Exercise on Knee OA With the Star Excursion Balance Test

May 1, 2018 updated by: Western University, Canada

Effects of Exercise on Joint Stiffness and Dynamic Balance in Individuals With Knee Osteoarthritis Evaluated Through Star Excursion Balance Test

Osteoarthritis is a prevalent and disabling condition. Exercise is recommended to maintain strength and mobility, and to decrease pain. However, acute bouts of exercise have conflicting outcomes: they are fatiguing and they also can increase coordination and balance. The purpose of this study is to assess the effects of a single bout of exercise (30 minutes) on balance performance of individuals with self-identified unilateral knee osteoarthritis. Balance will be assessed using the star excursion balance test before and after the exercise session. Differences in performance between the two star excursion balance tests will reflect the changes due to exercise. The changes between their balance performance on each limb will reflect the changes due to osteoarthritis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Knee OA affects over 241 million people worldwide, and poses a significant burden to the healthcare system (Cross et al., 2014). Knee OA leads to decreased quadriceps muscle strength, and impaired postural control and joint proprioception (Hurley et al., 1997). These factors lead to balance impairments in individuals with osteoarthritis compared to controls (Wegener et al., 1997). It has been reported that the completion of a warm-up program improves the dynamic and static balance of healthy individuals (Daneshjoo et al., 2012). Therefore, exercise may acutely facilitate neuromuscular control, reduce stiffness and significantly improve dynamic balance in individuals with knee OA. Alternatively, muscular fatigue that may negate these benefits (Nardone et al., 1997). Given that falls are a devastating injury in the elderly (Sri-On et al, 2017), and that exercise programs improve balance (Carter et al, 2001; Tse et al, 2015) it is important to evaluate the acute effects of a single bout of exercise on balance performance in individuals with osteoarthritis. The Star Excursion Balance Test (SEBT) has been validated for quantifying dynamic balance in healthy individuals (Kinzey & Armstrong, 1998) and individuals with knee OA (Kanko, 2017). It is important to evaluate the effects of exercise on balance in individuals with OA as changes in balance following exercise may lead to either impairments or improvements, and have direct implications for the safety of exercise as a recommended approach in OA.

This study will recruit 35 individuals with self-identified unilateral knee osteoarthritis, according to clinical criteria for classification of idiopathic knee OA (Altman et al., 1986). They will complete a Physical Activity Readiness Questionnaire for Everyone (PAR-Q+) to clear them for participation in physical activity (Warburton et al, 2011). They will complete a standard questionnaire assessing knee function: the Knee injury and Osteoarthritis Outcome Score (KOOS) (Roos et al, 2003). They will complete the star excursion balance test, on each of their affected and unaffected limbs, before and after completing a 30 minute bout of exercise. This exercise session will be supervised, and emphasizes optimal alignment of the trunk and lower limb joints relative to one another, as well as quality of movement performance, while dynamically and functionally strengthening the lower limb muscles (Bennell et al, 2011). The research participants will dictate the intensity and duration of the program.

Differences in performance between the two star excursion balance tests will reflect the changes due to exercise. The changes between their balance performance on each limb will reflect the changes due to osteoarthritis.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A3K7
        • University of Western Ontario

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • unilateral knee osteoarthritis according to clinical criteria for classification of idiopathic osteoarthritis (OA) of the knee (Altman et al., 1986)
  • routinely engaging in mild exercise, such as walking or gardening.
  • a completed PAR-Q+ indicating no contraindications

Exclusion Criteria:

  • lower extremity joint replacement
  • Inflammatory or Infectious Arthritis
  • Major neurological disorder (ex. Parkinson's disease, Huntington's disease, Multiple Sclerosis, peripheral neuropathy)
  • Major medical illness that would interfere with participating in a 30 minute bout of exercise
  • Inability to engage in moderate physical activity for 30-40 minutes
  • Inability to read English
  • Psychiatric illness that limits informed consent
  • Inability to stand on limb for more than 5 seconds

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: affected limb
measurements of balance from the affected side of individuals with unilateral knee osteoarthritis following an exercise session
Other: exercise
one 30 minute bout of mild exercise
ACTIVE_COMPARATOR: unaffected limb
measurements of balance from the unaffected side of individuals with unilateral knee osteoarthritis following an exercise session
Other: exercise
one 30 minute bout of mild exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
star excursion balance test
Time Frame: change in star excursion balance test after the 30 minute bout of exercise
standard test for assessing dynamic balance. Individuals stand on one limb and reach their other limb in each of eight directions (eg anterior, lateral, antero-lateral, etc) and the length of the reach is measured. The reach measurements are normalized by dividing by leg length.
change in star excursion balance test after the 30 minute bout of exercise

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Western University, Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 2, 2018

Primary Completion (ACTUAL)

April 30, 2018

Study Completion (ACTUAL)

April 30, 2018

Study Registration Dates

First Submitted

February 20, 2018

First Submitted That Met QC Criteria

February 27, 2018

First Posted (ACTUAL)

March 1, 2018

Study Record Updates

Last Update Posted (ACTUAL)

May 7, 2018

Last Update Submitted That Met QC Criteria

May 1, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 110819

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Each participant will be identified with a code (eg. STAR001) that correlates to his or her addition to the study. The master sheet will be the only document that contains the decoding system, and will be stored in a locked filing cabinet. All other data will be labeled using the participant's identification code.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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