Group 2: G II primary KOA

ACTIVE COMPARATOR

Exercise and balance training

Other: Balance exercise programOther: Strengthening exercise program

Group 3: G III primary KOA

ACTIVE COMPARATOR

Exercise and balance training

Other: Balance exercise programOther: Strengthening exercise program

Group 4: G IV primary KOA

ACTIVE COMPARATOR

Exercise and balance training

Other: Balance exercise programOther: Strengthening exercise program

Interventions

Balance exercise programOTHER

Patients will be engaged in lower extremity kinesthesia and balance exercise program 3 time per week for 6 weeks. Divided into 2 stages, stage 1 and 2, each stage 3 weeks. Patients who fulfill at least stage 1 of the program will be included in the study.

Group 1: G I primary KOAGroup 2: G II primary KOAGroup 3: G III primary KOAGroup 4: G IV primary KOA
Strengthening exercise programOTHER

Patients will be engaged in strengthening exercise program 3 time per week for 6 weeks. Divided into 3 stages, stage 1, 2 and 3, each stage 2 weeks. Patients who fulfill at least stage 1 of the program will be included in the study.

Group 1: G I primary KOAGroup 2: G II primary KOAGroup 3: G III primary KOAGroup 4: G IV primary KOA

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with primary knee osteoarthritis according to the EULAR recommendations 2010.
  • Patients can complete at least stage 1 of balance and exercise program (minimum of 2 weeks)

You may not qualify if:

  • Patients that cannot complete at least stage 1 of balance and exercise program
  • Patients with medical conditions affecting postural balance including visual, inner ear and neurological problems.
  • Patients with lower limb joint or bony problems other than primary knee osteoarthritis .
  • Patients with secondary KOA.
  • Patients who received intra- articular joint injection in 1 or both knees in the past 90 days.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria University, Faculty of Medicine

Alexandria, 00123, Egypt

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Yousra H Abdel Fattah

    Alexandria University Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Post-exercise training assessment will be done by an investigator not involved in the study and unaware of the grading of KOA or of the pre-exercise assessment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Physical Medicine, Rheumatology and Rehabilitation

Study Record Dates

First Submitted

January 9, 2020

First Posted

January 14, 2020

Study Start

January 20, 2020

Primary Completion

June 1, 2021

Study Completion

December 31, 2021

Last Updated

May 26, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)