NCT02753634

Brief Summary

Osteoarthritis (OA) is a growing burden in an aging society. There are few proven treatments and hence disability contributes to poor quality of life and direct/indirect costs to society. OA symptoms include both increased pain and reduced mobility. Strength training and aerobic exercise has been shown to improve symptoms in OA; however, the impact of targeted mobility and balance training in patients with osteoarthritis is unclear. The investigators propose a novel, low-impact exercise modality that improves balance and gait. The results of this research project should improve patient options and improve knowledge in OA management.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Apr 2015

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

April 1, 2015

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 28, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

November 29, 2016

Status Verified

March 1, 2016

Enrollment Period

1.2 years

First QC Date

March 22, 2016

Last Update Submit

November 25, 2016

Conditions

Outcome Measures

Primary Outcomes (2)

  • WOMAC Index

    self-report of knee pain for osteoarthritis

    Change from baseline to 24-weeks

  • WOMAC Index

    self-report of knee pain for osteoarthritis

    Change from baseline to 12-weeks

Secondary Outcomes (8)

  • 30 second Chair stand

    change from baseline to 24-weeks

  • 30 second Chair stand

    change from baseline to 12-weeks

  • Timed up and Go test

    change from baseline to 24-weeks

  • Timed up and Go test

    change from baseline to 12-weeks

  • Fullerton Advanced Balance Scale

    change from baseline to 24-weeks

  • +3 more secondary outcomes

Study Arms (2)

Square-stepping exercise Intervention

EXPERIMENTAL

Participant attend sessions 2 times per week for 24-weeks at a community location. An instructor demonstrated increasingly difficulty walking or stepping patterns across a gridded mat and participants are asked to try and remember and repeat the patterns. Social engagement is encouraged.

Behavioral: Square-stepping exercise

Usual care wait-list control group

NO INTERVENTION

This group will be invited to participate in square-stepping exercise after final assessments are completed.

Interventions

Participants are asked to remember and repeat stepping patterns across a gridded mat as shown to them by an instructor.

Also known as: Mind-motor exercise
Square-stepping exercise Intervention

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Knee osteoarthritis

You may not qualify if:

  • WOMAC less than 4
  • Use of braces
  • Uncontrolled hypertension
  • Significant psychiatric or psychotic disorder
  • Not able to attend 75% of sessions
  • Any other reason that would prevent participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Robert Petrella, MD, PhD

    Western University, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2016

First Posted

April 28, 2016

Study Start

April 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

November 29, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share